A Study of RO5072759 With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia


Tracking Information

Start Date  ICMJE 
Primary Completion Date 
Current Primary Outcome Measures  ICMJE 
 (submitted: November 6, 2009)
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 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT01010061 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: November 6, 2009)
  • 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 ] [ Designated as safety issue: No ]
  • Molecular remission: minimal residual disease (MRD) [ Time Frame: assessed after 3 cycles and 1,3,6 and 12 months after end of treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Pharmacokinetics of RO5072759 in combination with Clb [ Time Frame: pre- and post-dose sampling on day 1 of cycles 1-6 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEA Study of RO5072759 With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia
Official Title  ICMJEAn 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.
Brief Summary

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 to receive a maximum of 6 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. Target sample size is <800. In the US, this trial is sponsored/managed by Genentech.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJELymphocytic Leukemia, Chronic
Intervention  ICMJE
  • Drug: RO5072759
    1000 mg by iv infusion, on days 1,8 and 15 in cycle 1, day 1 in cycles 2-6
  • Drug: rituximab
    by iv infusion on day 1 of each cycle, 375 mg/m2 cycle 1, 500 mg/m2 cycles 2-6
  • Drug: chlorambucil
    0,5 mg/kg orally on day 1 and 15 of each cycle
Study Arms / Comparison Groups
  • A (GClb): Experimental
    Interventions:
    • Drug: RO5072759
    • Drug: chlorambucil
  • B (RClb): Active Comparator
    Interventions:
    • Drug: rituximab
    • Drug: chlorambucil
  • C (Clb): Active Comparator
    Intervention: Drug: chlorambucil

Recruitment Information

Estimated Enrollment  ICMJE786
Estimated Completion DateJanuary 2022
Primary Completion Date 
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • adults >/=18 years
  • documented CD20+B-CLL
  • previously untreated CLL requiring treatment according to the NCI criteria

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
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Please reference Study ID Number: BO21004888-662-6728 (U.S. Only)genentechclinicaltrials@druginfo.com
Location Countries  ICMJEArgentina,   Australia,   Austria,   Brazil,   Bulgaria,   Canada,   Croatia,   Czech Republic,   Denmark,   Estonia,   France,   Germany,   Hong Kong,   Italy,   Mexico,   Netherlands,   New Zealand,   Romania,  Russian Federation,   Slovakia,   Spain,   Switzerland,   Thailand,   United Kingdom

Administrative Information

NCT ID  ICMJENCT01010061
Responsible PartyDisclosures Group, Hoffmann-La Roche
Study ID Numbers  ICMJEBO21004, 2009-012476-28
Study Sponsor  ICMJEHoffmann-La Roche
Collaborators  ICMJEGenentech
Investigators  ICMJE
Study Director:Clinical TrialsHoffmann-La Roche
Information Provided ByHoffmann-La Roche