Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-01-05 @ 1:16 AM
Study NCT ID:
NCT03709758
Status:
RECRUITING
Last Update Posted:
2025-01-13
First Post:
2018-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Venetoclax in Combination With Intensive Induction and Consolidation Chemotherapy in Treatment Naïve AML
Sponsor:
Dana-Farber Cancer Institute
Organization:
Study Overview
Official Title:
Phase 1b Study of Venetoclax in Combination With Intensive Induction and Consolidation Chemotherapy in Treatment Naïve Subjects With Acute Myelogenous Leukemia
Status:
RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
The drugs involved in this study are:
* Venetoclax
* Daunorubicin
* Cytarabine
Detailed Description:
This research study is a Phase I clinical trial, which tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is being studied.
The FDA (the U.S. Food and Drug Administration) has not approved venetoclax for this specific disease but it has been approved for other uses.
In this research study, the investigators are combining the use of venetoclax (the investigational drug being studied) with chemotherapy drugs daunorubicin and cytarabine. The investigators are looking to determine the highest dose of venetoclax that can be given safely in combination with these chemotherapy drugs.
Depending on when the participant join the study, the participant may participate in part 1 (induction with venetoclax escalation), part 2 (consolidation with venetoclax escalation), or part 3 (an expansion cohort utilizing the maximum tolerated doses identified in parts 1 and 2). The study doctor will tell the participant which part of the study they will join.
The FDA (the U.S. Food and Drug Administration) has not approved venetoclax for this specific disease but it has been approved for other uses.
In this research study, the investigators are combining the use of venetoclax (the investigational drug being studied) with chemotherapy drugs daunorubicin and cytarabine. The investigators are looking to determine the highest dose of venetoclax that can be given safely in combination with these chemotherapy drugs.
Depending on when the participant join the study, the participant may participate in part 1 (induction with venetoclax escalation), part 2 (consolidation with venetoclax escalation), or part 3 (an expansion cohort utilizing the maximum tolerated doses identified in parts 1 and 2). The study doctor will tell the participant which part of the study they will join.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: