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

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05578378
• Other study ID #: 2022027
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: January 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2022
• Source: The First Affiliated Hospital of Soochow University
• Contact: Huizhu Kang, MD
• Phone: 8761925608
• Email: khz11826[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

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.
• 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

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (4)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Soochow University	Suzhou Municipal Hospital, The First People's Hospital of Changzhou, Zhongda Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Gökbuget N, Stanze D, Beck J, Diedrich H, Horst HA, Hüttmann 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. Epub 2012 Apr 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CR (complete remission rate)	Response to CLAG regimen.	the first cycle (4 weeks)
Secondary	Overall survival(OS)	The time from randomization to death from any cause.	From the 1st day to the 365th day after enrollment.
Secondary	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.	From the 1st day to the 365th day after enrollment.