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Younger Patients With AML: Can Venetoclax Be Added Safely to Intensive Chemotherapy?

By: Hope Craig, MSPH
Posted: Friday, December 3, 2021

Researchers at MD Anderson Cancer Center in Houston investigated the safety and activity of adding the BCL2 inhibitor venetoclax to intensive chemotherapy in patients younger than age 65 with newly diagnosed acute myeloid leukemia (AML). In The Lancet Haematology, the authors reported findings of an independent cohort study, which was part of a larger single-center, single-arm, phase II trial of cladribine, high-dose cytarabine, and idarubicin (CLIA). They found that adding venetoclax to the CLIA chemotherapy regimen was not only safe, but it produced “high rates of durable measurable residual disease–negative remissions.”

Led by Hagop M. Kantarjian, MD, the study enrolled 50 patients aged 65 years or younger with a new diagnosis of AML, mixed phenotype acute leukemia, or high-risk myelodysplastic syndrome. Enrolled patients had no prior potentially curative therapy for leukemia. The median age of patients was 48, ranging from 37 to 56 years. More than half of the patients (56%) were male, and 60% were White.

CLIA induction consisted of 28-day courses. On days 1 to 3, patients received cladribine and cytarabine. In addition, idarubicin was given on days 1 and 2, and venetoclax was given on days 2 to 8. Most patients (n = 47, 94%) had a composite complete response (defined as a complete response or a complete response with incomplete blood cell count recovery). Two patients (4%) did not respond, and one patient (2%) died during induction therapy. Of the 45 patients with AML (90%), most had undetectable MRD.

From our single-center experience, we observed high rates of durable MRD-negative remissions and encouraging event-free survival and overall survival across all prognostic subgroups. Larger numbers of patients and multi-institutional studies of the CLIA/venetoclax regimen are warranted to confirm the possible benefits and safety of the regimen,” the authors commented.

Disclosures: Full authors’ disclosures are available at www.thelancet.com.



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