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

NCT00398112 | Completed Phase 2 Results

• 5 other identifiers: NCI-2012-01830NCCTG-N0683CDR0000512979N0683U10CA025224
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

B-cell Chronic Lymphocytic Leukemia; Recurrent Small Lymphocytic Lymphoma; Refractory Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a Confirmed Response [Complete Response (CR) and Partial Response (PR)] on 2 Consecutive Evaluations at Least 4 Weeks Apart

  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

  Duration of Treatment (up to 12 cycles)

Secondary Outcomes (4)

• Complete Response Rate in Patients With B-cell Chronic Lymphocytic Leukemia

  Duration of Treatment (up to 12 cycles)

• Survival Time

  Duration of study (up to 2 years)

• Progression-free Survival

  Duration of study (up to 2 years)

• Duration of Response

  Duration on study (up 2 years)

Study Arms (1)

Arm I

EXPERIMENTAL

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.

Drug: sunitinib malate; Other: pharmacological study; Other: laboratory biomarker analysis

Interventions

sunitinib malate DRUG

Given orally

Also known as: SU11248, sunitinib, Sutent

Arm I

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Arm I

laboratory biomarker analysis OTHER

Correlative studies

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

North Central Cancer Treatment Group

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Tait Shanafelt
• Organization: Mayo Clinic

shanafelt.tait@mayo.edu

Study Officials

• Tait Shanafelt

  North Central Cancer Treatment Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2006
• First Posted: November 10, 2006
• Study Start: August 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: January 1, 2011
• Last Updated: May 14, 2014
• Results First Posted: February 10, 2014

Record last verified: 2012-12

Locations

US (1)