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Bendamustine and Rituximab Followed by 90-yttrium (Y) Ibritumomab Tiuxetan for Untreated Follicular Lymphoma (Fol-BRITe)

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ClinicalTrials.gov Identifier: NCT01234766
Recruitment Status : Active, not recruiting
First Posted : November 4, 2010
Results First Posted : May 14, 2018
Last Update Posted : May 14, 2018
Sponsor:
Collaborators:
Cephalon
Spectrum Pharmaceuticals, Inc
Information provided by (Responsible Party):
Frederick Lansigan, Dartmouth-Hitchcock Medical Center

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Lymphoma, Follicular
Interventions: Drug: Bendamustine
Drug: Rituximab
Radiation: Y-90 ibritumomab

  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
Single Arm

Subjects will receive bendamustine and rituximab, followed by 90-yttrium (Y) Ibritumomab Tiuxetan

Bendamustine: 90mg/m2, IV - Days 1 and 2 of every cycle

Rituximab: 375mg/m2, IV - Cycle 1 only: Day -7 (+1 day) Day 1 of every cycle

Y-90 ibritumomab: 0.4mCi/kg, IV - Within 4 hours of rituximab, give over 10 minutes


Participant Flow:   Overall Study
    Single Arm
STARTED   39 
COMPLETED   35 
NOT COMPLETED   4 



  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
Single Arm

Subjects will receive bendamustine and rituximab, followed by 90-yttrium (Y) Ibritumomab Tiuxetan

Bendamustine: 90mg/m2, IV - Days 1 and 2 of every cycle

Rituximab: 375mg/m2, IV - Cycle 1 only: Day -7 (+1 day) Day 1 of every cycle

Y-90 ibritumomab: 0.4mCi/kg, IV - Within 4 hours of rituximab, give over 10 minutes


Baseline Measures
   Single Arm 
Overall Participants Analyzed 
[Units: Participants]
 39 
Age 
[Units: Participants]
Count of Participants
 
Participants Analyzed   39 
<=18 years      0   0.0% 
Between 18 and 65 years      28  71.8% 
>=65 years      11  28.2% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Participants Analyzed   39 
Female      22  56.4% 
Male      17  43.6% 
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
  
[1] Race and Ethnicity were not collected from any participant.
Region of Enrollment 
[Units: Participants]
 
United States   
Participants Analyzed   39 
United States   39 


  Outcome Measures

1.  Primary:   Complete Response Rate   [ Time Frame: 3 years ]


  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
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Frederick Lansigan, MD
Organization: Dartmouth-Hitchcock Medical Center
phone: 603-650-4628
e-mail: Frederick.Lansigan@hitchcock.org



Responsible Party: Frederick Lansigan, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01234766     History of Changes
Other Study ID Numbers: D1015
First Submitted: October 6, 2010
First Posted: November 4, 2010
Results First Submitted: April 13, 2018
Results First Posted: May 14, 2018
Last Update Posted: May 14, 2018