NCT03719105

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

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: New York Medical College · Academic / Other
• Sex: All
• Age: 1 Year – 31 Years
• Healthy volunteers: Not accepted

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.

Conditions

• NK-Cell Lymphoma
• NK-Cell Leukemia
• Peripheral T Cell Lymphoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-03-01
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2018-10-25
• Last updated: 2025-08-08

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study