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FCR and Bevacizumab in the Treatment of Relapsed CLL
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, July 2007
First Received: March 13, 2007   Last Updated: July 26, 2007   History of Changes
Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00448019
  Purpose

Fludarabine is designed to interfere with DNA repair enzymes so that the leukemic cell cannot repair damaged DNA.

This increases the likelihood of the cell dying.

Cyclophosphamide is designed to destroy cancer cells by interfering with their multiplication and slowing or stopping their growth and spread throughout the body.

Rituximab is a protein that attaches to complementary proteins on leukemia cells. These targeted proteins may also be present on normal blood cells. When rituximab binds to the proteins on leukemia cells, it may help to stop or slow the growth of the disease.

Bevacizumab is a protein that helps to prevent growth of new blood vessels that may help "feed" the leukemia. The combination of fludarabine, cyclophosphamide, and rituximab has been used in the treatment of CLL.

The purpose of this study is to determine if there is added benefit with the addition of bevacizumab to this combination.


Condition Intervention Phase
Chronic Lymphocytic Leukemia
Drug: Fludarabine
Drug: Cyclophosphamide
Drug: Rituximab
Drug: Bevacizumab
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title: Fludarabine, Cyclophosphamide, Rituximab and Bevacizumab in the Treatment of Relapsed Chronic Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Estimated Enrollment: 66
Study Start Date: March 2007
Detailed Description:

Data exists to suggest that VEGF is important in development and progression of CLL. Currently the most effective regimen is FCR. Combining a VEGF-inhibitor (bevacizumab) with that therapy may provide benefit without increasing the toxicity of that regimen (myelosuppression).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of B-cell CLL
  • Relapsed, fludarabine-sensitive (duration of response > 6 months as assessed by prior treating physician) or fludarabine-naive patients
  • Rai Stage III or IV, or Rai Stage I or II if determined to have disease progression as evidenced by rapid doubling of peripheral lymphocyte count, progressive lymphadenopathy, progressive splenomegaly, or B symptoms.
  • Prestudy WHO Performance Status </= 2.
  • Signed, written IRB-approved informed consent.
  • Men and women of reproductive potential must agree to follow accepted birth control methods during treatment and for 3 months after completion of treatment.
  • Acceptable liver function: Bilirubin </= 2.0 mg/dL (26 umol/L), AST (SGOT) and/or ALT (SGPT) </= 2 times upper limit of normal.
  • Acceptable hematologic status: Platelet count >/= 50 x 10^9/L., ANC >/= 1 x 10^9/L.
  • Acceptable renal function: Serum creatinine </= 2.0 mg/dL

Exclusion Criteria:

  • Cancer radiotherapy, radioimmunotherapy, biological therapy, chemotherapy, or other investigational therapy within 4 weeks prior to Study Day 1.
  • Known infection with HIV, hepatitis B, or hepatitis C
  • Transformation to aggressive B-cell malignancy (e.g., large B-cell lymphoma, Richter's Syndrome, or prolymphocyte leukemia [PLL]).
  • Patients with secondary malignancy requiring active treatment (except hormonal therapy).
  • Active uncontrolled bacterial, viral, or fungal infections.
  • New York Heart Association Class II-IV cardiac disease or myocardial infarction within the past 6 months prior to Study Day 1.
  • Pregnant or currently breast-feeding.
  • 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.
  • Blood pressure of > 150/100 mmHg
  • Unstable angina
  • History of stroke within 6 months
  • Clinically significant peripheral vascular disease
  • Evidence of bleeding diathesis or coagulopathy
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1, anticipation of need for major surgical procedure during the course of the study.
  • Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to Day 1.
  • Urine protein:creatinine ratio >/= 1.0 at screening.
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1.
  • Serious, non-healing wound, ulcer, or bone fracture.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00448019

Contacts
Contact: Susan O'Brien, MD 713-792-7543 sobrien@mdanderson.org

Locations
United States, Texas
The University of Texas M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Susan O'Brien, MD     713-792-7543     sobrien@mdanderson.org    
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Susan O'Brien, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: MDACC-2005-0992
Study First Received: March 13, 2007
Last Updated: July 26, 2007
ClinicalTrials.gov Identifier: NCT00448019     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Chronic Lymphocytic Leukemia
Fludarabine
Cyclophosphamide
Rituximab
Bevacizumab
CLL

Study placed in the following topic categories:
Antimetabolites
Leukemia, Lymphoid
Immunoproliferative Disorders
Immunologic Factors
Rituximab
Bevacizumab
Cyclophosphamide
Fludarabine monophosphate
Angiogenesis Inhibitors
Immunosuppressive Agents
Leukemia
Lymphatic Diseases
Chronic Lymphocytic Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Antineoplastic Agents, Alkylating
Fludarabine
Antirheumatic Agents
Leukemia, B-Cell
Lymphoproliferative Disorders
Leukemia, B-cell, Chronic
Alkylating Agents

Additional relevant MeSH terms:
Antimetabolites
Leukemia, Lymphoid
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Cyclophosphamide
Bevacizumab
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Alkylating Agents
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Rituximab
Growth Substances
Fludarabine monophosphate
Angiogenesis Inhibitors
Immunosuppressive Agents
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Myeloablative Agonists
Fludarabine
Antineoplastic Agents, Alkylating
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on September 02, 2009