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A Study of TRU-016 in Combination With Rituximab and Bendamustine in Subjects With Relapsed Indolent Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aptevo Therapeutics
ClinicalTrials.gov Identifier:
NCT01317901
First received: March 15, 2011
Last updated: August 16, 2016
Last verified: August 2016
Results First Received: August 11, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: B-cell Small Lymphocytic Lymphoma Recurrent
Interventions: Drug: TRU-016
Drug: Bendamustine
Drug: Rituximab

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Twelve adult patients, 6 in each dose group, were enrolled at 4 hospitals between May and October 2011.

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
TRU-016+Bendamustine+Rituximab

TRU-016: 100 mg TRU-016 lyophilized solution for infusion at 10 or 20 mg/kg (or 6 mg/kg, if necessary) on Days 1 and 15 of each 28 day cycle Rituximab: 375 mg/m2 rituximab was administered by IV infusion on Day 2 of each cycle.

Bendamustine: 90 mg/m2 bendamustine was administered by IV infusion on Days 1 and 2 of each cycle.


Participant Flow:   Overall Study
    TRU-016+Bendamustine+Rituximab
STARTED   12 
COMPLETED   12 
NOT COMPLETED   0 



  Baseline Characteristics
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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
TRU-016 (10 mg/kg) +Bendamustine+Rituximab No text entered.
TRU-016 (20 mg/kg) +Bendamustine+Rituximab No text entered.
Total Total of all reporting groups

Baseline Measures
   TRU-016 (10 mg/kg) +Bendamustine+Rituximab   TRU-016 (20 mg/kg) +Bendamustine+Rituximab   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   6   12 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.3  (4.76)   64.3  (10.61)   60.8  (8.65) 
Gender 
[Units: Participants]
     
Female   1   3   4 
Male   5   3   8 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   1   0   1 
Not Hispanic or Latino   5   6   11 
Unknown or Not Reported   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   1   0   1 
White   5   6   11 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
β2-microglobulin 
[Units: MG/l]
Mean (Standard Deviation)
 2.4  (1.3)   2.9  (1.9)   2.6  (1.5) 
Sum of product diameters 
[Units: Cm2]
Mean (Standard Deviation)
 40.9  (26.5)   35.0  (32.6)   37.9  (28.5) 
Time since first diagnosis of primary cancer 
[Units: Years]
Mean (Standard Deviation)
 3.2  (2.8)   6.0  (4.7)   4.6  (4.0) 
Direct Anti-globulin Test 
[Units: Participants]
     
Positive   0   0   0 
Negative   6   5   11 
unknown   0   1   1 
Staging at diagnosis 
[Units: Participants]
     
Stage 1   1   0   1 
Stage 2   1   1   2 
Stage 3   1   2   3 
Stage 4   2   3   5 
Not done   1   0   1 
FLIPI [1] 
[Units: Participants]
     
Low risk (0-1 points)   3   3   6 
Intermediate risk (2 points)   3   1   4 
Highrisk (3-5 points)   0   2   2 
[1] Follicular Lymphoma International Prognostic Index


  Outcome Measures

1.  Primary:   Response   [ Time Frame: Day 15 and Day 28 of even-numbered cycles ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Scott C. Stromatt
Organization: Aptevo Therapeutics
phone: 206-859-6675
e-mail: sstromatt@apvo.com


Publications:

Responsible Party: Aptevo Therapeutics
ClinicalTrials.gov Identifier: NCT01317901     History of Changes
Other Study ID Numbers: 16011
Study First Received: March 15, 2011
Results First Received: August 11, 2016
Last Updated: August 16, 2016
Health Authority: United States: Food and Drug Administration