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New treatment option for Acute Myeloid Leukemia
Official title A Study of BTX-A51 in People With Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
ClinicalTrials.gov ID: NCT04243785
What this study is testing
What is BTX-A51?
BTX-A51 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for acute myeloid 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
- This is an open-label, dose escalation study to evaluate the safety, toxicity, and pharmacokinetics (PK) as well as preliminary efficacy of BTX-A51 capsules in participants with relapsed or refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS). The study will be done in three parts.
- Phase 1: an early, usually small safety study
- Time commitment: about 2 years
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
- Demonstration of understanding and voluntarily signing of an informed consent form
- Age ≥ 18 years
- Diagnosis of acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) according to the World Health Organization classification and, with...
- Eastern Cooperative Oncology Group performance status ≤ 2 and life expectancy of ≥ 6 weeks
- Adequate organ function (Grade 1 serum creatinine; Grade 1 total bilirubin; aspartate aminotransferase and/or alanine transaminase ≤ 2 × ULN)
You likely can't join if
- Diagnosis of acute promyelocytic leukemia
- White blood cell count \> 20 x 10\^9/L
- Receipt of cancer chemotherapy (other than hydroxyurea) within 2 weeks prior to the start of study drug
- In participants who have undergone autologous or allogeneic stem cell transplantation: transplantation within the 3 months prior to Screening; active...
- Immediate life-threatening severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated...
- Persistent toxicities from prior treatment of Grade 2 or higher
See the full eligibility criteria
- Demonstration of understanding and voluntarily signing of an informed consent form
- Age ≥ 18 years
- Diagnosis of acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) according to the World Health Organization classification and, with respect to MDS, that is high risk; participants must have refractory or...
- Eastern Cooperative Oncology Group performance status ≤ 2 and life expectancy of ≥ 6 weeks
- Adequate organ function (Grade 1 serum creatinine; Grade 1 total bilirubin; aspartate aminotransferase and/or alanine transaminase ≤ 2 × ULN)
- Females of childbearing age must not be pregnant at time of Screening/beginning of treatment and agree to either abstain from sexual intercourse or use highly effective methods of contraception (for up to 3 months after...
- Males sexually active with a woman of childbearing age must agree to use barrier method of birth control during and after the study (up to 3 months after last dose of study drug)
- Diagnosis of acute promyelocytic leukemia
- White blood cell count \> 20 x 10\^9/L
- Receipt of cancer chemotherapy (other than hydroxyurea) within 2 weeks prior to the start of study drug
- In participants who have undergone autologous or allogeneic stem cell transplantation: transplantation within the 3 months prior to Screening; active graft-versus-host disease requiring anything other than topical...
- Immediate life-threatening severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation
- Persistent toxicities from prior treatment of Grade 2 or higher
- Active uncontrolled systemic fungal, bacterial, mycobacterial, or viral infection
- Clinically significant cardiac disease
- Known dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally
- Any other concurrent medical condition or disease that is likely to interfere with study procedures or results, or that, in the opinion of the Investigator, would constitute a hazard for participating in this study
- If female, pregnant or breastfeeding
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- New York, New York, United States
- Houston, Texas, 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 study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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; New York, New York, United States; Houston, Texas, United States. 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.