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

NCT05578378 | Unknown Phase 2

• 1 other identifier: 2022027
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

• CR (complete remission rate)

  Response to CLAG regimen.

  the first cycle (4 weeks)

Secondary Outcomes (2)

• Overall survival(OS)

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

• Progression-Free Survival （PFS）

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

Study Arms (2)

CLAG arm

EXPERIMENTAL

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

Control arm

ACTIVE COMPARATOR

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

Interventions

Cladribine DRUG

Cladribine combine with cytarabine will be intravenous on days 1-5; G-CSF will be hypodermic injection on day0-5,4 weeks per cycle.

Also known as: G-CSF, Cytarabine

CLAG arm

Fludarabine DRUG

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

Also known as: cytosine arabinoside, methotrexate

Control arm

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The patients meet the diagnostic criteria for Relapsed/Refractroy B-ALL. ECOG score is 0-3. Expecting life span is more than 6 weeks.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead
• The First People's Hospital of Changzhou: collaborator
• Zhongda Hospital: collaborator
• Suzhou Municipal Hospital: collaborator

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 22493293 BACKGROUND

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Cladribine; Granulocyte Colony-Stimulating Factor; Cytarabine; fludarabine; Methotrexate

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

2-Chloroadenosine; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxyadenosines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides; Aminopterin; Pterins; Pteridines

Study Officials

• Yue Han, MD/PhD

  Study Principle investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huizhu Kang, MD

CONTACT

8761925608; khz11826@sina.com

Meng Zhou, MD

CONTACT

15606133002; zhoumeng@suda.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 13, 2022
• Study Start: January 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: October 13, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)