Health TrialsbyHealthPanel

Chemoimmunotherapy for ALK+ Relapsed/Refractory ALCL

ConditionAnaplastic Large Cell Lymphoma, ALK-Positive
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Vinblastine (Velban)

    Drug

    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).

  • Brentuximab vedotin (Adcetris)

    Drug

    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

  • Nivolumab (Opdivo)

    Drug

    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.

Treatment groups

20 Participants
are divided into 3 treatment groups
Group A: Low-risk ALK+ ALCLExperimental treatment 1 intervention
Group B: High Risk ALK+ ALCL (BV Naive)Experimental treatment 3 interventions
Group C: High Risk ALK+ ALCL (with prior BV)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

To determine the incidence of adverse events (safety) of NIVO and Vinblastine (VBL) in CAYA with high-risk R/R ALK+ ALCL with prior exposure to Brentuximab vedotin (BV)

adverse events possible probably or definitely related to NIVO will be reported.

Time frame
1 year
2

To determine the overall response rate of NIVO and Vinblastine (VBL) in CAYA with high-risk R/R ALK+ ALCL with prior exposure to Brentuximab vedotin (BV).

Patient will have disease assessments to determine best response to therapy with NIVO and Vinblastine

Time frame
1 year
3

To determine the safety of NIVO and BV in CAYA with high-risk R/R ALK+ ALCL who have never received BV.

adverse events probably or definitely related to NIVO will be collected.

Time frame
1 year
4

To determine the overall response rate to NIVO and BV in CAYA with high-risk R/R ALK+ ALCL who have never received BV.

disease assessments will be performed to determine best response post therapy

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Source ClinicalTrials.gov
Apply now