Nivolumab plus chemotherapy for ALK+ relapsed/refractory ALCL in kids, teens, and young adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 study evaluates a chemoimmunotherapy approach for children, adolescents, and young adults with relapsed or refractory ALK-positive ALCL. Participants start with nivolumab plus chemotherapy based on risk, aiming to achieve the best possible response, then continue with lower-dose chemoimmunotherapy and an allogeneic stem cell transplant. The trial builds on prior data suggesting benefit from CD30-targeted therapy and PD-1/PD-L1 blockade in related lymphomas. Primary safety and efficacy outcomes will inform whether this strategy can improve survival in a high-risk population. The study is conducted at multiple centers with New York Medical College as the lead sponsor.

Why it matters

Who can join: the full rules

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.

Where it's running

• New York Medical College
  Valhalla, New York, United States Recruiting

Study contacts

• Principal investigator: Mitchell S Cairo, MD — New York Medical College
• Study coordinator: Mitchell S Cairo, MD
• Email: mitchell_cairo@nymc.edu
• Phone: 914-594-2150

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.