Ofatumumab + Chlorambucil vs Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia

• Status: Terminated
• Trial end date: 2018-05-17
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to evaluate the safety and efficacy of ofatumumab added to chlorambucil in patients with untreated Chronic Lymphocytic Leukemia.

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

Details

• Lead Sponsor: Novartis; Novartis Pharmaceuticals
• Treatments: Antibodies, Monoclonal; Chlorambucil; Ofatumumab

Criteria

Inclusion Criteria:

• confirmed CLL diagnosis and active CLL requiring treatment

• considered inappropriate for fludarabine-based therapy

• not been treated for CLL before

• 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:

• prior CLL therapy

• abnormal/inadequate blood values, liver, and kidney function

• certain heart problems, active or chronic infections, serious significant diseases, active autoimmune hemolytic anemia (AIHA) requiring treatment, other current cancer or within last 5 years

• 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