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Safety and Efficacy Study of TRU-016 Plus Bendamustine vs. Bendamustine in Relapsed Chronic Lymphocytic Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aptevo Therapeutics
ClinicalTrials.gov Identifier:
NCT01188681
First received: August 20, 2010
Last updated: June 26, 2017
Last verified: June 2017
Results First Received: May 17, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Chronic Lymphocytic Leukemia (CLL)
Interventions: Drug: TRU-016 and bendamustine
Drug: Bendamustine
Drug: 15 mg/kg TRU-016 and bendamustine
Drug: 20 mg/kg TRU-016 and bendamustine

  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
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
Phase 1 15 mg/kg TRU-016 (15 mg/kg), weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles and bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles
Phase 1 20 mg/kg TRU-016 (20 mg/kg), weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles and bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles
Phase 2 TRU-016 and Bendamustine Patients in the combination arm received otlertuzumab (20 mg/kg) weekly by IV infusion for two 28-day cycles then every 14 days for four 28-day cycles. In both arms, bendamustine (70 mg/m2) was administered IV on Days 1 and 2 of each cycle for up to six 28-day cycles.
Phase 2 Bendamustine Patients in the bendamustine arm received bendamustine (70 mg/m2) administered IV on Days 1 and 2 of each cycle for up to six 28-day cycles.

Participant Flow:   Overall Study
    Phase 1 15 mg/kg   Phase 1 20 mg/kg   Phase 2 TRU-016 and Bendamustine   Phase 2 Bendamustine
STARTED   6   6   33 [1]   34 [2] 
COMPLETED   6   6   32   33 
NOT COMPLETED   0   0   1   1 
bladder cancer                0                0                1                0 
Withdrawal by Subject                0                0                0                1 
[1] 33 patients enrolled, 32 patients treated. One patient had bladder cancer and was not treated.
[2] 34 patients enrolled, 33 patients treated. One patient withdrew consent and was not treated.



  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.
patients with relapsed chronic lymphocytic leukemia

Reporting Groups
  Description
Phase 1: 15 mg/kg TRU-016

TRU-016 (15 mg/kg) and bendamustine (70 mg/m2)

TRU-016 and bendamustine: TRU-016 (20 mg/kg) weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles

Phase 1: 20 mg/kg TRU-016

TRU-016 (20 mg/kg) and bendamustine (70 mg/m2)

TRU-016 and bendamustine: TRU-016 (20 mg/kg) weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles

Phase 2: TRU-016 and Bendamustine

TRU-016 (20 mg/kg) and bendamustine (70 mg/m2)

TRU-016 and bendamustine: TRU-016 (20 mg/kg) weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles

Phase 2: Bendamustine

Bendamustine alone (70 mg/m2)

Bendamustine: 70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles

Total Total of all reporting groups

Baseline Measures
   Phase 1: 15 mg/kg TRU-016   Phase 1: 20 mg/kg TRU-016   Phase 2: TRU-016 and Bendamustine   Phase 2: Bendamustine   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   6   32   33   77 
Age 
[Units: Participants]
Count of Participants
         
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      1  16.7%      3  50.0%      16  50.0%      21  63.6%      41  53.2% 
>=65 years      5  83.3%      3  50.0%      16  50.0%      12  36.4%      36  46.8% 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.3  (5.8)   67.7  (8.9)   64.1  (9.4)   62.2  (8.1)   62.3  (8.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      2  33.3%      2  33.3%      12  37.5%      8  24.2%      24  31.2% 
Male      4  66.7%      4  66.7%      20  62.5%      25  75.8%      53  68.8% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
         
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Not Hispanic or Latino      6 100.0%      6 100.0%      32 100.0%      33 100.0%      77 100.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
         
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1  16.7%      1  16.7%      2   6.3%      1   3.0%      5   6.5% 
White      5  83.3%      5  83.3%      30  93.8%      32  97.0%      72  93.5% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Response Per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria   [ Time Frame: 1 and 2 months after end of treatment, then every 3 months until disease progression, death, initiation of new therapy, study withdrawal, or 2 years ]

2.  Secondary:   Response Per NCI Criteria   [ Time Frame: 1 and 2 months after end of treatment, then every 3 months until disease progression, death, initiation of new therapy, study withdrawal, or 2 years ]


  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: Emergent BioSolutions
phone: 206-859-6675
e-mail: sstromatt@ebsi.com


Publications:

Responsible Party: Aptevo Therapeutics
ClinicalTrials.gov Identifier: NCT01188681     History of Changes
Other Study ID Numbers: 16201
Study First Received: August 20, 2010
Results First Received: May 17, 2016
Last Updated: June 26, 2017