A Study of Rituximab and Bevacizumab in Patients With Follicular Non-Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00193492
First received: August 22, 2005
Last updated: May 2, 2014
Last verified: May 2014

August 22, 2005
May 2, 2014
September 2005
March 2013   (final data collection date for primary outcome measure)
Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
  • Overall response rate
  • Progression free survival
  • Safety of rituximab and bevacizumab when used in combination
Complete list of historical versions of study NCT00193492 on ClinicalTrials.gov Archive Site
Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease or Death [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Compare toxicities of each treatment arm
  • Assess pharmacokinetics of rituximab and bevacizumab when used in combination
Not Provided
Not Provided
 
A Study of Rituximab and Bevacizumab in Patients With Follicular Non-Hodgkin's Lymphoma
Rituximab +/- Bevacizumab in the Treatment of Patients With Follicular Non-Hodgkin's Lymphoma: A Randomized, Phase II Trial

The purpose of this study is to assess the feasibility, efficacy and safety of adding bevacizumab to rituximab compared to rituximab alone in patients with previously treated follicular non-hodgkin's lymphoma (NHL) whose disease has progressed following at least one previous chemotherapy regimen and not more than 2 previous chemotherapy regimens.

Upon determination of eligibility, patients will randomly be assigned to one of two treatment arms:

  • Rituximab
  • Rituximab + bevacizumab

For every 2 patients randomized, 1 will receive treatment number 1 (rituximab), and 1 patient will receive treatment number 2 (rituximab + bevacizumab). This is not a blinded study, so both the patient and doctor will know which treatment has been assigned.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma, Follicular
  • Drug: Bevacizumab
    Other Name: Avastin
  • Drug: Rituximab
    Other Names:
    • Rituxan
    • MabThera
  • Active Comparator: Rituximab
    All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). Patients who have objective response or stable disease at week 12 reevaluation will receive 4 additional doses of rituximab (375 mg/m2) administered in months 3 (week 12), 5, 7, and 9.
    Intervention: Drug: Rituximab
  • Experimental: Rituximab/Bevacizumab
    All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). During the 4-week course of rituximab, all patients will receive 2 doses of bevacizumab 10mg/kg IV, given on Days 3 and 15. The first dose will be given on Day 3, following rituximab on Day 1. If both drugs are well tolerated during the first dose, rituximab and bevacizumab should be given on the same day for the Day 15 dose and all subsequent doses.
    Interventions:
    • Drug: Bevacizumab
    • Drug: Rituximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
March 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

To be included in the study, you must meet the following criteria:

  • Follicular NHL, grades 1 or 2 confirmed by a biopsy sample
  • 18 years of age or older
  • Evidence of disease progression at time of study entry
  • Must have had at least one previous chemotherapy regimen and not more than two previous chemotherapy regimens.
  • Patients who have received previous rituximab are eligible as long as progression occurred more than six months following completion of previous rituximab therapy.
  • Measurable or evaluable disease
  • Able to perform activities of daily living without considerable assistance
  • Adequate bone marrow, kidney, and liver function
  • Signed informed consent obtained prior to initiation of any study-specific procedures or treatment.

Exclusion Criteria:

You cannot participate in the study if any of the following apply to you:

  • Treatment with more than two previous chemotherapy regimens
  • Prior treatment with bevacizumab or other similar agents
  • Progressive NHL less than 6 months after receiving previous rituximab
  • More than 1 prior treatment with investigational agents within 4 weeks prior to entering this study
  • Spread of NHL to brain or nervous system
  • History of any other uncontrolled or significant disease or medical condition that may put them at high risk for treatment complications with these agents

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00193492
SCRI LYM 37, U3234s
Yes
SCRI Development Innovations, LLC
SCRI Development Innovations, LLC
Genentech
Principal Investigator: John D Hainsworth, MD SCRI Development Innovations, LLC
SCRI Development Innovations, LLC
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP