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Chemoimmunotherapy for ALK+ Relapsed/Refractory ALCL

This study is for children, adolescents, and young adults (CAYA) aged 1 to 39 with a type of blood cancer called ALK-positive Anaplastic Large Cell Lymphoma (ALCL) that has come back or not responded to previous treatments. Researchers are testing a combination of Nivolumab (Opdivo), an immunotherapy that helps your immune system fight cancer, with chemotherapy drugs like Vinblastine (Velban) or Brentuximab vedotin (Adcetris). The specific treatment you receive depends on your risk level and if you've had Brentuximab vedotin before. The goal is to see how safe these combinations are and how well they shrink the cancer, hoping to improve survival rates for this high-risk group. The study plans to enroll 20 participants.

Study design
This interventional study is testing different drug combinations in participants with ALK-positive ALCL. It is not specified if this is a randomized or blinded study.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure safety and how well the treatment works for at least one year after treatment.

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

NCT07013565

Chemoimmunotherapy for ALK+ Relapsed/Refractory ALCL

Recruiting
PHASE2Ages 1–39InterventionalTreatment
New York Medical College
~20 participants
Updated 2026-05-20 on ClinicalTrials.gov
What's tested:Vinblastine (Velban)Brentuximab vedotin (Adcetris)Nivolumab (Opdivo)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To determine the incidence of adverse events (safety) of NIVO and Vinblastine (VBL) in CAYA with high-risk R/R ALK+ ALCL with prior exposure to Brentuximab vedotin (BV)
Measured over 1 year
+4 more outcomes measured

Conditions

Anaplastic Large Cell Lymphoma, ALK-Positive

Explore related trials

Anaplastic Large Cell LymphomaALK GeneCD3 Complex

NCT07013565

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • New York Medical College

    Valhalla, New Yorkstudy 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 S Cairo, MD · PRINCIPAL_INVESTIGATOR · New York Medical College

Who to contact

Mitchell S Cairo, MD
[email protected]
914-594-2150
Email the study team

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Eligibility criteria

Inclusion

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:
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).
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

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.

What this trial measures

  • To determine the incidence of adverse events (safety) of NIVO and Vinblastine (VBL) in CAYA with high-risk R/R ALK+ ALCL with prior exposure to Brentuximab vedotin (BV)1 year

    adverse events possible probably or definitely related to NIVO will be reported.

  • To determine the overall response rate of NIVO and Vinblastine (VBL) in CAYA with high-risk R/R ALK+ ALCL with prior exposure to Brentuximab vedotin (BV).1 year

    Patient will have disease assessments to determine best response to therapy with NIVO and Vinblastine

  • To determine the safety of NIVO and BV in CAYA with high-risk R/R ALK+ ALCL who have never received BV.1 year

    adverse events probably or definitely related to NIVO will be collected.

  • To determine the overall response rate to NIVO and BV in CAYA with high-risk R/R ALK+ ALCL who have never received BV.1 year

    disease assessments will be performed to determine best response post therapy

  • To significantly improve the 1 year EFS in CAYA with high-risk ALCL who received NIVO risk-adapted combining immunotherapy with re-induction followed by RTC and AlloHSCT compared to historical controls.1 year

    Events for EFS the first year will be reported and are defined as disease relapse, disease progression or toxic death.