Ofatumumab Added to Fludarabine-Cyclophosphamide vs Fludarabine-Cyclophosphamide Combination in Relapsed Subjects With Chronic Lymphocytic Leukemia

• Status: Completed
• Trial end date: 2017-10-25
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to evaluate the safety and efficacy of ofatumumab added to fludarabine-cyclophosphamide in patients with relapsed Chronic Lymphocytic Leukemia (CLL).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis; Novartis Pharmaceuticals
• Treatments: Antibodies, Monoclonal; Cyclophosphamide; Fludarabine; Fludarabine phosphate; Vidarabine

Criteria

Key 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

Key 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