Phase II Study of Pembrolizumab and ATRA for Relapsed Lymphoma

This study is testing a combination of two drugs, pembrolizumab and ATRA, for people with Hodgkin Lymphoma or B-cell Non-Hodgkin Lymphoma that has come back (relapsed) or is not responding to treatment (refractory). Researchers want to see how safe this combination is by tracking any side effects. You may be able to join if you are at least 18 years old, have a good general health status (ECOG Performance Scale 0-2), and are expected to live at least 12 weeks. This study is currently unclear about its recruitment status and plans to enroll 24 participants.

Study design
This is a Phase II, single-center, open-label study, meaning everyone knows which treatment they are receiving. It plans to enroll 24 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety from the start of treatment through a 90-day safety follow-up visit.

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NCT06484920

A Phase II Study of the Combination of Pembrolizumab and ATRA Combination Treatment of Relapsed HL and B-NHL

Recruiting
PHASE2Ages 18+InterventionalTreatment
Rita Assi
~24 participants
Updated 2026-02-10 on ClinicalTrials.gov
What's tested:ATRAPembrolizumab

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Adverse Events
Measured over from start of treatment through 90 days safety follow-up visit
Relapsed Hodgkin Lymphoma
Refractory Hodgkin Lymphoma
Relapsed Non-Hodgkin Lymphoma
Refractory Non-Hodgkin Lymphoma
B-cell Lymphoma
2 sites across 1 states
Indiana2
  • Rita Assi, MD · PRINCIPAL_INVESTIGATOR · Indiana University

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Eligibility criteria

Inclusion

1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels \> 1.5 ULN (patients with known Gilbert disease who have bilirubin levels ≤ 3 x ULN may be enrolled). Patients must be able to undergo biliary stenting if required before or, if required, during the trial AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR
5 X ULN for subjects with liver metastases Albumin \>2.5 mg/dL 8. Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Note: Female of childbearing potential definition: (ECOG definition) Any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
  • Incidence of Adverse Eventsfrom 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