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

This study is testing different combinations of chemotherapy drugs, including methotrexate, pralatrexate, ifosfamide, dexamethasone, and etoposide, followed by an allogeneic stem cell transplant (receiving healthy stem cells from a donor). It's for children, adolescents, and young adults (ages 1 to 31 years old) who have certain types of NK-cell lymphoma, NK-cell leukemia, or peripheral T-cell lymphoma. The main goal is to see how many patients respond to the treatment within one year. The study plans to enroll 40 participants, but its current status is unclear.

Study design
This is an interventional study with an enrollment goal of 40 participants. It involves two different treatment groups, both leading to a stem cell transplant if the disease responds.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study measures the overall response rate at 1 year, suggesting follow-up for at least that long.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03719105

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

Recruiting
EARLY_PHASE1Ages 1–31InterventionalTreatment
New York Medical College
~40 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:Methotrexatepralatraxate,IfosfamideDexamethasoneEtoposidecalaspargase pegol

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
overall response rate
Measured over 1 year

Conditions

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

Explore related trials

Aggressive NK-Cell LeukemiaEnteropathy-Associated T-Cell LymphomaFollicular Helper T-Cell Lymphoma, Angioimmunoblastic-TypeHepatosplenic T-Cell LymphomaMature T-Cell and NK-Cell Non-Hodgkin LymphomaNasal Type Extranodal NK/T-Cell Lymphoma

NCT03719105

Where you'd take part

This study runs at 6 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Children's Hospital Orange County

    Orange, Californiastudy coordinator listed

    Recruiting

  • Helen De Vos

    Grand Rapids, Michiganstudy coordinator listed

    Recruiting

  • Nationwide Children's Hospital

    Columbus, Ohiostudy coordinator listed

    Recruiting

  • New York Medical College

    Valhalla, New Yorkstudy coordinator listed

    Recruiting

  • University of Alabama

    Birmingham, Alabamastudy coordinator listed

    Recruiting

  • University of California San Francisco

    San Francisco, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Mitchell Cairo, MD · STUDY_DIRECTOR · New York Medical College

Who to contact

Ana Xavier
[email protected]
(205) 638-6763
Email the study team

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Eligibility criteria

Inclusion

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
Enteropathy-associated T-cell lymphoma (ICD-O code 9717/3)
Hepatosplenic T-cell lymphoma (ICD-O code 9716/3)
Peripheral T-cell lymphoma, non-otherwise specified (ICD-O code 9702/3)
Angioimmunoblastic T-cell lymphoma (ICD-O code 9705/3)
Other mature T- and NK-cell neoplasm histologies will considered after case-by-case discussion with Study Chairs and executive Vice-Chair Patients with lymphoma must have stage III or IV disease (See Appendix III for Staging).
Organ Function Requirements
Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age.
ALT (SGPT) \< 3 x ULN for age.
Shortening fraction of ≥ 27% by echocardiogram, or
Ejection fraction of ≥ 50% by radionuclide angiogram.

Exclusion

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.
Previous steroid treatment and/or radiation treatment are not allowed unless they are used for emergency management. Patients who have received emergency irradiation and/or steroid therapy will be eligible only if started on protocol therapy not more than one week from the start of radiotherapy or steroids.
Female patients who are pregnant. Pregnancy tests must be obtained in girls who are post menarchal.
Lactating females, unless they have agreed not to breastfeed their infants.
Patients with Down syndrome.
Patients taking CYP3A4 substrates with narrow therapeutic indices. Patients (COHORT 2 ONLY) chronically receiving medications known to be metabolized by CYP3A4 and with narrow therapeutic indices (See Appendix V). The topical use of these medications (if applicable) is allowed.
Patients taking CYP3A4 inhibitors. Patients (COHORT 2 ONLY) chronically receiving drugs that are known potent CYP3A4 inhibitors within 7 days prior to study enrollment (See Appendix V). The topical use of these medications (if applicable) is allowed.
Patients taking CYP3A4 inducers. Patients (COHORT 2 ONLY) chronically receiving drugs that are known potent CYP3A4 inducers within 12 days prior to study enrollment (See Appendix V).

What this trial measures

  • overall response rate1 year

    to assess overall response rate following chemoimmunotherapy induction therapy