Study of Venetoclax in Combination With Decitabine in Subjects With Acute Myeloid Leukemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03844815|
Recruitment Status : Not yet recruiting
First Posted : February 18, 2019
Last Update Posted : October 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Drug: Decitabine Drug: Venetoclax||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Study of Venetoclax in Combination With Decitabine 10-Day Regimen in Subjects With Acute Myeloid Leukemia|
|Estimated Study Start Date :||April 10, 2020|
|Estimated Primary Completion Date :||June 10, 2022|
|Estimated Study Completion Date :||June 10, 2024|
Cycle 1 of Treatment will be Decitabine days 1-10 plus Venetoclax ramp up on days 1-3 followed by Venetoclax target dose on days 4-21
Cycle 2 of Treatment will be Decitabine days 1-10 plus Venetcolax target dose days 1-21
During maintenance Decitabine on days 1-5 plus Venetoclax days 1-21
Decitabine will be administered intravenously at a dose of 20mg per day for 10 days during Cycle 1 (28 day cycle)
Decitabine will be administered intravenously at a dose of 20mg per day for 10 days of Cycle 2 (28 day cycle).
Decitabine will be administered intravenously at a dose of 20mg per day for 5 days of each 28 day maintenance cycle
Venetoclax administered orally on days 1-21 of cycle 1, cycle 2 and maintenance (28 day cycles). Dose levels will be assigned at time of enrollment anywhere from 100mg-400mg. Dose escalation will follow the 3+3 study design.
- The rate of dose limiting toxicity (DLT) [ Time Frame: 24 months ]Determine the rate of subjects who experience a dose limiting toxicity and the maximum tolerable dose
- Levels of toxicity with combination regimen [ Time Frame: 24 months ]Levels of toxicity experienced with the combination regimen will be reported using data summaries of adverse events, dose limiting toxicity and other safety parameters.
- Assessment of Overall Survival [ Time Frame: 24 months ]Survival will be measured in months from the date of subject enrollment to the date of death.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03844815
|Contact: Melissa Fridsteinfirstname.lastname@example.org|
|United States, Illinois|
|University Of Chicago Medicine Comprehensive Cancer Center|
|Chicago, Illinois, United States, 60637|
|Contact: Olatoyosi Odenike, MD 773-702-3354 email@example.com|
|Principal Investigator: Olatoyosi Odenike, MD|
|Principal Investigator:||Olatoyosi Odenike, MD||University of Chicago|