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NCT04493138 · ClinicalTrials.gov registry record · Phase 1
Azacitidine and Quizartinib for the Treatment of Myelodysplastic Syndrome or Myelodysplastic/Myeloproliferative Neoplasm With FLT3 or CBL Mutations
A Phase 1 study of Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 58
- Enrollment target
- 1
- Study location
NCT04493138: Recruiting Phase 1 study of Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia, sponsored by M.D. Anderson Cancer Center.
NCT04493138 is a Phase 1 study of Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 58 participants, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04493138, a Phase 1 study of Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 58 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I/II trial studies the side effects and best dose of quizartinib when given with azacitidine and to see how well they work in treating patients with myelodysplastic syndrome or myelodysplastic/myeloproliferative neoplasm with FLT3 or CBL mutations. Chemotherapy drugs, such as azacitidine, 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. Quizartinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving azacitidine and quizartinib may help to control myelodysplastic syndrome or myelodysplastic/myeloproliferative neoplasm.
Primary Outcome
Will be defined as complete remission, partial remission, complete remission with incomplete count recovery, marrow compete remission or hematological improvement. Will be estimated for all patients along with the 95% credible interval.
Conditions Studied
Interventions
- DRUG Azacitidine
- DRUG Quizartinib
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2020-07-21 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
What NCT04493138 shows while recruiting
NCT04493138 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (72% lower).
The record links to 6 conditions, with Myelodysplastic Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Azacitidine is the first listed.
NCT04493138 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04493138 about?
NCT04493138 is a clinical study titled "Azacitidine and Quizartinib for the Treatment of Myelodysplastic Syndrome or Myelodysplastic/Myeloproliferative Neoplasm With FLT3 or CBL Mutations". This phase I/II trial studies the side effects and best dose of quizartinib when given with azacitidine and to see how well they work in treating patients with myelodysplastic syndrome or myelodysplastic/myeloproliferative neoplasm with FLT3 or CBL mutations. Chemotherapy drugs, such as azacitidine,...
What is the current status of trial NCT04493138?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 58 participants. The study started on 2020-07-21. Estimated completion is 2027-12-31.
What conditions does trial NCT04493138 study?
This clinical trial studies the following conditions: Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, Myeloproliferative Neoplasm, Recurrent Myelodysplastic Syndrome, Recurrent Chronic Myelomonocytic Leukemia.
What interventions are being tested in trial NCT04493138?
The interventions under investigation include: Azacitidine (DRUG), Quizartinib (DRUG).
Who is sponsoring clinical trial NCT04493138?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04493138 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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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 NCT04493138's enrollment target sits among peer trials
58 57th of 134 higher than 77 of 134 other Myelodysplastic Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndrome 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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