Study on Chemoimmunotherapy for ALK+ Relapsed or Refractory Anaplastic Large Cell Lymphoma (ALCL)
Sponsor: New York Medical College
ClinicalTrials ID:NCT07013565
This clinical trial is exploring a new treatment approach for children, adolescents, and young adults with ALK+ Anaplastic Large Cell Lymphoma (ALCL) that has returned or not responded to previous treatments. The study combines a new immunotherapy drug, Nivolumab, with chemotherapy to improve survival rates.
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Program Overview
This study aims to find out if combining a new immunotherapy drug called Nivolumab with chemotherapy can help children, adolescents, and young adults with ALK+ Anaplastic Large Cell Lymphoma (ALCL) that has come back or not responded to treatment. The goal is to achieve the best possible response before giving lower doses of chemoimmunotherapy and a stem cell transplant from a donor. Researchers hope this new approach will improve survival rates for these high-risk patients.
Description
Anaplastic Large Cell Lymphoma (ALCL) is a type of cancer that can be difficult to treat, especially when it returns or doesn't respond to initial treatments. This study is testing a new combination of treatments to see if it can help patients with ALK+ ALCL. The treatment includes a drug called Nivolumab, which is an immunotherapy that helps the immune system fight cancer, combined with chemotherapy.
Previous studies have shown that using a drug called Brentuximab Vedotin (BV) with chemotherapy improved outcomes for patients with ALK+ ALCL. Nivolumab has also shown promise in treating other types of lymphoma. This study will test if combining BV and Nivolumab is safe and effective for patients with relapsed or refractory ALK+ ALCL.
The study will also explore if using a stem cell transplant from a donor can further improve outcomes. Stem cell transplants can help replace damaged cells with healthy ones, potentially leading to better long-term results. The researchers believe that this new treatment approach could lead to higher survival rates for patients with high-risk ALK+ ALCL.
Eligibility Criteria
Inclusion Criteria
- Must weigh at least 10 kilograms.
- Have relapsed or refractory ALK-positive Anaplastic Large Cell Lymphoma (ALCL) confirmed by tests.
- Have good organ function.
- Have a performance status score of 60 or above, indicating the ability to carry out daily activities.
Exclusion Criteria
- Have ALK-negative Anaplastic Large Cell Lymphoma.
- Have active lymphoma cells in the cerebrospinal fluid (CSF).
- Have previously been treated with vinblastine (for patients in the low-risk group).
- Are pregnant or breastfeeding.
- Have Down syndrome.
- Have an uncontrolled infection before starting the study.
- Have a primary or acquired immunodeficiency or have had a solid organ transplant.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| New York Medical College | 10595 | Valhalla | New York |
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