Acute Lymphoblastic Leukemia
Conditions
Brief summary
To explore the efficiency and safety of CLAG regimen in R/R ALL
Detailed description
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.
Interventions
DRUGCladribine
Cladribine combine with cytarabine will be intravenous on days 1-5; G-CSF will be hypodermic injection on day0-5,4 weeks per cycle.
DRUGFludarabine
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
Sponsors
The First People's Hospital of Changzhou
Zhongda Hospital
Suzhou Municipal Hospital
The First Affiliated Hospital of Soochow University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CR (complete remission rate) | the first cycle (4 weeks) | Response to CLAG regimen. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival(OS) | From the 1st day to the 365th day after enrollment. | The time from randomization to death from any cause. |
| Progression-Free Survival （PFS） | From the 1st day to the 365th day after enrollment. | It is defined as the total survival of a patient after CR until the tumor recurrence or death from any cause. |
Countries
China
Contacts
Primary ContactHuizhu Kang, MD
Backup ContactMeng Zhou, MD
Outcome results
None listed