BXCL701 Phase 1 R/R Acute Myeloid Leukemia or Myelodysplastic Syndrome
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorEric Stephen Winer, MD
About this trial
The goal of this research study is to find the safest and most effective dose of the study drug, BXCL701, for the treatment of Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS).
The names of the study drugs involved in this study are/is:
* BXCL701
Eligibility criteria
Qualifiers
Age 18 and older
Relapsed AML: as evidence by ≥5% myeloblasts in the bone marrow, or reappearance of blasts in the peripheral blood
Refractory AML: ≤2 prior induction regimens (example: patients who receive 7 + 3 followed by 5 + 2 would count as one induction regimen) OR
Subjects with WHO defined myelodysplastic syndrome with excess blasts-2 (MDS-EB-2) as defined by blast count between 10% - 19% in the bone marrow or peripheral blood blasts 5% - 19% or Auer rods noted and who are refractory or relapsed after at least 4 cycles of a hypomethylating agent (azacitidine, decitabine, or oral decitabine/cedazuridine)
Disqualifiers
Subjects who have known Acute Promyelocytic Leukemia.
Subjects with active CNS involvement with AML.
Participants who have had chemotherapy, other investigational therapy, immunotherapy, or radiotherapy within 2 weeks or 5 half-lives from prior therapy, whichever is longer, prior to the first dose of study medication. Hydroxyurea is allowed with no required washout, and hydroxyurea may be administered for the first cycle of the protocol for patients who have proliferative disease (WBC <25K) with a maximum allowed dose of 6 g per day.
Participants who have received oral tyrosine kinase inhibitors (TKIs) within two weeks or 5 half-lives (whichever is longer) of the first dose of study medication
Trial design
Treatments tested in this trial
- BXCL701
Treatment groups
24 Participants
are divided into 1 treatment groupSponsors and collaborators
Eric Stephen Winer, MD
Lead sponsor
Dana-Farber Cancer Institute
Sponsor institution
Source ClinicalTrials.gov