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 * Patients with relapsed HL involving extranodal sites * HL patients who are not regarded as a candidate for high-dose, conventional chemotherapy * Age of enrollment: Minimum age 1 year. No maximum age, study will include anyone in the pediatric/adolescent center at MD Anderson (MDA) * Eastern Cooperative Oncology Group (ECOG) performance status =\< 3 or Lansky performance status \>= 50 * Adequate renal function per age unless related to the disease * Total bilirubin \< 2 x upper limit o…
Interventions
- DrugAzacytidine
Given by Vein (IV)
- DrugPembrolizumab
Given by Vein (IV)
Location
- MD Anderson Cancer CenterHouston, Texas