Can a powerful combo of drugs and stem cell transplant beat tough lymphomas in kids?
NCT ID NCT03719105
First seen Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time
Summary
This trial is testing a two-step approach for children, teens, and young adults with advanced T-cell or NK-cell lymphoma or leukemia. First, patients receive a combination of chemotherapy and immunotherapy drugs to shrink the cancer. Then, those who respond go on to receive a stem cell transplant from a donor, which aims to replace the diseased immune system with a healthy one. The goal is to see how well this plan works at controlling the disease and improving long-term survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A combination of chemotherapy drugs (methotrexate, ifosfamide, dexamethasone, etoposide, pegaspargase, pralatrexate, cyclophosphamide, doxorubicin, prednisone) and immunotherapy (pembrolizumab, brentuximab vedotin), followed by an allogeneic stem cell transplant.
- What this could lead to
- If successful, this approach could offer a path to long-term remission or even a cure for aggressive T/NK lymphomas and leukemias in young patients.
- What could go wrong
- This is an early-phase pilot with a small number of patients, so results may not be conclusive. The treatment is intensive and carries risks like infection, graft-versus-host disease, and organ damage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2019
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 year to 31 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients must weigh at least 10 kilograms at the time of the study enrollment. * Diagnosis Newly diagnosed patients with histologically proven mature T- and NK- cell neoplasms: COHORT 1 * 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 Adequate liver function defined as: * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age. * ALT (SGPT) \< 3 x ULN for age. Adequate cardiac function defined as: * Shortening fraction of ≥ 27% by echocardiogram, or * Ejection fraction of ≥ 50% by radionuclide angiogram. Adequate pulmonary function defined as: • Patients with a history of pulmonary dysfunction must have no evidence of dyspnea at rest, no exercise intolerance due to pulmonary insufficiency, and a pulse oximetry \> 92% while breathing room air unless current dysfunction is due to the lymphoma, in which case the patient is eligible. Exclusion Criteria: * 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).
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Locations
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Children's Hospital Orange County
RECRUITINGOrange, California, 92968, United States
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Helen De Vos
RECRUITINGGrand Rapids, Michigan, 49503, United States
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Nationwide Children's Hospital
RECRUITINGColumbus, Ohio, 43205, United States
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New York Medical College
RECRUITINGValhalla, New York, 10595, United States
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University of Alabama
RECRUITINGBirmingham, Alabama, 35223, United States
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University of California San Francisco
RECRUITINGSan Francisco, California, 94143, United States
Contact Email: •••••@•••••
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