BLAST MRD CML 1 Trial: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease (MRD) in Chronic Myeloid Leukemia (CML)- A Phase II Study of Adding the Anti-PD-1 Pembrolizumab to Tyrosine Kinase Inhibitors in Patients with CML and Persistently Detectable MRD
Categories (click each to see list of all clinical trials associated with that category): Leukemia/Myelodysplastic syndromes (MDS)/Myeloproliferative disorders (MPD)
Current Status: Open to accrual
Phase: II
Principal Investigator: Bhatt, Vijaya
Contact Information:
Penny Hardiman, RN
402-559-4135
penny.hardiman@unmc.edu
Eligibility: https://clinicaltrials.gov/ct2/show/NCT03516279?cond=NCT03516279&draw=2&rank=1#eligibility
Summary
Primary Objectives: Assess the proportion of chronic myelogenous leukemia (CML) patients on stable-dose tyrosine kinase inhibitor (TKI) who convert to undetectable minimal residual disease (UMRD) (molecular response [MR] ^ 4.5) during or within 2 years of initiating pembrolizumab therapy. Secondary objectives: Among patients who have converted to UMRD (MR^4.5), assess the proportion of CML patients who maintain UMRD for 6 months and 12 months; among patients who have converted to UMRD (MR^4.5), assess the proportion of CML patients who discontinue their TKI; Among patients who have converted to UMRD (MR^4.5), assess the proportion of CML patients who are UMRD and TKI-free at 2 years from first determined UMRD; assess the proportion of CML patients who develop grade 3 or 4 immune related adverse events related to pembrolizumab treatment during the first 2 years after registration (not including grade 3 events that respond to corticosteroids and improve to grade 1 or less within 4 weeks).