Chemoimmunotherapy and Allogeneic Stem Cell Transplant for NK T-cell Leukemia/Lymphoma
a study on Lymphoma Leukemia T Cell Lymphoma Bone Marrow Transplant Stem Cell Transplant Transplants Immunotherapy
Summary
- Eligibility
- for people ages 1-31 (full criteria)
- Location
- at San Francisco, California and other locations
- Dates
- study startedcompletion around
- Principal Investigator
- by William Temple
Description
Summary
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.
Official Title
Pilot Study Using Induction Chemo-immunotherapy Followed by Consolidation With Reduced Toxicity Conditioning and Allogenic Stem Cell Transplant in Advanced Stage Mature Non-anaplastic T-Cell or NK Lymphoma/Leukemia in Children, Adolescents and Young Adults; A NK/T-Cell Lymphoma/Leukemia Consortium Study
Keywords
NK-Cell Lymphoma, NK-Cell Leukemia, Peripheral T Cell Lymphoma, Lymphoma, Leukemia, T-Cell Lymphoma, Lymphoma, T-Cell, Peripheral, Dexamethasone, Prednisone, Cyclophosphamide, Ifosfamide, Doxorubicin, Methotrexate, Etoposide, Brentuximab Vedotin, pralatraxate,, calaspargase pegol
Eligibility
You can join if…
Open to people ages 1-31
- Patients must weigh at least 10 kilograms at the time of the study enrollment.
- Diagnosis
Newly diagnosed patients with histologically proven mature T- and NK- cell neoplasms:
COHORT 1
- Aggressive NK cell leukemia (ICD-O code 9948/3)
- Extranodal NK/T-cell lymphoma, nasal type (ICD-O code 9719/3) COHORT 2
- Enteropathy-associated T-cell lymphoma (ICD-O code 9717/3)
- Hepatosplenic T-cell lymphoma (ICD-O code 9716/3)
- Peripheral T-cell lymphoma, non-otherwise specified (ICD-O code 9702/3)
- Angioimmunoblastic T-cell lymphoma (ICD-O code 9705/3)
- Other mature T- and NK-cell neoplasm histologies will considered after case-by-case discussion with Study Chairs and executive Vice-Chair Patients with lymphoma must have stage III or IV disease (See Appendix III for Staging).
- Organ Function Requirements
Adequate liver function defined as:
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age.
- ALT (SGPT) < 3 x ULN for age.
Adequate cardiac function defined as:
- Shortening fraction of ≥ 27% by echocardiogram, or
- Ejection fraction of ≥ 50% by radionuclide angiogram.
Adequate pulmonary function defined as:
• Patients with a history of pulmonary dysfunction must have no evidence of dyspnea at rest, no exercise intolerance due to pulmonary insufficiency, and a pulse oximetry > 92% while breathing room air unless current dysfunction is due to the lymphoma, in which case the patient is eligible.
You CAN'T join if...
- Alk+ or Alk- Anaplastic Large Cell Lymphoma (ALCL)
- Patients with active CNS disease.
- Patients with stage I or stage II disease (See Appendix III for Staging).
- Patients who have received any prior cytotoxic chemotherapy for the current diagnosis of NHL.
- Previous steroid treatment and/or radiation treatment are not allowed unless they are used for emergency management. Patients who have received emergency irradiation and/or steroid therapy will be eligible only if started on protocol therapy not more than one week from the start of radiotherapy or steroids.
- Female patients who are pregnant. Pregnancy tests must be obtained in girls who are post menarchal.
- Lactating females, unless they have agreed not to breastfeed their infants.
- Patients with Down syndrome.
- Patients taking CYP3A4 substrates with narrow therapeutic indices. Patients (COHORT 2 ONLY) chronically receiving medications known to be metabolized by CYP3A4 and with narrow therapeutic indices (See Appendix V). The topical use of these medications (if applicable) is allowed.
- Patients taking CYP3A4 inhibitors. Patients (COHORT 2 ONLY) chronically receiving drugs that are known potent CYP3A4 inhibitors within 7 days prior to study enrollment (See Appendix V). The topical use of these medications (if applicable) is allowed.
- Patients taking CYP3A4 inducers. Patients (COHORT 2 ONLY) chronically receiving drugs that are known potent CYP3A4 inducers within 12 days prior to study enrollment (See Appendix V).
Locations
- UCSF
accepting new patients
San Francisco California 94143 United States - Children's Hospital Orange County
accepting new patients
Orange California 92968 United States
Lead Scientist at UCSF
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- New York Medical College
- ID
- NCT03719105
- Phase
- Phase 1 research study
- Study Type
- Interventional
- Participants
- Expecting 40 study participants
- Last Updated
Frequently Asked Questions
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