Actively Recruiting
A Phase II Study of the Combination of Pembrolizumab and All-Trans Retinoic Acid Combination Treatment of Relapsed Hodgkin Lymphoma and B-Non-Hodgkin Lymphoma
Led by Rita Assi · Updated on 2026-02-10
24
Participants Needed
2
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a combination treatment of all-trans retinoic acid (ATRA) and pembrolizumab in adults with relapsed or refractory Hodgkin Lymphoma (HL) or B-cell Non-Hodgkin Lymphoma (B-NHL). This Phase II trial focuses on patients who have not responded to previous therapies or have experienced disease relapse. The study aims to assess safety and treatment effects in this specific lymphoma population. Participants receive pembrolizumab 200 mg every three weeks along with ATRA taken orally at a dose of 150 mg/m2 for three days around each of the first four pembrolizumab infusions (the day before, the day of, and the day after each infusion). This open-label trial involves one treatment arm combining these two drugs to investigate their joint impact on lymphoma. During the study, participants will be monitored for adverse events up to 90 days after treatment. Researchers will also evaluate response rates, including overall and complete remission, for up to two years following the last therapy. Blood samples will be collected at screening, before cycles 2 and 4, and shortly after cycle 4 to analyze immune cells. Participants must attend all scheduled visits and comply with study procedures throughout the trial duration.
CONDITIONS
Brief Title
A Phase II Study of the Combination of Pembrolizumab and ATRA Combination Treatment of Relapsed HL and B-NHL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years old or older at the time of informed consent
- Ability to provide written informed consent and HIPAA authorization
- Willingness to follow all study procedures and be available for the trial duration
- Performance status of 0 to 2 on the ECOG scale
- Life expectancy of at least 12 weeks
- Histologically confirmed relapsed or refractory Hodgkin Lymphoma or B-cell Non-Hodgkin Lymphoma after specified prior therapies
- Availability of tumor tissue sample or willingness to have biopsy
- Adequate blood counts and organ function within 10 days prior to first treatment
- Negative pregnancy test for females of childbearing potential within 72 hours before treatment
- Agreement to use effective contraception during and after study for both females and males of childbearing potential
- Patients with history of CAR-T therapy eligible if at least 3 months post treatment
You will not qualify if you...
- Participation in another investigational study or treatment within 4 weeks prior to treatment
- Known brain metastases or leptomeningeal disease unless stable and off steroids
- Significant decline in performance status to 3 or 4 before treatment
- Immunodeficiency or recent systemic immunosuppressive therapy within 7 days
- Allergy to pembrolizumab or its components
- Contraindications to ATRA or related compounds
- Recent prior monoclonal antibody or chemotherapy within specified windows without recovery
- History of recent malignancies except certain treated skin or cervical cancers
- Major surgery within 4 weeks prior to treatment
- Active non-infectious pneumonitis or uncontrolled infections
- Psychiatric or substance abuse disorders interfering with trial participation
- Pregnancy, breastfeeding, or intent to conceive during study period
- Use of prohibited medications or supplements unwilling to stop
- Prior anti-PD-1, anti-PD-L1, or anti-PD-L2 therapy
- Known HIV, active hepatitis B or C, or active tuberculosis
- Recent live vaccine use within 30 days except certain flu vaccines
- Recent COVID-19 vaccination within 4 weeks prior to treatment
- History of organ transplant unless over 5 years and approved by physician
- Use of micro-dosed progesterone "mini-pill" without willingness to change contraception method
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 12 weeks (4 cycles of pembrolizumab every 3 weeks)
Participants receive pembrolizumab every 3 weeks and oral ATRA for 3 days surrounding each of the first four pembrolizumab treatments.
Every 3 weeks for up to 4 cycles
Duration - 90 days
Participants are monitored for safety and treatment response for up to 90 days after treatment ends.
1 visit (safety follow-up)
Trial Site Locations
Total: 2 locations
1
Indiana University Health Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
2
Sidney and Lois Eskenazi Hospital
Indianapolis, Indiana, United States, 46202
Actively Recruiting
Research Team
K
Kat Ton, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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