Thalidomide in Treating Patients With Relapsed Chronic Lymphocytic Leukemia

Refractory Chronic Lymphocytic Leukemia Clinical Trial

Official title: A Phase II Trial of Thalidomide in Patients With Relapsed Chronic Lymphocytic Leukemia

Status Completed

Clinical Trial Summary

Phase II trial to study the effectiveness of thalidomide in treating patients who have relapsed chronic lymphocytic leukemia. Thalidomide may stop the growth of chronic lymphocytic leukemia by stopping blood flow to the tumor.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To determine whether thalidomide can induce objective responses in relapsed B-CLL patients.

II. To determine the toxicity of thalidomide in this patient population. III. To document if alterations in vascular growth factors and/or bone marrow angiogenesis patterns correlate with thalidomide related clinical responses.

OUTLINE:

Patients receive oral thalidomide daily for 4 weeks. Courses repeat every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 5 years. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• B-cell Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Refractory Chronic Lymphocytic Leukemia

• NCT number: NCT00006226
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Completed
• Phase: Phase 2
• Start date: September 2000