A Phase II Study of the Combination of Azacitidine and Pembrolizumab for Patients Relapsed/Refractory Hodgkin's Lymphoma
Overview
- Phase
- Phase 2
- Intervention
- Azacytidine
- Conditions
- Hodgkin's Lymphoma
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- To assess the overall response rate (ORR)
- Status
- Recruiting
- Last Updated
- 17 days ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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 of normal (ULN) unless increase is due to Gilbert's disease
- •Aspartate Aminotransferase (AST) \< 3 x ULN unless considered due to lymphoma involvement
- •Provision of written informed consent or assent as per MD Anderson Cancer Center (MDACC) policy for study subjects
- •Females must be surgically or biologically sterile or if of childbearing potential, must have a negative serum or urine pregnancy test within 72 hours before the start of the treatment and each subsequent dose
Exclusion Criteria
- •Allergy to azacitidine or pembrolizumab or the drugs' components
- •Active and uncontrolled comorbidities including active uncontrolled infection, uncontrolled hypertension despite adequate medical therapy, active and uncontrolled congestive heart failure New York Heart Association (NYHA) class III/IV, clinically significant and uncontrolled arrhythmia as judged by the treating physician
- •Patients with known infection with human immunodeficiency virus (HIV) or active Hepatitis B or C
- •Any other medical, psychological, or social condition that may interfere with study participation or compliance, or compromise patient safety in the opinion of the investigator
- •Pregnant or breastfeeding
- •Has received a live vaccine within 30 days of planned start study therapy
- •Current or prior use of immunosuppressive medication within 14 days prior to the first dose of pembrolizumab. The following are exceptions to this criterion:
- •Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection)
- •Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent
- •Steroids as premedication for hypersensitivity reactions (eg, computed tomography \[CT\] scan premedication)
Arms & Interventions
Pembrolizumab plus Azacitidine
Pembrolizumab by vein over about 30 minutes every 3 weeks. Azacitidine by vein over about 60-90 minutes on Days 1-7 of each 28-day study cycle
Intervention: Azacytidine
Pembrolizumab plus Azacitidine
Pembrolizumab by vein over about 30 minutes every 3 weeks. Azacitidine by vein over about 60-90 minutes on Days 1-7 of each 28-day study cycle
Intervention: Pembrolizumab
Outcomes
Primary Outcomes
To assess the overall response rate (ORR)
Time Frame: through study completion, an average of 1 year