Overview

This trial is active, not recruiting.

Condition leukaemia, lymphocytic, chronic
Treatments ofc infusion, fc infusion
Phase phase 3
Sponsor GlaxoSmithKline
Start date March 2009
End date December 2014
Trial size 352 participants
Trial identifier NCT00824265, 110913

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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
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
(Active Comparator)
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
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

Primary Outcomes

Measure
Progression-free-survival
time frame: 3 years

Secondary Outcomes

Measure
Clinical benefit
time frame: 3 years
Safety
time frame: 3 years
Patient Reported Outcomes
time frame: 3 years
Pharmacokinetics
time frame: 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

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 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

Additional Information

Official title A Phase III, Open Label, Randomized Trial of Ofatumumab Added to Fludarabine-Cyclophosphamide vs. Fludarabine-Cyclophosphamide Combination in Subjects With Relapsed Chronic Lymphocytic Leukemia
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 is 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by GlaxoSmithKline.