BCL2i CLAG-M in R/R Acute Myeloid Leukemia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorH. Lee Moffitt Cancer Center and Research Institute
About this trial
This multicenter, open-label phase II study combines CLAG-based therapy with or without venetoclax in patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) in order to improve measurable residual disease (MRD) clearance and event-free survival. Investigators hypothesize that the addition of venetoclax to CLAG-M in patients with relapsed or refractory AML is safe, and superior to CLAG-M alone in improving patient outcomes.
Eligibility criteria
Qualifiers
Provision of signed and dated informed consent form.
Ability to understand and stated willingness to comply with all study procedures and availability for the duration of the study.
Adults aged ≥18 years - 80 years.
Patients with documented refractory or relapsed AML: Refractory disease is defined as failure to achieve CR (i.e., <5% blasts in BM or blood) with or without normal restoration of hematopoiesis (Cri) after at least 1 cycle of intensive induction therapy (or 2 cycles of non-intensive induction). Relapse: Recurrence of disease after achieving remission, meeting one or more of the following criteria: ≥ 5% blasts in the marrow or peripheral blood, extramedullary disease.
Disqualifiers
Venetoclax-refractory disease or recent venetoclax exposure < 3 months prior to first dose of study therapy.
Prior treatment with a high-dose cytarabine-containing regimen (e.g., no prior CLAG/FLAG/MEC/CLIA/HAM, etc.).
Allogeneic stem cell transplant in the past 3 months.
Less than 14 days from last AML-directed therapy or five half-lives, whichever is shorter, not including hydroxyurea.
Trial design
Treatments tested in this trial
- Cladribine, Cytarabine, Mitoxantrone, G-CSF (CLAG-M) regimen
- Venetoclax
Treatment groups
52 Participants
are divided into 2 treatment groupsSponsors and collaborators
H. Lee Moffitt Cancer Center and Research Institute
Lead sponsor
AbbVie
Collaborator
Source ClinicalTrials.gov