A Study of BTX-A51 in People With Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
Phase 1
80
about 7.2 years
18+
3 sites in CA, NY, TX
What this study is about
Researchers are testing a treatment called BTX-A51 to see if it's safe and effective for people with relapsed or refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS). The trial will involve different doses of BTX-A51, either alone or in combination with azacitidine. Participants may receive treatment for up to eight 28-day cycles if their doctor thinks it's beneficial.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Azacitidine
- 2.Take BTX-A51
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
azacitidine
injection, subcutaneous
Primary: Incidence of dose-limiting toxicities (DLTs), Maximum tolerated dose (MTD), Number of participants with 12-lead electrocardiogram (ECG) abnormalities and/or AEs, Number of participants with echocardiogram (ECHO) abnormalities and/or AEs, Number of participants with laboratory abnormalities and/or AEs, Number of participants with non-serious AEs and serious AEs (SAEs), Number of participants with physical examination abnormalities and/or AEs, Number of participants with vital sign abnormalities and/or AEs
Secondary: Complete remission (CR) for participants with acute myeloid leukemia (AML), Complete remission (CR) for participants with high-risk myelodysplastic syndrome (MDS), Overall survival and event-free survival in participants with AML or high-risk MDS, PK parameter: AUC0-24, PK parameter: AUC0-24D5, PK parameter: C0, PK parameter: Maximum observed plasma concentration (Cmax), PK parameter: Plasma CmaxD5
Oncology