Venetoclax Combined With Azactidine in the Treatment of ALAL
ConditionAcute Leukemia of Ambiguous Lineage
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age15+
SponsorSheng-Li Xue, MD
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Venetoclax
DrugVenetoclax orally once daily (100 mg d1, 200 mg d2, 400 mg d3-28);
azactidine
Drugazacitidine 75 mg/m2 subcutaneously once daily on days 1-7
Treatment groups
23 Participants
are divided into 1 treatment groupGroup A: Venetoclax Combined With azactidine in the Treatment of Acute Leukaemias of Ambiguous LineageExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
At the end of Cycle 1 (each cycle is 28 days)2
Complete Remission Rate (CRR)
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 outcomes
1
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.
Time frame
1 year2
Progression-Free Survival (PFS)
It is measured from the date of entry into this trial to the date of progression or death.
Time frame
1 year3
Adverse events in hematological system
Record of adverse events in hematological system during and after designed venetoclax combined azacitidine regimen induction.
Time frame
1 year4
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.
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Sheng-Li Xue, MD
Lead sponsor
The First Affiliated Hospital of Soochow University
Sponsor institution
Jining Medical University
Collaborator
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
Northern Jiangsu People's Hospital
Collaborator
Pingdingshan first people's Hospital
Collaborator
The Second Affiliated Hospital of Wannan Medical College
Collaborator
Canglang Hospital of Suzhou
Collaborator
Source ClinicalTrials.gov