Chemoimmunotherapy for ALK+ Relapsed/Refractory ALCL

Recruiting now · Phase 2

Conditions studied: Anaplastic Large Cell Lymphoma, ALK-Positive

In brief

Children, adolescents, and young adults (CAYA) with relapsed/refractory (R/R) high-risk ALK+ Anaplastic Large Cell Lymphoma (ALCL) have a low incidence of overall survival. This clinical trial will investigate if a new FDA approved medication called Nivolumab (NIVO) (which is a checkpoint blockade immunotherapy) combined with chemotherapy based on the patients risk status to get the patient into the best response possible. Then patients will receive lower doses of chemoimmunotherapy and allogeneic stem cell transplantation (stem cells from another person). The investigators this this new treatment will improve survival rates in this high-risk population of patients.

Key facts

Study ID

NCT07013565

Run by

New York Medical College

People needed

20

Starts

2025-08-07

Expected to finish

2030-07-01

Last updated by the study team

2026-05-20

Who can join

Age: 1 and older, up to 39. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• New York Medical College — Valhalla, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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