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

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Rita Assi
Study ID
NCT06484920
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • B-cell Lymphoma
  • Refractory Hodgkin Lymphoma
  • Refractory Non-Hodgkin Lymphoma
  • Relapsed Hodgkin Lymphoma
  • Relapsed Non-Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ATRA — DRUG
    150 mg/m2 ATRA orally for 3 days surrounding each of the first four cycles (day -1, day 0, day +1)
  • Pembrolizumab — DRUG
    200mg Q3W pembrolizumab

Study Details

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.

Key Dates

Start date
Nov 18, 2024
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Sep 30, 2029

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ATRA and Pembrolizumab
    Patients will receive 200mg Q3W pembrolizumab treatment plus the supplemental treatment of 150 mg/m2 ATRA orally for 3 days surrounding each of the first four infusions of pembrolizumab (day -1, day 0, day +1).

Primary Outcome Measure

Incidence of Adverse Events [ Time Frame: from start of treatment through 90 days safety follow-up visit ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Indiana University Health Melvin and Bren Simon Comprehensive Cancer CenterIndianapolisIndiana46202
Kat Ton, RN
[email protected]
(317) 278-8506
Rita Assi, MD (PRINCIPAL_INVESTIGATOR)
Sidney and Lois Eskenazi HospitalIndianapolisIndiana46202
Kat Ton
[email protected]
(317) 278-8506
Ahmad Al-Hader (SUB_INVESTIGATOR)

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By research site
Indiana University Health Melvin and Bren Simon Comprehensive Cancer Center· Indianapolis, INSidney and Lois Eskenazi Hospital· Indianapolis, IN

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