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

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

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.

Sponsors & Collaborators

• University of Alabama at Birmingham

  collaborator OTHER

• New York Medical College

  lead OTHER

Principal Investigators

• Mitchell Cairo, MD · New York Medical College

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

31 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-03-01

Primary Completion

2027-12-31

Completion

2028-12-31

FDA Drug

Yes

Countries

• United States

Study Locations