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NCT03404193 · ClinicalTrials.gov registry record · Phase 2
Venetoclax and Decitabine in Treating Participants With Relapsed/Refractory Acute Myeloid Leukemia or Relapsed High-Risk Myelodysplastic Syndrome
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 235
- Enrollment target
NCT03404193: Clinical Trial Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT03404193 is a Phase 2 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 235 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03404193, a Phase 2 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 235 participants
- Enrollment target
Study Summary
This phase II trial studies how well venetoclax and decitabine work in treating participants with acute myeloid leukemia that has come back or does not respond to treatment, or with high-risk myelodysplastic syndrome that has come back. Drugs used in chemotherapy, such as venetoclax and 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.
Primary Outcome
Will be defined as the proportion of patients who had CR (complete remission), CRp (complete remission with incomplete platelet recovery), CRi (complete remission with incomplete count recovery), PR (partial response) or marrow clearance of blasts within 3 months of treatment initiation among adult patients with acute myeloid leukemia (AML); and complete remission (CR), partial remission (PR) or marrow CR (mCR) lasting at least 4 weeks for patients with myelodysplastic syndrome (MDS). Descriptiv
Interventions
- DRUG Venetoclax
- DRUG Decitabine
- OTHER Laboratory Biomarker Analysis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 235 participants |
| Start Date | 2018-01-18 |
| Est. Completion | 2026-03-05 |
| Phase | Phase 2 |
Why NCT03404193 stopped before completion
NCT03404193 is an interventional study that assigns participants to a tested intervention. The registered 235 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% higher).
The record links to 0 conditions, and to 3 interventions - of which Venetoclax is the first listed.
NCT03404193 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03404193 about?
NCT03404193 is a clinical study titled "Venetoclax and Decitabine in Treating Participants With Relapsed/Refractory Acute Myeloid Leukemia or Relapsed High-Risk Myelodysplastic Syndrome". This phase II trial studies how well venetoclax and decitabine work in treating participants with acute myeloid leukemia that has come back or does not respond to treatment, or with high-risk myelodysplastic syndrome that has come back. Drugs used in chemotherapy, such as venetoclax and decitabine, ...
What is the current status of trial NCT03404193?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 235 participants. The study started on 2018-01-18. Estimated completion is 2026-03-05.
What interventions are being tested in trial NCT03404193?
The interventions under investigation include: Venetoclax (DRUG), Decitabine (DRUG), Laboratory Biomarker Analysis (OTHER).
Who is sponsoring clinical trial NCT03404193?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03404193's enrollment target sits among peer trials
235 255th of 2000 higher than 1,746 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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