Back to results

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

Primary Purpose

Acute Lymphoblastic Leukemia

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Cladribine

Fludarabine

About this trial

This is an interventional treatment trial for Acute Lymphoblastic Leukemia

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The First Affiliated Hospital of Soochow UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CLAG arm

Control arm

Arm Description

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.

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

Outcomes

Primary Outcome Measures

CR (complete remission rate)

Response to CLAG regimen.

Secondary Outcome Measures

Overall survival(OS)

The time from randomization to death from any cause.

Progression-Free Survival （PFS）

It is defined as the total survival of a patient after CR until the tumor recurrence or death from any cause.

Full Information

NCT ID

NCT05578378

First Posted

October 5, 2022

Last Updated

October 12, 2022

Sponsor

The First Affiliated Hospital of Soochow University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05578378

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2022 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The First Affiliated Hospital of Soochow University

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Lymphoblastic Leukemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CLAG arm

Arm Type

Experimental

Arm Description

Arm Title

Control arm

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Cladribine

Other Intervention Name(s)

G-CSF, Cytarabine

Intervention 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.

Intervention Type

Drug

Intervention Name(s)

Fludarabine

Other Intervention Name(s)

cytosine arabinoside, methotrexate

Intervention 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

Primary Outcome Measure Information:

Title

CR (complete remission rate)

Description

Response to CLAG regimen.

Time Frame

the first cycle (4 weeks)

Secondary Outcome Measure Information:

Title

Overall survival(OS)

Description

The time from randomization to death from any cause.

Time Frame

From the 1st day to the 365th day after enrollment.

Title

Progression-Free Survival （PFS）

Description

It is defined as the total survival of a patient after CR until the tumor recurrence or death from any cause.

Time Frame

From the 1st day to the 365th day after enrollment.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Huizhu Kang, MD

Phone

8761925608

khz11826@sina.com

First Name & Middle Initial & Last Name or Official Title & Degree

Meng Zhou, MD

Phone

15606133002

zhoumeng@suda.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yue Han, MD/PhD

Organizational Affiliation

Study Principle investigator

Official's Role

Principal Investigator

Facility Information:

Facility Name

The First Affiliated Hospital of Soochow University

City

Suzhou

State/Province

Jiangsu

ZIP/Postal Code

215006

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yue Han, professor

Phone

+86 13901551669

hanyuesz@163.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

22493293

Citation

Gokbuget N, Stanze D, Beck J, Diedrich H, Horst HA, Huttmann A, Kobbe G, Kreuzer KA, Leimer L, Reichle A, Schaich M, Schwartz S, Serve H, Starck M, Stelljes M, Stuhlmann R, Viardot A, Wendelin K, Freund M, Hoelzer D; German Multicenter Study Group for Adult Acute Lymphoblastic Leukemia. Outcome of relapsed adult lymphoblastic leukemia depends on response to salvage chemotherapy, prognostic factors, and performance of stem cell transplantation. Blood. 2012 Sep 6;120(10):2032-41. doi: 10.1182/blood-2011-12-399287. Epub 2012 Apr 4.

Results Reference

background

Learn more about this trial

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

We'll reach out to this number within 24 hrs