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Venetoclax Combined With Azactidine in the Treatment of ALAL

Primary Purpose

Acute Leukemia of Ambiguous Lineage

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Venetoclax
azactidine
Sponsored by
Sheng-Li Xue, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Leukemia of Ambiguous Lineage

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients aged ≥ 15 and ≤ 65 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. Exclusion Criteria: 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.

Sites / Locations

  • The First Affliated Hospital of Soochow UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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 .

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall survival (OS)
It is measured from the date of entry into this trial to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive.
Progression-Free Survival (PFS)
It is measured from the date of entry into this trial to the date of progression or death.
Adverse events in hematological system
Record of adverse events in hematological system during and after designed venetoclax combined azacitidine regimen induction.
Adverse events in other organs or systems
Record of adverse events in other organs or systems during and after designed venetoclax combined azacitidine regimen induction.

Full Information

First Posted
June 4, 2023
Last Updated
July 17, 2023
Sponsor
Sheng-Li Xue, MD
Collaborators
Jining Medical University, The Second People's Hospital of Huai'an, First Affiliated Hospital Bengbu Medical College, Affiliated Hospital of Nantong University, Suzhou Hospital of Traditional Chinese Medicine, Northern Jiangsu Province People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05901974
Brief Title
Venetoclax Combined With Azactidine in the Treatment of ALAL
Official Title
A Multicenter Prospective Clinical Study of Venetoclax Combined With Azactidine in the Treatment of Acute Leukaemias of Ambiguous Lineage
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
July 1, 2025 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sheng-Li Xue, MD
Collaborators
Jining Medical University, The Second People's Hospital of Huai'an, First Affiliated Hospital Bengbu Medical College, Affiliated Hospital of Nantong University, Suzhou Hospital of Traditional Chinese Medicine, Northern Jiangsu Province People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Leukemia of Ambiguous Lineage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Venetoclax Combined With azactidine in the Treatment of Acute Leukaemias of Ambiguous Lineage
Arm Type
Experimental
Arm Description
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 .
Intervention Type
Drug
Intervention Name(s)
Venetoclax
Intervention Description
Venetoclax orally once daily (100 mg d1, 200 mg d2, 400 mg d3-28);
Intervention Type
Drug
Intervention Name(s)
azactidine
Intervention Description
azacitidine 75 mg/m2 subcutaneously once daily on days 1-7
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
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.
Time Frame
At the end of Cycle 1 (each cycle is 28 days)
Title
Complete Remission Rate (CRR)
Description
The complete remission rate achieved after one or two courses (28 days) induction therapy by venetoclax combined azacitidine regimen.
Time Frame
At the end of Cycle 1 (each cycle is 28 days)
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
It is measured from the date of entry into this trial to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive.
Time Frame
1 year
Title
Progression-Free Survival (PFS)
Description
It is measured from the date of entry into this trial to the date of progression or death.
Time Frame
1 year
Title
Adverse events in hematological system
Description
Record of adverse events in hematological system during and after designed venetoclax combined azacitidine regimen induction.
Time Frame
1 year
Title
Adverse events in other organs or systems
Description
Record of adverse events in other organs or systems during and after designed venetoclax combined azacitidine regimen induction.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged ≥ 15 and ≤ 65 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sheng-Li Xue, MD
Phone
0086-0512-67781139
Email
slxue@suda.edu.cn
Facility Information:
Facility Name
The First Affliated Hospital of Soochow University
City
Suzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheng-Li Xue

12. IPD Sharing Statement

Plan to Share IPD
No

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Venetoclax Combined With Azactidine in the Treatment of ALAL

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