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
About this study
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.
Based on ClinicalTrials.gov records.
What participants do
- 1.Take Azacitidine
- 2.Take BTX-A51
Participation effort
Estimated from trial records. Details can vary by site.
Logistics difficulty varies by site location and availability.
Trial highlights
Treatment details
Auto-extracted from trial records to preview treatments and outcomes.
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