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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

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

MedlinePlus related topics:   Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic    Leukemia, Childhood   

Drug Information available for:   Cyclophosphamide    Fludarabine    Fludarabine monophosphate    Rituximab    Bevacizumab   

U.S. FDA Resources

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

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


M.D. Anderson's Website  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   MDACC-2005-0992
First Received:   March 13, 2007
Last Updated:   July 26, 2007
ClinicalTrials.gov Identifier:   NCT00448019
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:
Chronic lymphocytic leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders
Rituximab
Cyclophosphamide
Fludarabine monophosphate
Bevacizumab
Leukemia
Lymphatic Diseases
Leukemia, Lymphocytic, Chronic, B-Cell
Fludarabine
Leukemia, B-Cell
Lymphoproliferative Disorders

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Immune System Diseases
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Angiogenesis Inhibitors
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Myeloablative Agonists
Growth Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on October 31, 2008




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