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

• Status: Unknown status
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Asparaginase; Cladribine; Cytarabine; Pegaspargase

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.