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RECRUITING
NCT03719105
EARLY_PHASE1

Chemoimmunotherapy and Allogeneic Stem Cell Transplant for NK T-cell Leukemia/Lymphoma

Sponsor: New York Medical College

View on ClinicalTrials.gov

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

DRUG

Methotrexate

Patients will receive methotrexate as part of chemoimmunotherapy regemin followed by allogeneic stem cell transplant.

DRUG

pralatraxate,

Patients will receive pralaxtraxate as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.

DRUG

Ifosfamide

Patients will receive Ifsofamide as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.

DRUG

Dexamethasone

Patients will receive dexamethasone as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.

DRUG

Etoposide

Patients will receive etoposide as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.

DRUG

calaspargase pegol

Patients will receive pegaspargase as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.

DRUG

cyclophosphamide

Patients will receive cyclophosphamide as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.

DRUG

Doxorubicin

Patients will receive doxorubicin as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.

DRUG

Prednisone

Patients will receive prednisone as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.

DRUG

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