Home › Anaplastic Large-Cell Lymphoma › NCT07013565

Chemoimmunotherapy for ALK+ Relapsed/Refractory ALCL

NYMC623: A Comprehensive Risk-adapted Chemommunotherapy Protocol of Emerging Immunotherapies for Relapsed/Refractory Alk+ Anaplastic Large Cell Lymphoma (ACCELERATE)

Who can join

Ages 1 to 39 · All sexes

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.

About the study

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.

What is being tested

• Vinblastine (Velban) (drug)
• Brentuximab vedotin (Adcetris) (drug)
• Nivolumab (Opdivo) (drug)

Sponsor: New York Medical College · Participants: 20 · Started: Aug 7, 2025

Contact the study team

• Mitchell S Cairo, MD · Phone: 914-594-2150
• Lauren Harrison, RN, MSN · Phone: 617-285-2844

Official record on ClinicalTrials.gov — NCT07013565

Locations in the U.S.

Conditions

• Anaplastic Large-Cell Lymphoma

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.