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Alkylating agents
Ofatumumab + Chlorambucil vs Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia (COMPLEMENT 1 Trial)
Phase 3
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization until the 259th pfs event occurred (median follow-up approximately 28.9 months)
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
Pivotal Trial
No Placebo-Only Group
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.
Eligible Conditions
- Chronic Lymphocytic Leukemia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization until the 259th pfs event occurred (median follow-up approximately 28.9 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization until the 259th pfs event occurred (median follow-up approximately 28.9 months)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression-Free Survival (PFS), as Assessed by the Independent Review Committee (IRC)
Secondary study objectives
AUC(0-tau) of Ofatumumab
Change From Baseline in Health Related Quality of Life (HRQOL)
Cmax and Ctrough of Ofatumumab
+21 moreAwards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ofatumumab + chlorambucilExperimental Treatment2 Interventions
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
Group II: chlorambucilActive Control1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Chlorambucil
FDA approved
Ofatumumab
FDA approved
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,918 Previous Clinical Trials
4,253,876 Total Patients Enrolled