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Trial Title:
Cladribine Combined With G-CSF and Cytarabine as a Salvage Treatment in R/R ALL
NCT ID:
NCT05578378
Condition:
Acute Lymphoblastic Leukemia
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Cytarabine
Methotrexate
Fludarabine
Cladribine
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Cladribine
Description:
Cladribine combine with cytarabine will be intravenous on days 1-5; G-CSF will be
hypodermic injection on day0-5,4 weeks per cycle.
Arm group label:
CLAG arm
Other name:
G-CSF
Other name:
Cytarabine
Intervention type:
Drug
Intervention name:
Fludarabine
Description:
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
Arm group label:
Control arm
Other name:
cytosine arabinoside
Other name:
methotrexate
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
14 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Zip:
215006
Country:
China
Status:
Recruiting
Contact:
Last name:
Yue Han, professor
Phone:
+86 13901551669
Email:
hanyuesz@163.com
Start date:
January 1, 2022
Completion date:
December 31, 2024
Lead sponsor:
Agency:
The First Affiliated Hospital of Soochow University
Agency class:
Other
Collaborator:
Agency:
The First People's Hospital of Changzhou
Agency class:
Other
Collaborator:
Agency:
Zhongda Hospital
Agency class:
Other
Collaborator:
Agency:
Suzhou Municipal Hospital
Agency class:
Other
Source:
The First Affiliated Hospital of Soochow University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05578378
