Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Study of BH-30236 in Relapsed/ Refractory Acute Myelogenous Leukemia and Higher Risk Myelodysplastic Syndrome
NCT06501196 · View on ClinicalTrials.gov ↗
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.
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 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06501196
The ClinicalTrials.gov registry entry for NCT06501196 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 170 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BlossomHill Therapeutics, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06501196 reports 13 study locations spanning 9 distinct geographic areas — top geographies include California, Florida, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06501196?
The interventions under investigation include: Venetoclax (DRUG), BH-30236 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06501196?
This trial is sponsored by BlossomHill Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.