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

October 12, 2022 updated by: The First Affiliated Hospital of Soochow University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • Recruiting
        • The First Affiliated Hospital of Soochow University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:

  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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CR (complete remission rate)
Time Frame: the first cycle (4 weeks)
Response to CLAG regimen.
the first cycle (4 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival(OS)
Time Frame: From the 1st day to the 365th day after enrollment.
The time from randomization to death from any cause.
From the 1st day to the 365th day after enrollment.
Progression-Free Survival （PFS）
Time Frame: 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.
From the 1st day to the 365th day after enrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Soochow University

Collaborators

Zhongda Hospital
Suzhou Municipal Hospital
The First People's Hospital of Changzhou

Investigators

  • Principal Investigator: Yue Han, MD/phD, study principle investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

October 5, 2022

First Submitted That Met QC Criteria

October 12, 2022

First Posted (Actual)

October 13, 2022

Study Record Updates

Last Update Posted (Actual)

October 13, 2022

Last Update Submitted That Met QC Criteria

October 12, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022027

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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