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

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ClinicalTrials.gov Identifier: NCT01317901
Recruitment Status : Completed
First Posted : March 17, 2011
Results First Posted : October 6, 2016
Last Update Posted : June 28, 2017
Sponsor:
Information provided by (Responsible Party):
Aptevo Therapeutics

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition B-cell Small Lymphocytic Lymphoma Recurrent
Interventions Drug: TRU-016
Drug: Bendamustine
Drug: Rituximab
Enrollment 12
Recruitment Details Twelve adult patients, 6 in each dose group, were enrolled at 4 hospitals between May and October 2011.
Pre-assignment Details  
Arm/Group Title 10 mg/kg TRU-016+Bendamustine+Rituximab 20 mg/kg TRU-016+Bendamustine+Rituximab
Hide Arm/Group Description

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

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

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

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

Period Title: Overall Study
Started 6 6
Completed 6 6
Not Completed 0 0
Arm/Group Title TRU-016 (10 mg/kg) +Bendamustine+Rituximab TRU-016 (20 mg/kg) +Bendamustine+Rituximab Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 6 6 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 12 participants
57.3  (4.76) 64.3  (10.61) 60.8  (8.65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Female
1
  16.7%
3
  50.0%
4
  33.3%
Male
5
  83.3%
3
  50.0%
8
  66.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Hispanic or Latino
1
  16.7%
0
   0.0%
1
   8.3%
Not Hispanic or Latino
5
  83.3%
6
 100.0%
11
  91.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  16.7%
0
   0.0%
1
   8.3%
White
5
  83.3%
6
 100.0%
11
  91.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
β2-microglobulin  
Mean (Standard Deviation)
Unit of measure:  MG/l
Number Analyzed 6 participants 6 participants 12 participants
2.4  (1.3) 2.9  (1.9) 2.6  (1.5)
Sum of product diameters  
Mean (Standard Deviation)
Unit of measure:  Cm2
Number Analyzed 6 participants 6 participants 12 participants
40.9  (26.5) 35.0  (32.6) 37.9  (28.5)
Time since first diagnosis of primary cancer  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 12 participants
3.2  (2.8) 6.0  (4.7) 4.6  (4.0)
Direct Anti-globulin Test  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Positive 0 0 0
Negative 6 5 11
unknown 0 1 1
Staging at diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 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] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Low risk (0-1 points) 3 3 6
Intermediate risk (2 points) 3 1 4
Highrisk (3-5 points) 0 2 2
[1]
Measure Description: Follicular Lymphoma International Prognostic Index
1.Primary Outcome
Title Response
Hide Description Response was assessed by the investigator on the basis of clinical, radiological, and pathological (i.e., bone marrow) criteria, using the IWG criteria (Cheson et al 2007). A CR is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A PR is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed.
Time Frame Day 15 and Day 28 of even-numbered cycles
Hide Outcome Measure Data
Hide Analysis Population Description
All treated subjects
Arm/Group Title TRU-016 (10 mg/kg) + Bendamustine + Rituximab 20 mg/kg of TRU 016 + Bendamustine + Rituximab
Hide Arm/Group Description:

10 mg/kg of TRU 016 combined with rituximab 375 mg/m^2 and bendamustine 90 mg/m^2 were evaluated during up to 6 cycles (28 days each). TRU-016 was administered by intravenous (IV) infusion on Days 1 and 15 of each cycle. Rituximab was administered by IV infusion on Day 2 of each cycle. Bendamustine was administered by IV infusion on Days 1 and 2 of each cycle. Subjects received study treatment for up to 6 cycles.

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

Bendamustine: Bendamustine by IV administration on Days 1 and 2 of each 28 day cycle.

Rituximab: Rituximab by IV administration at 375 mg/m^2 on Day 2 of each 28 day cycle.

20 mg/kg of TRU 016 combined with rituximab 375 mg/m^2 and bendamustine 90 mg/m^2 were evaluated during up to 6 cycles (28 days each). TRU-016 was administered by intravenous (IV) infusion on Days 1 and 15 of each cycle. Rituximab was administered by IV infusion on Day 2 of each cycle. Bendamustine was administered by IV infusion on Days 1 and 2 of each cycle. Subjects received study treatment for up to 6 cycles.
Overall Number of Participants Analyzed 6 6
Measure Type: Number
Unit of Measure: participants
Complete Response 3 2
Partial Response 1 4
Stable disease 1 0
Relapsed/progressive disease 1 0
Time Frame 1 year
Adverse Event Reporting Description After initiation of study medications (TRU-016, rituximab, or bendamustine), all adverse events (AEs) and serious adverse events (SAEs) regardless of attribution were collected until 60 days following the last administration of study treatment or initiation of new therapy, whichever was earlier.
 
Arm/Group Title TRU-016 (10 mg/kg) TRU-016 (20 mg/kg)
Hide Arm/Group Description TRU-016 (10 mg/kg) + bendamustine + rituximab TRU-016 (20 mg/kg) + bendamustine + rituximab
All-Cause Mortality
TRU-016 (10 mg/kg) TRU-016 (20 mg/kg)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
TRU-016 (10 mg/kg) TRU-016 (20 mg/kg)
Affected / at Risk (%) Affected / at Risk (%)
Total   2/6 (33.33%)   3/6 (50.00%) 
Blood and lymphatic system disorders     
febrile neutropenia * 1  1/6 (16.67%)  0/6 (0.00%) 
Ear and labyrinth disorders     
vestibular disorder * 1  1/6 (16.67%)  1/6 (16.67%) 
Eye disorders     
retinal vein occlusion * 1  1/6 (16.67%)  1/6 (16.67%) 
Infections and infestations     
pneumonia * 1  1/6 (16.67%)  1/6 (16.67%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
myelodysplastic syndrome * 1  1/6 (16.67%)  1/6 (16.67%) 
Respiratory, thoracic and mediastinal disorders     
pulmonary thrombosis * 1  1/6 (16.67%)  1/6 (16.67%) 
Vascular disorders     
deep vein thrombosis * 1  1/6 (16.67%)  1/6 (16.67%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (15.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
TRU-016 (10 mg/kg) TRU-016 (20 mg/kg)
Affected / at Risk (%) Affected / at Risk (%)
Total   6/6 (100.00%)   6/6 (100.00%) 
Blood and lymphatic system disorders     
neutropenia * 1  5/6 (83.33%)  2/6 (33.33%) 
anemia * 1  2/6 (33.33%)  1/6 (16.67%) 
thrombocytopenia * 1  3/6 (50.00%)  3/6 (50.00%) 
lymphopenia * 1  1/6 (16.67%)  1/6 (16.67%) 
febrile neutropenia * 1  1/6 (16.67%)  1/6 (16.67%) 
Cardiac disorders     
Non-cardiac chest pain * 1  0/6 (0.00%)  1/6 (16.67%) 
Ear and labyrinth disorders     
vestibular disorder * 1  1/6 (16.67%)  1/6 (16.67%) 
Eye disorders     
retinal vein occlusion * 1  1/6 (16.67%)  1/6 (16.67%) 
Gastrointestinal disorders     
nausea * 1  3/6 (50.00%)  4/6 (66.67%) 
abdominal pain * 1  3/6 (50.00%)  3/6 (50.00%) 
diarrhea * 1  1/6 (16.67%)  2/6 (33.33%) 
vomiting * 1  1/6 (16.67%)  2/6 (33.33%) 
constipation * 1  0/6 (0.00%)  2/6 (33.33%) 
dry mouth * 1  1/6 (16.67%)  0/6 (0.00%) 
dyspepsia * 1  0/6 (0.00%)  1/6 (16.67%) 
hemorrhoids * 1  1/6 (16.67%)  1/6 (16.67%) 
General disorders     
fatigue * 1  3/6 (50.00%)  4/6 (66.67%) 
chill * 1  0/6 (0.00%)  2/6 (33.33%) 
influenza ike illness * 1  1/6 (16.67%)  0/6 (0.00%) 
Infections and infestations     
Folliculitis * 1  0/6 (0.00%)  1/6 (16.67%) 
Herpes zoster * 1  0/6 (0.00%)  1/6 (16.67%) 
Pneumonia * 1  0/6 (0.00%)  1/6 (16.67%) 
Sinusitis * 1  0/6 (0.00%)  1/6 (16.67%) 
Injury, poisoning and procedural complications     
Contusion * 1  0/6 (0.00%)  1/6 (16.67%) 
Investigations     
White blood cell count decreased * 1  3/6 (50.00%)  1/6 (16.67%) 
Neutrophil count decreased * 1  3/6 (50.00%)  0/6 (0.00%) 
Alanine aminotransferase increased * 1  2/6 (33.33%)  0/6 (0.00%) 
Lymphocyte count decreased * 1  2/6 (33.33%)  0/6 (0.00%) 
Aspartate aminotransferase * 1  0/6 (0.00%)  1/6 (16.67%) 
Aspartate aminotransferase increased * 1  1/6 (16.67%)  0/6 (0.00%) 
Immunoglobulins decreased * 1  1/6 (16.67%)  0/6 (0.00%) 
Hyponatraemia * 1  1/6 (16.67%)  0/6 (0.00%) 
Metabolism and nutrition disorders     
Hypophosphataemia * 1  3/6 (50.00%)  0/6 (0.00%) 
Hyperglycaemia * 1  1/6 (16.67%)  1/6 (16.67%) 
Decreased appetite * 1  1/6 (16.67%)  0/6 (0.00%) 
Hypomagnesaemia * 1  1/6 (16.67%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/6 (16.67%)  1/6 (16.67%) 
Back pain * 1  0/6 (0.00%)  2/6 (33.33%) 
Joint swelling * 1  0/6 (0.00%)  1/6 (16.67%) 
Musculoskeletal chest pain * 1  0/6 (0.00%)  1/6 (16.67%) 
Myalgia * 1  0/6 (0.00%)  1/6 (16.67%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Myelodysplastic syndrome * 1  0/6 (0.00%)  1/6 (16.67%) 
Nervous system disorders     
Headache * 1  2/6 (33.33%)  1/6 (16.67%) 
Dizziness * 1  1/6 (16.67%)  0/6 (0.00%) 
Dysgeusia * 1  1/6 (16.67%)  0/6 (0.00%) 
Migraine * 1  0/6 (0.00%)  1/6 (16.67%) 
Paraesthesia * 1  1/6 (16.67%)  0/6 (0.00%) 
Post herpetic neuralgia * 1  0/6 (0.00%)  1/6 (16.67%) 
Psychiatric disorders     
Insomnia * 1  2/6 (33.33%)  2/6 (33.33%) 
Respiratory, thoracic and mediastinal disorders     
Upper respiratory tract infection * 1  0/6 (0.00%)  1/6 (16.67%) 
Productive cough * 1  0/6 (0.00%)  3/6 (50.00%) 
Cough * 1  1/6 (16.67%)  1/6 (16.67%) 
Dyspnoea exertional * 1  0/6 (0.00%)  2/6 (33.33%) 
Pulmonary thrombosis * 1  1/6 (16.67%)  1/6 (16.67%) 
Dysphonia * 1  1/6 (16.67%)  0/6 (0.00%) 
Dyspnoea * 1  1/6 (16.67%)  0/6 (0.00%) 
Nasal congestion * 1  0/6 (0.00%)  1/6 (16.67%) 
Oropharyngeal pain * 1  0/6 (0.00%)  1/6 (16.67%) 
Skin and subcutaneous tissue disorders     
Urticaria * 1  1/6 (16.67%)  1/6 (16.67%) 
Night sweats * 1  1/6 (16.67%)  0/6 (0.00%) 
Pruritus * 1  0/6 (0.00%)  1/6 (16.67%) 
Rash * 1  0/6 (0.00%)  1/6 (16.67%) 
Rash pruritic * 1  0/6 (0.00%)  1/6 (16.67%) 
Phlebitis * 1  0/6 (0.00%)  1/6 (16.67%) 
Vascular disorders     
Flushing * 1  1/6 (16.67%)  1/6 (16.67%) 
Deep vein thrombosis * 1  0/6 (0.00%)  1/6 (16.67%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (15.0)
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
Layout table for Results Point of Contact information
Name/Title: Scott C. Stromatt
Organization: Aptevo Therapeutics
Phone: 206-859-6675
EMail: sstromatt@apvo.com
Layout table for additonal information
Responsible Party: Aptevo Therapeutics
ClinicalTrials.gov Identifier: NCT01317901     History of Changes
Other Study ID Numbers: 16011
First Submitted: March 15, 2011
First Posted: March 17, 2011
Results First Submitted: August 11, 2016
Results First Posted: October 6, 2016
Last Update Posted: June 28, 2017