Venetoclax in Combination With Intensive Induction and Consolidation Chemotherapy in Treatment Naïve AML
Part of paid clinical trials in Chicago, Illinois.
- Sponsor
- Dana-Farber Cancer Institute
- Study ID
- NCT03709758
- Phase
- PHASE1
- Status
- Active Not Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 60 Years
- Healthy Volunteers
- Not accepted
Interventions
- Venetoclax — DRUGVenetoclax blocks an important pathway that promotes cell survival in tumor cells that overexpress BCL-2, so venetoclax causes cells to die
- Daunorubicin — DRUGChemotherapy is most effective at killing cells that are rapidly dividing.
- Cytarabine — DRUGChemotherapy is most effective at killing cells that are rapidly dividing.
Study Details
This research study is studying the combination of venetoclax and chemotherapy as a possible treatment for acute myelogenous leukemia (AML). The drugs involved in this study are: * Venetoclax * Daunorubicin * Cytarabine
Key Dates
- Start date
- Oct 17, 2018
- Status verified
- Jan 2026
- Primary completion
- Feb 23, 2025
- Completion
- Jun 1, 2026
Study Design
- Enrollment
- 50 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Venetoclax+Daunorubicin+Cytarabine* Venetoclax administered orally on days 1 to 11 daily * Daunorubicin administered intravenously on days 2-4 * Cytarabine administered on days 2-8 by continuous IV infusion
Primary Outcome Measure
Maximum Tolerated Dose (Induction) [ Time Frame: 2 years ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | - |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | - |
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