Chemoimmunotherapy for ALK+ Relapsed/Refractory ALCL

Conditions

• Anaplastic Large Cell Lymphoma, ALK-Positive

Eligibility Criteria

Sex

ALL

Age

1 Year - 39 Years

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

Aug 7, 2025

Status verified

May 2026

Primary completion

Jul 1, 2029

Completion

Jul 1, 2030

Study Design

Enrollment

20 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

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)

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 ]

Central Contacts

• Mitchell S Cairo, MD
  914-594-2150
  [email protected]
• Lauren Harrison, RN, MSN
  617-285-2844
  [email protected]

Locations (1)

Find similar trials in Valhalla, NY

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