ATRA + Pembrolizumab for Lymphoma
Trial Summary
What is the purpose of this trial?
This is a Phase II single-center open label trial of the combination of ATRA and pembrolizumab treatment in patients with histologically proven, relapsed or refractory Hodgkin Lymphoma or B-Non-Hodgkin-lymphoma.
Will I have to stop taking my current medications?
The trial requires you to stop taking Vitamin A supplements and certain medications that affect liver enzymes (CYP3A modulators) at least 3 days before starting the treatment and during the trial. If you're on a micro-dosed progesterone contraceptive, you'll need to switch to another form of birth control.
What data supports the effectiveness of the drug combination ATRA and Pembrolizumab for treating lymphoma?
Research shows that pembrolizumab, a drug that helps the immune system fight cancer, has been effective in treating various cancers, including melanoma and Hodgkin's lymphoma. ATRA, when combined with pembrolizumab, has shown promise in treating melanoma, suggesting potential benefits for other cancers like lymphoma.12345
Is the combination of ATRA and Pembrolizumab safe for humans?
Research on ATRA (All-trans retinoic acid) combined with other treatments like interferon shows that it generally has a manageable safety profile, with some studies reporting negligible side effects. However, specific safety data for the combination of ATRA and Pembrolizumab is not available in the provided research.678910
How is the drug combination of ATRA and Pembrolizumab unique for treating lymphoma?
The combination of ATRA and Pembrolizumab is unique because it targets the immune system in a novel way by combining a retinoic acid (ATRA) that influences cell differentiation with an immune checkpoint inhibitor (Pembrolizumab) that helps T cells attack cancer cells. This approach is different from standard treatments as it leverages both immune modulation and direct cancer cell targeting.1341112
Research Team
Rita Assi, MD
Principal Investigator
Indiana University
Eligibility Criteria
This trial is for people with certain types of lymphoma (Hodgkin's and B-Non-Hodgkin's) that have come back or didn't respond to previous treatments. Specific eligibility details are not provided, but typically participants would need a confirmed diagnosis and may be required to meet other health criteria.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 200mg Q3W pembrolizumab treatment plus 150 mg/m2 ATRA orally for 3 days surrounding each of the first four infusions
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- ATRA
- Pembrolizumab
ATRA is already approved in United States, European Union for the following indications:
- Acute promyelocytic leukemia (APL)
- Acute promyelocytic leukemia (APL)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rita Assi
Lead Sponsor