Study on Adding Ruxolitinib to Pembrolizumab for Treating Relapsed or Resistant Hodgkin and Non-Hodgkin Lymphomas
Sponsor: Seda S. Tolu
ClinicalTrials ID:NCT07283822
This clinical trial is exploring whether adding the drug ruxolitinib to pembrolizumab is safe and effective for patients with Hodgkin and non-Hodgkin lymphomas that have returned or are not responding to treatment.
Patient Parameters
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Program Overview
The aim of this study is to find out if combining ruxolitinib with pembrolizumab can help treat certain types of lymphomas that have either come back after treatment or are not responding to standard chemotherapy. The study includes patients with peripheral T-cell lymphoma (PTCL), cutaneous T-cell lymphomas (CTCL), Hodgkin Lymphoma (HL), Gray Zone Lymphomas (GZL), and Primary Mediastinal B-cell Lymphoma (PMBCL). Ruxolitinib is an investigational drug not yet approved for these lymphomas, but it has shown promise in combination with immunotherapy. Pembrolizumab is approved for some of these lymphomas and is often used when other treatments are limited.
Description
This study involves patients with certain types of lymphomas that have either not responded to treatment or have returned after treatment. It includes peripheral T-cell lymphoma (PTCL), cutaneous T-cell lymphomas (CTCL), Hodgkin Lymphoma (HL), Gray Zone Lymphomas (GZL), and Primary Mediastinal B-cell Lymphoma (PMBCL). The main goal for PTCL patients is to see how many achieve complete remission, meaning no signs of cancer. For CTCL patients, the focus is on how many show improvement. Ruxolitinib is being tested in combination with pembrolizumab to see if it can be effective in these cases. Ruxolitinib is not yet approved for these lymphomas, but has shown effectiveness in trials. Pembrolizumab is approved for some of these lymphomas and is used when other options are limited.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with relapsed or resistant Hodgkin or non-Hodgkin lymphomas, including specific subtypes like PTCL, CTCL, HL, GZL, and PMBCL.
- Must have received at least one prior systemic therapy.
- Must not have had chemotherapy or immunotherapy within two weeks before starting the study.
- Must be 18 years or older.
- Must have measurable disease as defined by the study protocol.
- Must not have active central nervous system disease.
- Must be screened for hepatitis B and C, and HIV, with specific requirements for those with positive results.
- Must have adequate organ function and performance status.
- Must be able to understand and sign a consent form.
- Women of childbearing potential must have a negative pregnancy test and agree to use contraception during the study and for six months after.
Exclusion Criteria
- Diagnosis of Adult T-Cell Leukemia/Lymphoma (ATLL).
- History of autoimmune disease requiring systemic treatment.
- Receiving immunosuppressive therapy within seven days before the study.
- Active use of systemic steroids exceeding 10mg daily.
- Not eligible for stem cell transplant or CAR-T therapy if applicable.
- History of solid organ transplant requiring immunosuppression.
- Active tuberculosis or severe allergies to study drugs.
- Inability to swallow medications.
- Pregnant or breastfeeding women.
- Recent major cardiac events or active infections.
- Concurrent active malignancy receiving treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Columbia University Irving Medical Center | 10032 | New York | New York |
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