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NCT05010772 · ClinicalTrials.gov registry record · Phase 1
Decitabine Alone or in Combination With Venetoclax, Gilteritinib, Enasidenib, or Ivosidenib as Maintenance Therapy for the Treatment of Acute Myeloid Leukemia in Remission
A Phase 1 study of Acute Myeloid Leukemia, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 125
- Enrollment target
- 1
- Study location
NCT05010772: Recruiting Phase 1 study of Acute Myeloid Leukemia, sponsored by M.D. Anderson Cancer Center.
NCT05010772 is a Phase 1 study of Acute Myeloid Leukemia that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 125 participants, roughly in line with the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05010772, a Phase 1 study of Acute Myeloid Leukemia, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 125 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase Ib trial is to find out the side effects and possible benefits of decitabine alone or given together with venetoclax, gilteritinib, enasidenib, or ivosidenib in treating patients with acute myeloid leukemia that is under control (remission). Chemotherapy drugs, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax may stop the growth of cancer cells by blocking a protein called Bcl-2 needed for cell growth. Gilteritinib, enasidenib, and ivosidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving decitabine alone or together with venetoclax, gilteritinib, enasidenib, or ivosidenib may help to control the disease.
Primary Outcome
Safety analyses in general will be descriptive and will be presented in tabular format with the appropriate summary statistics. Adverse events will be tabulated using frequency and percentage by severity and by relations to the treatments for each arm.
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Decitabine and Cedazuridine
- DRUG Gilteritinib
- DRUG Ivosidenib
- DRUG Enasidenib
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2021-10-25 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What NCT05010772 shows while recruiting
NCT05010772 is an interventional study that assigns participants to a tested intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target.
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.
NCT05010772 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT05010772 about?
NCT05010772 is a clinical study titled "Decitabine Alone or in Combination With Venetoclax, Gilteritinib, Enasidenib, or Ivosidenib as Maintenance Therapy for the Treatment of Acute Myeloid Leukemia in Remission". This phase Ib trial is to find out the side effects and possible benefits of decitabine alone or given together with venetoclax, gilteritinib, enasidenib, or ivosidenib in treating patients with acute myeloid leukemia that is under control (remission). Chemotherapy drugs, such as decitabine, work in...
What is the current status of trial NCT05010772?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 125 participants. The study started on 2021-10-25. Estimated completion is 2026-12-31.
What conditions does trial NCT05010772 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia.
What interventions are being tested in trial NCT05010772?
The interventions under investigation include: Venetoclax (DRUG), Decitabine and Cedazuridine (DRUG), Gilteritinib (DRUG), Ivosidenib (DRUG), Enasidenib (DRUG).
Who is sponsoring clinical trial NCT05010772?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05010772 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05010772's enrollment target sits among peer trials
125 65th of 306 higher than 241 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.
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