Phase II Study on Azacitidine and Pembrolizumab for Treating Relapsed or Hard-to-Treat Hodgkin's Lymphoma
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT05355051
This clinical trial is testing a combination of two drugs, azacitidine and pembrolizumab, to see if they are safe and effective in treating patients with Hodgkin's Lymphoma that has returned or is not responding to treatment.
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Program Overview
The study aims to evaluate how well the combination of azacitidine and pembrolizumab works in treating Hodgkin's Lymphoma that has come back or is not responding to other treatments. It will also look at how long the treatment effects last, the safety of the drugs, and whether patients can proceed to stem cell transplantation after treatment.
Description
This study is focused on patients with Hodgkin's Lymphoma that has either returned after treatment or is not responding to current therapies. The main goal is to see how effective the combination of azacitidine and pembrolizumab is in treating these patients. Researchers will also monitor how long the treatment effects last, the safety of the drugs, and whether patients can move on to stem cell transplantation after showing a positive response to the treatment. The study will include both children and adults, with no maximum age limit, and will be conducted at a single center.
Eligibility Criteria
Inclusion Criteria
- Patients with Hodgkin's Lymphoma that has returned or is not responding to treatment.
- Patients with Hodgkin's Lymphoma affecting areas outside the lymph nodes.
- Patients who are not suitable for high-dose chemotherapy.
- Age 1 year and older, including pediatric and adolescent patients.
- Good overall health with a performance status score of 3 or less.
- Adequate kidney function unless affected by the disease.
- Total bilirubin levels less than 2 times the normal limit unless due to Gilbert's disease.
- AST levels less than 3 times the normal limit unless due to lymphoma.
- Ability to provide informed consent or assent.
- Women must not be pregnant and must use effective birth control during and after the study.
- Men must use effective birth control and inform the doctor if their partner becomes pregnant.
Exclusion Criteria
- Allergy to azacitidine or pembrolizumab.
- Uncontrolled health conditions, such as infections or heart problems.
- Known HIV or active Hepatitis B or C infections.
- Any condition that may interfere with the study or patient safety.
- Pregnant or breastfeeding women.
- Recent live vaccine within 30 days before starting the study.
- Use of immunosuppressive medication within 14 days before the first dose, with some exceptions for certain types of steroids.
- Active or recent autoimmune diseases, except for certain conditions like childhood asthma or psoriasis not requiring treatment.
- Active cancer spread to the brain or spinal cord.
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