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

Phase 2

Recruiting

• Conditions: Acute Lymphoblastic Leukemia
• Interventions: Drug: Cladribine; Drug: Fludarabine

• Registration Number: NCT05578378
• Lead Sponsor: The First Affiliated Hospital of Soochow University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2022-01
• Study Start: 2022-01-01
• Study First Submitted: 2022-10-05
• Study First Submitted QC: 2022-10-12
• Last Update Submitted: 2022-10-12
• Study First Posted: 2022-10-13
• Last Update Posted: 2022-10-13
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CLAG arm	Cladribine	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.
Control arm	Fludarabine	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

Primary Outcome Measures

Name	Time	Method
CR (complete remission rate)	the first cycle (4 weeks)	Response to CLAG regimen.

Secondary Outcome Measures

Name	Time	Method
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.
Overall survival(OS)	From the 1st day to the 365th day after enrollment.	The time from randomization to death from any cause.

Trial Locations

Locations (1)

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China