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NCT05401097 · ClinicalTrials.gov registry record · Phase 2
IDH Targeted/Non- Targeted vs Non-targeted/IDH-targeted Approaches in the Treatment of Newly Diagnosed IDH Mutated AML Patients Not Candidates for Intensive Induction Therapy (I- DATA Study)
A Phase 2 study of Acute Myeloid Leukemia, sponsored by Alice Mims.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 125
- Enrollment target
- 1
- Study location
NCT05401097 is a Phase 2 study of Acute Myeloid Leukemia that is actively recruiting participants, run by Alice Mims. 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.
The verdict
NCT05401097, a Phase 2 study of Acute Myeloid Leukemia, is actively recruiting participants, sponsored by Alice Mims.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 125 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II study compares the order of treatment with ivosidenib or enasidenib and azacitidine plus venetoclax in treating older patients with acute myeloid leukemia with genetic changes in the IDH1 or IDH2 genes (IDH mutated). Ivosidenib is in a class of medications called isocitrate dehydrogenase-1 (IDH1) inhibitors. It works by slowing or stopping the growth of cancer cells. Enasidenib is in a class of medications called an IDH2 inhibitor. It also works by slowing or stopping the growth of cancer cells. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Azacitidine is in a class of medications called demethylation agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells. This study may help researchers determine which treatment order is best for older patients with IDH mutated acute myeloid leukemia: 1) ivosidenib or enasidenib followed by azacitidine plus venetoclax; or 2) azacitidine plus venetoclax followed by ivosidenib or enasidenib.
Conditions Studied
Interventions
- DRUG Venetoclax
- PROCEDURE Biopsy
- DRUG Azacitidine
- DRUG Ivosidenib
- DRUG Enasidenib
Study Locations (1)
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2022-09-13 |
| Est. Completion | 2029-06-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05401097
The ClinicalTrials.gov registry entry for NCT05401097 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 125 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target. The listed sponsor is Alice Mims, which has 2 total studies on file at ClinicalTrials.gov.
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.
NCT05401097 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT05401097 about?
NCT05401097 is a clinical study titled "IDH Targeted/Non- Targeted vs Non-targeted/IDH-targeted Approaches in the Treatment of Newly Diagnosed IDH Mutated AML Patients Not Candidates for Intensive Induction Therapy (I- DATA Study)". This phase II study compares the order of treatment with ivosidenib or enasidenib and azacitidine plus venetoclax in treating older patients with acute myeloid leukemia with genetic changes in the IDH1 or IDH2 genes (IDH mutated). Ivosidenib is in a class of medications called isocitrate dehydrogena...
What is the current status of trial NCT05401097?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 125 participants. The study started on 2022-09-13. Estimated completion is 2029-06-30.
What conditions does trial NCT05401097 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia.
What interventions are being tested in trial NCT05401097?
The interventions under investigation include: Venetoclax (DRUG), Biopsy (PROCEDURE), Azacitidine (DRUG), Ivosidenib (DRUG), Enasidenib (DRUG).
Who is sponsoring clinical trial NCT05401097?
This trial is sponsored by Alice Mims, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05401097 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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