Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007642

Trial Description

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Title

A Study to Compare the Efficacy and Safety of Obinutuzumab + GDC-0199 Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia

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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, multicenter, randomized Phase III study is designed to compare the efficacy
and safety of a combined regimen of obinutuzumab and GDC-0199 versu s obinutuzumab +
chlorambucil (GClb) in patients with chronic lymphocytic leukem ia (CLL) and coexisting
medical conditions. The anticipated time on study treatm ent will be approximately one year
and the follow-up period will be up to 5 year s.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00007642
  •   2015/01/21
  •   2014/09/16
  •   no
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Secondary IDs

  •   2014-001810-24 
  •   NCT02242942  (ClinicalTrials.gov)
  •   BO25323  (Hoffmann-La Roche)
  •   2014-001810-24 
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Health Condition or Problem studied

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

  •   Drug: Chlorambucil
  •   Drug: GDC-0199
  •   Drug: Obinutuzumab
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Treatment
  •   Parallel
  •   III
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Primary Outcome

- Progression-free survival (PFS), defined as the time from randomization to the first occurrence of progression, relapse or death from any cause as assessed by the investigator using IWCLL criteria; time frame: Up to 5 years

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Secondary Outcome

- PFS based on Institutional Review Committee (IRC)-assessments, defined as the time from randomization to the first occurrence of progression or relapse or death from any cause; time frame: Up to 5 years
- Objective response rate ([ORR] defined as rate of a clinical response of complete response [CR], CR with incomplete bone marrow recovery [CRi] or partial response [PR]) as determined by the investigator, according to the IWCLL criteria; time frame: At the completion of treatment assessment, approximately 1 year
- Minimal residual disease (MRD) response rate, as measured by allele-specific oligonucleotide polymerase chain reaction (ASO-PCR); time frame: At the completion of treatment assessment, approximately 1 year
- ORR at completion of combination treatment response assessment; time frame: Cycle 7 day 1 or 28 days after last IV infusion, approximately 6 months
- MRD response rate, as measured by ASO-PCR at completion of combination treatment response assessment; time frame: Cycle 9 day 1 or 3 months after last IV infusion, approximately 9 months
- Overall survival; time frame: Time between the date of randomization and the date of death due to any cause, up to approximately 5 years
- Duration of objective response; time frame: Time from the first occurrence of a documented objective response to the time of progressive disease as determined by the investigator or death from any cause, up to approximately 5 years
- Best response achieved (CR, CRi, PR, stable disease, or progressive disease); time frame: Up to and including the assessment at completion of treatment assessment, within 3 months of last day of treatment, approximately 1 year
- Event-free survival; time frame: Time between date of randomization and the date of disease progression/relapse on the basis of investigator-assessment, death, or start of a new anti-leukemic therapy, up to 5 years
- Time to next anti-leukemic treatment; time frame: Time between the date of randomization and the date of first intake of new anti-leukemic therapy, up to 5 years
- Incidence of adverse events assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0; time frame: 28 days after the last dose of GDC-0199 or after 90 days after last dose of obinutuzumab, whichever is longer
- Incidence of severe adverse events; time frame: Up to 5 years
- Incidence of adverse events of special interest; time frame: Up to 2 years after last dose of study drug

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Countries of Recruitment

  •   United States
  •   Australia
  •   New Zealand
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Locations of Recruitment

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Recruitment

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  •   2014/11/30
  •   432
  •   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

- Documented previously untreated CLL according to the International Workshop on
Chronic Lymphocytic Leukemia (IWCLL) criteria

- CLL requiring treatment according to IWCLL criteria

- Total Cumulative Illness Rating Scale (CIRS score) > 6

- Adequate marrow function independent of growth factor or transfusion support within 2
weeks of screening as per protocol, unless cytopenia is due to marrow involvement of
CLL

- Adequate liver function

- Life expectancy > 6 months

- Agreement to use highly effective contraceptive methods per protocol

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Exclusion Criteria

- Transformation of CLL to aggressive Non-Hodgkin's lymphoma (Richter's transformation
or pro-lymphocytic leukemia)

- Known central nervous system involvement

- Patients with a history of confirmed progressive multifocal leukoencephalopathy (PML)

- An individual organ/ system impairment score of 4 as assessed by the CIRS definition
limiting the ability to receive the treatment regimen of this trial with the
exception of eyes, ears, nose, throat organ system

- Patients with uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia

- Inadequate renal function

- History of prior malignancy, except for conditions as listed in the protocol if
patients have recovered from the acute side effects incurred as a result of previous
therapy

- Use of investigational agents or concurrent anti-cancer treatment within the last 4
weeks of registration

- Patients with active bacterial, viral, or fungal infection requiring systemic
treatment within the last two months prior to registration

- History of severe allergic or anaphylactic reactions to humanized or murine
monoclonal antibodies or known sensitivity or allergy to murine products

- Hypersensitivity to chlorambucil, obinutuzumab, or GDC-0199 or to any of the
excipients

- Pregnant women and nursing mothers

- Positive test results for chronic HBV infection (defined as positive HBsAg serology)
or positive test result for hepatitis C (hepatitis C virus [HCV] antibody serology
testing)

- Patients with known infection with human immunodeficiency virus (HIV) or human T-cell
leukemia virus-1 (HTLV-1)

- Requires the use of warfarin, marcumar, or phenprocoumon

- Received agents known to be strong CYP3A4 inhibitors or inducers within 7 days prior
to the first dose of study drug

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Addresses

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    • Hoffmann-La Roche
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    • AbbVie
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    • Hoffmann-La Roche
    • Clinical Trials 
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    • Reference Study ID Number: BO25323 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 .
  •   80
  •   2014/12/17
* This entry means the parameter is not applicable or has not been set.