Status:
UNKNOWN
Cladribine in Combination With GAP in Patients With Refractory/Relapsed Acute Lymphoblastic Leukemia
Lead Sponsor:
Sun Yat-sen University
Conditions:
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 Cladr...
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 define...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03318419
Start Date
January 1 2016
End Date
December 31 2020
Last Update
August 20 2019
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060