Chemoimmunotherapy for ALK+ Relapsed/Refractory ALCL
NYMC623: A Comprehensive Risk-adapted Chemommunotherapy Protocol of Emerging Immunotherapies for Relapsed/Refractory Alk+ Anaplastic Large Cell Lymphoma (ACCELERATE)
New York Medical College
20 participants
Aug 7, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria13
- 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 Criteria8
- 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.
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Interventions
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).
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
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07013565