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7-day venetoclax with intensive chemotherapy achieves 90.3% composite complete remission in AML

7-day venetoclax with intensive chemotherapy achieves 90.3% composite complete remission in AML
Photo by National Cancer Institute / Unsplash
Key Takeaway
Note that 7-day venetoclax induction achieves 90.3% remission rate but lacks long-term survival data at 18 months.

This clinical trial evaluated 259 newly diagnosed patients with acute myeloid leukemia (AML). The study compared a 7-day venetoclax induction period combined with three different dose-adjusted intensive chemotherapy regimens (DA, HAA, or HAD) against standard protocols.

The primary outcome was a composite complete remission rate of 90.3%. Secondary outcomes included an MRD negativity rate of 92.2%, an estimated 24-month overall survival of 72.9%, and an estimated 24-month event-free survival of 69.3%. The median time for absolute neutrophil count recovery was 14 days (range: 5-52), while the median time for platelet count recovery was 13 days (range: 4-63).

Regarding safety, a 7-day venetoclax schedule is potentially associated with reduced myelosuppressive risks compared to longer regimens. However, specific adverse event rates and discontinuation figures were not reported.

A primary limitation of this study is that median overall survival and event-free survival were not reached at the 18-month follow-up point. The data are derived from a combination of two clinical trials and one retrospective study. Clinicians may consider this regimen as a method to maintain high efficacy while potentially improving tolerability in AML patients.

Study Details

Study typeRct
EvidenceLevel 2
Follow-up18.0 mo
PublishedJun 2026
View Original Abstract ↓
While venetoclax (VEN) combined with intensive chemotherapy (IC) has demonstrated efficacy in newly diagnosed acute myeloid leukemia (AML), the optimal duration of VEN administration remains uncertain, leading to variability in its application during induction therapy. Herein, we reported the data of 259 ND AML patients who received 7-day VEN combined with dose-adjusted IC (DA, HAA, or HAD) as induction treatment, to further validate the efficacy and explore the safety of this combination. This study evaluated a truncated 7-day VEN regimen combined with dose-adjusted IC (DA, HAA, or HAD) as induction therapy. The patients included in this study were derived from 2 clinical trials (VEN+DA: ChiCTR2200061524; VEN+HAA: NCT05893472) and 1 retrospective study (VEN+HAD). All induction regimens include a 7-day oral administration of VEN, in combination with either DA, HAA, or HAD regimen. The composite complete remission rate was 90.3%, with a minimal residual disease (MRD) negativity rate of 92.2% as assessed by flow cytometry. After a median follow-up of 18 months, the median overall survival and event-free survival (EFS) were not reached. The estimated 24-month OS, EFS, and relapse-free survival (RFS) rates for the entire cohort were 72.9%, 69.3%, and 70.2%, respectively. No significant differences in survival outcomes were observed among the 3 treatment regimens (OS: P = .68; EFS: P = .73; RFS: P = .34). The median time of the absolute neutrophil count recovered to≥ 0.5 × 10/L and the platelet count to≥ 30 × 10/L after induction therapy was 14 (range: 5-52) days and 13 (range: 4-63) days, respectively. In conclusion, a 7-day VEN schedule maintains high efficacy while potentially reducing myelosuppressive risks of longer regimens.
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