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NCT07053020 · ClinicalTrials.gov registry record · Phase 1
A Phase 1b/2 Open-label, Dose-ranging Safety and Efficacy Study of Oral Cladribine in Patients With Acute Myeloid Leukemia (AML)
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Not yet
- Registry status
- Phase 1
- Development phase
- 58
- Enrollment target
NCT07053020: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT07053020 is a Phase 1 study that has not yet begun recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 58 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07053020, a Phase 1 study, has not yet begun recruiting, sponsored by M.D. Anderson Cancer Center.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 58 participants
- Enrollment target
Study Summary
The goal of Part 1 of this clinical research study is to find the highest tolerable dose of cladribine that can be given in combination with low dose cytarabine (LDAC) and venetoclax to patients who have AML. The goal of Part 2 of this clinical research study is to learn if the dose of cladribine found in Part 1, when combined with LDAC and venetoclax, can help to control the disease.
Primary Outcome
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Interventions
- DRUG Cytarabine
- DRUG Oral Cladribine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2027-12-01 |
| Est. Completion | 2030-06-30 |
| Phase | Phase 1 |
What is known before NCT07053020 opens enrollment
NCT07053020 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Cytarabine is the first listed.
NCT07053020 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07053020 about?
NCT07053020 is a clinical study titled "A Phase 1b/2 Open-label, Dose-ranging Safety and Efficacy Study of Oral Cladribine in Patients With Acute Myeloid Leukemia (AML)". The goal of Part 1 of this clinical research study is to find the highest tolerable dose of cladribine that can be given in combination with low dose cytarabine (LDAC) and venetoclax to patients who have AML. The goal of Part 2 of this clinical research study is to learn if the dose of cladribine f...
What is the current status of trial NCT07053020?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 58 participants. The study started on 2027-12-01. Estimated completion is 2030-06-30.
What interventions are being tested in trial NCT07053020?
The interventions under investigation include: Cytarabine (DRUG), Oral Cladribine (DRUG).
Who is sponsoring clinical trial NCT07053020?
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 NCT07053020's enrollment target sits among peer trials
58 895th of 2000 higher than 1,100 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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