drugset / Trial / NCT00072007

Cladribine and Rituximab as Remission Induction Therapy Followed By Rituximab and Stem Cell Mobilization in Treating Patients With CLL

NCT00072007

Phase 2 Completed 43 enrolled Swiss Cancer Institute
NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy, such as cladribine, use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining cladribine with rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving cladribine and rituximab as remission induction therapy together with rituximab and stem cell mobilization in treating patients with chronic lymphocytic leukemia.

Timeline

Start
2002-06
Primary completion
2003-03
Completion
2010-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Cladribine Small molecule 0.1 mg/kg Subcutaneous
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Background Cyclophosphamide Other / unclassified 4 g Intravenous
Background Doxorubicin Other / unclassified
Background Prednisone Other / unclassified Oral
Background Vincristine Small molecule
Background filgrastim Protein / enzyme biologic 10 ug/kg Subcutaneous

Indications