RecruitingRelapsed Hodgkin LymphomaRefractory Hodgkin LymphomaRelapsed Non-Hodgkin Lymphoma
A Phase II Study of the Combination of Pembrolizumab and ATRA Combination Treatment of Relapsed HL and B-NHL
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Rita Assi
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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.
Where it's recruiting
Indiana
Indianapolis
Source: ClinicalTrials.gov · NCT06484920 · last updated 2026-02-10