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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01644253
Other study ID # 16009
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
Start date September 2012
Est. completion date April 21, 2021

Study information

Verified date May 2021
Source Aptevo Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of TRU-016 in combination with rituximab, in combination with obinutuzumab, in combination with rituximab and idelalisib, or in combination with ibrutinib in patients with CLL; and in combination with bendamustine in patients with PTCL.


Description:

The study will consist of 8 dose cohorts: 1. Previously untreated patients 20 mg/kg TRU-016 + rituximab. 2. Relapsed patients, 20 mg/kg TRU-016 + rituximab. 3. Previously untreated patients 10 mg/kg TRU-016 + rituximab. 4. Previously untreated patients TRU-016 + obinutuzumab. 5. Relapsed patients, 20 mg/kg TRU-016 + rituximab + idelalisib. 6. Patients with CLL on ibrutinib or another BTK inhibitor for a total of more than 1 year who have not had a complete response (CR) will continue receiving ibrutinib or another BTK inhibitor. 7. Patients with CLL on ibrutinib or another BTK inhibitor with stable disease and in whom the cysteine 481 mutant clone is present at a level >1%, will continue receiving ibrutinib or the alternative BTK inhibitor. 8. Patients with relapsed or refractory PTCL will receive TRU-016 dosed 10 mg/kg for the first dose and then 20 mg/kg weekly for 2 cycles, followed by dosing every other week for an additional 4 cycles (cycle = 28 days) + bendamustine for 2 days every cycle for 6 cycles.


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Study Design


Intervention

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Locations

Country Name City State
United States Greenville Health System Greenville South Carolina
United States Eastern Regional Medical Center Philadelphia Pennsylvania
United States University of Pittsburgh Pittsburgh Pennsylvania
United States Fred Hutchinson Cancer Research Center Seattle Washington
United States Swedish Cancer Institute,1221 Madison St. Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
Aptevo Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence and severity of adverse events any time point during the study up to 18 months
Primary CLL Cysteine 481 mutation status The primary endpoint for Cohort 7 is the elimination of the cysteine 481 mutant clone (<1%). CLL patients in Cohort 7 will be followed for 9 months unless no cysteine 481 mutation is detected.
Secondary Overall Response Rate (ORR) any time point during the study up to 18 months
Secondary Progression-free survival (PFS) any time point during the study up to 18 months
Secondary Overall survival (OS) any time point during the study up to 18 months
Secondary Duration of response (DOR) any time point during the study up to 18 months
Secondary Resolution of disease-related symptoms Resolution of disease-related symptoms which are common to the disease include fever, weight loss, night sweats, fatigue, loss of appetite pain, and pruritus; symptoms will be assessed by descriptive statistics and data listings. any time point during the study up to 18 months
Secondary Maximum serum drug concentration (Cmax) any time point during the study up to 12 months
Secondary Minimum serum drug concentration (Cmin) any time point during the study up to 12 months
Secondary Area under the concentration-time curve (AUC0-t and AUC0-8) any time point during the study up to 12 months
Secondary Systemic clearance (CL) any time point during the study up to 12 months
Secondary Volume of distribution (Vd) any time point during the study up to 12 months
Secondary Elimination half-life (t1/2) any time point during the study up to 12 months
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