About this trial
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.
Eligibility criteria
Qualifiers
Patients must weigh ≥10 kilograms at the time of study enrollment.
Any patient with FIRST RELAPSE > ONE YEAR from initial diagnosis of de novo ALK+ ALCL,
Common histology,
CD3 negative, AND
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Vinblastine (Velban)
- Brentuximab vedotin (Adcetris)
- Nivolumab (Opdivo)
Treatment groups
Sponsors and collaborators
New York Medical College
Lead sponsor
University of Alabama at Birmingham
Collaborator
Helen DeVos Children's Hospital
Collaborator
Nationwide Children's Hospital
Collaborator
Memorial Sloan Kettering Cancer Center
Collaborator
University of Utah
Collaborator
Ohio State University
Collaborator
University of North Carolina
Collaborator
Children's Hospital of Philadelphia
Collaborator
Medical College of Wisconsin
Collaborator
Children's Hospital of Orange County
Collaborator