Sorafenib in Treating Patients With Relapsed Chronic Lymphocytic Leukemia

Stopped early · Phase 2

Conditions studied: Refractory Chronic Lymphocytic Leukemia, Stage I Chronic Lymphocytic Leukemia, Stage II Chronic Lymphocytic Leukemia, Stage III Chronic Lymphocytic Leukemia, Stage IV Chronic Lymphocytic Leukemia

In brief

Sorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. This phase II trial is studying how well sorafenib works in treating patients with relapsed chronic lymphocytic leukemia.

Key facts

Study ID

NCT00303966

Run by

National Cancer Institute (NCI)

People needed

5

Starts

2005-11-01

Expected to finish

2011-05-01

Last updated by the study team

2014-05-07

Who can join

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

You may qualify if…

• Histologically or cytologically confirmed chronic lymphocytic leukemia (CLL) by NCI-WG immunophenotype and blood criteria
• Documentation of current or prior peripheral blood (PB) or bone marrow (BM) immunophenotype compatible with CLL
• Patients who currently do not have > 5,000/mm³ absolute lymphocytosis are eligible if they have previously met PB lymphocytosis criteria and have a current immunophenotype documenting monoclonal B lymphocytosis morphologically and immunophenotypically compatible with CLL
• Intermediate-risk (Rai stage I or II) or high-risk (Rai stage III or IV) disease, including any of the following:
• Rai stage I disease with lymphocytosis and enlarged nodes
• Rai stage II disease with lymphocytosis plus splenomegaly and/or hepatomegaly (nodes positive or negative)
• Rai stage III disease with lymphocytosis plus anemia
• Rai stage IV disease with lymphocytosis and thrombocytopenia
• Must require treatment with active disease, experiencing disease related symptoms, or having deterioration of blood counts, meeting ≥ 1 of the following criteria:
• Presence of ≥ 1 of the following disease-related symptoms:
• Weight loss > 10% within the past 6 months
• Extreme fatigue (i.e., ECOG performance status 2: cannot work or unable to perform usual activities)
• Fever > 100.5°F for 2 weeks without evidence of infection
• Night sweats without evidence of infection
• Evidence of progressive marrow failure, as manifested by worsening of anemia (hemoglobin < 10 g/dL), thrombocytopenia (platelet count < 100,000/mm³), and/or neutropenia (neutrophil count < 2,000/mm³)
• Massive (i.e., > 6 cm below left costal margin) or progressive splenomegaly or discomfort from splenomegaly
• Massive nodes or clusters (i.e., > 10 cm in longest diameter), progressive adenopathy, or discomfort from lymphadenopathy
• Deterioration of blood counts and/or progressive lymphocytosis, with an increase of ≥ 10% documented over a 2-month period OR an anticipated doubling time < 6 months
• Relapsed disease
• Must receive at least 1, but no more than 3, prior chemotherapy regimens with any cytotoxic agent or antibody therapy
• No fludarabine refractory disease
• Responded to prior fludarabine without relapse or disease progression for at least 6 months
• Patients with a history of Coombs-positive hemolytic anemia are eligible provided recovery from treatment of hemolysis and off steroids
• No stage 0 CLL
• No known CNS involvement

Where it is running

• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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