Ofatumumab + Chlorambucil vs Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia (COMPLEMENT 1)

Novartis

Status and phase: Terminated; Phase 3

Conditions: Leukaemia, Lymphocytic, Chronic

Treatments: Drug: ofatumumab (GSK1841157) infusion; Drug: chlorambucil, tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT00748189

OMB110911 (Other Identifier)

Details and patient eligibility

About

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

Full description

Chlorambucil, is currently approved for treatment of frontline chronic lymphocytic leukemia, especially, but not limited to the ailing and elderly patient population. Several other more aggressive treatment options are available (e.g. fludarabine), however they are not suitable for all CLL patients, especially the ailing and elderly, due to greater toxicity. Ofatumumab is effective with low toxicity. The addition of ofatumumab to chlorambucil offers potentially a more effective therapy, with limited toxicity. The objective of this study was to evaluate progression-free survival (PFS), overall response and overall survival in subjects with previously untreated CLL with ofatumumab added to chlorambucil versus chlorambucil.

Enrollment: 447 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

447 participants in 2 patient groups

ofatumumab + chlorambucil

Experimental group

Description:

ofatumumab dose: cycle 1 300mg day 1 and 1000mg day 8, subsequent cycles: 1000mg at day 1 every 28 days; chlorambucil dose: 10mg/m2 PO at days 1-7 every 28 days; duration: minimum of 3 cycles until best response or maximum of 12 treatment cycles

Treatment:

Drug: chlorambucil, tablets

Drug: ofatumumab (GSK1841157) infusion

chlorambucil

Active Comparator group

Description:

chlorambucil dose: 10mg/m2 PO at days 1-7 every 28 days; duration: minimum of 3 cycles until best response or maximum of 12 cycles

Treatment:

Drug: chlorambucil, tablets