Thalidomide in Treating Patients With Relapsed Chronic Lymphocytic Leukemia

Completed · Phase 2

Conditions studied: B-cell Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia

In brief

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.

Key facts

Study ID

NCT00006226

Run by

National Cancer Institute (NCI)

People needed

41

Starts

2000-09-01

Last updated by the study team

2013-10-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• North Central Cancer Treatment Group — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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