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.
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
* Secondary AML arising out of MDS previously treated with HMA, HMA + venetoclax (if \> 3 months from venetoclax exposure), and/or 1 cycle of induction chemotherapy.
* Extramedullary AML with marrow involvement is allowed as long as concurrent medullary AML is present.
* ECOG performance status ≤ 2.
* Participants must have adequate organ function as defined within the protocol.
* Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Testing is not mandatory.
* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
* Participants with a history of hepatitis C vi…
What they're measuring
1
MRD-Negative Remission Rate
Timeframe: Up to 18 months
Trial details
NCT IDNCT06660368
SponsorH. Lee Moffitt Cancer Center and Research Institute