Sunitinib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Completed · Phase 2

Conditions studied: B-cell Chronic Lymphocytic Leukemia, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia

In brief

This phase II trial is studying how well sunitinib works in treating patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. Sunitinib 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.

Key facts

Study ID

NCT00398112

Run by

National Cancer Institute (NCI)

People needed

18

Starts

2007-08-01

Expected to finish

2011-01-01

Last updated by the study team

2014-05-14

Who can join

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

You may qualify if…

• Diagnosis of 1 of the following:
• Biopsy proven small lymphocytic lymphoma (SLL)
• Chronic lymphocytic leukemia (CLL) meeting all of the following criteria:
• Peripheral blood lymphocyte count > 5,000/mm\^3
• Lymphocytes must consist of small to moderate size lymphocytes, with < 55% prolymphocytes, atypical lymphocytes, or lymphoblasts morphologically
• Immunophenotyping consistent with CLL, defined by the following criteria:
• Predominant population of lymphocytes share both B-cell antigens (i.e., CD19, CD20, or CD23) as well as CD5 in the absence of other pan-T-cell markers (e.g., CD3 or CD2)
• Dim surface immunoglobulin expression
• Exclusively kappa and lambda light chains
• Splenomegaly, hepatomegaly, or lymphadenopathy are not required
• Refractory or relapsed disease as evidenced by 1 of the following criteria:
• Progression after ≥ 1 course of a purine nucleoside (i.e., fludarabine phosphate, cladribine, pentostatin) regimen
• Progression after ≥ 1 course of an alkylator (i.e., cyclophosphamide or chlorambucil) regimen
• Relapse after ≥ 1 prior purine nucleoside oral kylator (i.e., cyclophosphamide or chlorambucil) regimen
• Requires chemotherapy, as indicated by any of the following criteria:
• Measurable (i.e., > 5,000/mm\^3) and progressive clonal lymphocytosis
• Measurable (i.e., single diameter > 2 cm) and progressive lymphadenopathy
• Disease-related symptoms, including 1 or more of the following:
• Weight loss > 10% within the past 6 months
• Extreme fatigue attributed to CLL/SLL
• Fevers > 100.5\^oF for 2 weeks without evidence of infection
• Night sweats without evidence of infection
• Evidence of progressive marrow failure, as manifested by the development of or worsening anemia (hemoglobin < 10 g/dL) and/or thrombocytopenia (platelet count < 100,000/mm\^3)
• Massive (i.e. > 6 cm below left costal margin) or progressives plenomegaly
• No mantle cell lymphoma, as demonstrated by a negative fluorescent in situ hybridization (FISH) analysis fort(11;14)(IgVH/CCND1) on peripheral blood or tissue biopsy

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.