NCT05578378

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

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	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.
DRUG	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

Timeline

• Start date: 2022-01-01
• Primary completion: 2023-12-31
• Completion: 2024-12-31
• First posted: 2022-10-13
• Last updated: 2022-10-13

Locations

1 site across 1 country: China