West Cancer Center

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LEUKEMIA: CLL; Maintenance; "PROLONG"

Title

GSK OMB112517

Study Title

Site Link

NCT01039376

Malignancy

Leukemia, Lymphoma, CLL, Chronic Lymphocytic Leukemia

Stage

N/A

Disease Setting

N/A

Line Of Therapy

Post 2nd line or Post 3rd line

Investigational Agent

Ofatumumab

Drug Class

Anti-CD20 antibody

Brad Somer, MD

Sponsor

GlaxoSmithKline

Phase

Phase 3

Status

Closed to Accrual

Key Eligibility Criteria

http://www.clinicaltrials.gov/ct2/show/NCT01039376?term=112517&rank=1

Key Eligibility Criteria Details

At least 3 months/3 cycles of anti-leukemic tx immediatelyprior to trial
At least PR according to NCI-WG criteria after last dose of 2nd/3rd line treatment
ECOG PS 0-2
No fludarabine-refractory subjects
No prior maintencance therapy
No known transformation to acute leukemia
No prior BMT
No active AIHA

Objective

Primary- PFS: Secondary- OS, CBR, PK, Safety

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

CLL

Dosing Frequency

300mg IV wk1, then 1000mg IV wk2 then q8wks up to 2 years

Control Agents

observation

Study Protocol

Randomized

Yes