Clinical trial NCT03181815: Cladribine in Combination With CAG in Patients With Refractory/Relapsed Acute Myeloid Leukemia
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Relapse Leukemia
Keywords: CLADRIBINE
ACUTE MYELOID LEUKEMIA
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2017-06-09
Enrollment: 48
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Complete Remission (CR) rate
timeFrame: Bone marrow aspiration will be done within 2 weeks after blood cell count recovery (about 4 weeks after initiation of C-CAG treatment)
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: From initiation of C-CAG treatment to end of the study (about within 3 months since enrollment)
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Liang Wang
state: Guangdong
Study officials:
affiliation: Sun Yat-sen Univerisity
name: Liang Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: