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NCT04801797 · ClinicalTrials.gov registry record · Phase 2
Venetoclax + Azacitidine vs. Induction Chemotherapy in AML
A Phase 2 study of Acute Myeloid Leukemia, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 172
- Enrollment target
- 9
- Study locations
NCT04801797: Recruiting Phase 2 study of Acute Myeloid Leukemia, sponsored by Massachusetts General Hospital.
NCT04801797 is a Phase 2 study of Acute Myeloid Leukemia that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 172 participants, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (50% higher). The trial reports 9 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04801797, a Phase 2 study of Acute Myeloid Leukemia, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 172 participants
- Enrollment target
- 9
- Study locations
Study Summary
This research is being done to assess the therapeutic activity of a promising combination (azacitidine and venetoclax) versus conventional cytotoxic chemotherapy in induction-eligible patients with acute myeloid leukemia. This study involves the following: * Venetoclax and azacitidine (investigational combination) * Cytarabine and idarubicin or daunorubicin (per standard of care) or Liposomal daunorubicin and cytarabine (per standard of care)
Primary Outcome
Primary endpoint is event-free-survival of patients treated with venetoclax and azacitidine compared to patients treated with standard induction with either 7+3 regimen or liposomal daunorubicin and cytarabine Events are described in the protocol and will include * Progressive Disease as defined above * Any change in therapy due to leukemic persistence. * Transition to hospice * Relapse following CR, CRi, or CRh * Any death Assessments of differences in EFS between the randomized arms will be
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Cytarabine
- DRUG Idarubicin
- DRUG Daunorubicin
- DRUG Liposomal daunorubicin and cytarabine
Study Locations (9)
California
- City of Hope - Duarte
- Stanford Cancer Center - Palo Alto
- University of California - Davis - Sacramento
Massachusetts
- Massachusetts General Hospital Cancer Center - Boston
- Beth Israel Deaconess Medical Center - Boston
- Dana-Farber Cancer Institute - Boston
North Carolina
- Atrium Health Levine Cancer Institute - Charlotte
Ohio
- Ohio State University Medical Center - Columbus
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 172 participants |
| Start Date | 2021-05-20 |
| Est. Completion | 2028-01-01 |
| Phase | Phase 2 |
What NCT04801797 shows while recruiting
NCT04801797 is an interventional study that assigns participants to a tested intervention. The registered 172 participants enrollment target is mid-sized for trials with a published cap, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (50% higher).
The record links to 1 condition, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Venetoclax is the first listed.
NCT04801797 lists 9 locations in 5 states (California, Massachusetts, North Carolina).
Frequently Asked Questions
What is clinical trial NCT04801797 about?
NCT04801797 is a clinical study titled "Venetoclax + Azacitidine vs. Induction Chemotherapy in AML". This research is being done to assess the therapeutic activity of a promising combination (azacitidine and venetoclax) versus conventional cytotoxic chemotherapy in induction-eligible patients with acute myeloid leukemia. This study involves the following: * Venetoclax and azacitidine (investigati...
What is the current status of trial NCT04801797?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 172 participants. The study started on 2021-05-20. Estimated completion is 2028-01-01.
What conditions does trial NCT04801797 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia.
What interventions are being tested in trial NCT04801797?
The interventions under investigation include: Venetoclax (DRUG), Cytarabine (DRUG), Idarubicin (DRUG), Daunorubicin (DRUG), Liposomal daunorubicin and cytarabine (DRUG).
Who is sponsoring clinical trial NCT04801797?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04801797 being conducted?
This trial has 9 study locations across California, Massachusetts, North Carolina, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04801797's enrollment target sits among peer trials
172 52nd of 306 higher than 255 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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