Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006063

Trial Description

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Title

A MULTICENTER, PHASE III, OPEN-LABEL, RANDOMIZED STUDY IN RELAPSED/REFRACTORY PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA TO EVALUATE THE BENEFIT OF GDC-0199 (ABT-199) PLUS RITUXIMAB COMPARED WITH BENDAMUSTINE PLUS RITUXIMAB

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This open-label, randomized study will compare the efficacy of GDC-0199 plus rituximab
(GDC-0199+R) with bendamustine plus MabThera/Rituxan (Rituximab) (B+R) in patients with
relapsed or resistant chronic lymphocytic leukemia. Patients will be randomized 1:1 into the
two arms. Patients randomized to GDC-0199+R will be given GDC-0199 daily (oral, target dose
400 mg) and will receive 6 cycles of rituximab infused intravenously (IV) on Day 1 of each
28-day cycle (Cycle 1: 375 mg/m2; Cycles 2-6: 500 mg/m2).

Patients randomized to B+R will receive 6 cycles of treatment consisting of a rituximab
infusion (Cycle 1: 375 mg/m2; Cycles 2-6: 500 mg/m2) on Day 1 and bendamustine infusions (70
mg/m2) on Days 1 and 2 of each 28-day cycle.

Patients in the GDC-0199+R arm will continue GDC-0199 treatment until disease progression or
2 years since treatment start, whichever comes first. Anticipated time on study is up to 5
years.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00006063
  •   2014/04/29
  •   2013/12/04
  •   no
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Secondary IDs

  •   NCT02005471  (ClinicalTrials.gov)
  •   GO28667  (Hoffmann-La Roche)
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Health Condition or Problem studied

  •   Chronic Lymphocytic Leukemia
  •   C91.1 -  Chronic lymphocytic leukaemia of B-cell type
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Interventions/Observational Groups

  •   Drug: GDC-0199
  •   Drug: Rituximab [MabThera/Rituxan]
  •   Drug: Bendamustine
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
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Primary Outcome

- Investigator-assessed progression-free survival (PFS), defined as time from randomization until disease progression or death from any cause.; time frame: Up to 5 years

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Secondary Outcome

- Overall response rates; time frame: Assessed 2-3 months after end of treatment
- Incidence of adverse events; time frame: Up to 5 years
- Patient-reported outcome measure; time frame: Up to 5 years

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Countries of Recruitment

  •   United States
  •   Australia
  •   Austria
  •   Belgium
  •   Canada
  •   Czech Republic
  •   Denmark
  •   France
  •   Germany
  •   Hungary
  •   Italy
  •   Korea, Republic of
  •   Netherlands
  •   New Zealand
  •   Poland
  •   Spain
  •   Sweden
  •   Switzerland
  •   Taiwan, Province of China
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2013/12/31
  •   370
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Age > / = 18 years.

- Diagnosis of chronic lymphocytic leukemia (CLL) per diagnostic criteria and relapsed
or refractory CLL per the iwCLL guidelines.

- Previously treated with 1-3 lines of therapy (e.g. completed > / = two treatment
cycles per therapy), including at least one standard chemotherapy-containing regimen.

- Patients previously treated with bendamustine only if their duration of response was
> / = 24 months.

- Eastern Cooperative Oncology Group (ECOG) performance score of < / = 1.

- Adequate bone marrow function.

- Adequate renal and hepatic function.

- Patients must use effective birth control throughout study until 1 year after
rituximab treatment; female patients must not be pregnant or breast-feeding.

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Exclusion Criteria

- Transformation of CLL to aggressive non-Hodgkin lymphoma or CNS involvement by CLL.

- Undergone an allogenic stem cell transplant.

- A history of significant renal, neurologic, psychiatric, endocrine, metabolic,
immunologic, cardiovascular or hepatic disease.

- Hepatitis B or C or known HIV positive.

- Receiving warfarin treatment.

- Received an anti-CLL monoclonal antibody within 8 weeks prior to the first dose of
study drug.

- Received any anti-cancer or investigational therapy within 14 days prior to the first
dose of study drug or has not recovered from previous therapy.

- Received CYP3A4 inhibitors (such as fluconazole, ketoconazole and clarithromycin) or
inducers (such as rifampin, carbamezapine, phenytoin, St. John's Wort) within 7 days
prior to the first dose of GDC-0199.

- Prior GDC-0199 treatment.

- Patients with another cancer, history of another cancer considered uncured on in
complete remission for < 5 years, or currently under treatment for another suspected
cancer except non-melanoma skin cancer or carcinoma in situ of the cervix that has
been treated or excised and is considered resolved.

- Malabsorption syndrome or other condition that precludes enteral route of
administration.

- Other clinically significant uncontrolled condition(s) including, but not limited to,
systemic infection (viral, bacterial or fungal).

- Vaccination with a live vaccine within 28 days prior to randomization.

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Addresses

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    • Hoffmann-La Roche
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    • Hoffmann-La Roche
    • Clinical Trials 
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    • Reference Study ID Number: GO28667 www.roche.com/about_roche/roche_worldwide.htm 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   84
  •   2014/04/01
* This entry means the parameter is not applicable or has not been set.