Ofatumumab Plus Bendamustine in Frontline and Relapsed Chronic Lymphocytic Leukaemia (CLL)
Status:
Completed
Trial end date:
2015-11-01
Target enrollment:
Participant gender:
Summary
This is a Phase II, open label, single arm, multi-centre study investigating the safety and
efficacy of ofatumumab plus bendamustine in subjects with untreated or relapsed CLL.
Each subject from the screening phase who is willing to participate in the study and is found
eligible according to the inclusion and exclusion criteria will enter the treatment phase and
will receive a maximum of 6 Cycles of study treatment (ofatumumab plus bendamustine). All
subjects will receive 3 Cycles of study treatment (Cycles 1, 2 and 3). Eligibility to receive
study treatment for Cycles 4, 5 and 6 will be assessed following the 3rd Cycle. Subjects who
have achieved at least stable disease with acceptable toxicity following 3 Cycles of
treatment will be eligible to continue to receive study treatments for a maximum of 3 further
Cycles. In case of progressive disease, at, or at any time after the start of Cycle 4,
subjects must discontinue further study treatment and move into the study's follow-up period.
During the treatment phase, all eligible subjects will be allocated to receive the following
study treatments:
1. Subjects with Untreated CLL: Up to 6 monthly intravenous infusions of ofatumumab (Cycle
1: 300 mg Day 1 and 1000 mg Day 8; subsequent Cycles: 1000 mg at Day 1 every 28 Days) in
combination with up to 6 Cycles of intravenously infused bendamustine (90 mg/m2, Days 1
and 2, every 28 Days).
2. Subjects with Relapsed CLL: Up to 6 monthly intravenous infusions of ofatumumab (Cycle
1: 300 mg Day 1 and 1000 mg Day 8; subsequent Cycles: 1000 mg at Day 1 every 28 Days) in
combination with up to 6 Cycles of intravenously infused bendamustine (70 mg/m2, Days 1
and 2, every 28 Days).
The studies primary endpoint is overall response rate (ORR) as determined by Investigator
evaluation. The ORR is the percentage of subjects achieving an objective response (i.e.,
partial response or better), using the IWCLL updated NCI-WG guidelines. Response assessments
are planned at the following time-points: After 3 Cycles of ofatumumab plus bendamustine
treatment, after 6 Cycles of ofatumumab plus bendamustine treatment and after the last dose,
if not after 6 cycles, of ofatumumab plus bendamustine treatment.
Follow-up assessments will be performed every 3 months following the last study treatment.
The follow-up period will last for a maximum of 3 years. Response evaluation assessments to
determine subject response or progression will be performed during the follow-up period,
according to the IWCLL updated NCI-WG guidelines. Following progression, only survival status
and details concerning the subject's next CLL therapy will be recorded.