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RECRUITINGPHASE2

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

A Phase II Study of the Combination of Pembrolizumab and All-Trans Retinoic Acid Combination Treatment of Relapsed Hodgkin Lymphoma (HL) and B-Non-Hodgkin- Lymphoma (B-NHL)

NCT06484920•Rita Assi

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. ≥ 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:
•7. Adequate hematologic and end organ function, defined by the following laboratory results obtained within 10 days prior to the first study treatment: Hematological Absolute neutrophil count (ANC) ≥1,500 /mcL Platelets ≥100,000 / mcL Hemoglobin ≥9 g/dL or ≥5.6 mmol/L without transfusion or EPO dependency (within 7 days of assessment) INR and aPTT ≤1.5 x ULN; this applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose. Renal calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) calculated creatinine clearance ≥ 60 mL/min Hepatic Serum total bilirubin
+26 more criteria

Exclusion Criteria

•1. Patients currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
•2. Known brain metastases and/or leptomeningeal disease. Subjects with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
•3. Significant reduction in ECOG performance status between the screening/ baseline visit and within 72 hours prior to commencement of treatment as per trial protocol, as per the Investigator's assessment, defined as a reduction in ECOG score to 3 or 4.
•4. Patients with a diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) within 7 days prior to the first dose of trial treatment.
•Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
•5. Hypersensitivity to pembrolizumab or any of its excipients.
•6. Contraindication to the use of ATRA including but not limited to: patients with a history of hypersensitivity reaction to tretinoin, vesanoid or related compounds ( i.e. acitretin, isotretinoin, vitamin A); , Tetracyclines, Progesterone (low dose), drugs inducing P450 (rifampicin, glucocorticoids, phenobarbital, etc), ketoconazole and drugs inhibiting p450 (cimetidine, erythromycin, cyclosporine, etc); antifibrinolytic agents (e.g. tranexamic acid, aminocaproic acid, aprotinin) and hydroxyurea)
•7. Prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day -1 or who have not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
•8. Prior chemotherapy targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day -1 or who have not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent. Subjects with chronic conditions such as vision changes or prior hearing loss that is not reasonably expected to be exacerbated by the investigational product may be included. Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study. Note: Subjects with Grade 2 adrenal insufficiency or thyroid conditions who are not expected to resolve to baseline, are on a stable dose of medication may be included if it is not reasonably expected to be exacerbated by the investigational product, and asymptomatic whilst on treatment.

Locations (2)

Indiana University Health Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, United States

Sidney and Lois Eskenazi Hospital

Indianapolis, Indiana, United States

Key Dates

Start Date

November 18, 2024

Primary Completion Date

December 1, 2027

Completion Date

September 1, 2029

Last Updated

February 10, 2026

Enrollment

ESTIMATED participants

Conditions

Relapsed Hodgkin LymphomaRefractory Hodgkin LymphomaRelapsed Non-Hodgkin LymphomaRefractory Non-Hodgkin LymphomaB-cell Lymphoma

Interventions

ATRA

DRUG

Pembrolizumab

DRUG

Contacts

Kat Ton, RN

CONTACT

(317) 278-8506 katton@iu.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 10, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma

Treatment Strategy for Relapsed/Refractory Hodgkin Lymphoma

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