Phase II Study of Pembrolizumab and ATRA for Treating Relapsed Hodgkin and B-Cell Non-Hodgkin Lymphoma

Sponsor: Rita Assi

Sponsor score: 0
Inactive

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.

Patient Parameters

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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