Summary

Eligibility
for people ages 20 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Rebecca Olin, MD
Headshot of Rebecca Olin
Rebecca Olin

Description

Summary

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.

Official Title

Seamless Phase II-Phase III Randomized Clinical Trial to Identify and Confirm the Most Promising Novel Intervention to Alleviate Morbidity and Mortality After Allogeneic Hematopoietic Cell Transplantation Among Older, Medically Infirm, or Frail Patients With Hematological Diseases

Details

OUTLINE: Patients are randomized to 1 of 4 arms. ARM I: Patients undergo SPC on days -15 before to +56 after transplant. ARM II: Patients undergo a CMC program on days -15 before to +56 after transplant. ARM III: Patients undergo interventions as outlined in Arm I and Arm II. ARM IV: Patients receive standard of care. In all arms, patients undergo HCT on day 0 and complete questionnaires and surveys at enrollment and 30, 90, 180, and 365 days post HCT. In all arms patients complete a 4-meter walk test, 6-minute walk test, up and go test, measured strength test and cognitive assessment at enrollment, 90, 180, and 365 days post HCT.

Keywords

Hematopoietic and Lymphoid Cell Neoplasm, Non-Neoplastic Hematologic and Lymphocytic Disorder, Hematologic Diseases, Supportive Palliative Care, Clinical Management, Best Practice, Allogeneic Hematopoietic Stem Cell Transplantation, Quality-of-Life Assessment, SPC and CMC

Eligibility

You can join if…

Open to people ages 20 years and up

  • Vulnerable patients as defined by one or more of the following criteria
  • Age 65 years or older
  • Having Hematopoietic Cell Transplantation - Comorbidity Index (HCT-CI) scores of >= 3 (for patients that could be 20 years old and older)
  • Having frailty as determined by walk speed of < 0.8 m/s using 4-meter walk test (for patients that could be 40 years old and older)
  • Patients considered or referred for allogeneic HCT to treat a hematological malignant or non-malignant disease
  • Able to speak and read English - interaction with the interventionist trainer and endpoint measurement must occur in English
  • Willing and able to provide informed consent
  • Planned allogeneic HCT within 3 weeks - all types of donors and all sorts of conditioning regimens are allowed. Patients with suspected active disease (relatively old disease staging or relatively old intervention) or significant comorbidity (e.g. suspicious untreated pulmonary nodules) based on prior evaluations, that could delay the transplant would be considered for enrollment within a tighter window (10-14 days before allogeneic HCT) to allow for completed pre-HCT work-up evaluations that would confirm readiness to proceed with transplant
  • Able to exercise at low to moderate intensity, specifically taking into consideration the rare circumstances where subjects are not able to exercise due to either birth deformity or prior traumatic injury that affects their gait
  • Adequate cardiopulmonary reserve, as judged by data from the patient's electronic medical record as to whether a patient could walk up one flight of stairs, no need for supplemental oxygen, and/or physician judgment

You CAN'T join if...

  • Orthopedic, neurologic or other problems which prevent safe ambulation and protocol adherence. Information on prior falls and other recent orthopedic or neurologic problems will be used to make judgment about protocol eligibility
  • Participation in another intervention clinical trial with HRQOL as a primary endpoint
  • Planned donor lymphocyte infusion (DLI) within 90 days post-transplant
  • Planned anti-cytotoxic therapies, other than tyrosine kinase inhibitors or single-agent monoclonal antibody, or FLT-3 inhibitors within 90 days of post-transplant unless pre-approved by the protocol principal investigator (PI)

Locations

  • University of California, San Francisco not yet accepting patients
    San Francisco California 94143 United States
  • Stanford Cancer Institute Palo Alto accepting new patients
    Palo Alto California 94304 United States

Lead Scientist at UCSF

  • Rebecca Olin, MD
    Professor, Medicine, School of Medicine. Authored (or co-authored) 86 research publications. Research interests: acute myeloid leukemia (AML) · acute lymphoblastic leukemia (ALL) · acute promyelocytic leukemia (APL) · myelodysplastic syndrome (MDS) · hematopoietic stem cell transplantation · myeloproliferative neoplasms (MPN) · aplastic anemia · lymphoma · multiple myeloma

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Fred Hutchinson Cancer Center
ID
NCT03870750
Phase
Phase 2/3 research study
Study Type
Interventional
Participants
Expecting 600 study participants
Last Updated