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NCT06501196 · ClinicalTrials.gov registry record · Phase 1
A Study of BH-30236 in Relapsed/ Refractory Acute Myelogenous Leukemia and Higher Risk Myelodysplastic Syndrome
A Phase 1 study of Leukemia and Myelodysplastic Syndromes, sponsored by BlossomHill Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 170
- Enrollment target
- 13
- Study locations
NCT06501196: Recruiting Phase 1 study of Leukemia and Myelodysplastic Syndromes, sponsored by BlossomHill Therapeutics.
NCT06501196 is a Phase 1 study of Leukemia and Myelodysplastic Syndromes that is actively recruiting participants, run by BlossomHill Therapeutics. The registered enrollment target is 170 participants, below the 486-participant average among 233 other Leukemia trials with a reported enrollment target (65% lower). The trial reports 13 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06501196, a Phase 1 study of Leukemia and Myelodysplastic Syndromes, is actively recruiting participants, sponsored by BlossomHill Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 170 participants
- Enrollment target
- 13
- Study locations
Study Summary
Study BH-30236-01 is a first-in-human (FIH), Phase 1/1b, open-label, dose escalation and expansion study in participants with relapsed/refractory acute myelogenous leukemia (R/R AML) or higher-risk myelodysplastic syndrome (HR-MDS). Phase 1, Part 1 Dose Escalation - Monotherapy will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of BH-30236 administered orally. Approximately 50 participants may be enrolled in Phase 1, Part 1 Dose Escalation - Monotherapy. Phase 1, Part 2 Dose Escalation - Combination with Venetoclax will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of BH-30236 administered as a combination therapy with venetoclax. Approximately 48 participants may be enrolled in Phase 1, Part 2 Dose Escalation - Combination with Venetoclax. Phase 1b (Dose Expansion) will follow Phase 1 to further understand the relationships among dose, exposure, toxicity, tolerability, and clinical activity. Up to 72 participants may be enrolled in Phase 1b of the study as a monotherapy or in combination with venetoclax.
Primary Outcome
DLTs are dose-limiting toxicities as defined in the study protocol.
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG BH-30236
Study Locations (13)
California
- City of Hope Medical Center - Duarte
- University of California Los Angeles - Los Angeles
- Stanford Cancer Center - Palo Alto
Florida
- Sylvester Comprehensive Cancer Center - Miami
- Moffitt Cancer Center - Tampa
New York
- Roswell Park Cancer Institute - Buffalo
- Memorial Sloan Kettering Cancer Center - New York
Illinois
- Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion - Chicago
Ohio
- The Ohio State University Wexner Medical Center - James Cancer Hosp - Columbus
Tennessee
- Sarah Cannon Research Institute - Nashville
Texas
- The University of Texas M.D. Anderson Cancer Center - Houston
Washington
- Fred Hutchinson Cancer Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 170 participants |
| Start Date | 2024-06-19 |
| Est. Completion | 2027-06 |
| Phase | Phase 1 |
What NCT06501196 shows while recruiting
NCT06501196 is an interventional study that assigns participants to a tested intervention. The registered 170 participants enrollment target is mid-sized for trials with a published cap, below the 486-participant average among 233 other Leukemia trials with a reported enrollment target (65% lower).
The record links to 6 conditions, with Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Venetoclax is the first listed.
NCT06501196 lists 13 locations in 9 states (California, Florida, New York).
Frequently Asked Questions
What is clinical trial NCT06501196 about?
NCT06501196 is a clinical study titled "A Study of BH-30236 in Relapsed/ Refractory Acute Myelogenous Leukemia and Higher Risk Myelodysplastic Syndrome". Study BH-30236-01 is a first-in-human (FIH), Phase 1/1b, open-label, dose escalation and expansion study in participants with relapsed/refractory acute myelogenous leukemia (R/R AML) or higher-risk myelodysplastic syndrome (HR-MDS). Phase 1, Part 1 Dose Escalation - Monotherapy will evaluate the sa...
What is the current status of trial NCT06501196?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 170 participants. The study started on 2024-06-19. Estimated completion is 2027-06.
What conditions does trial NCT06501196 study?
This clinical trial studies the following conditions: Leukemia, Myelodysplastic Syndromes, Refractory Acute Myeloid Leukemia, Leukemia, Myeloid, Acute, Leukemia, Myeloid.
What interventions are being tested in trial NCT06501196?
The interventions under investigation include: Venetoclax (DRUG), BH-30236 (DRUG).
Who is sponsoring clinical trial NCT06501196?
This trial is sponsored by BlossomHill Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06501196 being conducted?
This trial has 13 study locations across California, Florida, Illinois, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06501196's enrollment target sits among peer trials
170 45th of 233 higher than 189 of 233 other Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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