A Phase II Study of Sunitinib Malate for Treatment of Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
Overview
- Phase
- Phase 2
- Intervention
- sunitinib malate
- Conditions
- B-cell Chronic Lymphocytic Leukemia
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Number of Participants With a Confirmed Response [Complete Response (CR) and Partial Response (PR)] on 2 Consecutive Evaluations at Least 4 Weeks Apart
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Detailed Description
PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- Not provided
Arms & Interventions
Arm I
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.
Intervention: sunitinib malate
Arm I
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.
Intervention: pharmacological study
Arm I
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.
Intervention: laboratory biomarker analysis
Outcomes
Primary Outcomes
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)
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
Secondary Outcomes
- Survival Time(Duration of study (up to 2 years))
- Progression-free Survival(Duration of study (up to 2 years))
- Complete Response Rate in Patients With B-cell Chronic Lymphocytic Leukemia(Duration of Treatment (up to 12 cycles))
- Duration of Response(Duration on study (up 2 years))