Recruiting

Phase 2

Nivolumab with ChemotherapyChemoimmunotherapy for ALK+ Relapsed/Refractory ALCL

Sponsor:

New York Medical College

Code:

NCT07013565

Conditions

Anaplastic Large Cell Lymphoma, ALK-Positive

Eligibility Criteria

Sex: All

Age: 1 - 39

Healthy Volunteers: Not accepted

Interventions

Vinblastine (Velban)

Brentuximab vedotin (Adcetris)

Nivolumab (Opdivo)

Study Details

Brief 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

Study ID

NCT07013565

Start date

Aug 7, 2025

Status verified date

May, 2026

Completion date

Jul 1, 2030

Anticipated

Primary completion date

Jul 1, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 1 - 39

Healthy Volunteers: Not accepted

Inclusion Criteria:

Patients must weigh ≥10 kilograms at the time of study enrollment.
Patients with relapsed or refractory histologically or cytologically proven ALK-positive anaplastic large cell lymphoma meeting Low or High Risk Criteria:

Low Risk Cohort (LR cohort):

Any patient with FIRST RELAPSE > ONE YEAR from initial diagnosis of de novo ALK+ ALCL,
Common histology,
CD3 negative, AND
No prior exposure to vinblastine (VBL).

High-Risk Cohort (HR cohort):

Any patient with RELAPSED OR PROGRESSIVE DISEASE less than ONE YEAR from initial diagnosis of de novo ALK+ ALCL,
Small cell/histiocytic histology,
CD3 positive (homogeneous staining of CD3 positive T-cells)
Patients must have adequate organ function.
Patients must have performance status 60 or above.

Exclusion Criteria:

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.
Lactating females unless they have agreed not to breastfeed their infants.
Patients with Down syndrome.
Any patient with uncontrolled infection prior to study entry.
Any patient known to have primary or acquired immunodeficiency and/or prior solid organ transplant.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Low-risk ALK+ ALCL

Low risk patients include any patient with FIRST RELAPSE > ONE YEAR from initial diagnosis of de novo ALK+ ALCL,Common histology, CD3 negative, Minimum disseminated disease (MDD) negative at de novo diagnosis (if MDD known), AND No prior exposure to vinblastine (VBL).

experimental: High Risk ALK+ ALCL (BV Naive)

Any patient with RELAPSED OR PROGRESSIVE DISEASE ONE YEAR from initial diagnosis of de novo ALK+ ALCL,
Small cell/histiocytic histology,
CD3 positive (homogeneous staining of CD3 positive T-cells)
Second or later relapse,
Induction failure during initial treatment for de novo ALK+ ALCL, OR
Minimal disseminated disease (MDD) positive at de novo diagnosis (if MDD known)

experimental: High Risk ALK+ ALCL (with prior BV)

Any patient with RELAPSED OR PROGRESSIVE DISEASE ONE YEAR from initial diagnosis of de novo ALK+ ALCL,
Small cell/histiocytic histology,
CD3 positive (homogeneous staining of CD3 positive T-cells)
Second or later relapse,
Induction failure during initial treatment for de novo ALK+ ALCL, OR
Minimal disseminated disease (MDD) positive at de novo diagnosis (if MDD known)

Interventions

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).

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

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.

Primary outcome measure

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) [ Time Frame: 1 year ]
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). [ Time Frame: 1 year ]
To determine the safety of NIVO and BV in CAYA with high-risk R/R ALK+ ALCL who have never received BV. [ Time Frame: 1 year ]
To determine the overall response rate to NIVO and BV in CAYA with high-risk R/R ALK+ ALCL who have never received BV. [ Time Frame: 1 year ]
To significantly improve the 1 year EFS in CAYA with high-risk ALCL who received NIVO risk-adapted combining immunotherapy with re-induction followed by RTC and AlloHSCT compared to historical controls. [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Mitchell S Cairo, MD

914-594-2150 mitchell_cairo@nymc.edu

Lauren Harrison, RN, MSN

617-285-2844 lauren_harrison@nymc.edu

Locations

New York Medical College

Recruiting

Valhalla, New York, United States, 10595

Contacts

Lauren Harrison, RN, MSN

617-285-7844 lauren_harrison@nymc.edu

Mitchell S Cairo, MD

914-594-2150 mitchell_cairo@nymc.edu

More Information

Sponsor

New York Medical College

Last update posted

May 20, 2026

Last verified

May, 2026

Keywords

ALCL
Relapsed ALCL

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by New York Medical College on 2026-05-20.