Phase I Study of Q702 With Azacitidine and Venetoclax for Relapsed or Refractory Acute Myeloid Leukemia
M.D. Anderson Cancer Center
Summary
To learn about the safety and tolerability of the drug combination of Q702, azacitidine, and venetoclax when given to participants with relapsed/refractory AML.
Description
Primary Objective: \- To evaluate safety of Q702 and the combination of azacitidine, venetoclax. Secondary Objectives: * To estimate rate of CR/CRh/CRi by 4 treatment cycles * To estimate overall response rate (ORR) * To estimate rate of MRD negative by 4 treatment cycles * To estimate overall survival (OS) * To estimate relapse-free survival (RFS) Exploratory Objectives: * To determine the plasma concentration and pharmacokinetic (PK) parameters of Q702 when dosed in combination with azole antifungals in AML patients * To estimate duration of response (DOR) * To estimate median time to b…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients need to have a confirmed diagnosis of AML, or MDS/AML with 10% to 19% blasts, per the International Consensus Classification 2022 or the WHO 2022 classification.23,24 2. Patients .18 years with R/R AML or R/R MDS/AML, other than acute promyelocytic leukemia (APL), with no available standard treatment options. 3. Relapsed or refractory disease defined by standard criteria as follows: a. Relapsed: Bone marrow blasts .5%, reappearance of blasts in the blood, or development of extramedullary disease following achievement of CR/CRi/MLFS b. Refractory: Failure to…
Interventions
- DrugAzacitidine
Given by IV
- DrugVenetoclax
Given by PO
- DrugQ702
Given by PO
Location
- MD Anderson Cancer CenterHouston, Texas