NCT07013565RecruitingPhase 2
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)
Source: ClinicalTrials.gov · Last updated 20 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 6 May 2025
- Start date
- 7 Aug 2025
- Primary completion date
- 1 Jul 2029
- Lead sponsor
- New York Medical College
- Diseases
- Childhood cancers
- NCT number
- NCT07013565
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 20
- From 7 Aug 2025 to the primary completion date, 1 Jul 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with vinblastine (only in patients in the LR cohort).
- Any patient with uncontrolled infection prior to study entry.
- Any patient known to have primary or acquired immunodeficiency and/or prior solid organ transplant.
Other illness
- Patients with active leptomeningeal disease (lymphoma cells in CSF).
- Patients with Down syndrome.
Other
- ALK-NEGATIVE anaplastic large cell lymphoma.
- 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.
Who the study is looking for
- 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.
Age in the registry: 1 year to 39 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| New York Medical College Coordinator of this site? Confirm its status | Valhalla | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.