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

• Status: Unknown status
• Trial end date: 2019-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Aclacinomycins; Aclarubicin; Cladribine; Cytarabine

Criteria

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; 垫·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.