Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005496

Trial Description

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Title

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Brentuximab Vedotin and CHP (A+CHP) Versus CHOP in the Frontline Treatment of Patients With CD30-positive Mature T-cell Lymphomas

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This is a double-blind, randomized, multicenter, phase 3 clinical trial to compare the
efficacy and safety of brentuximab vedotin in combination with CHP with the standard-of-care
CHOP in patients with CD30-positive mature T-cell lymphomas.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00005496
  •   2014/04/17
  •   2013/01/23
  •   no
  •   [---]*
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Secondary IDs

  •   NCT01777152  (ClinicalTrials.gov)
  •   SGN35-014  (Seattle Genetics, Inc.)
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Health Condition or Problem studied

  •   Lymphoma, Large-Cell, Anaplastic
  •   Lymphoma, Non-Hodgkin
  •   Lymphoma, T-Cell
  •   C84 -  Mature T/NK-cell lymphomas
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Interventions/Observational Groups

  •   Drug: brentuximab vedotin
  •   Drug: doxorubicin
  •   Drug: prednisone
  •   Drug: vincristine
  •   Drug: cyclophosphamide
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
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Primary Outcome

- Progression-free survival per independent review facility (IRF); time frame: Until disease progression, subsequent anticancer chemotherapy, death, or study closure, up to 5 years post-treatment

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Secondary Outcome

- Progression-free survival per IRF in patients with systemic anaplastic large cell lymphoma (sALCL); time frame: Until disease progression, subsequent anticancer chemotherapy, death, or study closure, up to 5 years post-treatment
- Complete remission rate per IRF at end of treatment; time frame: Through 1 month following last dose
- Overall survival; time frame: Until death or study closure, up to 7 years post-treatment
- Objective response rate per IRF at end of treatment; time frame: Through 1 month following last dose
- Type, incidence, severity, seriousness, and relatedness of adverse events; time frame: Through 1 month following last dose
- Incidence of laboratory abnormalities; time frame: Through 1 month following last dose

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Countries of Recruitment

  •   United States
  •   Canada
  •   Czech Republic
  •   Denmark
  •   France
  •   Israel
  •   Italy
  •   Korea, Republic of
  •   Poland
  •   Spain
  •   Taiwan, Province of China
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2013/01/31
  •   300
  •   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

- Patients with newly diagnosed, CD30-positive mature T-cell lymphomas

- Fluorodeoxyglucose (FDG)-avid disease by PET and measurable disease of at least 1.5
cm by CT

- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2

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Exclusion Criteria

- History of another primary invasive malignancy that has not been in remission for at
least 3 years

- Current diagnosis of primary cutaneous CD30-positive T-cell lymphoproliferative
disorders and lymphomas or mycosis fungoides

- History of progressive multifocal leukoencephalopathy (PML)

- Cerebral/meningeal disease related to the underlying malignancy

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Addresses

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    • Seattle Genetics, Inc.
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    • Millennium Pharmaceuticals, Inc.
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    • Seattle Genetics, Inc.
    • Dana Kennedy, PharmD 
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    •   [---]*
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    • Terri Lowe 
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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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    •   [---]*
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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 .
  •   7
  •   2013/11/26
* This entry means the parameter is not applicable or has not been set.