Cladribine in Combination With CAG in Patients With Refractory/Relapsed Acute Myeloid Leukemia
NCT03181815 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2019-08-20
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.
Conditions
- Acute Myeloid Leukemia
- Relapse Leukemia
Interventions
- DRUG
-
Cladribine
5mg/㎡ d1-5
- DRUG
-
G-CSF
300ug d0-9
- DRUG
-
Aclarubicin
10mg d3-6
- DRUG
-
10mg/㎡ q12h SC d3-9
Sponsors & Collaborators
-
Sun Yat-sen University
lead OTHER
Principal Investigators
-
Liang Wang, M.D. · Sun Yat-sen Univerisity
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 15 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-01-01
- Primary Completion
- 2019-12-31
- Completion
- 2019-12-31
Countries
- China
Study Locations
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