Thalidomide in Treating Patients With Relapsed Chronic Lymphocytic Leukemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-09-30

Brief Summary

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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

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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

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B-cell Chronic Lymphocytic Leukemia Refractory Chronic Lymphocytic Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment (thalidomide)

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.

Group Type EXPERIMENTAL

thalidomide

Intervention Type DRUG

Given PO

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

Interventions

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thalidomide

Given PO

Intervention Type DRUG

laboratory biomarker analysis

Correlative studies

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of chronic lymphocytic leukemia (CLL) evidenced by monoclonal population of mature CD5+, CD19+, CD23+, and B cells
* Relapsed after prior treatment for CLL
* Active disease with 1 or more of the following characteristics:

* At least 10% weight loss within the past 6 months
* Fever greater than 100.5 degrees F for at least 2 weeks without evidence of infection
* Night sweats without evidence of infection
* Evidence of progressive marrow failure with anemia (hemoglobin less than 11 g/dL) and/or thrombocytopenia (platelet count less than 100,000/mm\^3) (i.e., any stage III or IV disease)
* Autoimmune anemia and/or thrombocytopenia poorly responsive to corticosteroid therapy
* Massive or progressive splenomegaly (i.e., greater than 6 cm below the left costal margin or more than 50% increase over 2 months)
* Progressive lymphadenopathy (i.e., more than 50% increase over 2 months)
* Progressive lymphocytosis (not due to corticosteroids) with an increase of more than 50% over a 2-month period or an anticipated doubling time of less than 6 months
* Marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease are not considered evidence of active disease
* Measurable disease

* Absolute lymphocyte count greater than 5,000/mm\^3
* No bulky lymph node disease greater than 10 cm in at least 1 dimension except splenomegaly
* Performance status - ECOG 0-2
* Absolute neutrophil count at least 500/mm\^3
* Platelet count at least 20,000/mm\^3 (in absence of sargramostim \[GM-CSF\])
* Hemoglobin at least 8 g/dL
* Bilirubin no greater than 2.5 times upper limit of normal (ULN)
* AST no greater than 2.5 times ULN
* Creatinine no greater than 1.5 mg/dL
* Creatinine clearance at least 60 mL/min
* No other active malignancy
* No peripheral neuropathy (sensory) grade 2 or greater
* No active infection
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use 1 highly effective method of contraception AND 1 additional effective method of contraception for at least 4 weeks before, during, and for 4 weeks after study completion
* No prior allogeneic bone marrow transplantation
* At least 10 days since prior filgrastim (G-CSF) or GM-CSF
* No more than 3 prior chemotherapy regimens
* At least 30 days since prior chemotherapy
* No concurrent corticosteroids except for adrenal insufficiency

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neil Kay

Role: PRINCIPAL_INVESTIGATOR

North Central Cancer Treatment Group

Locations

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North Central Cancer Treatment Group

Rochester, Minnesota, United States

Site Status

Countries

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Canada United States