NCT05355051

A Phase II Study of the Combination of Azacitidine and Pembrolizumab for Patients Relapsed/Refractory Hodgkin's Lymphoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 1 Year
• Healthy volunteers: Accepted

Summary

This study is a Phase II single-center clinical trial designed to assess the efficacy, safety, and tolerability of pembrolizumab in combination with the 7-day regimen of azacitidine for the treatment of relapsed/refractory HL.

Detailed description

OBJECTIVES: Primary Objectives: • To assess the overall response rate (ORR) of Pembrolizumab in combination with azacitidine in patients with relapsed or progressed classical Hodgkin lymphoma (HL). Secondary Objectives: * To assess the duration of response (DOR), relapse-free survival (RFS), and overall survival (OS) of patients with refractory/relapsed HL treated with this combination. * To assess the safety of Pembrolizumab in combination with azacitidine in children with refractory/relapsed HL. * To assess the proportion of patients who proceed to stem cell transplantation upon achieving response with the combination of Pembrolizumab and Azacitidine regimen.

Conditions

• Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	Azacytidine	Given by Vein (IV)
DRUG	Pembrolizumab	Given by Vein (IV)

Timeline

• Start date: 2022-10-05
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2022-05-02
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study