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NCT07228273 · ClinicalTrials.gov registry record · Phase 2
Induction and Consolidation With Fludarabine, Cytarabine, Idarubicin, and Venetoclax for the Treatment of Acute Myeloid Leukemia
A Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by OHSU Knight Cancer Institute.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 102
- Enrollment target
- 1
- Study location
NCT07228273: Recruiting Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by OHSU Knight Cancer Institute.
NCT07228273 is a Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome that is actively recruiting participants, run by OHSU Knight Cancer Institute. The registered enrollment target is 102 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (12% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07228273, a Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, is actively recruiting participants, sponsored by OHSU Knight Cancer Institute.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 102 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial compares induction and consolidation therapy with fludarabine, cytarabine, idarubicin, and venetoclax to cytarabine and daunorubicin induction and cytarabine consolidation for the treatment of acute myeloid leukemia (AML). Patients with AML often receive induction and consolidation therapy. Induction therapy is given first to get the patient's AML under control (remission). Consolidation therapy is given after the cancer has disappeared following the initial therapy. Consolidation therapy is used to kill any cancer cells that may be left in the body. Chemotherapy drugs, such as fludarabine, cytarabine, idarubicin, and daunorubicin, 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 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. Giving fludarabine, cytarabine, idarubicin, and venetoclax for induction and consolidation therapy may be more effective in treating AML.
Primary Outcome
Will be defined as the achievement of both measurable disease negative (MRD-) by multiparameter flow cytometry and complete response (CR), CR with partial hematologic recovery (CRh), or CR with incomplete blood count recovery (CRi). Participants who do not qualify as efficacy-evaluable (usually due to early death or withdrawal because of toxicity) will be considered non-responders. A point estimate and 95% exact confidence interval (CI) for CRc MRD- will be computed for each arm (and time point)
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Aspiration
- PROCEDURE Bone Marrow Biopsy
- DRUG Cytarabine
- DRUG Daunorubicin
Study Locations (1)
Oregon
- OHSU Knight Cancer Institute - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2025-12-12 |
| Est. Completion | 2029-08-24 |
| Phase | Phase 2 |
What NCT07228273 shows while recruiting
NCT07228273 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (12% lower).
The record links to 2 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT07228273 reports a single indexed study location in Oregon.
Frequently Asked Questions
What is clinical trial NCT07228273 about?
NCT07228273 is a clinical study titled "Induction and Consolidation With Fludarabine, Cytarabine, Idarubicin, and Venetoclax for the Treatment of Acute Myeloid Leukemia". This phase II trial compares induction and consolidation therapy with fludarabine, cytarabine, idarubicin, and venetoclax to cytarabine and daunorubicin induction and cytarabine consolidation for the treatment of acute myeloid leukemia (AML). Patients with AML often receive induction and consolidati...
What is the current status of trial NCT07228273?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 102 participants. The study started on 2025-12-12. Estimated completion is 2029-08-24.
What conditions does trial NCT07228273 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndrome.
What interventions are being tested in trial NCT07228273?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Cytarabine (DRUG), Daunorubicin (DRUG).
Who is sponsoring clinical trial NCT07228273?
This trial is sponsored by OHSU Knight Cancer Institute, which has 211 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07228273 being conducted?
This trial has 1 study location across Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acute Myeloid Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07228273's enrollment target sits among peer trials
102 77th of 306 higher than 230 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
-
Azacitidine or Decitabine With Venetoclax for Acute Myeloid Leukemia With Prior Hypomethylating Agent Failure
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