NCT00006226

Thalidomide in Treating Patients With Relapsed Chronic Lymphocytic Leukemia

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (estimated)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• B-cell Chronic Lymphocytic Leukemia
• Refractory Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	thalidomide	Given PO
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2000-09-01
• Primary completion: 2007-12-01
• First posted: 2003-01-27
• Last updated: 2013-10-08

Locations

1 site across 1 country: United States