Venetoclax and Azacitidine for Non-Elderly Adult Patients With Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT03573024|
Recruitment Status : Recruiting
First Posted : June 28, 2018
Last Update Posted : December 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Drug: Azacitidine Drug: Venetoclax||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy of Venetoclax and Azacitidine for Newly Diagnosed Non-Elderly Adult Patients (Aged 18-59) With Acute Myeloid Leukemia|
|Actual Study Start Date :||November 14, 2018|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||June 2023|
Experimental: Azacitidine and Venetoclax
Azacitidine will be given intravenously for 7 days. Venetoclax will be given orally. The patient will start out with 100mg and progress to 600mg. Once 600mg is reached, the patient will stay at this dose until the 28 day cycle is finished.
On day 1 of cycle 1, azacitidine 75 mg/m2 SC or IV will be given, and will continue for 7 days.
Starting on day 2 of cycle 1, venetoclax will be initiated. It will be dose escalated to a target dose of 600 mg in the following manner: 100 mg on day 2, 200 mg on day 3, 400 mg on day 4 and 600 mg on day 5. The patient then continues to take the 600mg dose for the remainder of the 28 day cycle. Each dose of venetoclax will be self-administered with approximately 240 mL of water within 30 minutes after the completion of a meal, preferably breakfast. The dose should be administered at the same time each day. On days the subject is given azacitidine, venetoclax must be given first.
- Response Rate, measured by the European Leukemia Net definition: (CRMRD-+CR+CRi+MLFS) [ Time Frame: Study start date to study end date, or death, whichever comes first, up to 4 years ]The (CRMRD-+CR+CRi+MLFS) shows non-inferiority of venetoclax with azacitidine when compared with historical controls who received induction chemotherapy.
- Incidence of Minimal Residual Disease (MRD) Negative Responses [ Time Frame: Study start date to study end date, or death, whichever comes first, up to 4 years ]Number of new cases of Complete Remission, Complete Remission with Incomplete Blood Count Recovery, or Morphologic Leukemia Free State. This will be measure by multi-dimensional flow cytometry with a sensitivity to 0.1%.
- Remission Duration [ Time Frame: Study start date to study end date, or death, whichever comes first, up to 4 years ]Remission Duration will be defined as the length of time a patient does not display leukemic blasts or extramedullary disease
- One Year Event Free Survival [ Time Frame: Study start date to study end date, or death, whichever comes first, up to 4 years ]Determined using Kaplan Meier survival analysis methods with 95% confidence intervals.
- Overall Survival [ Time Frame: Study start date to study end date, or death, whichever comes first, up to 4 years ]Overall Survival will be defined as the time from administration of the initial doses until death from any cause. Determined using Kaplan Meier survival analysis methods with 95% confidence intervals.
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Study start date to study end date, or death, whichever comes first, up to 4 years ]Safety and tolerability analysis of azacitidine and venetoclax will be summarized by dose and severity as assessed by the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0 and relationship to study drug.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03573024
|Contact: Lauren Dabdoubemail@example.com|
|United States, Colorado|
|Universtiy of Colorado Hospital||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Lauren Dabdoub 720-848-1156 firstname.lastname@example.org|
|Principal Investigator: Daniel Pollyea, MD|
|Principal Investigator:||Daniel Pollyea, MD||University of Colorado, Denver|