Cladribine Combined With G-CSF and Cytarabine as a Salvage Treatment in R/R ALL

Study Overview
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Brief Summary
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To explore the efficiency and safety of CLAG regimen in R/R ALL

Detailed Description
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R/R Acute Lymphoblastic Leukemia has poor response to second-line chemotherapy.Here,we want to explore efficiency and safety of CLAG regimen in R/R ALL.

Official Title
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Cladribine Combined With G-CSF and Cytarabine as a Salvage Treatment in Refractory/Relapsed Acute Lymphoblastic Leukemia

Conditions
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Acute Lymphoblastic Leukemia

Intervention / Treatment
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* Drug: Cladribine
* Drug: Fludarabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients meet the diagnostic criteria for Relapsed/Refractroy B-ALL. ECOG score is 0-3. Expecting life span is more than 6 weeks. Exclusion Criteria: Patients are combined with severe organ dysfunction or organ failure: Cardiac failure, Liver and kidney insufficiency. Patients are combined with severe infection or other complications that can not tolerate chemotherapy. Patients are considered as other tumor progression. Patients have used cladribine. Pregnant and lactating women will not be included.

Ages Eligible for Study
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Minimum Age: 14 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CLAG arm<br>Cladribine (5 mg/m2)should be intravenous use on day 1-5, granulocyte colony-stimulating factor will be hypodermic injection using 300 μg per day on days 0-5,cytarabine (1.5 mg/m2) every 12 hours, intravenous infusion on day1-5,4 weeks per cycle. | Drug: Cladribine<br>* Cladribine combine with cytarabine will be intravenous on days 1-5; G-CSF will be hypodermic injection on day0-5,4 weeks per cycle.<br>* Other names: Cytarabine;|
| Active Comparator: Control arm<br>Patients in the control arm received the investigator's choice of one of the following three regimens: FLAG:Fludarabine(30mg/m2)should be intravenous use on day 1-5, granulocyte colony-stimulating factor will be hypodermic injection using 300 μg per day on days 0-5,cytarabine (1.5 mg/m2) every 12 hours, intravenous infusion on day1-5,4 weeks per cycle. a high-dose cytosine arabinoside-based regimen; a high-dose methotrexate-based regimen | Drug: Fludarabine<br>* Control arm Patients in the control arm received the investigator's choice of one of the following three regimens: FLAG:Fludarabine(30mg/m2)should be intravenous use on day 1-5, granulocyte colony-stimulating factor will be hypodermic injection using 300 μg per day on days 0-5,cytarabine (1.5 mg/m2) every 12 hours, intravenous infusion on day1-5,4 weeks per cycle. a high-dose cytosine arabinoside-based regimen; a high-dose methotrexate-based regimen<br>* Other names: methotrexate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CR (complete remission rate) | Response to CLAG regimen. | the first cycle (4 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival(OS) | The time from randomization to death from any cause. | From the 1st day to the 365th day after enrollment. | 
| Progression-Free Survival （PFS） | It is defined as the total survival of a patient after CR until the tumor recurrence or death from any cause. | From the 1st day to the 365th day after enrollment. |