We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Bevacizumab + CHOP-Rituximab in Untreated Mantle Cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00401817
Recruitment Status : Completed
First Posted : November 22, 2006
Results First Posted : October 20, 2017
Last Update Posted : October 20, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Untreated Mantle Cell Lymphoma Drug: Bevacizumab Drug: Rituximab Drug: CHOP Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Bevacizumab Plus CHOP-Rituximab in Patients With Untreated Mantle Cell Lymphoma (NHL)
Actual Study Start Date : November 2007
Primary Completion Date : July 2011
Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Study Treatment Arm
Bevacizumab-R-CHOP therapy included bevacizumab administered at 15 mg/kg on day 1, and standard dose R-CHOP on day 3, for six 21-day cycles
Drug: Bevacizumab
15 mg/kg on day 1 of each of 6 cycles
Drug: Rituximab

Rituximab will be administered prior to CHOP on day 3 of every cycle for a total of 6 cycles.

The dose to be administered is:

Rituximab: 375 mg/m2

Drug: CHOP
Standard CHOP chemotherapy will be administered at full dose every 21 days for a total of 6 cycles. The doses to be used are: Cyclophosphamide: 750 mg/m2 IV on day 3 Doxorubicin: 50 mg/m2 IV on day 3 Vincristine: 1.4 mg/m2 IV (not to exceed 2.0 mg total) on day 3 Prednisone: 100 mg PO days 3 - 7

Outcome Measures

Primary Outcome Measures :
  1. Number of Participants With Toxicity [ Time Frame: 38 months ]
    Number of patients with reversible myelosuppression (Primary toxicity was reversible myelosuppression) Toxicities were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.

Secondary Outcome Measures :
  1. Overall Response Rate [ Time Frame: 38 Months (min 33 months, max 62 months) ]

    Overall Response Rate measured using Kaplan-Meier survival analysis

    Response criteria were those reported by Cheson et al. (1999)

  2. Progression-Free Survival [ Time Frame: 3 years ]

    The percentage of patients who have not progressed at the three year time point.

    The 3-year PFS rate was estimated based on the Kaplan-Meier analysis.

  3. Overall Survival [ Time Frame: 3 years ]

    The percentage of patients who have survived at the three year time point.

    The 3-year OS rate was estimated based on the Kaplan-Meier analysis.

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00401817

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
Principal Investigator: John P Leonard, MD Weill Medical College of Cornell University
More Information

Additional Information:
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00401817     History of Changes
Other Study ID Numbers: 0604008463
First Posted: November 22, 2006    Key Record Dates
Results First Posted: October 20, 2017
Last Update Posted: October 20, 2017
Last Verified: September 2017

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