NCT07013565 Chemoimmunotherapy for ALK+ Relapsed/Refractory ALCL
| NCT ID | NCT07013565 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | New York Medical College |
| Condition | Anaplastic Large Cell Lymphoma, ALK-Positive |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-08-07 |
| Primary Completion | 2029-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2025-08-07 with a primary completion date of 2029-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Mitchell S Cairo, MD
PRINCIPAL INVESTIGATOR
New York Medical College
Frequently Asked Questions
Who can join the NCT07013565 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 39 Years, studying Anaplastic Large Cell Lymphoma, ALK-Positive. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07013565 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07013565 currently recruiting?
Yes, NCT07013565 is actively recruiting participants. Contact the research team at mitchell_cairo@nymc.edu for enrollment information.
Where is the NCT07013565 trial being conducted?
This trial is being conducted at Valhalla, United States.
Who is sponsoring the NCT07013565 clinical trial?
NCT07013565 is sponsored by New York Medical College. The principal investigator is Mitchell S Cairo, MD at New York Medical College. The trial plans to enroll 20 participants.