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.

Phase 3

Recruiting

Conditions: blood cancer
leukemia
10025320

Registration Number: NL-OMON39141

Lead Sponsor: Hoffmann-La Roche

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 3

Inclusion Criteria

Have documented previously untreated CD20+ B-CLL according to NCI criteria
Total CIRS score >6 or creatinine clearance <70 ml/min or both
no additional bone marrow dysfunction
Age 18 years or older
Life expectancy >6 months

Exclusion Criteria

Patients who have received previous CLL therapy
Transformation of CLL to aggressive NHL (Richter*s transformation)
Inadequate renal function: Creatinine clearance < 30 ml/min
Inadequate liver function
Patients with manifest auto-immune haemolytic anemia (AIHA). However, Coombs positive with no clinical signs of AIHA are eligible.
Patients with active bacterial, viral, or fungal infection requiring systemic treatment.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Progression -free Survival</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Progression-free survival based on independent review committee (IRC)<br /><br>Progression-free survival censoring patients who started new anti-leukemic<br /><br>therapy before showing signs of disease progression<br /><br>Overall response (CR, CRi, PR), complete response (CR, CRi) and partial<br /><br>response (PR) at the end of study treatment<br /><br>Best overall response, complete response and partial response during treatment<br /><br>and up to 6 months after treatment.<br /><br>Molecular Remission (Minimal Residual Disease negative)<br /><br>Event-free survival<br /><br>Disease-free survival in CR/CRi patients<br /><br>Duration of response in CR/CRi and PR patients<br /><br>Time to re-treatment/new anti-leukemia therapy<br /><br>Overall survival<br /><br>Pharmacoeconomic analyses<br /><br>Patient-reported outcomes</p><br>