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B-cell Chronic Lymphocytic LeukemiaPhase 2NCT00290810

Bevacizumab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

A Phase 2 study testing bevacizumab in people with B-cell Chronic Lymphocytic Leukemia and Refractory Chronic Lymphocytic Leukemia, 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 bevacizumab works in treating patients with relapsed or refractory B-cell chronic lymphocytic leukemia. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
Dec 2005to Aug 2010
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 B-cell chronic lymphocytic leukemia (CLL)*, as defined by the following phenotypic characteristics:
  • Predominant population of cells share both B-cell antigens (CD19, CD20, or CD23) as well as the T-cell antigen (CD-5), in the absence of other pan-T-cell markers (CD-3, CD-2, etc.)
  • Mantle cell lymphoma must be excluded by demonstrating the absence of the t(11;14) by fluorescent in situ hybridization (FISH)
  • Dim surface immunoglobulin expression
  • Exclusively kappa and lambda light chains
  • Peripheral blood absolute lymphocyte count > 5,000/mm^3
Show all 51Show fewer
  • Lymphocytosis must consist of small to moderate size lymphocytes, with ≤ 55% prolymphocytes, atypical lymphocytes, or lymphoblasts morphologically
  • Requires chemotherapy, as indicated by any of the following:
  • Disease related symptoms, including the following:
  • Weight loss ≥ 10% within the previous 6 months
  • Extreme fatigue
  • Fevers > 100.5°F 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 progressive splenomegaly
  • Measurable and progressive lymphadenopathy
  • Measurable (i.e., > 5,000/mm^3) and progressive lymphocytosis
  • Progressive disease or relapsed after or refractory to 1 course of an alkylating agent-based or purine nucleoside-based (e.g., fludarabine) regimen
  • No marrow function attributable to dysplasia related to prior therapy
  • ECOG performance status 0, 1, or 2
  • Serum creatinine < 2 mg/dL
  • If serum creatinine > 1.5 mg/dL but < 2 mg/dL, creatinine clearance must be ≥ 30 mL/min
  • Platelet count > 30,000/mm^3
  • Direct bilirubin ≤ 2 mg/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other second malignancy within the past 2 years except squamous cell or basal cell carcinoma of the skin or in situ carcinoma of the cervix
  • No New York Heart Association class III or IV heart failure
  • No blood pressure > 150/90 mm Hg
  • No unstable angina
  • No myocardial infarction or stroke within the past 6 months
  • No clinically significant peripheral vascular disease
  • No evidence of bleeding diathesis or coagulopathy
  • No significant traumatic injury within the past 28 days
  • Urine protein:creatinine (UPC) ratio ≤ 1.0
  • Patients with a UPC ratio > 1.0 must undergo a 23-hour urine collection and must demonstrate < 1 gram of protein per day
  • No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
  • No serious, non-healing wound, ulcer, or bone fracture
  • No active infections requiring oral or intravenous antibiotics
  • No active bleeding or pathological conditions that carry a high risk of bleeding (e.g., known varices)
  • No thrombocytopenia requiring transfusion
  • See Disease Characteristics
  • More than 4 weeks since prior participation in an experimental drug study
  • At least 8 weeks since prior rituximab
  • At least 6 weeks since prior chemotherapy
  • More than 28 days since prior major surgery or open biopsy
  • More than 7 days since prior minor surgery, fine needle aspirations, or core biopsies
  • No concurrent major surgery
  • No concurrent participation in another experimental drug study
  • Concurrent full-dose warfarin or low molecular weight heparin allowed provided patient is on a stable dose AND INR is in range

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: A Phase II Trial of Bevacizumab to Prevent or Delay Disease Progression in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)

This phase II trial is studying how well bevacizumab works in treating patients with relapsed or refractory B-cell chronic lymphocytic leukemia. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Bevacizumab may also stop the growth of cancer cells by blocking blood flow to the cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Assess the treatment success rate of Bevacizumab in patients with relapsed or refractory B-cell chronic lymphocytic leukemia (CLL).

II. Assess the toxicity associated with this regimen in patients with relapsed or refractory CLL

SECONDARY OBJECTIVES:

  1. Assess sensitivity to apoptosis/cell death of residual B-cell clone during therapy (e.g. is treatment selecting out a resistant clone).

II. Evaluate if the risk stratification parameters (ie immunoglobulin mutational, ZAP-70, FISH defects and /or CD38 status) corresponds to both baseline apoptosis/cell death and the rates of apoptosis of CLL B-cells when cultured with Bevacizumab.

III. Examine if Bevacizumab can be synergistic with other chemotherapeutic drugs such as chlorambucil or fludarabine.

IV. Assess if marrow vascularity is increased at entry to study and if it is modulated following therapy with Bevacizumab.

  1. Examine the association of VEGF plasma levels at baseline with clinical responses to Bevacizumab.

VI. Examine the levels of VCAM at entry to the study and during treatment with Bevacizumab.

OUTLINE: This is a multicenter study. Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15.

Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for up to 5 years.

Being tested
bevacizumab
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.

  • bevacizumabBiological

    Also called anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF

    Given IV

Study groups in NCT00290810
Study groupRoleWhat they receive
Treatment (monoclonal antibody therapy)ExperimentalPatients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Biological: bevacizumab

What is being measured

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

  1. Number of Patients With Confirmed Objective Status of Complete Response (CR), Complete Clinical Response (CCR), Nodular Partial Response (nPR), or Partial Response (PR).

    The NCI Working Group criteria will be used to assess response to therapy. A confirmed response is defined as a response documented on 2 consecutive evaluations at least 4 weeks apart.

    Complete Response:

    • No lymphadenopathy
    • No hepatomegaly or splenomegaly
    • Absense of constitutional symptoms
    • Polymorphonuclear leukocytes ≥ 1500/ul
    • Platelets > 100,000/ul
    • Hemoglobin > 11.0 gm/dl
    • Peripheral blood lymphocytes ≤ 4000/uL.
    • Confirmation by Marrow Aspirate and biopsy.

    Complete Clinical Response:

    -CR without bone marrow biopsy confirmation.

    Nodular Partial Response:

    -CR with the presence of residual clonal nodules.

    Partial Response requires:

    • ≥ 50% decrease in peripheral blood lymphocyte count
    • ≥ 50% reduction in lymphadenopathy
    • ≥ 50% reduction in size of liver and/or spleen
    • 1 or more of the following:
    • Polymorphonuclear leukocytes ≥ 1500/ul
    • Platelets >100,000/ul
    • Hemoglobin >11.0 gm/dl

    Measured: Up to 5 years

Secondary outcomes (3)

  1. Toxicity Associated With This Regimen in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL).

    As per NCI Common Toxicity Criteria for Adverse Effects (CTCAE) Version 3.0, the term toxicity is defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment. The number of participants experiencing grade 3 or higher toxicity will be reported here.

    Measured: From the date of registration to the to the date of last treatment evaluation, median number of days on treatment was 56 days.

  2. Overall Survival

    The Kaplan-Meier method will be used to estimate distributions in the B-CLL population.

    Measured: From the date of registration to the date of the event (i.e., death or the date of last follow-up), up to 5 years.

  3. Time to Progression

    Progression is defined as one of the following:

    • A ≥50% increase in the sum of the products of at least 2 lymph nodes on 2 consecutive determinations 2 weeks apart (at least one node must be ≥2 cm) or the appearance of new palpable lymph nodes, or
    • A ≥50% increase in the size of the liver and/or spleen as determined by measurement below the respective costal margin or the appearance of hepatomegaly or splenomegaly which was not previously present, or
    • The transformation to a more aggressive histology (e.g. Richter's transformation), or
    • A ≥ 50% increase in the absolute number of circulating lymphocytes.

    The Kaplan-Meier method will be used to estimate time to progression.

    Measured: From the date of registration to the date of the event (i.e., death or disease progression) or the date of last follow-up, up to 5 years

Timeline

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

  1. First posted13 Feb 2006 (estimated)
  2. Study startDec 2005
  3. Primary completionOct 2008
  4. Study completionAug 2010

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
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00290810
Sponsor's protocol ID
NCI-2009-00137
Other IDs
NCI-2009-00137, MAYO-MC048C, NCI-7211, CDR0000459933, MC048C, 7211, P30CA015083, N01CM62205
Status last verified
Apr 2012
First submitted
9 Feb 2006
Last updated
9 May 2014

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bevacizumab in people with B-cell Chronic Lymphocytic Leukemia and Refractory Chronic Lymphocytic Leukemia, 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 51 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 9 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 14 May 2013). 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 Patients With Confirmed Objective Status of Complete Response (CR), Complete Clinical Response (CCR), Nodular Partial Response (nPR), or Partial Response (PR). (time frame: Up to 5 years). 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 NCT00290810.

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 9 May 2014.

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