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New treatment option for Leukemia
Official title A Study of BH-30236 in Relapsed/ Refractory Acute Myelogenous Leukemia and Higher Risk Myelodysplastic Syndrome
ClinicalTrials.gov ID: NCT06501196
What this study is testing
What is BH-30236?
BH-30236 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥18 years.
- Diagnosis of relapsed/refractory acute myelogenous leukemia (R/R) AML or higher-risk myelodysplastic syndrome (HR-MDS) with ≥5% bone marrow blast at...
- Prior treatment history must include 1-5 prior lines of therapy.
- ECOG performance status ≤2.
- Adequate organ function evidenced by the following laboratory values:
You likely can't join if
- Diagnosis of acute promyelocytic leukemia or chronic myeloid leukemia with blast crisis.
- Prior allogeneic HSCT within 3 months or donor lymphocyte infusion within 30 days of start of therapy;
- Active and uncontrolled infections.
- Unresolved AEs greater than Grade from prior therapies.
- History of other active malignancy (with certain exceptions)
- Prior treatment with a CLK inhibitor.
See the full eligibility criteria
- ≥18 years.
- Diagnosis of relapsed/refractory acute myelogenous leukemia (R/R) AML or higher-risk myelodysplastic syndrome (HR-MDS) with ≥5% bone marrow blast at time of inclusion.
- Prior treatment history must include 1-5 prior lines of therapy.
- ECOG performance status ≤2.
- Adequate organ function evidenced by the following laboratory values:
- Hepatic: Transaminase levels aspartate aminotransferase [AST]/ alanine transaminase [ALT] ≤ 2.5 × upper limit of normal (ULN). In cases of liver involvement by AML or MDS, AST and ALT \< 5.0 × ULN is acceptable. Total...
- Renal: Measured or calculated creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula) The above are a summary, other details may apply.
- Diagnosis of acute promyelocytic leukemia or chronic myeloid leukemia with blast crisis.
- Prior allogeneic HSCT within 3 months or donor lymphocyte infusion within 30 days of start of therapy;
- Active and uncontrolled infections.
- Unresolved AEs greater than Grade from prior therapies.
- History of other active malignancy (with certain exceptions)
- Prior treatment with a CLK inhibitor.
- Any acute or chronic graft versus host disease requiring systemic therapy within 4 weeks prior to study drug administration with the exception of topical steroids or the equivalent of 20 mg of prednisone or less. The...
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Los Angeles, California, United States
- Palo Alto, California, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Chicago, Illinois, United States
- Buffalo, New York, United States
- New York, New York, United States
- Columbus, Ohio, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Seattle, Washington, United States
- Madison, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Los Angeles, California, United States; Palo Alto, California, United States; Miami, Florida, United States; Tampa, Florida, United States; Chicago, Illinois, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.