drugset / Trial / NCT00096018

Fludarabine and Thalidomide in Treating Patients With Newly Diagnosed Chronic Lymphocytic Leukemia

NCT00096018

Phase 1/2 Completed 43 enrolled Roswell Park Cancer Institute
NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Biological therapies such as thalidomide use different ways to stimulate the immune system and stop cancer cells from growing. Combining fludarabine with thalidomide may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of thalidomide when given together with fludarabine and to see how well they work in treating patients with newly diagnosed B-cell chronic lymphocytic leukemia.

Timeline

Start
2002-05
Primary completion
2010-11
Completion
2012-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Fludarabine Small molecule 25 mg/m2 Intravenous
Subject Thalidomide Other / unclassified 100 mg Oral
Subject Thalidomide Other / unclassified 200 mg Oral
Subject Thalidomide Other / unclassified 300 mg Oral

Indications