RecruitingEarly Phase 1NCT03719105

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


Sponsor

New York Medical College

Enrollment

40 participants

Start Date

Mar 1, 2019

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 1 YearMax Age: 31 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new combination treatment — including immunotherapy (brentuximab vedotin and pembrolizumab) along with standard chemotherapy — followed by a stem cell transplant from a donor, for children and young adults newly diagnosed with aggressive T-cell and NK-cell lymphomas and leukemias (rare blood cancers of immune cells). **You may be eligible if...** - You have been newly diagnosed with one of several types of T-cell or NK-cell blood cancers, such as aggressive NK cell leukemia, extranodal NK/T-cell lymphoma, peripheral T-cell lymphoma, hepatosplenic T-cell lymphoma, angioimmunoblastic T-cell lymphoma, or others - Your lymphoma is at stage III or IV (widespread disease) - You weigh at least 10 kilograms - Your heart, liver, and lung function meet minimum requirements **You may NOT be eligible if...** - You have a specific type called anaplastic large cell lymphoma (ALCL) - You have cancer spread to the brain - Your disease is early stage (stage I or II) - You have already received chemotherapy for this diagnosis (emergency steroids or radiation may be acceptable) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.

DRUGcyclophosphamide

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

DRUGDoxorubicin

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

DRUGPrednisone

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

DRUGBrentuximab 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

View Full Details on ClinicalTrials.gov

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NCT03719105


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