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

Sponsor

The First Affiliated Hospital of Soochow University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05578378

Collaborator

The First People's Hospital of Changzhou (Other), Zhongda Hospital (Other), Suzhou Municipal Hospital (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To explore the efficiency and safety of CLAG regimen in R/R ALL

Condition or Disease	Intervention/Treatment	Phase
Acute Lymphoblastic Leukemia	Drug: Cladribine Drug: Fludarabine	Phase 2/Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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. Other Names: G-CSF Cytarabine
Active Comparator: 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	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 Other Names: cytosine arabinoside methotrexate

Arm

Intervention/Treatment

Experimental: 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.

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.

Other Names:

G-CSF

Cytarabine

Active Comparator: 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

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

Other Names:

cytosine arabinoside

methotrexate

Outcome Measures

Primary Outcome Measures

CR (complete remission rate) [the first cycle (4 weeks)]
Response to CLAG regimen.

Secondary Outcome Measures

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.