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

ConditionsNK-Cell Lymphoma NK-Cell Leukemia Peripheral T Cell Lymphoma

Trial statusRecruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

Age1-31

SponsorNew York Medical College

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Patients must weigh at least 10 kilograms at the time of the study enrollment.

Diagnosis

Aggressive NK cell leukemia (ICD-O code 9948/3)

Extranodal NK/T-cell lymphoma, nasal type (ICD-O code 9719/3) COHORT 2

Disqualifiers

Alk+ or Alk- Anaplastic Large Cell Lymphoma (ALCL)

Patients with active CNS disease.

Patients with stage I or stage II disease (See Appendix III for Staging).

Patients who have received any prior cytotoxic chemotherapy for the current diagnosis of NHL.

Trial design

Design model

Parallel

Treatments tested in this trial

Methotrexate
Drug
Patients will receive methotrexate as part of chemoimmunotherapy regemin followed by allogeneic stem cell transplant.
pralatraxate,
Drug
Patients will receive pralaxtraxate as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.
Ifosfamide
Drug
Patients will receive Ifsofamide as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.
Dexamethasone
Drug
Patients will receive dexamethasone as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.
Etoposide
Drug
Patients will receive etoposide as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.
calaspargase pegol
Drug
Patients will receive pegaspargase as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.
cyclophosphamide
Drug
Patients will receive cyclophosphamide as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.
Doxorubicin
Drug
Patients will receive doxorubicin as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.
Prednisone
Drug
Patients will receive prednisone as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.
Brentuximab Vedotin
Drug
Patients will receive brentuximab vedotin as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Cohort 1Experimental treatment 5 interventions

Group B: Cohort 2Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

overall response rate

to assess overall response rate following chemoimmunotherapy induction therapy

Time frame

1 year

Secondary outcomes

event free survival

to determine the event free survival after induction chemoimmunotherapy and allogeneic stem cell transplantation

Time frame

2 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

New York Medical College

Lead sponsor

University of Alabama at Birmingham

Collaborator

Source ClinicalTrials.gov

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