Actively Recruiting
NYMC623: A Risk-adapted Chemotherapy and Immunotherapy Protocol for Relapsed/Refractory ALK-positive Anaplastic Large Cell Lymphoma in Children, Adolescents, and Young Adults
Led by New York Medical College · Updated on 2026-05-20
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
N
New York Medical College
Lead Sponsor
U
University of Alabama at Birmingham
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial focuses on children, adolescents, and young adults with relapsed or refractory high-risk ALK-positive Anaplastic Large Cell Lymphoma (ALCL), a condition with low overall survival rates. Researchers are studying whether combining the FDA-approved immunotherapy drug Nivolumab (NIVO) with chemotherapy, tailored to the patient's risk status, can improve treatment response and survival. The study also evaluates the use of allogeneic stem cell transplantation (stem cells from another person) following this combined therapy to further improve outcomes in this high-risk group. Participants are assigned to different treatment groups based on their risk level. Low-risk patients receive Vinblastine alone for induction and possibly extended therapy if remission is achieved. High-risk patients without prior exposure to Brentuximab vedotin (BV) receive a combination of BV and NIVO for induction, followed by stem cell transplant if remission is reached. High-risk patients previously treated with BV receive Vinblastine plus NIVO initially, with possible addition of BV based on response. Treatment cycles are typically given every 21 days, and therapy is adjusted according to disease response. During the study, participants will undergo disease assessments after induction cycles to evaluate treatment response. Researchers will monitor safety by tracking adverse events related to the drugs used. They will measure overall response rates and event-free survival over one year. The study includes regular performance status evaluations and organ function assessments. Participants may receive stem cell transplantation as part of their treatment plan. The total participation duration includes induction therapy, consolidation, and follow-up assessments to monitor safety and effectiveness over time.
CONDITIONS
Brief Title
Chemoimmunotherapy for ALK+ Relapsed/Refractory ALCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must weigh 610 kilograms at study enrollment
- Diagnosis of relapsed or refractory ALK-positive anaplastic large cell lymphoma meeting Low or High Risk criteria
- Low Risk Cohort includes patients with first relapse more than one year after initial diagnosis, common histology, CD3 negative, and no prior vinblastine exposure
- High Risk Cohort includes patients with relapse or progression less than one year from diagnosis, small cell/histiocytic histology, CD3 positive T-cells
- Adequate organ function
- Performance status of 60 or above
You will not qualify if you...
- ALK-negative anaplastic large cell lymphoma
- Active leptomeningeal disease (lymphoma in cerebrospinal fluid)
- Prior vinblastine treatment for Low Risk patients
- Pregnant females; pregnancy tests required for post-menarche girls
- Lactating females who do not agree to avoid breastfeeding
- Patients with Down syndrome
- Uncontrolled infections before study entry
- Known primary or acquired immunodeficiency or prior solid organ transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Treatment duration varies based on response and cohort, with some participants receiving up to 24 months of therapy if no disease progression or unacceptable toxicity occurs.
Participants receive risk-adapted chemotherapy and immunotherapy with different drug combinations depending on their risk cohort, including vinblastine, brentuximab vedotin, and nivolumab.
Visits every 21 days for induction cycles, with additional assessments depending on response
Duration - Up to 1 year
Participants are monitored after treatment to assess safety, overall response, and survival outcomes.
Periodic visits during the follow-up period
Trial Site Locations
Total: 1 location
1
New York Medical College
Valhalla, New York, United States, 10595
Actively Recruiting
Research Team
M
Mitchell S Cairo, MD
L
Lauren Harrison, RN, MSN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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