Actively Recruiting
A Study of BTX-A51 in People With Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
Led by Edgewood Oncology Inc. · Updated on 2024-03-20
80
Participants Needed
3
Research Sites
373 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. Part 1a (Monotherapy Dose Escalation) of this study is designed to determine the dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD) of orally administered BTX-A51 in up to 35 participants who are evaluable for toxicity. Once the MTD is determined, it is planned that an additional 15 participants will be enrolled in Part 1b (Monotherapy Cohort Expansion) of this study for additional experience with safety and efficacy, and to determine the recommended Phase 2 dose (RP2D) which may or may not be different from the MTD. After determination of MTD and RP2D from Part 1a, Part 1c (Azacitidine Combination Dose Escalation) will enroll up to 30 participants. Continued treatment will be available under this study protocol for up to eight 28-day cycles (Continued Treatment Phase) if the Investigator judges the benefit outweighs the risk. Once BTX-A51 treatment has completed, participants will be contacted by telephone every 3 months for up to 2 years after their last treatment for survival status and anticancer therapy (Overall Survival Follow-up).
CONDITIONS
Official Title
A Study of BTX-A51 in People With Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understanding and signing informed consent
- Age 18 years or older
- Diagnosed with relapsed or refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) per WHO classification
- Ineligible for or exhausted standard treatments likely to provide benefit
- ECOG performance status of 2 or less and life expectancy of at least 6 weeks
- Adequate organ function with Grade 1 serum creatinine and bilirubin, and AST/ALT no more than twice the upper limit of normal
- Females of childbearing age must not be pregnant and agree to abstain or use highly effective contraception during and for 3 months after treatment
- Males sexually active with females of childbearing age must use a barrier method of birth control during and for 3 months after treatment
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia
- White blood cell count greater than 20 x 10^9/L
- Received cancer chemotherapy (other than hydroxyurea) within 2 weeks before study drug start
- Stem cell transplant within 3 months before screening or active graft-versus-host disease requiring more than topical corticosteroids or budesonide
- Use of systemic immunosuppressive medications including high-dose steroids, calcineurin inhibitors, or other specified immunosuppressants within specified timeframes before screening
- Life-threatening severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, or disseminated intravascular coagulation
- Persistent Grade 2 or higher toxicities from prior treatment
- Active uncontrolled systemic fungal, bacterial, mycobacterial, or viral infection
- Clinically significant heart disease
- Known swallowing or gastrointestinal absorption problems
- Any other medical condition that may interfere with study participation or safety
- Pregnant or breastfeeding females
AI-Screening
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Trial Site Locations
Total: 3 locations
1
City of Hope National Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
3
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
Z
Zung Thai, MD
CONTACT
E
Edgar Bautista
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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