drugset / Trial / NCT03181815

Cladribine in Combination With CAG in Patients With Refractory/Relapsed Acute Myeloid Leukemia

NCT03181815

Phase 2 Unknown 48 enrolled Sun Yat-sen University
NaSingle-groupOpen-labelTreatment

Summary

The vast majority of patients with AML will die of the disease, and no standard chemotherapy regimen were defined for patients with relapsed/refractory AML. Previous studies have confirmed the efficacy of cladribine in the treatment of AML, both de novo or relapse/refractory AML. Our previous experience has shown that Cladribine in combination of CAG (G-CSF priming, low dose cytarabine, and aclarubicin) are effective with tolerable toxicity profiling.Thus, this phase 2 clincial trial is going to evaluate the efficacy and safety of cladribine in combination with G-CSF, low-dose cytarabine and aclarubicin (C-CAG) in patients with refractory/relapsed acute myeloid leukemia.

Timeline

Start
2016-01-01
Primary completion
2019-12-31
Completion
2019-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Cladribine Small molecule 5 mg/m2
Background Aclarubicin Small molecule 10 mg
Background Cytarabine Small molecule 10 mg/m2 Subcutaneous
Background G-CSF Unknown 300 ug