Chemoimmunotherapy for ALK+ Relapsed/Refractory ALCL

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1-39
SponsorNew York Medical College

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

20 Participants
are divided into 3 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