Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003740

Trial Description

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Title

An Open-label, Multi-center, Three Arm Randomized Study to Investigate the Safety and Efficacy on Progression-free Survival of RO5072759 + Chlorambucil (GClb) Compared to Rituximab + Chlorambucil (RClb) or Chlorambucil (Clb) Alone in Previously Untreated CLL Patients With Comorbidities.

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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, 3-arm study will evaluate the efficacy and safety of RO5072759
in combination with chlorambucil as compared to rituximab plus chlorambucil or chlorambucil
alone in patients with previously untreated chronic lymphocytic leukemia. Patients will be
randomized 2:2:1 to receive a maximum of six 28-day cycles of either RO5072759 (1000mg iv
infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2-6) plus chlorambucil
(0.5mg/kg orally, days 1 and 15 of cycles 1-6), or rituximab (iv infusion day 1, 375mg/m2
cycle 1, 500mg/m2 cycles 2-6) plus chlorambucil, or chlorambucil alone. Anticipated time on
study treatment is >6 months and follow-up for disease-progression and safety will be at
least 5 years. In the US, this trial is sponsored/managed by Genentech.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00003740
  •   2012/05/03
  •   2009/11/06
  •   no
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Secondary IDs

  •   2009-012476-28 
  •   NCT01010061  (ClinicalTrials.gov)
  •   BO21004  (Hoffmann-La Roche)
  •   2009-012476-28; CLL1 
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Health Condition or Problem studied

  •   Lymphocytic Leukemia, Chronic
  •   C91.1 -  Chronic lymphocytic leukaemia
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Interventions/Observational Groups

  •   Drug: RO5072759
  •   Drug: rituximab
  •   Drug: chlorambucil
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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

- Progression-free survival; time frame: assessed every 2 weeks on study treatment, 28 days after last dose and at intervals for at least 5 years of follow-up

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Secondary Outcome

- Response rate (ORR/CR/PR), duration of response and disease-free survival in CR-patients, overall survival; time frame: assessed every 2 weeks on study treatment, 28 days after last dose and at intervals for at least 5 years of follow-up
- Molecular remission: minimal residual disease (MRD); time frame: assessed after 3 cycles and 1,3,6 and 12 months after end of treatment
- Safety profile: AEs, laboratory parameters; time frame: monitored throughout study, laboratory assessments every 2 weeks on study treatment, 28 days after last dose and at intervals during follow-up
- Pharmacokinetics of RO5072759 in combination with Clb; time frame: pre- and post-dose sampling on day 1 of cycles 1-6
- Patient-reported outcomes and symptom burden by EORTC questionnaire; time frame: after 3 cycles, 28 days after last dose and at intervals during follow-up

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Countries of Recruitment

  •   United States
  •   Argentina
  •   Australia
  •   Austria
  •   Brazil
  •   Bulgaria
  •   Canada
  •   Croatia
  •   Czech Republic
  •   Denmark
  •   Egypt
  •   Estonia
  •   France
  •   Germany
  •   Hong Kong
  •   Italy
  •   Mexico
  •   Netherlands
  •   New Zealand
  •   Romania
  •   Russian Federation
  •   Slovakia
  •   Spain
  •   Switzerland
  •   Thailand
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2009/12/31
  •   786
  •   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

- Adults >/=18 years

- Documented CD20+B-CLL

- Previously untreated CLL requiring treatment according to the NCI criteria

- Total CIRS > 6 and/or creatinine clearance < 70 ml/min

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Exclusion Criteria

- Prior CLL therapy

- Transformation of CLL to aggressive NHL (Richter's transformation)

- History of other malignancy unless the malignancy has been in remission without
treatment for >/=2 years prior to enrolment, and except for carcinoma in situ of the
cervix, basal or squamous cell skin cancer, surgically treated low-grade prostate
cancer, or DCIS of the breast treated with lymphectomy alone

- Positive hepatitis serology (HBV, HCV) or positive HIV or HTLV testing

- Patients with active infection requiring systemic treatment

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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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    • Hoffmann-La Roche
    • Clinical Trials 
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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 complete, follow-up continuing
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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 .
  •   97
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.