Trial document





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

  DRKS00003833

Trial Description

start of 1:1-Block title

Title

An Open-label, Multi-centre, Randomized, Phase Ib Study to Investigate the Safety and Efficacy of RO5072759 Given in Combination With CHOP, FC or Bendamustine Chemotherapy in Patients With CD20+ B-cell Follicular Non-Hodgkin's Lymphoma

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 6 arm study will assess the safety and efficacy of RO5072759 given in combination with
CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), FC (fludarabine,
cyclophosphamide) or bendamustine chemotherapy in patients with CD20+ B-cell follicular
non-Hodgkin's lymphoma. Patients with relapsed or refractory disease will be assigned by
physician choice to either the CHOP treatment arm, to receive a maximum of 8x3weekly cycles
of treatment, or the FC treatment arm, to receive a maximum of 6x4weekly cycles of
treatment, and will then be randomized to receive combination treatment with RO5072759
either at a dose of 400 mg iv for all infusions, or at a dose of 1600 mg iv for the first 2
infusions, followed by 800 mg for all subsequent infusions. Previously untreated patients
will receive first-line treatment with RO5072759 at a dose of 1000 mg for either a maximum
of 8x3 weekly cycles in combination with CHOP or for a maximum of 6x4 weekly cycles in
combination with bendamustine. The anticipated time on study treatment is 3-27 months.

Patients with complete response or partial response after first line RO5072759 +
chemotherapy may receive maintenance treatment with RO5072759 every 3 months for 2 years or
until disease progression, whichever comes first.

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 organizational data

Organizational Data

  •   DRKS00003833
  •   2012/05/04
  •   2009/01/16
  •   no
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   2008-001643-19 
  •   NCT00825149  (ClinicalTrials.gov)
  •   BO21000  (Hoffmann-La Roche)
  •   2008-001643-19 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Non-Hodgkin's Lymphoma
  •   C83.3 -  Non-Hodgkin's lymphoma: Large cell (diffuse)
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Drug: RO5072759
  •   Drug: RO5072759
  •   Drug: CHOP(cyclophosphamide,doxorubicin,vincristine,prednisone)
  •   Drug: FC(fludarabine,cyclophosphamide)
  •   Drug: RO5072759
  •   Drug: bendamustine
  •   Drug: RO5072759
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   [---]*
  •   Treatment
  •   Parallel
  •   I
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- Safety: Incidence of adverse events; time frame: up to 6 years

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

Secondary Outcome

- Overall response rate :assessments according to the Criteria for evaluation of response in Non-Hodgkin's Lymphoma (International Workshop to Standardize Response criteria for NHL); time frame: 12 weeks
- Complete response rate: assessments according to the Criteria for evaluation of response in Non-Hodgkin's Lymphoma (International Workshop to Standardize Response criteria for NHL); time frame: 12 weeks
- Progression- and event-free survival; time frame: up to 6 years
- Pharmacokinetics of RO5072759 (AUC, Cmax, CL); time frame: 26 weeks
- Pharmacodynamics: peripheral blood B-cell depletion and recovery; time frame: up to 27 months

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

Countries of Recruitment

  •   Australia
  •   France
  •   Germany
  •   Italy
  •   Spain
  •   United Kingdom
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

  •   [---]*
  •   2009/02/27
  •   136
  •   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

- Adult patients, >18 years of age

- Either CD20+ relapsed or refractory B-cell follicular non-Hodgkin's lymphoma (after a
maximum of 2 prior chemotherapy regimens) or CD20+ B-cell follicular non-Hodgkin's
lymphoma with no prior systemic therapy

- ECOG performance status of 0-2

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

Exclusion Criteria

- Prior administration of rituximab within 8 weeks of study entry, or 3 months for any
radioimmunotherapy

- Central nervous lymphoma

- History of other malignancies within 2 years of study entry which could affect
compliance with the protocol or interpretation of results

- Active infection, or any major episode of infection requiring hospitalization or
treatment with iv antibiotics within 4 weeks of dosing

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Hoffmann-La Roche
    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 scientific-contact
    • Hoffmann-La Roche
    • 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: BO21000 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 .
  •   123
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.