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
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.
Eligibility
- Age range
- 1–31 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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…
Interventions
- DrugMethotrexate
Patients will receive methotrexate as part of chemoimmunotherapy regemin followed by allogeneic stem cell transplant.
- Drugpralatraxate,
Patients will receive pralaxtraxate as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.
- DrugIfosfamide
Patients will receive Ifsofamide as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.
- DrugDexamethasone
Patients will receive dexamethasone as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.
- DrugEtoposide
Patients will receive etoposide as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.
- Drugcalaspargase pegol
Patients will receive pegaspargase as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.
Locations (6)
- University of AlabamaBirmingham, Alabama
- Children's Hospital Orange CountyOrange, California
- University of California San FranciscoSan Francisco, California
- Helen De VosGrand Rapids, Michigan
- New York Medical CollegeValhalla, New York
- Nationwide Children's HospitalColumbus, Ohio