Transplants clinical trials at UCSF
50 in progress, 23 open to eligible people
10°C Vs 4°C Lung Preservation RCT
open to eligible people ages 18-80
Despite lung transplantation (LTx) being the most effective treatment for end-stage lung disease, its success rate is lower than that of other solid organ transplantations. Primary graft dysfunction (PGD) is the most common post-operative complication and a major factor in early mortality and morbidity, affecting ~25% of lung transplant patients. Induced by ischemia reperfusion, PGD represents a severe and acute lung injury that occurs within the first 72 hours after transplantation, and has a significant impact on short- and long-term outcomes, and a significant increase in treatment costs. Any intervention that reduces the risk of PGD will lead to major improvements in short- and long-term transplant outcomes and health care systems. One of the main strategies to reduce the risk and severity of post-transplant PGD is to improve pre-transplant donor lung preservation methods. In current practice, lung preservation is typically performed by cold flushing the organ with a specialized preservation solution, followed by subsequent hypothermic storage on ice (~4°C). This method continues to be used and applied across different organ systems due to its simplicity and low cost. Using this method for the preservation of donor lungs, the current maximum accepted preservation times have been limited to approximately 6-8h. While the goal of hypothermic storage is to sustain cellular viability during ischemic time through reduced cellular metabolism, lower organ temperature has also been shown to progressively favor mitochondrial dysfunction. Therefore, the ideal temperature for donor organ preservation remains to be defined and should maintain a balance between avoidance of mitochondrial dysfunction and prevention of cellular exhaustion. In addition to that, safe and longer preservation times can lead to multiple advantages such as moving overnight transplants to daytime, more flexibility to transplant logistics, more time for proper donor to recipient matching etc. Building on pre-clinical research suggesting that 10°C may be the optimal lung storage temperature, a prospective, multi-center, non-randomized clinical trial was conducted at University Health Network, Medical University of Vienna and Puerta de Hierro Majadahonda University Hospital. Donor lungs meeting criteria for direct transplantation and with cross clamp times between 6:00pm - 4:00am were intentionally delayed to an earliest allowed start time of 6:00am and a maximum preservation time from donor cold flush to recipient anesthesia start time of 12 hours. Lungs were retrieved and transported in the usual fashion using a cooler with ice and transferred to a 10°C temperature-controlled cooler upon arrival to transplant hospital until implantation. The primary outcome of this study was incidence of Primary Graft Dysfunction (PGD) Grade 3 at 72h, with secondary endpoints including: recipient time on the ventilator, ICU Length of Stay (LOS), hospital LOS, 30-day survival and lung function at 1-year. Outcomes were compared to a contemporaneous conventionally transplanted recipient cohort using propensity score matching at a 1:2 ratio. 70 patients were included in the study arm. Post-transplant outcomes were comparable between the two groups for up to 1 year. Thus, intentional prolongation of donor lung preservation at 10°C was shown to be clinically safe and feasible. In the current study design, the investigators will conduct a multi-centre, non-inferiority, randomized, controlled trial of 300 participants to compare donor lung preservation from the time of explant to implant at ~10°C in X°Port Lung Transport Device (Traferox Technologies Inc.) vs a standard ice cooler. When eligible donor lungs become available for a consented recipient, the lungs will be randomized to undergo a preservation protocol using either 10°C (X°Port Lung Transport Device, Traferox Technologies Inc.) or standard of care. The primary outcome of the study is incidence of ISHLT Primary Graft Dysfunction Grade 3 at 72 hours. Post-transplant outcomes will be followed for one year.
San Francisco, California and other locations
Feasibility Study Using CLINIMACS® for Alpha/Beta T-Cell Depletion in Stem Cell Transplant
open to eligible people ages up to 30 years
Patients in need of an allogeneic hematopoietic cell transplant (HCT) are at risk of developing graft-versus-host-disease (GVHD). In certain clinical situations, the optimal approach to minimize the risk of GVHD is to perform ex vivo alpha-beta T-cell depletion of the donor cells. However, the CliniMACS® Device is FDA-approved only for a narrow indication. All other uses of ex vivo processed cells must be done under a feasibility study protocol.
San Francisco, California
Drug Letermovir as Prevention of Cytomegalovirus Infection After Stem Cell Transplant in Pediatric Patients
open to eligible people ages 2-18
This phase III trial determines whether taking prophylactic letermovir will reduce the likelihood of infection with cytomegalovirus (CMV) in children and adolescents after stem cell transplant. The treatments used to prepare for HCT reduce the body's natural infection-fighting ability and increase the likelihood of an infection with a virus called cytomegalovirus. "Prophylaxis" means to take a drug to prevent a disease or side effect. Letermovir is an antiviral drug that stops cytomegalovirus from multiplying and may prevent cytomegalovirus infection and make the disease less severe.
Oakland, California and other locations
BIVV020 (SAR445088) n Prevention and Treatment of Antibody-mediated Rejection (AMR)
open to eligible people ages 18 years and up
Primary Objectives: - Cohort A: To evaluate the efficacy of BIVV020 in prevention of AMR - Cohort B: To evaluate the efficacy of BIVV020 in treatment of active AMR Secondary Objectives: - To assess the overall efficacy of BIVV020 in prevention or treatment of AMR - To characterize the safety and tolerability of BIVV020 in kidney transplant participants - To characterize the pharmacokinetic (PK) profile of BIVV020 in kidney transplant participants - To evaluate the immunogenicity of BIVV020
San Francisco, California and other locations
Chemoimmunotherapy and Allogeneic Stem Cell Transplant for NK T-cell Leukemia/Lymphoma
open to eligible people ages 1-31
Patients are in 2 cohorts: Cohort 1: dexamethasone, methotrexate, ifosfamide, pegaspargase, and etoposide (modified SMILE) chemotherapy regimen alone and pembrolizumab in children, adolescents, and young adults with advanced stage NK lymphoma and leukemia Cohort 2: combining pralatrexate (PRX) (Cycles 1, 2, 4, 6) and brentuximab vedotin (BV) (Cycles 3, 5) to cyclophosphamide, doxorubicin, and prednisone in children, adolescent, and young adults with advanced peripheral T-cell lymphoma (non-anaplastic large cell lymphoma or non-NK lymphoma/leukemia) . Both groups proceed to allogeneic stem cell transplant with disease response.
San Francisco, California and other locations
Daratumumab and Belatacept for Desensitization
open to eligible people ages 18-65
Some kidney transplant candidates have a very low chance of getting a kidney transplant because their immune systems are "highly sensitized" to most kidney donors. Being "highly sensitized" means that they will likely have to wait a long time (more than 5 years) before an acceptable donor is found for them or, they never receive a compatible donor, and die on waitlist. The purpose of this study is to find out whether two drugs, daratumumab (Darzalex®), and belatacept (Nulojix®), can make these kidney transplant candidates less sensitized, and make it easier and quicker to find a kidney donor for them.
San Francisco, California
EDIT-301 for Autologous Hematopoietic Stem Cell Transplant (HSCT) in Participants With Transfusion-Dependent Beta Thalassemia (TDT)
open to eligible people ages 18-35
The purpose of this study is to evaluate the safety, tolerability, and efficacy of treatment with EDIT-301 in adult participants with Transfusion Dependent beta Thalassemia
Oakland, California and other locations
Identifying Best Approach in Improving Quality of Life and Survival After a Donor Stem Cell Transplant in Older, Medically Infirm, or Frail Patients With Blood Diseases
open to eligible people ages 20 years and up
This phase II/III trial studies the best approach in improving quality of life and survival after a donor stem cell transplant in older, weak, or frail patients with blood diseases. Patients who have undergone a transplant often experience increases in disease and death. One approach, supportive and palliative care (SPC), focuses on relieving symptoms of stress from serious illness and care through physical, cultural, psychological, social, spiritual, and ethical aspects. While a second approach, clinical management of comorbidities (CMC) focuses on managing multiple diseases, other than cancer, such as heart or lung diseases through physical exercise, strength training, stress reduction, medication management, dietary recommendations, and education. Giving SPC, CMC, or a combination of both may work better in improving quality of life and survival after a donor stem cell transplant compared to standard of care in patients with blood diseases.
San Francisco, California and other locations
LAM-001 in Lung Transplant Recipients With Bronchiolitis Obliterans Syndrome.
open to eligible people ages 18 years and up
The goal of this clinical trial is to learn about the safety and effectiveness of LAM-001 in patients who have developed bronchiolitis obliterans syndrome (BOS), a form of chronic rejection, after lung transplantation. The main questions it aims to answer are: - Is LAM-001 safe in these patients? - Is LAM-001 effective in slowing BOS progression? Participants will: - Be randomly assigned to inhale either LAM-001 or placebo (a look-alike substance that contains no active drug) daily for 48 weeks - Attend 10 study visits (mixture of in-person and telehealth) over the 48 week period - Undergo pulmonary function testing, bronchoscopy, lab testing, and physical examination - Submit weekly home spirometry monitoring Researchers will compare participants assigned to LAM-001 versus placebo to see if LAM-001 is safely tolerated and to assess the effectiveness of LAM-001 on slowing BOS progression.
San Francisco, California
Levothyroxine Supplementation for Heart Transplant Recipients
open to eligible people ages 18 years and up
This will be a prospective, randomized study performed at a single tertiary referral academic medical center (University of California San Francisco, CA), evaluating the survival benefits of levothyroxine compared with no levothyroxine for patients who have undergone heart transplant. It will be double-blinded and placebo-control; participants will be randomized to receive levothyroxine or receive no levothyroxine.
San Francisco, California
MCNAIR Study: coMparative effeCtiveness of iN-person and teleheAlth cardIac Rehabilitation
open to eligible people ages 18 years and up
Cardiac rehabilitation is a medically recommended program for patients with certain heart conditions. It includes exercise training, health education, and counseling. Unfortunately, many patients do not participate in cardiac rehabilitation. Some find it challenging to attend the in-person sessions. This study aims to compare two methods of delivering cardiac rehabilitation: in-person and through telehealth. The investigators want to know if the effects of these two programs are alike and if certain individuals benefit more from one program over the other.
San Francisco, California and other locations
Tegoprubart in Patients Undergoing Kidney Transplantation
open to eligible people ages 18-100
This study will evaluate the safety and efficacy of AT-1501 compared with tacrolimus in patients undergoing kidney transplantation.
San Francisco, California and other locations
Structured Program of Exercise for Recipients of Kidney Transplantation
open to eligible people ages 50 years and up
Older patients with end- stage kidney disease (ESKD) are at very high risk for functional impairment. Kidney transplantation (KT) has the potential to ameliorate the detrimental effects of ESKD on physical activity and functional status. However, KT alone may not meet the full extent of this potential, particularly for older or more impaired adults. In fact, activity declines immediately post-KT and fails to return to expected levels even 5 years post-KT. Older patients waitlisted for KT (most of whom are on dialysis) are therefore reliant on their pre-KT levels of exercise, which are also predictive of post-KT mortality. "Prehabilitation" has been used in other surgical populations to minimize functional loss, and a structured exercise program may be beneficial in the pre- KT setting. However, few waitlisted patients are able to participate in typical exercise interventions due to barriers such as severe fatigue. Older patients have additional barriers such as further mobility impairment and requiring substantial caregiver support. Therefore for older living donor kidney transplant candidates, it is necessary to address issues such as specifics of coaching, timing, and importantly, incorporate caregiver participation. The overall objective of this proposal is to adapt a previously developed 8- week, home- based, structured exercise program among older (≥50 years) dialysis patients awaiting living donor KT, with a focus on caregiver involvement. The investigators will trial the exercise program as compared to usual care. The investigators will then pilot the refined intervention in a total of 72 patient-caregiver dyads, 48 of whom will undergo the proposed intervention (24 with caregiver participation, 24 without). The primary outcomes for the pilot will be change in physical performance and activity from baseline to after the intervention, along with measurements of exploratory quality of life outcomes. In addition, the investigators will measure these same outcomes at 3- months post KT to evaluate for a durable effect of the intervention. An additional post-transplantation outcome of interest will be number of days hospitalized within 3 months of transplantation.
San Francisco, California
Desensitization of Chronic Kidney Disease in Adult Patients in Need of a Kidney Transplant Who Are Highly Sensitized to Human Leukocyte Antigen
open to eligible people ages 18-70
The primary objective of the study is to assess the safety and tolerability of REGN5459 (Part A) or REGN5458 (Part B) as monotherapy in patients with chronic kidney disease (CKD) who need kidney transplantation and are highly sensitized to human leukocyte antigen (HLA). The secondary objectives of the study are to determine/assess the following for REGN5459 (Part A) or REGN5458 (Part B): - Dose regimen(s) that result in a clinically meaningful reduction of anti-HLA alloantibody levels - Effect on calculated panel-reactive antibody (cPRA) levels - Time to maximal and clinically meaningful reduction in anti-HLA alloantibody levels - Duration of the effect of study drug on the reduction of anti-HLA alloantibodies - Effect on circulating immunoglobulin (Ig) classes (isotypes) - Pharmacokinetics (PK) properties - Immunogenicity
San Francisco, California and other locations
Treosulfan-Based Conditioning Regimen Before a Blood or Bone Marrow Transplant for the Treatment of Bone Marrow Failure Diseases (BMT CTN 1904)
open to eligible people ages 1-49
This phase II trial tests whether treosulfan, fludarabine, and rabbit antithymocyte globulin (rATG) work when given before a blood or bone marrow transplant (conditioning regimen) to cause fewer complications for patients with bone marrow failure diseases. Chemotherapy drugs, such as treosulfan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Fludarabine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. rATG is used to decrease the body's immune response and may improve bone marrow function and increase blood cell counts. Adding treosulfan to a conditioning regimen with fludarabine and rATG may result in patients having less severe complications after a blood or bone marrow transplant.
San Francisco, California and other locations
Ultrasound Elastography to Predict Development of Hepatic Sinusoidal Obstruction Syndrome
open to eligible people ages 1 month to 99 years
To perform an receiver operating characteristic (ROC) analysis, define a threshold and quantify the sensitivity and specificity of US SWE for risk stratification of patients into three categories as defined by the European Bone Marrow Transplant (EBMT) adult and pediatric criteria: no sinusoidal obstruction syndrome (SOS), mild to moderate SOS, and severe to very severe SOS. Secondarily, the investigators would also like to quantify the temporal relationship between US SWE changes and SOS diagnosis according to various clinical criteria (Modified Seattle, Baltimore, EBMT consortium).
San Francisco, California and other locations
AlloSure Lung Assessment and Metagenomics Outcomes Study
open to eligible people ages 18 years and up
ALAMO is a prospective, multi-center, perspective, registry of patients receiving LungCare™ (AlloSure®-Lung, AlloMap Lung, and HistoMap) for surveillance post-transplant. This study aims to evaluate the diagnostic performance characteristics of AlloSure Lung (dd-cfDNA) to detect a spectrum of rejection (ACR, AMR) and allograft infection (Bacterial, Viral, Fungal, Mycobacterial, Parasitic).
San Francisco, California and other locations
Observational Extension Study for Adult Patients Treated in Study R5459-RT-1944 Who Receive A Kidney Transplant
open to eligible people ages 18-70
The primary objective of the study is to assess adverse events (AEs) and serious adverse events (SAEs) in kidney transplant recipients previously treated with REGN5459 or REGN5458 in the R5459-RT-1944 study. The secondary objectives of the study are to evaluate each of the following in kidney transplant recipients previously treated with REGN5459 or REGN5458: - Rates and classification of antibody-mediated and T-cell-mediated kidney allograft rejection - Graft survival - Allograft function - Delayed allograft function - Anti-human leukocyte antigen (HLA) alloantibody levels and calculated panel-reactive antibody (cPRA) - Emergence of de novo donor-specific antibodies - Circulating immunoglobulin (Ig) classes (isotypes) - Pharmacokinetics (PK) of REGN5459 or REGN5458
San Francisco, California and other locations
Collecting Blood and Tissue Sample Donations for Research for HIV/AIDS-Related Cancers
open to eligible people ages 18 years and up
This study collects blood and tissue samples for research of human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS)-related cancers. Collecting blood and tissue samples and studying biomarkers in the laboratory may help doctors to learn how are biologic or genetic factors related to HIV and cancers that occur commonly in people living with HIV.
San Francisco, California and other locations
Molecular Evaluation of AML Patients After Stem Cell Transplant to Understand Relapse Events
open to eligible people ages 18 years and up
Prospective determination of the clinical utility of measurable residual disease (MRD) testing for relapse and survival of patients with acute myeloid leukemia (AML) undergoing allogeneic hematopoietic cell transplantation (alloHCT).
San Francisco, California and other locations
Research on Donor and Recipient Management Strategies to Improve Lung Transplant Outcomes
open to eligible people ages 18 years and up
This project aims to collect detailed clinical data, blood samples, and patient-reported outcomes from 2,600 lung transplant candidates, donors, and recipients at Lung Transplant Centers. The goal is to create a robust resource for various research objectives, including studying the impact of variations in donor and medical practices on clinical outcomes. The project also seeks to identify serum biomarkers associated with or predictive of specific post-transplant complications and conditions.
San Francisco, California and other locations
Sponsor-Initiated OCS Heart Perfusion Registry
open to all eligible people
OHP-II Registry is a sponsor-initiated, multi-center, observational post-approval registry.
San Francisco, California and other locations
TRANSPIRE: Lung Injury in a Longitudinal Cohort of Pediatric HSCT Patients
open to eligible people ages up to 24 years
Hematopoietic stem cell transplant (HSCT) is an effective but toxic therapy and pulmonary morbidity affects as many as 25% of children receiving transplant. Early pulmonary injury includes diffuse alveolar hemorrhage (DAH), thrombotic microangiopathy (TMA) interstitial pneumonitis (IPS) and infection, while later, bronchiolitis obliterans is a complication of chronic GVHD associated with severe morbidity and mortality. Improved diagnosis and treatment of pulmonary complications are urgently needed as survival after HSCT improves, and as HSCT is increasingly used for non-malignant disorders such as sickle cell disease. Currently, there are large and important gaps in the investigator's knowledge regarding incidence, etiology and optimal treatment of pulmonary complications. Moreover, young children unable to perform spirometry are often diagnosed late, and strategies for monitoring therapeutic response are limited. This is a prospective multi-institutional cohort study in pediatric patients undergoing allogeneic hematopoietic stem cell transplantation (alloHSCT). Assembly of a large prospective uniformly screened cohort of children receiving HSCT, together with collection of biological samples, will be an effective strategy to identify mechanisms of lung injury, test novel diagnostic strategies for earlier diagnosis, and novel treatments to reduce morbidity and mortality from lung injury after transplant.
San Francisco, California and other locations
Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Participants With Newly Diagnosed Multiple Myeloma Who Are Minimal Residual Disease Positive After Frontline Autologous Stem Cell Transplant
Sorry, in progress, not accepting new patients
The purpose of this study is to evaluate conversion rate to minimal residual disease (MRD) negativity following the addition of daratumumab to lenalidomide relative to lenalidomide alone, when administered as maintenance treatment to anti-cluster of differentiation 38 (CD38) treatment naive participants with newly diagnosed multiple myeloma who are MRD positive as determined by next generation sequencing (NGS) at screening, following high-dose therapy (HDT) and autologous stem cell transplant (ASCT).
San Francisco, California and other locations
Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma
Sorry, not currently recruiting here
The purpose of this study is to compare the efficacy of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Ciltacabtagene Autoleucel versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Autologous Stem Cell Transplant (ASCT) in newly diagnosed multiple myeloma patients.
San Francisco, California and other locations
Combination Chemotherapy Followed By Peripheral Stem Cell Transplant in Treating Young Patients With Newly Diagnosed Supratentorial Primitive Neuroectodermal Tumors or High-Risk Medulloblastoma
Sorry, in progress, not accepting new patients
This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work in treating young patients with newly diagnosed supratentorial primitive neuroectodermal tumors or high-risk medulloblastoma when given before additional intense chemotherapy followed by peripheral blood stem cell rescue. It is not yet known which combination chemotherapy regimen is more effective when given before a peripheral stem cell transplant in treating supratentorial primitive neuroectodermal tumors or medulloblastoma.
San Francisco, California and other locations
Combination Chemotherapy, Autologous Stem Cell Transplant, and/or Radiation Therapy in Treating Young Patients With Extraocular Retinoblastoma
Sorry, in progress, not accepting new patients
This phase III trial is studying the side effects and how well giving combination chemotherapy together with autologous stem cell transplant and/or radiation therapy works in treating young patients with extraocular retinoblastoma. Giving chemotherapy before an autologous stem cell transplant stops the growth of tumor cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and/or bone marrow and stored. More chemotherapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Radiation therapy uses high energy x-rays to kill tumor cells. Giving radiation therapy after combination chemotherapy and/or autologous stem cell transplant may kill any remaining tumor cells.
San Francisco, California and other locations
COVID Protection After Transplant - Sanofi GSK (CPAT-SG) Study
Sorry, in progress, not accepting new patients
An open label, non-randomized pilot study in kidney transplant recipients who received a completed primary series and bivalent booster of mRNA based COVID-19 vaccine and have =<2500 U/mL SARS-CoV-2 S antibody concentration using the Roche Elecsys(R) anti-RBD assay. Up to 80 participants will be enrolled in this study. Eligible participants will receive a dose of the Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine candidate.. The primary objective is to determine whether a booster dose of the Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine will elicit an increased SARS-CoV-2 antibody response in participants who have failed to maintain an antibody titer >2500 U/mL (using the Roche Elecsys(R) anti-RBD assay) to 2 or more doses of mRNA based COVID-19 vaccine
San Francisco, California and other locations
COVID Protection After Transplant-Immunosuppression Reduction
Sorry, in progress, not accepting new patients
This study will enroll individuals who have: - Completed primary series of mRNA COVID-19 vaccine, and - An antibody response ≤ 2500 U/mL measured at least 30 days after the last dose of vaccine. This group of patients is at high risk for severe COVID-19 disease due to pharmacologic immunosuppression and a high prevalence of non-transplant risk factors such as obesity and diabetes.
San Francisco, California and other locations
Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Single Lung Transplant (BOSTON-1)
Sorry, in progress, not accepting new patients
The objective of the trial is to assess efficacy and safety of add-on aerosolized liposomal cyclosporine A (L-CsA) to Standard of Care (SoC) therapy as compared to SoC therapy alone in the treatment of Bronchiolitis obliterans syndrome (BOS) in single lung transplant recipients.
San Francisco, California and other locations
Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Single Lung Transplant (BOSTON-2)
Sorry, in progress, not accepting new patients
The objective of the trial is to assess efficacy and safety of add-on aerosolized liposomal cyclosporine A (L-CsA) to Standard of Care (SoC) therapy as compared to SoC therapy alone in the treatment of Bronchiolitis obliterans syndrome (BOS) in double lung transplant recipients.
San Francisco, California and other locations
Extension Trial on Efficacy / Safety of L-CsA + SoC in Treating BOS in Post Single or Double Lung Transplant (BOSTON-3)
Sorry, accepting new patients by invitation only
The objective of the trial is to assess the long-term safety and efficacy of L-CsA plus Standard of Care (SoC) in the treatment of BOS in single (SLT) and double lung transplant (DLT) recipients.
San Francisco, California and other locations
Gene Therapy in Treating Patients With Human Immunodeficiency Virus-Related Lymphoma Receiving Stem Cell Transplant
Sorry, in progress, not accepting new patients
This phase I/II trial studies the side effects and best dose of gene therapy in treating patients with human immunodeficiency virus (HIV)-related lymphoma that did not respond to therapy or came back after an original response receiving stem cell transplant. In gene therapy, small stretches of deoxyribonucleic acid (DNA) called "anti-HIV genes" are introduced into the stem cells in the laboratory to make the gene therapy product used in this study. The type of anti-HIV genes and therapy in this study may make the patient's immune cells more resistant to HIV-1 and prevent new immune cells from getting infected with HIV-1.
San Francisco, California and other locations
High Dose Flu Vaccine in Treating Children Who Have Undergone Donor Stem Cell Transplant
Sorry, in progress, not accepting new patients
This phase II randomized trial studies how well high dose flu vaccine works in treating children who have undergone done stem cell transplant. Higher dose flu vaccine may build a better immune response and may provide better protection against the flu than the standard vaccine.
San Francisco, California and other locations
Ibrutinib Before and After Stem Cell Transplant in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma
Sorry, in progress, not accepting new patients
This randomized phase III trial studies ibrutinib to see how well it works compared to placebo when given before and after stem cell transplant in treating patients with diffuse large B-cell lymphoma that has returned after a period of improvement (relapsed) or does not respond to treatment (refractory). Before transplant, stem cells are taken from patients and stored. Patients then receive high doses of chemotherapy to kill cancer cells and make room for healthy cells. After treatment, the stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Ibrutinib is a drug that may stop the growth of cancer cells by blocking a protein that is needed for cell growth. It is not yet known whether adding ibrutinib to chemotherapy before and after stem cell transplant may help the transplant work better in patients with relapsed or refractory diffuse large B-cell lymphoma.
San Francisco, California and other locations
Improving Medication Adherence in Adolescents Who Had a Liver Transplant
Sorry, in progress, not accepting new patients
The study's aim is to test a tailored telemetric intervention to reduce rejection incidence by improving medication adherence in a group of adolescent liver transplant recipients identified as nonadherent by a marker (the Medication Level Variability Index, MLVI).
San Francisco, California and other locations
Induction Therapy Including 131 I-MIBG and Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma Undergoing Stem Cell Transplant, Radiation Therapy, and Maintenance Therapy With Isotretinoin
Sorry, in progress, not accepting new patients
This pilot clinical trial studies induction therapy followed by iobenguane I 131 and chemotherapy in treating patients with newly diagnosed high-risk neuroblastoma undergoing stem cell transplant, radiation therapy, and maintenance therapy with isotretinoin. Radioisotope therapy, such as iobenguane I 131, releases radiation that kills tumor cells. Drugs used in chemotherapy, such as carboplatin, etoposide phosphate, busulfan, and melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. A peripheral stem cell transplant may be able to replace blood-forming cells that are destroyed by iobenguane I 131 and chemotherapy. Giving radioisotope therapy, chemotherapy, and peripheral stem cell transplant may kill more tumor cells.
San Francisco, California and other locations
Lactobacillus Plantarum in Preventing Acute Graft Versus Host Disease in Children Undergoing Donor Stem Cell Transplant
Sorry, in progress, not accepting new patients
This randomized phase III trial studies how well Lactobacillus plantarum works in preventing acute graft versus host disease in children undergoing donor stem cell transplant. Lactobacillus plantarum may help prevent the development of gastrointestinal graft versus host disease in children, adolescents, and young adults undergoing donor stem cell transplant.
Oakland, California and other locations
Lenalidomide in Treating Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplant
Sorry, in progress, not accepting new patients
This randomized phase III trial studies lenalidomide to see how well it works compared to a placebo in treating patients with multiple myeloma who are undergoing autologous stem cell transplant. Giving chemotherapy before a peripheral blood stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Biological therapies, such as lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Giving lenalidomide after autologous stem cell transplant may be an effective treatment for multiple myeloma.
San Francisco, California and other locations
Preventive Human Papillomavirus (HPV) Vaccine Trial in Kidney Transplant Recipients
Sorry, in progress, not accepting new patients
This phase II trial studies whether the nonavalent human papillomavirus vaccine given to adults prior to kidney transplantation can help the body build and maintain an effective immune response during the post-transplant period when they receive immunosuppressive drugs to prevent transplant rejection. This study will help inform our scientific understanding about vaccine-induced immune responses among immunosuppressed individuals.
San Francisco, California and other locations
Lenalidomide, Bortezomib, Dexamethasone vs High-Dose Treatment With SCT in MM Patients up to Age 65
Sorry, in progress, not accepting new patients
In this research study, we are looking to explore the drug combination, lenalidomide, bortezomib and dexamethasone alone or when combined with autologous stem cell transplantation to see what side effects it may have and how well it works for treatment of newly diagnosed multiple myeloma. Specifically, the objective of this trial is to determine if, in the era of novel drugs, high dose therapy (HDT) is still necessary in the initial management of multiple myeloma in younger patients. In this study, HDT as compared to conventional dose treatment would be considered superior if it significantly prolongs progression-free survival by at least 9 months or more, recognizing that particular subgroups may benefit more compared to others.
San Francisco, California and other locations
Standard-Dose Combination Chemotherapy or High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patients With Relapsed or Refractory Germ Cell Tumors
Sorry, in progress, not accepting new patients
This randomized phase III trial studies how well standard-dose combination chemotherapy works compared to high-dose combination chemotherapy and stem cell transplant in treating patients with germ cell tumors that have returned after a period of improvement or did not respond to treatment. Drugs used in chemotherapy, such as paclitaxel, ifosfamide, cisplatin, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as filgrastim or pegfilgrastim, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. It is not yet known whether high-dose combination chemotherapy and stem cell transplant are more effective than standard-dose combination chemotherapy in treating patients with refractory or relapsed germ cell tumors.
San Francisco, California and other locations
Delirium in Children Undergoing Stem Cell Transplantation
Sorry, in progress, not accepting new patients
Children undergoing stem cell transplants are at risk for delirium, a temporary change in thinking and behavior. This study will define delirium rates, risk factors, and outcomes. Our eventual goal is to reduce delirium in this population.
San Francisco, California and other locations
Patient Outcomes From the Kidney Allograft Outcomes AlloSure Registry
Sorry, in progress, not accepting new patients
This is an observational study to evaluate safety and efficacy outcomes in renal transplant recipients in whom post-transplant care is managed using AlloSure®. AlloSure® is a non-invasive test to measure donor-derived cell-free DNA (dd-cfDNA). The AlloSure test is intended to assess the probability of allograft rejection in kidney transplant recipients with clinical suspicion of rejection and to inform clinical decision-making regarding the necessity of renal biopsy in such patients at least 2 weeks post-transplant in conjunction with standard clinical assessment. Amendment 1 (A1): Is an observational study to develop and validate the clinical use of KidneyCare®.
San Francisco, California and other locations
Long - Term Follow Up of Sickle Cell Disease and Beta-thalassemia Subjects Previously Exposed to BIVV003 or ST-400.
Sorry, accepting new patients by invitation only
Primary Objectives: Long-term safety of BIVV003 in participants with severe sickle cell disease (SCD) and ST- 400 in participants with transfusion-dependent beta-thalassemia (TDT) Secondary Objectives: - Long-term efficacy of the biological treatment effect of BIVV003 in SCD - Long-term efficacy of the clinical treatment effect of BIVV003 on SCD-related clinical events - Long-term efficacy of the biological treatment effect of ST-400 in TDT - Long-term efficacy of the clinical treatment effect of ST-400 in TDT
Oakland, California and other locations
Long Term Follow up of the LTOG Cohort
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The purpose of the study is to follow participants who enrolled in the Lung Transplant Outcomes Group. Clinical data, functional assessments, and surveys will be collected to determine long term graft function and functional status of lung transplant recipients.
San Francisco, California and other locations
OCS Heart Perfusion Post-Approval Registry
Sorry, in progress, not accepting new patients
The objective of this post-approval registry is to provide additional real-world evidence of the performance of the OCS Heart System to preserve DBD and DCD donor hearts.
San Francisco, California and other locations
Predicting Mortality in Kidney Transplant Recipients
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Accurately predicting kidney recipient risk of death has a crucial interest because of the organ shortage, the need to optimize allograft allocation by identifying high-risk patients who may not benefit from a transplant and improve the clinical decision-making after transplant to ensure that each patient survives as long as possible. However, according to a literature review the investigators performed, studies attempting to develop a kidney recipient death prediction model suffer from many shortcomings, including the lack of key risk factors, use of biased registry data, small sample size, lack of external validation in different countries and subpopulations, and short follow-up. The present study thus aimed to address these limitations and develop a robust, generalizable kidney recipient death prediction model.
San Francisco, California and other locations
Surveillance HeartCare® Outcomes Registry
Sorry, in progress, not accepting new patients
This is an observational registry to assess the clinical utility of surveillance using HeartCare testing services, in association with clinical care of heart transplant recipients.
San Francisco, California and other locations
DISCOVER Trial (Diagnosis of Infection in Stem Cell Transplant Patients OVER Time)
Sorry, in progress, not accepting new patients
Demonstrate that the Karius Infectious Disease Diagnostic Sequencing Assay performed on plasma can accurately detect the microbiologic etiology in febrile allogeneic stem-cell transplant patients when compared with standard clinical diagnostics
San Francisco, California
Our lead scientists for Transplants research studies include Nahal R. Lalefar Jon Singer, MD, MS Thomas Martin Liviu Klein, MD Steven Hays, MD Jason Smith, MD Gabriel Salinas Cisneros, MD Christine Higham, MD Kristin Shimano, MD Aaron Logan, MD, PhD Christopher C Dvorak, MD Alexis Beatty, MD, MAS Flavio G. Vincenti Jasleen Kukreja, MD MPH Peter Chin-Hong, MD Anoop Sheshadri, MD, MAS Michelle Hermiston Jeffrey Wolf.
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