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Trial record 4 of 4 for:    TRU-016

Phase 1b Safety and Efficacy Study of TRU-016 and Rituximab, Obinutuzumab, Idelalisib, or Ibrutinib in Chronic Lymphocytic Leukemia

This study is currently recruiting participants.
Verified March 2017 by Aptevo Therapeutics
Sponsor:
ClinicalTrials.gov Identifier:
NCT01644253
First Posted: July 19, 2012
Last Update Posted: June 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Aptevo Therapeutics
July 12, 2012
July 19, 2012
June 26, 2017
September 2012
June 2018   (Final data collection date for primary outcome measure)
  • Overall response rate (ORR) [ Time Frame: any time point during the study up to 18 months ]
    ORR by the 2008 International Workshop on CLL (IWCLL) criteria
  • Cysteine 481 mutant clone [ Time Frame: any time point during the study ]
    The primary endpoint for Cohort 7 is the elimination of the cysteine 481 mutant clone
Overall response rate (ORR) [ Time Frame: any time point during the study up to 18 months ]
ORR by the 2008 International Workshop on CLL (IWCLL) criteria
Complete list of historical versions of study NCT01644253 on ClinicalTrials.gov Archive Site
  • Safety [ Time Frame: any time point during the study up to 18 months ]
    The incidence and severity of adverse events, and changes from baseline in laboratory parameters, vital signs, and physical examination will be determined.
  • ORR [ Time Frame: any time point during the study up to 18 months ]
    ORR by 1996 NCI Working Group Criteria
  • Progression-free survival (PFS) [ Time Frame: any time point during the study up to 18 months ]
  • Overall survival (OS) [ Time Frame: any time point during the study up to 18 months ]
  • Duration of response (DOR) [ Time Frame: any time point during the study up to 18 months ]
  • Resolution of disease-related symptoms [ Time Frame: Any time point during the study up to 18 months ]
Safety [ Time Frame: any time point during the study up to 18 months ]
The incidence and severity of adverse events, and changes from baseline in laboratory parameters, vital signs, and physical examination will be determined.
Not Provided
Not Provided
 
Phase 1b Safety and Efficacy Study of TRU-016 and Rituximab, Obinutuzumab, Idelalisib, or Ibrutinib in Chronic Lymphocytic Leukemia
A Phase 1b, Open Label Study to Evaluate the Safety and Efficacy 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 Chronic Lymphocytic Leukemia
The purpose of this study is to evaluate the safety and efficacy of TRU-016 when when administered in combination with rituximab or obinutuzumab, in combination with idelalisib and rituximab, or in combination with ibrutinib in patients with chronic lymphocytic leukemia (CLL).
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Chronic Lymphocytic Leukemia
  • Biological: 20 mg/kg TRU-016 + Rituximab

    TRU-016: 10 mg/kg for first dose, all subsequent doses 20 mg/kg, IV once weekly for 8 weeks followed by 4 monthly doses

    Rituximab: 375 mg/m2 for first dose, all subsequent doses 500 mg/m2, IV once weekly for 8 weeks followed by 4 monthly doses

    Other Name: Rituxan
  • Biological: 10 mg/kg TRU-016 + Rituximab

    TRU-016: 6 mg/kg for first dose, all subsequent doses 10 mg/kg, IV on Day 1, 8 and 15, followed by 5 monthly doses

    Rituximab: 375 mg/m2 for first dose, all subsequent doses 500 mg/m2, IV following TRU-016 schedule

    Other Name: Rituxan
  • Biological: TRU-016 20 mg/kg + Obinutuzumab

    TRU-016: 6 mg/kg on Day 1, 20 mg/kg on Day 8 and 15, then 20 mg/kg once a month for 5 months

    Obinutuzumab: 100 mg on Day 1, 900 mg on Day 2, 1,000 mg on Day 8 and 15, then 1,000 mg once a month for 5 months

    Other Name: Gazyva
  • Biological: TRU-016 6-20 mg/kg + idelalisib + rituximab
    TRU-016: 6 mg/kg on Days 15-36 weekly, 10 mg/kg on Days 43 and 50, then 20 mg/kg once a month for 5 months.
    Other Name: Zydelig, Rituxan
  • Biological: TRU-016 10-20 mg/kg + ibrutinib
    TRU-016: Dosed weekly for 8 weeks followed by 4 monthly intravenous (IV) infusions. The first dose will be 10 mg/kg and all subsequent doses will be 20 mg/kg.
    Other Name: Imbruvica
  • Experimental: Cohort 1 - Previously Untreated CLL
    20 mg/kg TRU-016 + Rituximab
    Intervention: Biological: 20 mg/kg TRU-016 + Rituximab
  • Experimental: Cohort 2 - Relapsed CLL
    20 mg/kg TRU-016 + Rituximab
    Intervention: Biological: 20 mg/kg TRU-016 + Rituximab
  • Experimental: Cohort 3 - Previously Untreated CLL
    10 mg/kg TRU-016 + Rituximab
    Intervention: Biological: 10 mg/kg TRU-016 + Rituximab
  • Experimental: Cohort 4 - Previously Untreated CLL
    20 mg/kg TRU-016 20 + Obinutuzumab
    Intervention: Biological: TRU-016 20 mg/kg + Obinutuzumab
  • Experimental: Cohort 5 - Relapse CLL
    20 mg/kg TRU-016 + idelalisib + rituximab
    Intervention: Biological: TRU-016 6-20 mg/kg + idelalisib + rituximab
  • Experimental: Cohort 6 - With CLL on ibrutinib with no complete response
    20 mg/kg TRU-016 + ibrutinib
    Intervention: Biological: TRU-016 10-20 mg/kg + ibrutinib
  • Experimental: Cohort 7 - With CLL on ibrutinib with stable disease
    20 mg/kg TRU-016 + ibrutinib
    Intervention: Biological: TRU-016 10-20 mg/kg + ibrutinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
123
December 2018
June 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of CLL by 2008 IWCLL criteria and with Rai stage intermediate or high risk CLL
  • No prior therapy for CLL for Cohorts 1, 3 and 4. For Cohort 2, 1-3 prior treatments. For Cohort 5, patients must have failed to respond or relapsed after 1 or more treatment regimens. For Cohort 6, patients who have been receiving ibrutinib for at least 12 months, have not had a CR, and in whom no cysteine 481 mutation is detected. For Cohort 7, patients who are receiving ibrutinib with stable disease and now have the cysteine 481 mutant clone present at levels of >1%.
  • At least one of the following criteria for active disease requiring treatment: progressive splenomegaly and/or lymphadenopathy; anemia or thrombocytopenia due to bone marrow involvement; or progressive lymphocytosis with an increase of >50% over a 2-month period or an unanticipated doubling time of less than 6 months
  • For Cohorts 1, 3 and 4, contraindication to chemotherapy as first-line therapy due to patient age, comorbidity or patient preference
  • Age >/= to 18 years
  • ECOG performance status of </= 2
  • Life expectancy > 6 months in opinion of Investigator
  • Serum creatinine, total bilirubin, ALT/SGPT </= 2.0 x upper limit of normal
  • ANC >/= 800/mm3
  • Platelets >/= 30,000/mm3

Exclusion Criteria:

  • For Cohorts 1, 3 and 4 only: Has received treatment with rituximab, alemtuzumab, ofatumumab or any other chemotherapeutic agent for CLL
  • Has received an investigational therapy within 30 days of first dose of study drug
  • Previous or concurrent additional malignancy
  • Clinically significant pulmonary dysfunction, active infection, prior allogeneic bone marrow transplant, active autoimmune disease
  • Positive serology for HIV or hepatitis C
  • Hepatitis B surface antigen or hepatitis B core antibody positive
  • Pregnant or breastfeeding
  • Known current drug or alcohol abuse
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: David Schaaf 206-859-6655 schaafd@apvo.com
United States
 
 
NCT01644253
16009
No
Not Provided
Not Provided
Aptevo Therapeutics
Aptevo Therapeutics
Not Provided
Study Director: Scott C. Stromatt, M.D. Aptevo Therapeutics
Aptevo Therapeutics
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP