NCT06484920 · Rita Assi
A Phase II Study of the Combination of Pembrolizumab and ATRA Combination Treatment of Relapsed HL and B-NHL
What this study 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.
View original scientific description
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.
Interventions
DRUG
ATRA
150 mg/m2 ATRA orally for 3 days surrounding each of the first four cycles (day -1, day 0, day +1)
DRUG
Pembrolizumab
200mg Q3W pembrolizumab
Primary outcome measures
Incidence of Adverse Events
Time frame: from start of treatment through 90 days safety follow-up visit
Safety will be assess by the NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- ≥ 18 years old at the time of informed consent 2. Ability to provide written informed consent and HIPAA authorization 3. Willingness to comply with all study procedures and be available for the duration of the trial 4. Have a performance status of 0 to 2 on the ECOG Performance Scale. 5. Life expectancy ≥12 weeks as per investigator discretion 6. Patients with histologically proven, relapsed or refractory HL or B-NHL as follows: 1. HL after failure of at least 1 prior line of systemic therapy 2. Primary mediastinal large B-cell lymphoma (PMBCL) that is refractory to first-line therapy 3. Other B-cell NHLs after failure of at least 2 prior lines of systemic therapy. The eligible types of B-cell NHLs are: i. Diffuse large B cell lymphoma ii. Follicular lymphoma iii. Marginal Zone lymphoma iv. Mantle Cell Lymphoma d. Indolent lymphoma are only eligible if they require systemic treatment e. Lymphocyte predominant HL are eligible Note: Formalin-fixed, p
Where
- Indianapolis, Indiana
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 10, 2026 · Source of record for eligibility and locations