NCT07013565 · New York Medical College
Chemoimmunotherapy for ALK+ Relapsed/Refractory ALCL
(ACCELERATE)
What this study is about
Children, adolescents, and young adults (CAYA) with relapsed/refractory (R/R) high-risk ALK+ Anaplastic Large Cell Lymphoma (ALCL) have a low incidence of how long patients live.
View original scientific description
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 participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Valhalla, New York
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 20, 2026 · Source of record for eligibility and locations