Acute Myeloid Leukemia Clinical Trial
Official title:
Efficacy and Safety of Cladribine in Combination With G-CSF, Low-dose Cytarabine and Aclarubicin in Patients With Refractory/Relapsed Acute Myeloid Leukemia: a Phase 2 Clinical Trial
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.
Status | Recruiting |
Enrollment | 48 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Men and women; - Clinical diagnosis of Relapsed/Refractory AML (non-APL); - ECOG performance status (PS) score 0-3; - AST and ALT <=2.5 times the institutional ULN; - Total bilirubin <=2.0 times the institutional ULN - Serum creatinine<2.0 times the institutional ULN; - Subjects should take effective contraceptive measures,and serum or urine pregnancy tests must be negative during the screening and study periods in women subjects; - Patients should understand the disease and voluntarily receive the study regimen and follow-up. Exclusion Criteria: - Concurrent diagnosis of tumors other than AML, with exclusion of superficial bladder cancer, basal cell and squamous cell carcinoma, cervical intraepithelial neoplasms (CIN), prostatic intraepithelial neoplasms(PIN); - Active viral or bacterial infection that would impair the ability of the subject to receive protocol therapy; - Concurrent autoimmune hemolytic anemia or immune thrombocytopenia; - Subjects suffered from AIDS,active hepatitis B or C virus infection; ?·Dementia or altered mental status that would prohibit the understanding or rendering of informed consent; - Be allergic to any component of C-CAG regimen; - Subjects ever exposed to cladribine or CAG-based regimen. |
Country | Name | City | State |
---|---|---|---|
China | Liang Wang | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-sen University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete Remission (CR) rate | Less than 5% of blast cells in bone marrow aspiration is defined as CR. | Bone marrow aspiration will be done within 2 weeks after blood cell count recovery (about 4 weeks after initiation of C-CAG treatment) | |
Secondary | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | The hematologic toxicities and non-hematologic toxicities will be graded according to CTCAE version 3.0 | From initiation of C-CAG treatment to end of the study (about within 3 months since enrollment) |
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