Clinical Trial of BP1001 in Combination With With Venetoclax Plus Decitabine in AML
ConditionAcute Myeloid Leukemia (AML)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBio-Path Holdings, Inc.
About this trial
The primary objectives of this study are to assess: (1) whether the combination of BP1001 plus venetoclax plus decitabine provides greater efficacy (Complete Remission \[CR\], Complete Remission with incomplete hematologic recovery \[CRi\], Complete Remission with partial hematologic recovery \[CRh\], than venetoclax plus decitabine alone (by historical comparison) in participants with untreated AML that cannot or elect not to be treated with more intensive chemotherapy; (2) whether BP1001-based treatment provides greater efficacy (CR, CRi, CRh) than intensive chemotherapy (by historical comparison) in participants with refractory/relapsed AML.
Eligibility criteria
Qualifiers
Adults ≥18 years of age
Females must be of non-childbearing potential, surgically sterile, postmenopausal, or practice adequate methods of contraception during the study and for 30 days after the last dose of study drug or decitabine
Males must agree to use an adequate method of contraception during the study and for at least 30 days after the last dose of study drug or decitabine
Newly diagnosed untreated AML; or
Disqualifiers
Active non-hematologic or lymphoid malignancy other than AML treated with immuno- or chemotherapy within the previous 12 months except active non- melanoma, non-invasive skin cancer will be allowed.
Known, active leptomeningeal leukemia requiring intrathecal therapy. NOTE: Patients with a history of CNS disease may be allowed to participate based on at least 1 documented, negative spinal fluid assessment within 28 days prior to Screening
Isolated extramedullary leukemia without also meeting bone marrow criteria for acute leukemia (for AML usually = 20% blasts in BMA or BMB). Patients may have leukemia with lower blast counts (Dohner et al. 2010). Bio-Path Holdings and Investigator concurrence required.
Acute promyelocytic leukemia (APL) with t(15;17)(q22;q12) PML-RARA
Trial design
Treatments tested in this trial
- BP1001 in combination with Ventoclax plus decitabine
- BP1001 plus decitabine
Treatment groups
108 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov