drugset / Trial / NCT00337246

Combination Chemotherapy With or Without Rituximab in Treating Patients With Previously Treated Chronic Lymphocytic Leukemia

NCT00337246

Phase 2 Completed 56 enrolled Cancer Research UK
RandomizedOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy, such as fludarabine, cyclophosphamide, and mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving combination chemotherapy together with rituximab may kill more cancer cells. It is not yet known whether giving combination chemotherapy together with rituximab is more effective than combination chemotherapy alone in treating chronic lymphocytic leukemia. PURPOSE: This randomized phase II trial is studying how well giving combination chemotherapy with or without rituximab works in treating patients with previously treated chronic lymphocytic leukemia.

Timeline

Start
2005-07
Primary completion
Completion
2011-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified Oral
Subject Fludarabine Small molecule Oral
Subject Mitoxantrone Small molecule Intravenous
Subject Rituximab Monoclonal antibody Intravenous

Indications