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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy and Safety of Cladribine in Combination With G-CSF, Low-dose Cytarabine and Pegaspargase in Patients With Refractory/Relapsed Acute Lymphoblastic Leukemia: a Phase 2 Clinical Trial

Conditions
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Acute Lymphoblastic Leukemia

Intervention / Treatment
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* Drug: Cladribine
* Drug: G-CSF
* Drug: Cytarabine
* Drug: Pegaspargase


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cladribine group<br>Cladribine in combination of GAP (G-CSF priming, low dose cytarabine, and Pegaspargase) will be administrated in this arm | Drug: Cladribine<br>* 5mg/㎡ d1-5<br>* Other names: cladribine injection;Drug: G-CSF<br>* 300ug d0-14<br>* Other names: granulocyte;Drug: Cytarabine<br>* 10mg/㎡ q12h SC d1-14<br>* Other names: Ara-C;Drug: Pegaspargase<br>* 2500U/m2 im d1<br>* Other names: Pegaspargase injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CR rate | Complete Remission: less than 5% blasts in bone marrow | Bone marrow aspiration will be done within 2 weeks after blood cell count recovery (about 4 weeks after initiation of C-GAP treatment |