Sprung-Navigation
| Title | An open-label, multi-center, three arm randomized, phase III study to compare the efficacy and safety of RO5072759 + chlorambucil (GClb), rituximab + chlorambucil (RClb) or chlorambucil (Clb) alone in previously untreated CLL patients with comorbidities |
|---|---|
| Protocol IDs | EUDRACT-2009-012476-28 NCT01010061 (06 Nov. 2009) BO21004 |
| Recruitment Status | active |
| Design | Prospective, international, multicentre, open label, 3-arm randomized phase III study |
| Primary Endpoint(s) | progression free survival (PFS) |
| Secondary Endpoints | - Response rate (ORR/CR/PR), duration of response and disease-free survival in CR-patients, overall survival - Molecular remission: minimal residual disease (MRD) - Safety profile: AEs, laboratory parameters - Pharmacokinetics of RO5072759 (GA101) in combination with Clb - Quality of Life (EORTC questionnaire) |
| Study Population | B-CLL according to NCI criteria Stage Binet C or stage Binet B / A requiring treatment according to the NCI criteria Relvant comorbidities (CIRS-score > 6 and/or creatinine clearance < 70 ml/min) No pretreatment Age ≥ 18 years |
| Treatment | Maximum of 6 cycles, each with a duration of 28 days: |
| Arm A (GClb) RO5072759 (GA101): 1000 mg i.v.; day 1, 8 and 15 (cycle 1), day 1 (cycle 2 - 6) + Chlorambucil: 0.5 mg/kg body weight p.o., day 1 and 15 |
|
| Arm B: (RClb) Rituximab: 375 mg/m² i.v., day 1, cycle 1 Rituximab: 500 mg/m² i.v., day 1, cycle 2-6 + Chlorambucil: 0.5 mg/kg body weight p.o., day 1 and 15 |
|
| Arm C (Clb) Chlorambucil: 0.5 mg/kg body weight p.o., day 1 and 15 |
|
| Targeted Accrual | 786 eligible patients: 337 GClb (6 in safety run in + 331 randomized) 331 RClb 118 Clb alone |
| Time schedule | Start of recruitment: 04/2010 Recruitment duration: 3 years Treatment duration: Maximum of 6 months (12 months for patients that cross-over treatment arms) Follow-up for disease progression: 5 years from last patient enrolled Follow-up for survival: 8 years from last patient enrolled Total study duration: 12 years End of study: 8 years after the last patient was enrolled |
| Protocol Version | 25 Jan. 2010 Protocol |
| Sponsor | Hoffmann-La Roche (exUS),
Genentech (USA) in collaboration with the German CLL study group (GCLLSG) |
| Principal Investigator | Dr. Valentin Goede, Internal Medicine I, University Hospital of Cologne |
| Contact for public queries | German CLL Study Group (GCLLSG) |
| Contact for scientific queries | Dr. Valentin Goede, Internal Medicine I, University Hospital of Cologne Dr. Kirsten Fischer, GCLLSG |