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Chemoimmunotherapy and Allogeneic Stem Cell Transplant for NK T-cell Leukemia/Lymphoma
Sponsor: New York Medical College
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
Key Details
Gender
All
Age Range
1 Year - 31 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2019-03-01
Completion Date
2028-12-31
Last Updated
2025-08-08
Healthy Volunteers
No
Interventions
Methotrexate
Patients will receive methotrexate as part of chemoimmunotherapy regemin followed by allogeneic stem cell transplant.
pralatraxate,
Patients will receive pralaxtraxate as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.
Ifosfamide
Patients will receive Ifsofamide as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.
Dexamethasone
Patients will receive dexamethasone as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.
Etoposide
Patients will receive etoposide as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.
calaspargase pegol
Patients will receive pegaspargase as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.
cyclophosphamide
Patients will receive cyclophosphamide as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.
Doxorubicin
Patients will receive doxorubicin as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.
Prednisone
Patients will receive prednisone as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.
Brentuximab Vedotin
Patients will receive brentuximab vedotin as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.
Locations (6)
University of Alabama
Birmingham, Alabama, United States
Children's Hospital Orange County
Orange, California, United States
University of California San Francisco
San Francisco, California, United States
Helen De Vos
Grand Rapids, Michigan, United States
New York Medical College
Valhalla, New York, United States
Nationwide Children's Hospital
Columbus, Ohio, United States