Cladribine Combined With G-CSF and Cytarabine as a Salvage Treatment in R/R ALL
NCT ID: NCT05578378
Last Updated: 2022-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
32 participants
INTERVENTIONAL
2022-01-01
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CLAG arm
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.
Cladribine
Cladribine combine with cytarabine will be intravenous on days 1-5; G-CSF will be hypodermic injection on day0-5,4 weeks per cycle.
Control arm
Patients in the control arm received the investigator's choice of one of the following three regimens:
1. 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.
2. a high-dose cytosine arabinoside-based regimen;
3. a high-dose methotrexate-based regimen
Fludarabine
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
Interventions
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Cladribine
Cladribine combine with cytarabine will be intravenous on days 1-5; G-CSF will be hypodermic injection on day0-5,4 weeks per cycle.
Fludarabine
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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.
14 Years
ALL
No
Sponsors
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The First People's Hospital of Changzhou
OTHER
Zhongda Hospital
OTHER
Suzhou Municipal Hospital
OTHER
The First Affiliated Hospital of Soochow University
OTHER
Responsible Party
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Principal Investigators
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Yue Han, MD/PhD
Role: PRINCIPAL_INVESTIGATOR
Study Principle investigator
Locations
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The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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References
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Gokbuget N, Stanze D, Beck J, Diedrich H, Horst HA, Huttmann A, Kobbe G, Kreuzer KA, Leimer L, Reichle A, Schaich M, Schwartz S, Serve H, Starck M, Stelljes M, Stuhlmann R, Viardot A, Wendelin K, Freund M, Hoelzer D; German Multicenter Study Group for Adult Acute Lymphoblastic Leukemia. Outcome of relapsed adult lymphoblastic leukemia depends on response to salvage chemotherapy, prognostic factors, and performance of stem cell transplantation. Blood. 2012 Sep 6;120(10):2032-41. doi: 10.1182/blood-2011-12-399287. Epub 2012 Apr 4.
Other Identifiers
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2022027
Identifier Type: -
Identifier Source: org_study_id
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