drugset / Trial / NCT07013565
Chemoimmunotherapy for ALK+ Relapsed/Refractory ALCL
Phase 2
Recruiting
20 enrolled
New York Medical College
Children's Hospital of Orange County · collabChildren's Hospital of Philadelphia · collabHelen DeVos Children's Hospital · collabMedical College of Wisconsin · collabMemorial Sloan Kettering Cancer Center · collabNationwide Children's Hospital · collabOhio State University · collabUniversity of Alabama at Birmingham · collabUniversity of North Carolina · collabUniversity of Utah · collab
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-08-07
- Primary completion
- 2029-07-01
- Completion
- 2030-07-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Brentuximab Vedotin | Monoclonal antibody | — | — |
| Subject | Nivolumab | Monoclonal antibody | — | — |
| Subject | Vinblastine | Small molecule | — | — |