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New combo therapy aims to beat tough childhood lymphoma

NCT ID NCT07013565

Disease control Sponsor: New York Medical College Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tests a risk-adapted treatment for children, adolescents, and young adults with relapsed or refractory ALK-positive anaplastic large cell lymphoma. Participants receive nivolumab (an immunotherapy) combined with chemotherapy drugs like vinblastine or brentuximab vedotin, followed by a stem cell transplant from a donor. The goal is to improve survival and reduce side effects by tailoring treatment to each patient's risk level.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Nivolumab (immunotherapy), vinblastine (chemotherapy), and brentuximab vedotin (targeted drug)
What this could lead to
If successful, this could improve survival rates for children and young adults with hard-to-treat ALK+ anaplastic large cell lymphoma.
What could go wrong
This is a small, early-phase trial with only 20 participants, so results may not apply to everyone. The treatment includes strong chemotherapy and stem cell transplant, which carry serious risks like infection 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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Jul 2030

An estimate. End dates often move.

Lead sponsor

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

1 year to 39 years

Sex

Anyone

Healthy volunteers

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

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 ≥10 kilograms at the time of study enrollment. * Patients with relapsed or refractory histologically or cytologically proven ALK-positive anaplastic large cell lymphoma meeting Low or High Risk Criteria: Low Risk Cohort (LR cohort): * Any patient with FIRST RELAPSE \> ONE YEAR from initial diagnosis of de novo ALK+ ALCL, * Common histology, * CD3 negative, AND * No prior exposure to vinblastine (VBL). High-Risk Cohort (HR cohort): * Any patient with RELAPSED OR PROGRESSIVE DISEASE less than ONE YEAR from initial diagnosis of de novo ALK+ ALCL, * Small cell/histiocytic histology, * CD3 positive (homogeneous staining of CD3 positive T-cells) * Patients must have adequate organ function. * Patients must have performance status 60 or above. Exclusion Criteria: * ALK-NEGATIVE anaplastic large cell lymphoma. * Patients with active leptomeningeal disease (lymphoma cells in CSF). * Previous treatment with vinblastine (only in patients in the LR cohort). * Female patients who are pregnant. Pregnancy tests must be obtained in girls who are post menarche. * Lactating females unless they have agreed not to breastfeed their infants. * Patients with Down syndrome. * Any patient with uncontrolled infection prior to study entry. * Any patient known to have primary or acquired immunodeficiency and/or prior solid organ transplant.

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Conditions

The condition(s) this trial relates to.

ALK-positive anaplastic large cell lymphoma anaplastic large cell lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anaplastic large cell lymphoma, ALK-positive

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

Locations

  • New York Medical College

    RECRUITING

    Valhalla, New York, 10595, United States

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