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New treatment option for Relapsed and Refractory Acute Myeloid Leukemia (RR-AML)
Official title HPB-092 for the Treatment of Relapsed and Refractory Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT07137637
What this study is testing
What is HPB-092 tablet?
HPB-092 tablet is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for relapsed and refractory acute myeloid leukemia (rr-aml).
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
- HPB-092 effectively inhibits Fms-like tyrosine kinase 3 (FLT3) mutants with comparable or superior potency to approved FLT3 inhibitors and demonstrates improved selectivity, potentially reducing toxicity. Its highly selective and potent inhibition of Interleukin-1 Receptor-Associated Kinase 4 (IRAK4) may provide additional therapeutic benefits that could enhance treatment efficacy and durability for patients with relapsed or refractory acute myeloid leukemia (RR-AML), further improving clinical outcomes in this population.
- 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
- Patients must meet all of the following to be eligible for enrollment in the study:
- The patient must have a diagnosis of morphologically documented relapsed or refractory acute myeloid leukemia (AML) according to the World Health...
- The patients should have a stable transfusion requirement prior to enrollment as specified in the protocol.
- Male or non-pregnant, non-lactating female patients aged 18 years or older.
- The patient is not suitable for other known therapies that have clinical benefits for the disease.
You likely can't join if
- Patients with any of the following characteristics/conditions will not be able to enroll in the study:
- Diagnosed with acute promyelocytic leukemia (APL) or BCR-ABL-positive leukemia.
- The patient has had a malignancy other than AML within the past five years as specified in the protocol.
- The patient has persistent non-hematological toxicities of ≥ Grade 2 (per CTCAE v5.0) from prior treatment.
- History of Hematopoietic Stem Cell Transplant (HSCT) as specified in the protocol.
- The patient has clinically active central nervous system (CNS) leukemia.
See the full eligibility criteria
- Patients must meet all of the following to be eligible for enrollment in the study:
- The patient must have a diagnosis of morphologically documented relapsed or refractory acute myeloid leukemia (AML) according to the World Health Organization (WHO) 2022 criteria, and must meet one of the following...
- The patients should have a stable transfusion requirement prior to enrollment as specified in the protocol.
- Male or non-pregnant, non-lactating female patients aged 18 years or older.
- The patient is not suitable for other known therapies that have clinical benefits for the disease.
- Life expectancy of ≥12 weeks, and Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Renal Function: Serum creatinine \ 50% as measured by echocardiogram or MUGA scan.
- Acute effects of any prior therapy must be resolved to baseline severity or Grade ≤ 1 per CTCAE v5.0, except for adverse events (AEs) that do not constitute a safety risk according to the investigator's judgment.
- For females of childbearing potential, a serum pregnancy test must be negative within 7 days before enrollment.
- Male and female patients of childbearing potential who are at risk for pregnancy must agree to use at least two highly effective methods of contraception throughout the study and for at least 90 days (or 180 days if...
- The interval from prior treatment to the time of study drug administration must be at least 2 weeks for cytotoxic agents (except hydroxyurea given for controlling blast cells), or at least 5 half-lives for prior...
- The patient must have the ability to understand and be willing to sign the informed.
- Patients with any of the following characteristics/conditions will not be able to enroll in the study:
- Diagnosed with acute promyelocytic leukemia (APL) or BCR-ABL-positive leukemia.
- The patient has had a malignancy other than AML within the past five years as specified in the protocol.
- The patient has persistent non-hematological toxicities of ≥ Grade 2 (per CTCAE v5.0) from prior treatment.
- History of Hematopoietic Stem Cell Transplant (HSCT) as specified in the protocol.
- The patient has clinically active central nervous system (CNS) leukemia.
- The patient has a disseminated intravascular coagulation (DIC) abnormality.
- Recent surgery or radiation therapy as specified in the protocol.
- History of Class 3 or more severe heart failure according to NYHA classification, or left ventricular ejection fraction (LVEF) below 45%, or Fridericia-corrected QT interval (QTcF) \> 450 ms at screening.
- The patient has hypokalemia or hypomagnesemia at screening.
- The patient requires treatment with drugs that are strong inhibitors or inducers of CYP3A4 or P-glycoprotein (P-gp) as specified in the protocol.
- Active graft-versus-host disease (GVHD) and immunosuppressive treatment as specified in the protocol.
- Use of systemic corticosteroids or immunosuppressive drugs as specified in the protocol.
- The patient is known to be infected with human immunodeficiency virus (HIV), active hepatitis B or C, or other active hepatic disorders. The patient has an active uncontrolled infection.
- The patient has any condition that, in the investigator's opinion, makes the patient unsuitable for study participation.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, China
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 Tianjin, China. 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.