A Phase 4 interventional study of Cladribine and Cytarabine in Relapsed/Refractory AML, sponsored by Nanfang Hospital, Southern Medical University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-01-08.
Sponsored by Nanfang Hospital, Southern Medical University · Phase 4, Interventional, and Treatment
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.
The efficacy and prognosis of relapsed/refractory(r/r) AML are very poor, and there is no standard chemotherapy regimen were defined for r/r AML. Cladribine, a purine analogue, exerts cytotoxic, proapoptotic, and antiproliferative effects on AML cells. Previous studies have confirmed the efficacy of cladribine in the treatment of r/r AML, with a response rate of 30-45%.Our previous experience has shown that CLAG in combination of venetoclax are effective with tolerable toxicity profiling. However, there is a lack of multicenter, prospective, randomized controlled trials to further confirm the results. Therefore, a clinical study is planned to evaluate the efficacy and safety of CLAG+VEN compared to CLAG in r/r AML who were eligible for intensive therapy.
Nanfang Hospital, Southern Medical University is the lead sponsor of 480 studies on the registry; 212 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Cladribine · Drug: Cytarabine · Drug: G-CSF · Drug: Venetoclax
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.
Drug: Cladribine · Drug: Cytarabine · Drug: G-CSF
Given IV
Also known as: 2-CdA, CdA
Given IV
Also known as: Ara-C
Given SC
Also known as: Filgrastim, Granulocyte Colony-stimulating Factor
Given PO
Also known as: Venclexta
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)
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)
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)
Overall Survival(OS)
Will compare OS between the study arms
Time frame: 1 year post treatment
Relapse free survival(RFS)
Will compare RFS between the study arms
Time frame: 1 year post treatment
Duration of completed response(DoR)
Will compare DoR between the study arms
Time frame: 1 year post treatment
Relapse rate
Will compare relapse rate between the study arms
Time frame: 1 year post treatment
Incidence of Adverse Events
Will use the CTCAE (National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events) version 5.0 for toxicity and adverse event reporting. Will describe the incidence of infection and treatment-related adverse events.
Time frame: Duration of treatment, up to 1 year
Plan to share: No
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This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Nanfang Hospital, Southern Medical University