Acute Myeloid Leukemia, Relapse Leukemia
Conditions
Keywords
CLADRIBINE, ACUTE MYELOID LEUKEMIA
Brief 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.
Detailed description
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.
Interventions
DRUGCladribine
5mg/㎡ d1-5
DRUGG-CSF
300ug d0-9
DRUGAclarubicin
10mg d3-6
DRUGCytarabine
10mg/㎡ q12h SC d3-9
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Remission (CR) rate | Bone marrow aspiration will be done within 2 weeks after blood cell count recovery (about 4 weeks after initiation of C-CAG treatment) | Less than 5% of blast cells in bone marrow aspiration is defined as CR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | From initiation of C-CAG treatment to end of the study (about within 3 months since enrollment) | The hematologic toxicities and non-hematologic toxicities will be graded according to CTCAE version 3.0 |
Countries
China
Contacts
Primary ContactLiang Wang, M.D.
Outcome results
None listed