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NCT04047641 · ClinicalTrials.gov registry record · Phase 1
Cladribine, Idarubicin, Cytarabine, and Quizartinib in Treating Patients With Newly Diagnosed, Relapsed, or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
A Phase 1 study of Acute Myeloid Leukemia and Refractory Acute Myeloid Leukemia, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT04047641: Recruiting Phase 1 study of Acute Myeloid Leukemia and Refractory Acute Myeloid Leukemia, sponsored by M.D. Anderson Cancer Center.
NCT04047641 is a Phase 1 study of Acute Myeloid Leukemia and Refractory Acute Myeloid Leukemia that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 80 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (31% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04047641, a Phase 1 study of Acute Myeloid Leukemia and Refractory Acute Myeloid Leukemia, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I/II trial studies the side effects and how well cladribine, idarubicin, cytarabine, and quizartinib work in treating patients with acute myeloid leukemia or high-risk myelodysplastic syndrome that is newly diagnosed, has come back (relapsed), or does not respond to treatment (refractory). Drugs used in chemotherapy, such as cladribine, idarubicin, and cytarabine, 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 quizartinib with cladribine, idarubicin, and cytarabine may help to control acute myeloid leukemia or high-risk myelodysplastic syndrome.
Primary Outcome
Will be estimate using the Kaplan-Meier method for each patient cohort. In addition, efficacy EFS will be analyzed in the intent to treat (ITT) population per cohort.
Conditions Studied
Interventions
- DRUG Cladribine
- DRUG Cytarabine
- DRUG Idarubicin
- DRUG Quizartinib
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2019-10-22 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
What NCT04047641 shows while recruiting
NCT04047641 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (31% lower).
The record links to 8 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 4 interventions - of which Cladribine is the first listed.
NCT04047641 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04047641 about?
NCT04047641 is a clinical study titled "Cladribine, Idarubicin, Cytarabine, and Quizartinib in Treating Patients With Newly Diagnosed, Relapsed, or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome". This phase I/II trial studies the side effects and how well cladribine, idarubicin, cytarabine, and quizartinib work in treating patients with acute myeloid leukemia or high-risk myelodysplastic syndrome that is newly diagnosed, has come back (relapsed), or does not respond to treatment (refractory)...
What is the current status of trial NCT04047641?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2019-10-22. Estimated completion is 2027-12-31.
What conditions does trial NCT04047641 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia, High Risk Myelodysplastic Syndrome, Recurrent High Risk Myelodysplastic Syndrome.
What interventions are being tested in trial NCT04047641?
The interventions under investigation include: Cladribine (DRUG), Cytarabine (DRUG), Idarubicin (DRUG), Quizartinib (DRUG).
Who is sponsoring clinical trial NCT04047641?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04047641 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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Where NCT04047641's enrollment target sits among peer trials
80 97th of 306 higher than 206 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.
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