International study evaluating safety of Obinutuzumab alone or in combination with chemotherapy in patients with Chronic Lymphocytic Leukemia.

Phase 1

• Conditions: Chronic lymphocytic leukemia; MedDRA version: 20.1Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemiaSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10008977Term: Chronic lymphocytic leukemia recurrentSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-000087-29-LT
• Lead Sponsor: F. Hoffmann- La Roche Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-28
• Last Update Posted: 7 January 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 950

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified