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

NCT ID: NCT03181815

Last Updated: 2019-08-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2019-12-31

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.

Conditions

Acute Myeloid Leukemia; Relapse Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

treatment arm

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

Group Type: EXPERIMENTAL

Cladribine

Intervention Type: DRUG

5mg/㎡ d1-5

G-CSF

Intervention Type: DRUG

300ug d0-9

Aclarubicin

Intervention Type: DRUG

10mg d3-6

Cytarabine

Intervention Type: DRUG

10mg/㎡ q12h SC d3-9

Interventions

Cladribine

5mg/㎡ d1-5

Intervention Type: DRUG

G-CSF

300ug d0-9

Intervention Type: DRUG

Aclarubicin

10mg d3-6

Intervention Type: DRUG

Cytarabine

10mg/㎡ q12h SC d3-9

Intervention Type: DRUG

Other Intervention Names

cladribine injection; granulocyte; Aclacinomycin; Ara-C

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Liang Wang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liang Wang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen Univerisity

Locations

Liang Wang

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Liang Wang, M.D.

Role: CONTACT

wangliang@sysucc.org.cn

+862087342439

Facility Contacts

Liang Wang, M.D.

Role: primary

wangliang@sysucc.org.cn

+862087342439

Other Identifiers

C-CAG in AML

Identifier Type: -

Identifier Source: org_study_id