Venetoclax Combined With Azactidine in the Treatment of ALAL

Sponsor
Sheng-Li Xue, MD
Study ID
NCT05901974
Phase
PHASE2
Status
Recruiting
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Conditions

  • Acute Leukemia of Ambiguous Lineage

Eligibility Criteria

Sex
ALL
Age
15 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    Venetoclax orally once daily (100 mg d1, 200 mg d2, 400 mg d3-28);
  • azactidine — DRUG
    azacitidine 75 mg/m2 subcutaneously once daily on days 1-7

Study Details

The prognosis of acute leukaemias of ambiguous lineage is poor. The effect of chemotherapy regimen and hematopoietic stem cell transplantation are still unclear. Therefore, we will explore new therapy to improve the remission rate of acute leukaemias of ambiguous lineage. Venetoclax can significantly improve the remission rate and prolong PFS and OS. At present, venetoclax combined with azacitidine or decitabine has become the preferred treatment regimen for elderly AML patients. It also shows a high response rate in relapsed/refractory AML or MDS patients. There are few clinical studies on the treatment of ALAL. The purpose of this study is to explore the efficacy and safety of venetoclax combined with azacitidine in the treatment of newly diagnosed ALAL patients.

Key Dates

Start date
Jul 1, 2023
Status verified
Dec 2025
Primary completion
Mar 1, 2026
Completion
Mar 1, 2026

Study Design

Enrollment
23 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Venetoclax Combined With azactidine in the Treatment of Acute Leukaemias of Ambiguous Lineage
    Venetoclax combined with azacitidine regimen. Venetoclax orally once daily (100 mg d1, 200 mg d2, 400 mg d3-28); azacitidine 75 mg/m2 subcutaneously once daily on days 1-7 .

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]

Central Contacts

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