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B-cell Chronic Lymphocytic LeukemiaPhase 2NCT00398112

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

A Phase 2 study testing sunitinib malate, pharmacological study and laboratory biomarker analysis in people with B-cell Chronic Lymphocytic Leukemia and Recurrent Small Lymphocytic Lymphoma, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
sunitinib malate, pharmacological study and laboratory biomarker analysis
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited States
Study dates
Aug 2007to Jan 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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
  • ECOG performance status 0-2
  • Life expectancy ≥ 12 months
  • Creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance ≥ 60 mL/min
  • AST and ALT ≤ 2.5 times ULN
  • Bilirubin normal
  • Alkaline phosphatase ≤ 3 times ULN
  • Platelet count > 30,000/mm^3 (without transfusion)
  • Absolute neutrophil count > 1,000/mm^3
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Able to complete patient diaries alone or with assistance
  • No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
  • No other malignancy except for squamous cell or basal cell carcinoma of the skin or in situ carcinoma of the cervix, unless the tumor was curatively treated within the past 2 years
  • No history of allergic reactions attributed to compounds of similar chemical or biological composition to sunitinib malate
  • No inability to swallow or retain sunitinib malate capsules due to any of the following:
  • Gastrointestinal tract disease
  • Requirement for IV alimentation
  • Prior surgical procedures affecting absorption
  • Active peptic ulcer disease
  • No pre-existing thyroid abnormality that would make the patient unable to maintain normal thyroid function with medication
  • No pulmonary embolism within the past 12 months
  • No serious or nonhealing wound, ulcer, or bone fracture
  • No uncontrolled intercurrent illness including, but not limited to, any of the following:
  • Ongoing or active infections
  • Psychiatric illness or social situation that would limit compliance with study requirements
  • No cerebrovascular accident or transient ischemic attack within the past 12 months
  • No uncontrolled hypertension (i.e., systolic blood pressure [BP] ≥ 140 mm Hg or diastolic BP ≥ 90 mm Hg)
  • No significant cardiac arrhythmia, including any of the following:
  • QTc prolongation (i.e., QTc interval ≥ 500 msec)
  • Ventricular tachycardia
  • Atrial fibrillation
  • Atrial flutter
  • Second or third degree heart block
  • No cardiac disease within the past 12 months, including any of the following:
  • Myocardial infarction
  • Cardiac arrhythmia
  • Stable/unstable angina
  • Symptomatic congestive heart failure
  • Coronary/peripheral artery bypass graft or stenting
  • No New York Heart Association (NYHA) class III or IV heart failure
  • The following patients are eligible provided they have NYHA class II cardiac function on baseline ECHO/MUGA:
  • History of NYHA class II heart failure and asymptomatic on treatment
  • No prior anthracycline exposure
  • No prior central thoracic radiation that included the heart in the radiation port
  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy
  • At least 4 weeks since prior rituximab or alemtuzumab
  • At least 4 weeks since prior major surgery
  • At least 4 weeks since prior oral steroids
  • No prior treatment with any other antiangiogenic agent, including any of the following:
  • Bevacizumab
  • Sorafenib
  • Pazopanib
  • AZD2171
  • Vatalanib
  • VEGF Trap
  • At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following:
  • Ketoconazole
  • Itraconazole
  • Clarithromycin
  • Erythromycin
  • Diltiazem
  • Verapamil
  • HIV protease inhibitors (i.e., indinavir, saquinavir,ritonavir, atazanavir, nelfinavir)
  • Delavirdine
  • At least 12 days since prior and no concurrent CYP3A4 inducers, including any of the following:
  • Rifampin
  • Rifabutin
  • Carbamazepine
  • Phenobarbital
  • Phenytoin
  • Hypericum perforatum (St. John's wort)
  • Efavirenz
  • Tipranavir
  • No other concurrent investigational agents
  • No concurrent agents with proarrhythmic potential, including any of the following:
  • Terfenadine
  • Quinidine
  • Procainamide
  • Disopyramide
  • Sotalol
  • Probucol
  • Bepridil
  • Haloperidol
  • Risperidone
  • Indapamide
  • Flecainide
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent anticancer agents or therapies
  • No concurrent therapeutic doses of coumarin-derivative anticoagulants (e.g., warfarin)
  • Concurrent prophylactic low molecular weight heparin or warfarin at doses ≤ 2 mg daily for thrombosis prophylaxis allowed

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • North Central Cancer Treatment Group

    Rochester, Minnesota, 55905

Other trials in United States

About this study

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)

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
sunitinib malate, pharmacological study, laboratory biomarker analysis
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sunitinib malateDrug

    Also called SU11248, sunitinib, Sutent

    Given orally

  • pharmacological studyOther

    Also called pharmacological studies

    Correlative studies

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00398112
Study groupRoleWhat they receive
Arm IExperimentalPatients 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.
Receives: Drug: sunitinib malate; Other: pharmacological study; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Duration of Treatment (up to 12 cycles)

Secondary outcomes (4)

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

    Complete response is described in the primary outcome

    Measured: Duration of Treatment (up to 12 cycles)

  2. Survival Time

    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.

    Measured: Duration of study (up to 2 years)

  3. Progression-free Survival

    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.

    Measured: Duration of study (up to 2 years)

  4. Duration of Response

    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

    Measured: Duration on study (up 2 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2006 (estimated)
  2. Study startAug 2007
  3. Primary completionNov 2008
  4. Study completionJan 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00398112
Sponsor's protocol ID
NCI-2012-01830
Other IDs
NCI-2012-01830, NCCTG-N0683, CDR0000512979, N0683, N0683, U10CA025224
Status last verified
Dec 2012
First submitted
9 Nov 2006
Last updated
14 May 2014

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing sunitinib malate, pharmacological study and laboratory biomarker analysis in people with B-cell Chronic Lymphocytic Leukemia and Recurrent Small Lymphocytic Lymphoma, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 117 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00398112.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2014.

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