Chemoimmunotherapy for ALK+ Relapsed/Refractory ALCL

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.

Conditions

• Anaplastic Large Cell Lymphoma, ALK-Positive

Interventions

DRUG

Vinblastine (Velban)

Low risk cohort patients will receive 2 cycles of Induction therapy with single-drug vinBLAStine (VBL), then undergo disease assessment. If complete remission (CR) and MRD -, LR patients will continue single-drug VBL for a total of 24 months (if absent disease progression or unacceptable toxicity).

DRUG

Brentuximab vedotin (Adcetris)

HR cohort patients with no previous exposure to BV will receive 2 cycles of Induction therapy with BV and NIVO \[BV + NIVO\] one every 21 days, then undergo disease assessment. Patients in CR will proceed with consolidation with RTC allogeneic SCT (SCT)\*. If patient has any response other than CR and MRD-, they will receive 2 cycles of BV, VBL, and NIVO \[BV + VBL + NIVO\] once every 21 days

DRUG

Nivolumab (Opdivo)

High risk cohort patients with previous exposure to Brentuximab vedotin (BV) will receive 2 cycles of Induction therapy with VBL and NIVO \[VBL + NIVO\] on day 1 and 15, then undergo disease assessment. If response is not CR, or patient has PR/SD/PD, patient will receive \[BV+VBL+NIVO\] and subsequent therapy as defined for the HR2 cohort.

Sponsors & Collaborators

• University of Alabama at Birmingham

  collaborator OTHER

• Helen DeVos Children's Hospital

  collaborator OTHER

• Nationwide Children's Hospital

  collaborator OTHER

• Memorial Sloan Kettering Cancer Center

  collaborator OTHER

• University of Utah

  collaborator OTHER

• Ohio State University

  collaborator OTHER

• University of North Carolina

  collaborator OTHER

• Children's Hospital of Philadelphia

  collaborator OTHER

• Medical College of Wisconsin

  collaborator OTHER

• Children's Hospital of Orange County

  collaborator OTHER

• New York Medical College

  lead OTHER

Principal Investigators

• Mitchell S Cairo, MD · New York Medical College

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

1 Year

Max Age

39 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-07

Primary Completion

2029-07-01

Completion

2030-07-01

FDA Drug

Yes

Countries

• United States

Study Locations