Overview

High Dose Cytarabine Followed by Pembrolizumab in Relapsed/Refractory AML

Status:
Active, not recruiting
Trial end date:
2024-11-01
Target enrollment:
Participant gender:
Summary
Rationale:The purpose of this research study is to test the effectiveness of the standard high dose cytarabine (HiDAC) on days 1 through 5 followed by a single dose of pembrolizumab on day 14 as induction therapy in patients with relapsed and refractory acute myeloid leukemia (AML). Patients who achieve a response to treatment will continue on the study drug (pembrolizumab) every 3 weeks for up to 2 years maintenance therapy. Purpose:This is a study about a new investigative drug, pembrolizumab (MK-3475) that is being studied in a clinical research trial together with standard chemotherapy (HiDAC) in relapsed and refractory AML. The study will also explore the association between potential immune biomarkers and clinical outcomes with pembrolizumab; therefore all patients will have blood and bone marrow samples collected before and after treatment to determine the dynamic nature of immune signatures pre and post-treatment.
Phase:
Phase 2
Details
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborator:
Merck Sharp & Dohme Corp.
Treatments:
Cytarabine
Pembrolizumab