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NCT06466395 · ClinicalTrials.gov registry record · Phase 1
A Phase I Study of Hyper-CVAD In Combination With Venetoclax In Pediatric Patients With Relapsed or Refractory Acute Leukemias That Are of the Lymphoid Lineage Including Bi-Phenotypic or Undifferentiated Leukemias
A Phase 1 study of Refractory Acute Leukemia and Undifferentiated Leukemia, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT06466395: Recruiting Phase 1 study of Refractory Acute Leukemia and Undifferentiated Leukemia, sponsored by M.D. Anderson Cancer Center.
NCT06466395 is a Phase 1 study of Refractory Acute Leukemia and Undifferentiated Leukemia that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 22 participants, below the 36-participant average among 3 other Refractory Acute Leukemia trials with a reported enrollment target (39% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06466395, a Phase 1 study of Refractory Acute Leukemia and Undifferentiated Leukemia, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study Summary
To find the recommended dose of hyper-CVAD in combination with venetoclax that can be given to participants with relapsed or refractory leukemia.
Primary Outcome
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Hyper-CVAD
Study Locations (1)
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2025-02-18 |
| Est. Completion | 2031-12-31 |
| Phase | Phase 1 |
What NCT06466395 shows while recruiting
NCT06466395 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 36-participant average among 3 other Refractory Acute Leukemia trials with a reported enrollment target (39% lower).
The record links to 4 conditions, with Refractory Acute Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Venetoclax is the first listed.
NCT06466395 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT06466395 about?
NCT06466395 is a clinical study titled "A Phase I Study of Hyper-CVAD In Combination With Venetoclax In Pediatric Patients With Relapsed or Refractory Acute Leukemias That Are of the Lymphoid Lineage Including Bi-Phenotypic or Undifferentiated Leukemias". To find the recommended dose of hyper-CVAD in combination with venetoclax that can be given to participants with relapsed or refractory leukemia.
What is the current status of trial NCT06466395?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2025-02-18. Estimated completion is 2031-12-31.
What conditions does trial NCT06466395 study?
This clinical trial studies the following conditions: Refractory Acute Leukemia, Undifferentiated Leukemia, Relapsed Acute Leukemia, Bi-Phenotypic Leukemia.
What interventions are being tested in trial NCT06466395?
The interventions under investigation include: Venetoclax (DRUG), Hyper-CVAD (DRUG).
Who is sponsoring clinical trial NCT06466395?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06466395 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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