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Trial record 6 of 71 for:    Peru | Panama

A Study of Bevacizumab (Avastin) in Combination With Rituximab (MabThera) and CHOP (Cyclophosphamide, Hydroxydaunorubicin [Doxorubicin], Oncovin [Vincristine], Prednisone) Chemotherapy in Patients With Diffuse Large B-cell Lymphoma

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ClinicalTrials.gov Identifier: NCT00486759
Recruitment Status : Terminated (Due to an unfavorable benefit/risk ratio.)
First Posted : June 15, 2007
Results First Posted : December 31, 2012
Last Update Posted : July 25, 2017
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: B-cell Lymphoma
Interventions: Drug: Bevacizumab
Drug: Rituximab
Drug: CHOP
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Bevacizumab + Rituximab + CHOP Patients received bevacizumab 5 mg/kg/week on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
Placebo + Rituximab + CHOP Patients received placebo to bevacizumab on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).

Participant Flow for 2 periods

Period 1:   Treatment
    Bevacizumab + Rituximab + CHOP   Placebo + Rituximab + CHOP
STARTED   390   397 
COMPLETED   203   260 
NOT COMPLETED   187   137 
Adverse event/intercurrent illness                86                39 
Insufficient therapeutic response                37                39 
Death                17                10 
Withdrew consent                15                12 
Administrative/reason not specified                17                21 
Refused treatment                10                7 
Violation of selection criteria at entry                3                3 
Other protocol violation                1                5 
Failure to return                1                1 

Period 2:   Safety Follow-up
    Bevacizumab + Rituximab + CHOP   Placebo + Rituximab + CHOP
STARTED   203   260 
COMPLETED   64   142 
NOT COMPLETED   139   118 
Insufficient therapeutic response                40                50 
Death                40                29 
Withdrew consent                32                23 
Failure to return                9                6 
Administrative/not specified                8                6 
Refused treatment/did not cooperate                6                4 
Adverse event/intercurrent illness                4                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Bevacizumab + Rituximab + CHOP Patients received bevacizumab 5 mg/kg/week on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
Placebo + Rituximab + CHOP Patients received placebo to bevacizumab on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
Total Total of all reporting groups

Baseline Measures
   Bevacizumab + Rituximab + CHOP   Placebo + Rituximab + CHOP   Total 
Overall Participants Analyzed 
[Units: Participants]
 390   397   787 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.89  (14.256)   56.98  (15.399)   57.44  (14.841) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      207  53.1%      193  48.6%      400  50.8% 
Male      183  46.9%      204  51.4%      387  49.2% 


  Outcome Measures

1.  Primary:   Progression-free Survival (PFS)   [ Time Frame: Baseline to end of the study (up to 4 years, 4 months) ]

2.  Secondary:   Overall Survival   [ Time Frame: Baseline to end of the study (up to 4 years, 4 months) ]

3.  Secondary:   Overall Response (OR) Assessed According to the Revised Response Criteria for Malignant Lymphoma   [ Time Frame: At the end of treatment (Cycle 8, up to 12 months) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Due to premature termination of the study, the efficacy results should be interpreted with caution.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
phone: 800 821-8590


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00486759     History of Changes
Other Study ID Numbers: BO20603
First Submitted: June 14, 2007
First Posted: June 15, 2007
Results First Submitted: November 28, 2012
Results First Posted: December 31, 2012
Last Update Posted: July 25, 2017