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Bevacizumab + CHOP-Rituximab in Untreated Mantle Cell Lymphoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Weill Medical College of Cornell University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00401817
First received: November 20, 2006
Last updated: April 18, 2011
Last verified: April 2011
  Purpose

Primary Objective

1. To evaluate the safety profile of Bevacizumab (Bevacizumab™)- Rituximab (Rituxan®)-CHOP (RA-CHOP) in patients with newly diagnosed mantle cell lymphoma (MCL).

Secondary Objectives

  1. To evaluate the response rate and time to disease progression of the RA-CHOP regimen in patients with newly diagnosed MCL.
  2. To prospectively characterize the angiogenic profiles of MCL patients during RA-CHOP treatment.

Condition Intervention Phase
Untreated Mantle Cell Lymphoma
Drug: Bevacizumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Bevacizumab Plus CHOP-Rituximab in Patients With Untreated Mantle Cell Lymphoma (NHL)

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • effect of bevacizumab + CHOP-rituximab on untreated mantle cell lymphoma [ Time Frame: duration of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: November 2007
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Bevacizumab
    15 mg/kg on day 1 of each of 6 cycles
Detailed Description:

Bevacizumab administered at 15 mg/kg on day 1 of each of 6 cycles

Rituximab administered 375 mg/m2 on day 3 of each of 6 cycles (with usual premedications)

Standard CHOP chemotherapy administered on day 3 every 21 days (full dose) for 6 cycles of treatment

Once completed six cycles of therapy (~18 weeks), patients will be evaluated every 3 months for the first year post treatment, then every 6 months until disease progression or death for years 2 through 5 post treatment. Patients who have disease progression will be contacted every 6 months until death to assess for survival status.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed diagnosis of mantle cell Non-Hodgkin's Lymphoma with characteristic immunophenotypic profile: CD5(+), CD19(+) or CD20(+), cyclin D1(+), CD23(-) and CD10(-)
  • Patient has not received any prior anti-cancer therapy for lymphoma
  • Laboratory parameters (unless considered by investigator to be due to lymphoma):

Absolute neutrophil count > 1000 cells/mm3 Platelet count > 50,000 cells/mm3 Hemoglobin > 7 gm/dL Creatinine < 2.0 x ULN Total bilirubin < 2.0 x ULN

  • Patient has at least one tumor mass > 1.5 cm in one dimension
  • Available tumor tissue for correlative studies (rebiopsy to be performed if needed)
  • Patient is > 18 years old
  • Patient has KPS > 50%
  • Patient has signed IRB-approved informed consent
  • Patient agrees to use birth control for duration of study

Exclusion Criteria:

  • Known central nervous system (CNS) involvement by lymphoma
  • Known hepatitis infection
  • Known HIV positivity
  • Known history of renal disease with proteinuria; urine protein:creatinine ratio ³1.0 at screening
  • Uncontrolled hypertension: blood pressure of >150/100 mmHg at screening
  • Unstable angina
  • History of myocardial infarction within 6 months
  • History of stroke within 6 months
  • Clinically significant peripheral vascular disease
  • New York Heart Association (NYHA) Grade II or greater congestive heart failure
  • Patient has ejection fraction < 50%
  • Patient is taking coumadin, or has known history of thrombosis within last 6 months
  • 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
  • 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
  • Concomitant malignancies or previous malignancies within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
  • Patient is pregnant or nursing
  • Patient is receiving other investigational drugs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00401817

Locations
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, New York
Weill Medical College of Cornell University
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: John P Leonard, MD Weill Medical College of Cornell University
  More Information

Additional Information:
No publications provided

Responsible Party: John P. Leonard, MD, Weill Cornell Medical College
ClinicalTrials.gov Identifier: NCT00401817     History of Changes
Other Study ID Numbers: 0604008463
Study First Received: November 20, 2006
Last Updated: April 18, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Mantle-Cell
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014