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

Study Overview
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Brief Summary
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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.

Detailed Description
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AML is most common in the elderly patients, who can not tolerate the intensified treatments. 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.

Official Title
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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

Conditions
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Acute Myeloid Leukemia, Relapse Leukemia

Intervention / Treatment
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* Drug: Cladribine
* Drug: G-CSF
* Drug: Aclarubicin
* Drug: Cytarabine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment arm<br>The patients in this arm will receive C-CAG regimen for salvage treatment,detailed as following: Cladribine 5mg/㎡，d1-5；G-CSF 300ug,d0-9; aclarubicin 10mg,d3-6;cytarabine 10mg/㎡ q12h, SC, d3-9;4 weeks a cycle | Drug: Cladribine<br>* 5mg/㎡ d1-5<br>* Other names: cladribine injection;Drug: G-CSF<br>* 300ug d0-9<br>* Other names: granulocyte;Drug: Aclarubicin<br>* 10mg d3-6<br>* Other names: Aclacinomycin;Drug: Cytarabine<br>* 10mg/㎡ q12h SC d3-9<br>* Other names: Ara-C;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CLADRIBINE, ACUTE MYELOID LEUKEMIA