Venetoclax Combined With Azactidine in the Treatment of ALAL

NCT05901974 | Recruiting Phase 2

• 1 other identifier: SZALAL01
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Leukemia of Ambiguous Lineage

Outcome Measures

Primary Outcomes (2)

• Overall Response Rate (ORR)

  The overall response (complete remission, complete remission with incomplete blood count recovery) rate achieved after one or two courses (28 days) induction therapy by venetoclax combined azacitidine regimen.

  At the end of Cycle 1 (each cycle is 28 days)

• Complete Remission Rate (CRR)

  The complete remission rate achieved after one or two courses (28 days) induction therapy by venetoclax combined azacitidine regimen.

  At the end of Cycle 1 (each cycle is 28 days)

Secondary Outcomes (4)

• Overall survival (OS)

  1 year

• Progression-Free Survival (PFS)

  1 year

• Adverse events in hematological system

  1 year

• Adverse events in other organs or systems

  1 year

Study Arms (1)

Venetoclax Combined With azactidine in the Treatment of Acute Leukaemias of Ambiguous Lineage

EXPERIMENTAL

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 .

Drug: Venetoclax; Drug: azactidine

Interventions

Venetoclax DRUG

Venetoclax orally once daily (100 mg d1, 200 mg d2, 400 mg d3-28);

Venetoclax Combined With azactidine in the Treatment of Acute Leukaemias of Ambiguous Lineage

azactidine DRUG

azacitidine 75 mg/m2 subcutaneously once daily on days 1-7

Venetoclax Combined With azactidine in the Treatment of Acute Leukaemias of Ambiguous Lineage

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥ 15 years.
• Patients diagnosed with ALAL according to 5th edition of WHO Acute Leukaemias of Ambiguous Lineage diagnosis standard.
• New diagnosed patients.
• ECOG performance status score less than 3.
• Expected survival time ≥3 months.
• Patients without serious heart, lung, liver, or kidney disease.
• Ability to understand and voluntarily provide informed consent.

You may not qualify if:

• Patients who are allergic to the study drug or drugs with similar chemical structures.
• Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception.
• Active infection.
• Active bleeding.
• Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment.
• Patients with mental disorders or other conditions whereby informed consent cannot be obtained and where the requirements of the study treatment and procedures cannot be met.
• Liver function abnormalities (total bilirubin \> 1.5 times the upper limit of the normal range, ALT/AST \> 2.5 times the upper limit of the normal range or patients with liver involvement whose ALT/AST \> 1.5 times the upper limit of the normal range), or renal anomalies (serum creatinine \> 1.5 times the upper limit of the normal value).
• Patients with a history of clinically significant QTc interval prolongation (male \> 450 ms; female \> 470 ms), ventricular heart tachycardia and atrial fibrillation, II-degree heart block, myocardial infarction attack within one year before enrollment, and congestive heart failure, and patients with coronary heart disease who have clinical symptoms and requiring drug treatment.
• Surgery on the main organs within the past six weeks.
• Drug abuse or long-term alcohol abuse that would affect the evaluation results.
• Patients who have received organ transplants (excepting bone marrow transplantation).
• Patients not suitable for the study according to the investigator's assessment.

Sponsors & Collaborators

• The Second People's Hospital of Huai'an: collaborator
• The First Affiliated Hospital of Bengbu Medical University: collaborator
• Affiliated Hospital of Nantong University: collaborator
• Suzhou Hospital of Traditional Chinese Medicine: collaborator
• Pingdingshan first people's Hospital: collaborator
• Canglang Hospital of Suzhou: collaborator
• Sheng-Li Xue, MD: lead
• Jining Medical University: collaborator
• Northern Jiangsu People's Hospital: collaborator
• The Second Affiliated Hospital of Wannan Medical College: collaborator

Study Sites (1)

The First Affliated Hospital of Soochow University

Suzhou, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Biphenotypic, Acute

Interventions

venetoclax

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Sheng-Li Xue, MD

CONTACT

0086-0512-67781139; slxue@suda.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 4, 2023
• First Posted: June 13, 2023
• Study Start: July 1, 2023
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)