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B-cell Chronic Lymphocytic LeukemiaPhase 2NCT00845104

Fludarabine Phosphate, Rituximab, and Bevacizumab in Treating Patients With B-Cell Chronic Lymphocytic Leukemia That Has Relapsed or Not Responded To Treatment

A Phase 2 study testing fludarabine phosphate, rituximab and bevacizumab in people with B-cell Chronic Lymphocytic Leukemia and Refractory Chronic Lymphocytic Leukemia, run by Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as fludarabine phosphate, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab and bevacizumab, can block cancer growth in different ways. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
fludarabine phosphate, rituximab and bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jan 2009to not given
Phase
Phase 2
Are there results?
None posted in the registry

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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Relapse or refractory chronic Lymphocytic leukemia as defined by the WHO criteria and exhibit active disease requiring treatment as per the NCI working group in CLL
  • Disease measurable defined by a combination of lymphocytosis >= 5,000/mm^3 in peripheral blood and lymphocytosis >= 30% in bone marrow
  • Confirmed CD20 expression on malignant CLL cells
  • ECOG performance status of 0-2
  • Life expectancy of at least 6 months
  • Documented negative serologic testing for human immunodeficiency virus (HIV), hepatitis B (unless serologically positive due to prior vaccination), and hepatitis C within the year prior to enrollment
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  • Aspartate aminotransferase (AST) < 2.5 x upper limit of normal (ULN)
  • Total serum bilirubin < 2.5 x ULN
  • Serum creatinine < 1.5 x ULN
  • Hemoglobin > 8 g/dL
  • Absolute neutrophil count (ANC) > 1,000 cells/mm^3
  • Platelet count > 50,000/mm^3
  • PT/INR and PTT < 1.5 x ULN
  • Within 2 weeks prior to registration, patients must have had a urinalysis negative for protein or a 24-hour urine collection demonstrating < 500 mg protein
  • If female and of child-bearing potential, have a negative serum pregnancy test within 14 days of enrollment
  • If sexually active male or sexually active female of reproductive capability, has agreed to use a medically accepted form of contraception from time of enrollment to completion of all follow-up study visits
  • Signed an institutional review board (IRB)-approved informed consent document for this protocol

Who cannot join

  • Patients must not require sustained support of hematopoietic cytokines or transfusion of blood products
  • Presence of acute infection or other significant systemic illness
  • Central nervous system involvement by malignancy, history of CVA, or seizure
  • Previously received Bevacizumab
  • Received transplant or Alemtuzumab within 3 months of enrollment
  • Received an investigational agent, systemic corticosteroids, chemotherapy, immunotherapy, biologic therapy, antibody therapy (e.g., Rituximab) and/or radiation therapy within one month of enrollment
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  • Radiation to > 25% of bone marrow or any radiation therapy within 4 weeks prior to start of therapy
  • Inability to comply with study and/or follow-up procedures
  • Life expectancy of less than 6 months
  • Fludarabine-refractory disease (no response of disease to >= 3 cycles of a fludarabine-based regimen or relapse within 6 months of fludarabine-based regimen)
  • Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study
  • Patients with prior malignancy other than lymphoma, except for adequately-treated skin cancer (basal cell or squamous cell carcinoma), in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years unless approved by the PI
  • Inadequately controlled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg)
  • Prior history of hypertensive crisis or hypertensive encephalopathy
  • New York Heart Association (NYHA) Grade II or greater congestive heart failure
  • History of myocardial infarction or unstable angina within 6 months prior to Day 1
  • History of stroke or transient ischemic attack within 6 months prior to Day 1
  • Known CNS disease, except for treated brain metastasis; Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded
  • Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1
  • History of hemoptysis (>= 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1
  • Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1, or anticipation of need for major surgical procedure during the course of the study
  • Core biopsy or minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1
  • History of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1
  • Serious, non-healing wound, active ulcer, or untreated bone fracture
  • Proteinuria as demonstrated by a UPC ratio >= 1.0 at screening
  • Known hypersensitivity to any component of bevacizumab
  • Pregnancy (positive pregnancy test) or lactation; use of effective means of contraception (men and women) in subjects of childbearing potential

About this study

Official title: A Phase II Study of Fludarabine (F), Rituxan (R) and Avastin (A) Followed by RA Maintenance in Patients With Relapsed/Refractory B-cell Chronic Lymphocytic Leukemia (CLL)

RATIONALE: Drugs used in chemotherapy, such as fludarabine phosphate, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab and 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. Giving fludarabine phosphate together with rituximab and bevacizumab may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving fludarabine phosphate together with rituximab and bevacizumab works in treating patients with B-cell chronic lymphocytic leukemia that has relapsed or not responded to treatment.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To estimate PFS at 2 years after FR plus Avastin (A) induction followed by Rituximab plus Avastin (RA) maintenance therapy for relapsed/refractory CLL patients.

SECONDARY OBJECTIVES:

  1. To evaluate response rates after FR-A induction and RA maintenance therapy. II. To eliminate residual disease (documented by flow cytometry and/or PCR) in patients who have achieved a CR after FR-A.

III. To estimate the rate of conversion of PR to CR after FR-A. IV. To determine the safety and pharmacokinetics of FR-A and RA maintenance.

OUTLINE:

INDUCTION THERAPY: Patients receive fludarabine phosphate IV over 20-30 minutes once daily on days 1-5 and rituximab IV once daily on days 4 or 5. Treatment repeats every 35 days for 6 courses in the absence of disease progression or unacceptable toxicity. Beginning on day 8 of course 1, patients also receive bevacizumab IV over 30 minutes. Treatment repeats every 21 days for 9 courses in the absence of disease progression or unacceptable toxicity.

Patients achieving complete response, partial response, or nodular partial response proceed to maintenance therapy.

MAINTENANCE THERAPY: Beginning 2 months after completion of induction treatment, patients receive rituximab IV every 3 months and bevacizumab IV over 30 minutes every 3 weeks. Treatment continues for 2 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and annually thereafter.

Being tested
fludarabine phosphate, rituximab, bevacizumab, laboratory biomarker analysis, flow cytometry
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.

  • fludarabine phosphateDrug

    Also called 2-F-ara-AMP, Beneflur, Fludara

    Given IV

  • rituximabBiological

    Also called C2B8 Monoclonal Antibody, IDEC-C2B8, IDEC-C2B8 monoclonal antibody, Mabthera

    Given IV

  • bevacizumabBiological

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

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

  • flow cytometryOther

    Correlative studies

  • polymerase chain reactionGenetic

    Also called PCR

    Correlative studies

  • fluorescence in situ hybridizationGenetic

    Also called fluorescence in situ hybridization (FISH)

    Correlative studies

Study groups in NCT00845104
Study groupRoleWhat they receive
Arm IExperimentalSee Detailed Description
Receives: Drug: fludarabine phosphate; Biological: rituximab; Biological: bevacizumab; Other: laboratory biomarker analysis; Other: flow cytometry; Genetic: polymerase chain reaction; Genetic: fluorescence in situ hybridization

What is being measured

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

  1. Progression-free survival

    Measured: At 2 years

Secondary outcomes (1)

  1. Response (complete, partial, or nodular partial response, progressive disease, stable disease, or minimal residual disease)

    Measured: At 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 posted18 Feb 2009 (estimated)
  2. Study startJan 2009

Why it stopped: No patients enrolled.

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00845104
Sponsor's protocol ID
2278.00
Other IDs
NCI-2010-00316
Status last verified
Mar 2015
First submitted
17 Feb 2009
Last updated
6 Mar 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing fludarabine phosphate, rituximab and bevacizumab in people with B-cell Chronic Lymphocytic Leukemia and Refractory Chronic Lymphocytic Leukemia, run by Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium.

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 17 inclusion and 28 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: withdrawn, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Progression-free survival (time frame: At 2 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 NCT00845104.

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 6 Mar 2015.

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