Clinical Trial

Chemoimmunotherapy for ALK+ Relapsed/Refractory ALCL

Study acronym: ACCELERATE
Recruiting Phase 2
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Summary
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-06-09; most recent amendment 2026-05-18.
Status change: Active, Not Recruiting → Recruiting 2026-05-18
Status change: Not Yet Recruiting → Active, Not Recruiting 2025-10-19
Trial Details
NCT Number NCT07013565
Lead Sponsor New York Medical College
Collaborators: University of Alabama at Birmingham, Helen DeVos Children's Hospital, Nationwide Children's Hospital, Memorial Sloan Kettering Cancer Center, University of Utah, Ohio State University, University of North Carolina, Children's Hospital of Philadelphia, Medical College of Wisconsin, Children's Hospital of Orange County
Conditions Anaplastic Large Cell Lymphoma, ALK-Positive
Enrollment 20 participants
Start Date 2025-08-07
Primary Completion 2029-07-01 (estimated)
Study Completion 2030-07-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-20