NCT00824265

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 365 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Fludarabine is currently approved for treatment of relapsed Chronic Lymphocytic Leukemia. Studies have shown that drugs in combination with fludarabine have shown more effectiveness than fludarabine alone. The addition of ofatumumab to fludarabine-cyclophosphamide combination offers potentially a more effective therapy, without additional toxicity. The objective of this study was to determine the effect of ofatumumab added to fludarabine and cyclophosphamide in patients with Chronic Lymphocytic Leukemia who have responded previously to therapy but later develop progressive disease and require additional therapy.

Conditions

• Leukaemia, Lymphocytic, Chronic

Interventions

Type	Name	Description
DRUG	OFC Infusion	Ofatumumab Cycle 1-Day 1 300mg, Cycle 1-Day 8 1000mg, then Cycles 2-6 Day 1 1000mg every 28 days, Fludarabine 25mg/m2 Days 1-3 every 28 days for 6 cycles, Cyclophosphamide 250 mg/m2 Days 1-3 every 28 days for 6 cycles
DRUG	FC infusion	Fludarabine 25mg/m2 Days 1-3 every 28 days for 6 cycles, Cyclophosphamide 250mg/m2 Days 1-3 every 28 days for 6 cycles

Timeline

• Start date: 2009-03-12
• Primary completion: 2014-12-17
• Completion: 2017-10-25
• First posted: 2009-01-16
• Last updated: 2020-06-18
• Results posted: 2016-07-25

Locations

135 sites across 18 countries: United States, Brazil, Bulgaria, Canada, Germany, Greece, India, Italy, Mexico, Netherlands, Poland, Romania, Russia, Spain, Taiwan, Thailand, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study