Sunitinib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
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
B-cell Chronic Lymphocytic Leukemia
Recurrent Small Lymphocytic Lymphoma
Refractory Chronic Lymphocytic Leukemia
Drug: sunitinib malate
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Sunitinib Malate for Treatment of Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)|
- Number of Participants With a Confirmed Response [Complete Response (CR) and Partial Response (PR)] on 2 Consecutive Evaluations at Least 4 Weeks Apart [ Time Frame: Duration of Treatment (up to 12 cycles) ] [ Designated as safety issue: No ]
National Cancer Institute working group criteria (NCIWG) was used to assess response.
- CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy
- PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100000/μL platelets, >11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions
- Complete Response Rate in Patients With B-cell Chronic Lymphocytic Leukemia [ Time Frame: Duration of Treatment (up to 12 cycles) ] [ Designated as safety issue: No ]Complete response is described in the primary outcome
- Survival Time [ Time Frame: Duration of study (up to 2 years) ] [ Designated as safety issue: No ]Survival time was defined as the time from registration to death due to any cause. The distribution of survival time was estimated using the Kaplan-Meier method.
- Progression-free Survival [ Time Frame: Duration of study (up to 2 years) ] [ Designated as safety issue: No ]Progression-free survival (PFS) was defined as the time from registration to progression or death due to any cause. The distribution of PFS was estimated using the Kaplan-Meier method.
- Duration of Response [ Time Frame: Duration on study (up 2 years) ] [ Designated as safety issue: No ]Duration of response was calculated from the documentation (date) of first response (CR or PR) until the date of progression or last follow-up in the subset of patients who responded. The median duration of response with 95%CI was estimated using the Kaplan Meier method
|Study Start Date:||August 2007|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
Experimental: Sunitinib Malate
Patients receive oral sunitinib malate 37.5 mg daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Drug: sunitinib malate
I. Assess the response rate (complete response [CR] and partial response) in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma treated with sunitinib malate.
II. Assess the toxicity of this drug in these patients. III. Assess duration of response, time to progression, overall survival, and CR rate in patients treated with this drug.
I. Evaluate if known risk stratification parameters (i.e., immunoglobulin mutational status, ZAP-70 status, fluorescent in situ hybridization [FISH] defects, and/or CD38 status) are related to clinical response to sunitinib malate.
OUTLINE: This is a multicenter study.
Patients receive oral sunitinib malate daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo blood collection periodically for translational and pharmacological studies, including IgVH gene mutation status and ZAP-70 status. Samples are examined by fluorescent in situ hybridization (FISH) and other assays.
After completion of study treatment, patients are followed every 3 months for up to 2 years.
|United States, Minnesota|
|North Central Cancer Treatment Group|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Tait Shanafelt||North Central Cancer Treatment Group|