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NCT04708054 · ClinicalTrials.gov registry record · Phase 2
Venetoclax to Improve Outcomes of Fractionated Busulfan Regimen in Patients With High-Risk AML and MDS
A Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 324
- Enrollment target
- 1
- Study location
NCT04708054: Recruiting Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by M.D. Anderson Cancer Center.
NCT04708054 is a Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 324 participants, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (182% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04708054, a Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 324 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies the effect of venetoclax together with busulfan, cladribine, and fludarabine in treating patients with high-risk acute myeloid leukemia or myelodysplastic syndrome who are undergoing stem cell transplant. Chemotherapy drugs, such as venetoclax, busulfan, cladribine, and fludarabine, 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. Adding venetoclax to the current standard of care stem cell transplant regimen of busulfan, fludarabine, and cladribine may help to control high-risk acute myeloid leukemia or myelodysplastic syndrome.
Primary Outcome
The proportion of patients who are alive without disease relapse (PFS) at one year will be reported along with the corresponding 95% credible interval. Cox proportional hazards regression will be used to assess the association between PFS and clinical and treatment covariates of interest.
Conditions Studied
Interventions
- DRUG Busulfan
- DRUG Cladribine
- DRUG Thiotepa
- DRUG Fludarabine Phosphate
- PROCEDURE Hematopoietic Cell Transplantation
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 324 participants |
| Start Date | 2021-10-21 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
What NCT04708054 shows while recruiting
NCT04708054 is an interventional study that assigns participants to a tested intervention. The registered 324 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 (182% higher).
The record links to 3 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Busulfan is the first listed.
NCT04708054 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04708054 about?
NCT04708054 is a clinical study titled "Venetoclax to Improve Outcomes of Fractionated Busulfan Regimen in Patients With High-Risk AML and MDS". This phase II trial studies the effect of venetoclax together with busulfan, cladribine, and fludarabine in treating patients with high-risk acute myeloid leukemia or myelodysplastic syndrome who are undergoing stem cell transplant. Chemotherapy drugs, such as venetoclax, busulfan, cladribine, and f...
What is the current status of trial NCT04708054?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 324 participants. The study started on 2021-10-21. Estimated completion is 2027-12-31.
What conditions does trial NCT04708054 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia.
What interventions are being tested in trial NCT04708054?
The interventions under investigation include: Busulfan (DRUG), Cladribine (DRUG), Thiotepa (DRUG), Fludarabine Phosphate (DRUG), Hematopoietic Cell Transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT04708054?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04708054 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
Similar trials for Acute Myeloid Leukemia
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Where NCT04708054's enrollment target sits among peer trials
324 20th of 306 higher than 287 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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Azacitidine or Decitabine With Venetoclax for Acute Myeloid Leukemia With Prior Hypomethylating Agent Failure
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A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy
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