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Trial Title:
Venetoclax Combined With Azactidine in the Treatment of ALAL
NCT ID:
NCT05901974
Condition:
Acute Leukemia of Ambiguous Lineage
Conditions: Official terms:
Leukemia
Venetoclax
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Venetoclax
Description:
Venetoclax orally once daily (100 mg d1, 200 mg d2, 400 mg d3-28);
Arm group label:
Venetoclax Combined With azactidine in the Treatment of Acute Leukaemias of Ambiguous Lineage
Intervention type:
Drug
Intervention name:
azactidine
Description:
azacitidine 75 mg/m2 subcutaneously once daily on days 1-7
Arm group label:
Venetoclax Combined With azactidine in the Treatment of Acute Leukaemias of Ambiguous Lineage
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients aged ≥ 15 and ≤ 65 years.
2. Patients diagnosed with ALAL according to 5th edition of WHO Acute Leukaemias of
Ambiguous Lineage diagnosis standard.
3. New diagnosed patients.
4. ECOG performance status score less than 3.
5. Expected survival time #3 months.
6. Patients without serious heart, lung, liver, or kidney disease.
7. Ability to understand and voluntarily provide informed consent.
Exclusion Criteria:
1. Patients who are allergic to the study drug or drugs with similar chemical
structures.
2. Pregnant or lactating women, and women of childbearing age who do not want to
practice effective methods of contraception.
3. Active infection.
4. Active bleeding.
5. Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a
medical history within one year before enrollment.
6. 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.
7. 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).
8. 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.
9. Surgery on the main organs within the past six weeks.
10. Drug abuse or long-term alcohol abuse that would affect the evaluation results.
11. Patients who have received organ transplants (excepting bone marrow
transplantation).
12. Patients not suitable for the study according to the investigator's assessment.
Gender:
All
Minimum age:
15 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affliated Hospital of Soochow University
Address:
City:
Suzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Sheng-Li Xue
Start date:
July 1, 2021
Completion date:
July 1, 2025
Lead sponsor:
Agency:
Sheng-Li Xue, MD
Agency class:
Other
Collaborator:
Agency:
Jining Medical University
Agency class:
Other
Collaborator:
Agency:
The Second People's Hospital of Huai'an
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital Bengbu Medical College
Agency class:
Other
Collaborator:
Agency:
Affiliated Hospital of Nantong University
Agency class:
Other
Collaborator:
Agency:
Suzhou Hospital of Traditional Chinese Medicine
Agency class:
Other
Collaborator:
Agency:
Northern Jiangsu People's Hospital
Agency class:
Other
Source:
The First Affiliated Hospital of Soochow University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05901974
