Actively Recruiting
A Phase II Study of the Combination of Pembrolizumab and ATRA Combination Treatment of Relapsed HL and B-NHL
Led by Rita Assi · Updated on 2026-02-10
24
Participants Needed
2
Research Sites
249 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 or older at the time of informed consent
- Able to provide written informed consent and HIPAA authorization
- Willing to follow all study procedures and available for the entire trial duration
- ECOG performance status between 0 and 2
- Life expectancy of at least 12 weeks as determined by the investigator
- Histologically confirmed relapsed or refractory HL or B-NHL, including HL after at least one prior systemic therapy, primary mediastinal large B-cell lymphoma refractory to first-line therapy, and other specified B-cell NHLs after at least two prior systemic therapies
- Availability of a formalin-fixed, paraffin-embedded tumor sample or willingness to undergo biopsy before study entry
- Adequate blood counts and organ function within 10 days before treatment, including ANC ≥ 1,500/mcL, platelets ≥ 100,000/mcL, hemoglobin ≥ 9 g/dL without transfusion dependency, and renal and hepatic function within specified limits
- Negative pregnancy test within 72 hours before first dose for females of childbearing potential
- Willingness to use effective contraception during the study and for 120 days after last dose for 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 use of investigational agents within 4 weeks before treatment
- Known brain metastases or leptomeningeal disease unless stable for at least 4 weeks without steroids
- Significant decline in ECOG status to 3 or 4 within 72 hours before treatment
- Immunodeficiency or use of systemic immunosuppressive therapy within 7 days before treatment
- Hypersensitivity to pembrolizumab or ATRA or related compounds
- Recent anti-cancer monoclonal antibody therapy within 4 weeks or chemotherapy, targeted therapy, or radiation within 2 weeks without recovery
- History of other malignancies within 5 years except certain treated skin or cervical cancers
- Major surgery within 4 weeks before treatment without recovery
- Active non-infectious pneumonitis or uncontrolled infections requiring systemic therapy
- Psychiatric or substance abuse disorders interfering with trial participation
- Pregnant or breastfeeding, or unwillingness to use effective contraception
- Prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents
- Known HIV, active Hepatitis B or C, or active tuberculosis
- Receipt of live vaccines within 30 days before treatment
- COVID-19 vaccination within 4 weeks before treatment
- Use of prohibited medications including Vitamin A supplements and CYP3A modulators without washout
- History of allogenic stem cell or solid organ transplant unless more than 5 years ago and approved by physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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