Trial document





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

  DRKS00005327

Trial Description

start of 1:1-Block title

Title

A Phase Ib, Open-Label Study Evaluating the Safety and Pharmacokinetics of GDC-0199 (ABT-199) in Combination With Bendamustine/Rituximab (BR) in Patients With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

This multi-center, open-label, dose-finding study will evaluate the safety and
pharmacokinetics of GDC-0199 (ABT-199) administered in combination with bendamustine and
MabThera/Rituxan (rituximab) to patients with relapsed/refractory or previously untreated
chronic lymphocytic leukemia.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

[---]*

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00005327
  •   2013/11/08
  •   2012/08/10
  •   no
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   2012-002351-42 
  •   NCT01671904  (ClinicalTrials.gov)
  •   GO28440  (Genentech)
  •   2012-002351-42 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Lymphocytic Leukemia, Chronic
  •   C91.1 -  Chronic lymphocytic leukaemia
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Drug: GDC-0199 (ABT-199)
  •   Drug: rituximab [MabThera/Rituxan]
  •   Drug: bendamustine
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   I
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- Maximum tolerated dose; time frame: approximately 30 months
- Safety: incidence of adverse events; time frame: approximately 30 months

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- Pharmacokinetics: Area under the concentration time curve; time frame: approximately 30 months

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   United States
  •   France
  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  •  
  •  
  •  
  •  
  •  
  •  
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   [---]*
  •   2012/12/31
  •   70
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- Diagnosis of relapsing/refractory or previously untreated chronic lymphocytic
leukemia

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

- Adequate bone marrow function

- Adequate renal and hepatic function

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- Patient received an allogeneic stem cell transplant

- Infection with human immunodeficiency virus, hepatitis B, or hepatitis C

- Uncontrolled autoimmune hemolytic anemia or thrombocytopenia

- Investigational or anti-cancer therapy within 14 days of study start (30 days for
biologic agents for anti-neoplastic intent)

- History of significant renal, neurologic, psychiatric, endocrinologic, metabolic,
immunologic, cardiovascular, or hepatic disease

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Genentech
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • AbbVie (prior sponsor, Abbott)
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Genentech
    • Clinical Trials 
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Reference Study ID Number: GO28440 www.roche.com/about_roche/roche_worldwide.htm 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
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 .
  •   83
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.