This study will evaluate the safety and efficacy of alvocidib in patients with AML who have either relapsed from or are refractory to venetoclax in combination with azacytidine or decitabine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Alvocidib (flavopiridol), administered intravenously, + cytarabine (Ara-C), administered by subcutaneous injection
Administered intravenously
Community Medical Providers
Clovis, California, United States
City of Hope National Medical Center, City of Hope Medical Center
Combined Complete Remission
Rate of combined complete remission (complete remission (CR) + CR with incomplete hematological recovery (CRi)), as defined by the International Working Group Criteria and 2017 European LeukemiaNet). Combined complete remissions (patients with a best response of CR or CRi), complete remissions, composite complete remissions (patients with a best response of CR, CRi or CRh), and combined responses (patients with a best response of CR, CRi, CRh, MLFS or PR) will be summarized by observed response rates and estimated 95% CIs.
Time frame: Response assessments were measured from date of first dose through End of Treatment date, an average of 3 months.
Median Overall Survival
Time from treatment (Day 1) until death from any cause
Time frame: From first dose until disease progression or death; through study termination, an average of 10 months
Complete Response Rate
Percentage of patients achieving complete response (CR) whose bone marrow is determined to be negative for minimal residual disease (MRD) using standardized techniques (ie, multiparametric flow cytometry \[MPFC\] and molecular testing including next generation sequencing \[NGS\]
Time frame: Response assessments were measured from date of first dose through end of treatment date, an average of 3 months
Composite CR Rate
Patients with a best response of CR + CRi + CRh (CR + partial recovery of both blood cell types)
Time frame: Response assessments were measured from date of first dose through end of treatment date, an average of 3 months
Combined Response Rate
Combined Percentage of Patients Achieving One of the Following: CR \< CRi, CRh, MLFS, PR Morphologic leukemia-free state (MLFS) = Bone marrow blasts \<5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required; Partial Response (PR) = Meets all hematologic values required for CR but with a decrease of at least 50% in the percentage of blasts to ≥5% to ≤25% in bone marrow
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Duarte, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
University of California, San Francisco Medical Center
San Francisco, California, United States
Advent Health Medical Group Blood & Marrow Transplant at Orlando
Orlando, Florida, United States
Orlando Health, Inc, Univ of Florida Health Cancer Center
Orlando, Florida, United States
Indiana Blood and Marrow Translplantation - Clinic
Indianapolis, Indiana, United States
University of Kansas Medical Center
Westwood, Kansas, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
University of New Mexico
Albuquerque, New Mexico, United States
...and 8 more locations
Time frame: Response assessments were measured from date of first dose through end of treatment date, an average of 3 months
Event Free Survival (EFS)
Event Free Survival - time from first treatment (D1) until (a) treatment failure, (b) relapse after CR/Cri or CRh, or (c) death from any cause, whichever occurs first
Time frame: From first dose until disease progression or death; through study termination, an average of 10 months
Duration of Composite Complete Remission (CR)
Duration of Composite CR, defined as the time from first documented response of CR, CRi or CRhi to relapse or death from any cause
Time frame: Response assessments were measured from date of first dose through end of treatment date, an average of 3 months
Transfusion Independence
Rates of 28- and 56-day Transfusion Independence (TI) = Percentages of patients who do not receive red blood cell (RBC) transfusions, platelet (PLT) transfusions, and neither RBC nor PLT transfusions for 28 and 56 days; comprised of 6 secondary endpoints
Time frame: Transfusion dependence was measured from 28 days prior to first dose through 56 days after last dose, an average of 6 months