Phase III, Open Label, Randomized Trial of Ofatumumab Added to Fludarabine-Cyclophosphamide vs. Fludarabine-Cyclophosphamide Combination in Subjects with Relapsed Chronic Lymphocytic Leukemia

Not Applicable

• Conditions: -C911 Chronic lymphocytic leukaemia of B-cell type; Chronic lymphocytic leukaemia of B-cell type; C911

• Registration Number: PER-118-10
• Lead Sponsor: GlaxoSmithKline,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-05-31
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

• confirmed and active CLL requiring treatment
• at least one previous treatment for CLL and having achieved a complete or partial remission/response but after a period of 6 or more months, shows evidence of disease progression
• fully active at a minimum or fully capable of selfcare and up and about more than 50% of waking hours
• age 18yrs or older
• signed written informed consent

Exclusion Criteria

• diagnosis of refractory CLL (failure to achieve a complete or partial remission/response or disease progression within 6 months of last anti-CLL treatment
• abnormal/inadequate blood values, liver and kidney function
• certain heart problems, serious significant diseases, AIHA, other current cancers or within the last 5 years
• active or chronic infections
• use of drugs to suppress allergic or inflammatory responses (glucocorticoids)
• CLL transformation
• CLL central nervous system involvement
• current participation in other clinical study
• inability to comply with the protocol activities
• lactating or pregnant women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception

Study & Design

• Study Type: Interventional
• Study Design: Not specified