EUCTR2013-000087-29-SKActive, not recruitingPhase 1
A multicenter, open-label, single-arm, phase IIIb, international study evaluating the safety of Obinutuzumab alone or in combination with chemotherapy in patients with previously untreated or relapsed/refractory Chronic Lymphocytic Leukemia.
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- F. Hoffmann- La Roche Ltd.
- Enrollment
- 972
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •Documented CLL either previously untreated or relapsed and/or refractory
- •Age = 18 years
- •ECOG performance status 0–2
- •Adequate haematological function
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 629
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 321
Exclusion Criteria
- •Patients who have received more than 3 previous CLL treatment lines
- •Documented transformation of CLL to aggressive lymphoma (Richter’s transformation)
- •Patients who are refractory to immunochemotherapy
- •Calculated CrCl < 30 mL/min, or AST or ALT > 2.5 × ULN, or Total bilirubin = 3 × ULN
- •One or more individual organ/system impairment score of 4 as assessed by the CIRS definition
- •Patients with a history of progressive multifocal leukoencephalopathy (PML)
- •Regular treatment (i.e. more than 5 consecutive days) with corticosteroids during the 4 weeks prior to the start of Cycle 1, Day 1, unless administered for indications other than CLL at a dose equivalent to = 30 mg/day prednisone
- •Regular treatment with immunosuppressive medications following previous organ transplantation
- •Vaccination with live vaccines within 28 days prior to start of treatment
- •Positive test results for chronic hepatitis B, hepatitis C infections (HCV antibody are eligible only if PCR is negative for HCV RNA), positive test results (serology) for HIV, positive test results for HTLV 1 (un endemic areas)
- •Women that are pregnant or lactating
- •Fertile men or women of childbearing potential unless: (1) surgically sterile or (for women) = 2 years after the onset of menopause; (2) willing to use a highly effective contraceptive method, during study and for 12 months (females) or 6 months (males) after end of treatment
Investigators
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