CLAG+VEN vs CLAG in the Treatment of Relapsed/Refractory AML
ConditionRelapsed/Refractory AML
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNanfang Hospital, Southern Medical University
About this trial
This is a multicenter, prospective, randomized controlled clinical study comparing the efficacy and safety of CLAG+VEN and CLAG regimens in relapsed/refractory(r/r) AML.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed of AML according to the World Health Organization (WHO) classification.
All patients should aged 18 to 65 years.
Diagnosed of relapsed and refractory AML, according to The guidelines for diagnosis and treatment of relapse /refractory acute myelogenous leukemia in China（2023）
Diagnostic criteria for relapsed AML: Leukemia cells reappear in the peripheral blood or primitive cells in the bone marrow ≥ 5% (excluding other reasons such as bone marrow regeneration after consolidation chemotherapy) after CR, or leukemia cell infiltration appears outside the marrow.
Disqualifiers
Diagnosed of acute promyelocytic leukemia (AML-M3)
Patients with central nervous system (CNS) invasion.
Cardiac function < grade 2.
Known human immunodeficiency virus (HIV) infection.
Trial design
Design model
Parallel
Treatments tested in this trial
Cladribine
DrugGiven IV
Cytarabine
DrugGiven IV
G-CSF
DrugGiven SC
Venetoclax
DrugGiven PO
Treatment groups
172 Participants
are divided into 2 treatment groupsGroup A: CLAGV regimenExperimental treatment 4 interventions
Group B: CLAG regimenActive comparator 3 interventions
Trial outcomes
Primary outcomes
1
Composite Complete remission (cCR, CR+CRi)
Will compare composite complete remission(CR+CRi: complete response \[CR\] and complete response with incomplete blood count recovery \[CRi\]) between CLAGV regimen and CLAG regimen
Time frame
At the end of Cycle 1 (each cycle is 28 days)Secondary outcomes
1
Overall Response rate (ORR)
Will compare ORR(completed remission\[CR\], completed remission with incomplete blood count recovery\[CRi\], and partial remission\[PR\]) rates between the study arms
Time frame
At the end of Cycle 1 (each cycle is 28 days)2
MRDneg CR rate
Will compare MRD-negative cCR rates between the study arms
Time frame
At the end of Cycle 1 (each cycle is 28 days)3
Overall Survival(OS)
Will compare OS between the study arms
Time frame
1 year post treatment4
Relapse free survival(RFS)
Will compare RFS between the study arms
Time frame
1 year post treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Nanfang Hospital, Southern Medical University
Lead sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborator
Guangzhou No.12 People's Hospital
Collaborator
Guangzhou Panyu Central Hospital
Collaborator
Guangzhou General Hospital of Guangzhou Military Command
Collaborator
Guangzhou First People's Hospital
Collaborator
Foresea Life Insurance Guangzhou General Hospital
Collaborator
Guangdong Second Provincial General Hospital
Collaborator
Jiangmen Central Hospital
Collaborator
Shantou Central Hospital
Collaborator
Maoming People's Hospital
Collaborator
First Affiliated Hospital of Guangxi Medical University
Collaborator
Hainan General Hospital
Collaborator
Dongguan People's Hospital
Collaborator
Tungwah Hospital of Sun Yat-Sen University
Collaborator
Shenzhen Hospital of Southern Medical University
Collaborator
Central People's Hospital of Zhanjiang
Collaborator
ZhuHai Hospital
Collaborator
Shenzhen Second People's Hospital
Collaborator
Zhongshan People's Hospital, Guangdong, China
Collaborator
LiuZhou People's Hospital
Collaborator
First People's Hospital of Foshan
Collaborator
Southern Medical University, China
Collaborator
Affiliated Hospital of Guangdong Medical University
Collaborator
Guilin Medical University, China
Collaborator
Yuebei People's Hospital
Collaborator
Huizhou Municipal Central Hospital
Collaborator
Second Affiliated Hospital of Guangzhou Medical University
Collaborator
Peking University Shenzhen Hospital
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: