Phase II Study of Pembrolizumab and ATRA for Treating Relapsed Hodgkin and B-Cell Non-Hodgkin Lymphoma
Sponsor: Rita Assi
ClinicalTrials ID:NCT06484920
This clinical trial is testing a combination of two drugs, Pembrolizumab and ATRA, to see if they can help treat patients with Hodgkin Lymphoma or B-Cell Non-Hodgkin Lymphoma that has returned or not responded to previous treatments.
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Program Overview
This study is exploring the effectiveness of combining Pembrolizumab and ATRA in treating patients with Hodgkin Lymphoma (HL) or B-Cell Non-Hodgkin Lymphoma (B-NHL) that has come back or is not responding to treatment. The trial is open-label, meaning both the researchers and participants know what treatment is being given. It is being conducted at a single center and aims to find out if this combination can help control the disease.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Able to provide written consent and agree to follow study procedures.
- Have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
- Expected to live at least 12 more weeks.
- Have a confirmed diagnosis of relapsed or refractory Hodgkin Lymphoma or B-Cell Non-Hodgkin Lymphoma, including specific subtypes like Diffuse Large B Cell Lymphoma or Follicular Lymphoma.
- Must have adequate blood cell counts and organ function based on recent lab tests.
- Women of childbearing potential must have a negative pregnancy test before starting treatment and agree to use effective contraception during the study and for 120 days after the last dose.
- Men must agree to use effective contraception during the study and for 120 days after the last dose.
- Patients with a history of CAR-T cell therapy are eligible if it has been at least one year since treatment.
Exclusion Criteria
- Currently participating in another study or have used an investigational drug or device within 4 weeks before starting this study.
- Have known brain metastases unless previously treated and stable.
- Significant decline in health status before starting treatment.
- Have an immune deficiency or are taking immunosuppressive drugs.
- Allergic to Pembrolizumab or ATRA.
- Have had certain other cancer treatments recently and not fully recovered from side effects.
- Have had another cancer in the last 5 years, except for certain skin cancers or in situ cancers that have been treated.
- Have had major surgery recently and not fully recovered.
- Have active lung inflammation or infections.
- Have conditions or treatments that might interfere with the study.
- Pregnant or breastfeeding, or planning to conceive or father a child during the study.
- Have a history of certain viral infections like HIV or active Hepatitis B or C.
- Have received a live vaccine recently.
- Have a history of organ transplant, unless it was more than 5 years ago and deemed eligible by the doctor.
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