drugset

drugset / Trial / NCT05578378

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

NCT05578378 ↗

Phase 2/3 Unknown 32 enrolled The First Affiliated Hospital of Soochow University Suzhou Municipal Hospital · collab The First People's Hospital of Changzhou · collab Zhongda Hospital · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

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

Timeline

Start: 2022-01-01
Primary completion: 2023-12-31
Completion: 2024-12-31

Publications

Background 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cladribine	Small molecule	5 mg/m2	Intravenous
Comparator	Fludarabine	Small molecule	30 mg/m2	Intravenous
Comparator	Methotrexate	Small molecule	—	—
Background	Cytarabine	Small molecule	1.5 mg/m2	Intravenous
Background	G-CSF	Unknown	300 ug	Subcutaneous

Indications