Chemoimmunotherapy for ALK+ Relapsed/Refractory ALCL (NCT07013565)
NYMC623: A Comprehensive Risk-adapted Chemommunotherapy Protocol of Emerging Immunotherapies for Relapsed/Refractory Alk+ Anaplastic Large Cell Lymphoma (ACCELERATE)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (11 items) and avoid the listed exclusions (9 items).
Location: New York Medical College — Valhalla, New York
Age range: 1 Year to 39 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- New York Medical College — Valhalla, New York
📞 Contact the Study Coordinator
Phone: (914) 594-2150
Email: mitchell_cairo@nymc.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
- 💵 Compensation indicated: Then patients will receive lower doses of chemoimmunotherapy and allogeneic stem cell transplantation (stem cells from another person).
Explore by condition: All Anaplastic Large Cell Lymphoma, ALK-Positive clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.