Cladribine in Combination With GAP in Patients With Refractory/Relapsed Acute Lymphoblastic Leukemia

NCT ID: NCT03318419

Last Updated: 2019-08-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2020-12-31

Brief Summary

The vast majority of patients with ALL will die of the disease, and no standard chemotherapy regimen were defined for patients with relapsed/refractory ALL.Our previous experience has shown that Cladribine in combination of GAP (G-CSF priming, low dose cytarabine, and Pegaspargase) 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 Pegaspargase (C-GAP) in patients with refractory/relapsed acute Lymphoblastic Leukemia

Detailed Description

ALL is common in the elderly patients, who can not tolerate the intensified treatments. The vast majority of patients with ALL will die of the disease, and no standard chemotherapy regimen were defined for patients with relapsed/refractory ALL. Our previous experience has shown that Cladribine in combination of GAP(G-CSF priming, low dose cytarabine, and Pegaspargase) 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 Lymphoblastic Leukemia

Study Design

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

Study Groups

Cladribine group

Cladribine in combination of GAP (G-CSF priming, low dose cytarabine, and Pegaspargase) will be administrated in this arm

Group Type: EXPERIMENTAL

Cladribine

Intervention Type: DRUG

5mg/㎡ d1-5

G-CSF

Intervention Type: DRUG

300ug d0-14

Cytarabine

Intervention Type: DRUG

10mg/㎡ q12h SC d1-14

Pegaspargase

Intervention Type: DRUG

2500U/m2 im d1

Interventions

Cladribine

5mg/㎡ d1-5

Intervention Type: DRUG

G-CSF

300ug d0-14

Intervention Type: DRUG

Cytarabine

10mg/㎡ q12h SC d1-14

Intervention Type: DRUG

Pegaspargase

2500U/m2 im d1

Intervention Type: DRUG

Other Intervention Names

cladribine injection; granulocyte; Ara-C; Pegaspargase injection

Eligibility Criteria

Inclusion Criteria

• Men and women;
• Clinical diagnosis of Relapsed/Refractory ALL;
• 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 ALL, 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;
• Dementia or altered mental status that would prohibit the understanding or rendering of informed consent;
• Be allergic to any component of C-GAP regimen;
• Subjects ever exposed to cladribine or CAG-based regimen.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

dr. luyue

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

yue lv, MD.

Role: PRINCIPAL_INVESTIGATOR

sun-yat sun university cancer center

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

hua wang, MD.

Role: CONTACT

wanghua@sysucc.org.cn

Facility Contacts

yue lu, MD.

Role: primary

dr_luyue@sina.com

0086-02087342438

Other Identifiers

ALL-2017

Identifier Type: -

Identifier Source: org_study_id