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Thalidomide in Treating Patients With Asymptomatic, Indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

Phase 1
Completed
Conditions
Leukemia
Lymphoma
Registration Number
NCT00052416
Lead Sponsor
Beth Israel Deaconess Medical Center
Brief Summary

RATIONALE: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.

PURPOSE: Phase I trial to determine the effectiveness of thalidomide in treating patients who have asymptomatic, indolent non-Hodgkin's lymphoma or chronic lymphocytic leukemia.

Detailed Description

OBJECTIVES:

* Determine the feasibility, in terms of toxicity and patient compliance, of thalidomide in patients with asymptomatic, indolent non-Hodgkin's lymphoma or chronic lymphocytic leukemia.

* Determine the event-free and progression-free survival of patients treated with this drug.

* Determine disease response and time to next treatment in patients treated with this drug.

* Determine the quality of life of patients treated with this drug.

OUTLINE: Patients receive oral thalidomide once daily. Treatment continues for 18 months in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, monthly during study, and at the end of the study.

PROJECTED ACCRUAL: A total of 30-36 patients will be accrued for this study within 2 years.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

Beth Israel Deaconess Medical Center

🇺🇸

Boston, Massachusetts, United States

Fletcher Allen Health Care - University Health Center Campus

🇺🇸

Burlington, Vermont, United States

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