A Phase II Study of the Combination of Azacitidine and Pembrolizumab for Patients Relapsed/Refractory Hodgkin's Lymphoma
M.D. Anderson Cancer Center
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.
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 achievin…
Eligibility
- Age range
- 1+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * HL patients with relapse or progression. Prior checkpoint inhibitors will be allowed * AML patients with relapse or progression. Patients may receive cytoreduction prior to enrollment for patients with rapidly proliferative disease before the start of study therapy, as needed, for clinical benefit and after discussion with the PI. Concurrent therapy for central nervous system (CNS) prophylaxis or continuation of therapy for controlled CNS disease is permitted * Patients with relapsed HL involving extranodal sites * HL patients who are not regarded as a candidate for high…
Interventions
- DrugAzacytidine
Given by Vein (IV)
- DrugPembrolizumab
Given by Vein (IV)
Location
- MD Anderson Cancer CenterHouston, Texas