CLAG+VEN vs CLAG in the Treatment of Relapsed/Refractory AML
NCT ID: NCT06763666
Last Updated: 2025-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
172 participants
INTERVENTIONAL
2025-02-28
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CLAGV regimen
CLAG combined with venetoclax for relapsed/refractory AML. Patients were randomized and those entering the experimental group received cladribine, cytarabine, G-CSF and venetoclax.
Venetoclax is administered orally at 400mg/d on days 2-8. When combination with P450 3A4 inhibitor, VEN should be reduced to 100-200mg/d and monitoring of VEN blood concentrations is recommended at qualified centers. Cladribine is administered intravenously at a dose of 5 mg/m2/d on days 1-5. Cytarabine is administered intravenously at a dose of 1g/m2/d on days 1-5, starting 2h after cladribine and maintained for more than 3h. The dose of G-CSF was 5ug/kg/d subcutaneously injected on days 0-5. Generally, starting 12 hours before the start of chemotherapy, if the absolute value of white blood cell count is ≥ 20×10\^9/L, the use is suspended.For patients with FLT3 mutations, corresponding inhibitors such as sorafenib and gilteritinib can be combined.
Cladribine
Given IV
Cytarabine
Given IV
G-CSF
Given SC
Venetoclax
Given PO
CLAG regimen
CLAG regimen for relapsed/refractory AML. Patients were randomized and those entering the experimental group received cladribine, cytarabine, G-CSF.
Cladribine is administered intravenously at a dose of 5 mg/m2/d on days 1-5. Cytarabine is administered intravenously at a dose of 1g/m2/d on days 1-5, starting 2h after cladribine and maintained for more than 3h. The dose of G-CSF was 5ug/kg/d subcutaneously injected on days 0-5. Generally, starting 12 hours before the start of chemotherapy, if the absolute value of white blood cell count is ≥ 20×10\^9/L, the use is suspended.For patients with FLT3 mutations, corresponding inhibitors such as sorafenib and gilteritinib can be combined.
Cladribine
Given IV
Cytarabine
Given IV
G-CSF
Given SC
Interventions
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Cladribine
Given IV
Cytarabine
Given IV
G-CSF
Given SC
Venetoclax
Given PO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. All patients should aged 18 to 65 years.
3. Diagnosed of relapsed and refractory AML, according to The guidelines for diagnosis and treatment of relapse /refractory acute myelogenous leukemia in China（2023）
4. 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.
5. Diagnostic criteria for refractory AML: The newly diagnosed patients who failed to respond to two courses of standard treatment; Patients who relapsed within 12 months after consolidation intensive therapy; Patients who relapsed after 12 months and failed to respond to conventional chemotherapy; Patients with two or more recurrences; Patients with persistent extramedullary leukemia.
6. The score of Eastern Cooperative Oncology Group (ECOG) is 0-2.
7. Renal function: creatinine clearance rate ≥ 30ml/min.
8. Liver function: ALT\<5 times normal value, bilirubin\<3 times normal value.
9. Predicted survival ≥ 3 months.
10. Able to accept oral Venetoclax.
11. Sign an informed consent form and be able to understand and follow the procedures required by this protocol.
Exclusion Criteria
2. Patients with central nervous system (CNS) invasion.
3. Cardiac function \< grade 2.
4. Known human immunodeficiency virus (HIV) infection.
5. Other clinically significant uncontrolled conditions, including but not limited to: a. uncontrolled or active systemic infections (viruses, bacteria, or fungi); b. Chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) requiring treatment; c. Secondary tumors requiring active treatment.
6. Allergy to experimental drugs.
7. Pregnant and lactating women.
8. Patients who ineligible for the study according to the investigator's assessment.
18 Years
65 Years
ALL
No
Sponsors
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Guangzhou No.12 People's Hospital
OTHER_GOV
Guangzhou Panyu Central Hospital
OTHER
Guangzhou General Hospital of Guangzhou Military Command
OTHER
Guangzhou First People's Hospital
OTHER
Foresea Life Insurance Guangzhou General Hospital
UNKNOWN
Guangdong Second Provincial General Hospital
OTHER
Jiangmen Central Hospital
OTHER
Shantou Central Hospital
OTHER
Maoming People's Hospital
OTHER
First Affiliated Hospital of Guangxi Medical University
OTHER
Hainan General Hospital
OTHER
Dongguan People's Hospital
OTHER_GOV
Tungwah Hospital of Sun Yat-Sen University
UNKNOWN
Shenzhen Hospital of Southern Medical University
OTHER
Central People's Hospital of Zhanjiang
OTHER
ZhuHai Hospital
OTHER
Shenzhen Second People's Hospital
OTHER
Zhongshan People's Hospital, Guangdong, China
OTHER
LiuZhou People's Hospital
OTHER
First People's Hospital of Foshan
OTHER
Southern Medical University, China
OTHER
Affiliated Hospital of Guangdong Medical University
OTHER
Guilin Medical University, China
OTHER
Yuebei People's Hospital
OTHER
Huizhou Municipal Central Hospital
OTHER
Second Affiliated Hospital of Guangzhou Medical University
OTHER
Peking University Shenzhen Hospital
OTHER
Nanfang Hospital, Southern Medical University
OTHER
Responsible Party
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Principal Investigators
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Guopan Yu
Role: PRINCIPAL_INVESTIGATOR
Nanfang Hospital, Southern Medical University
Locations
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Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Guopan Yu
Role: CONTACT
Facility Contacts
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Other Identifiers
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NFEC-2024-639
Identifier Type: -
Identifier Source: org_study_id
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