West Cancer Center

LYMPHOMA: NHL: Indolent B-cell; Phase 1: CD20+; "113603"

An open-label phase I drug-drug interaction study of ofatumumab with bendamustine for the treatment of subjects with indolent B-cell non-Hodgkin's lymphoma

Title

GSK 113603

Study Title

An open-label phase I drug-drug interaction study of ofatumumab with bendamustine for the treatment of subjects with indolent B-cell non-Hodgkin's lymphoma

Site Link

NCT01691807

Malignancy

Lymphoma - indolent B-cell: follicular lymphoma, SLL (small lymphocytic lymphoma), marginal zone lymphoma, lymphplasmacytic lymphoma

Stage

Disease Setting

N/A

Line Of Therapy

Any

Investigational Agent

ofatumumab

Drug Class

anti-CD20 antibody

Daruka Mahadevan, MD, PhD

Sponsor

GlaxoSmithKline

Phase

Phase 1

Status

Closed to Accrual

Key Eligibility Criteria

http://www.clinicaltrials.gov/ct2/show/NCT01691807

Key Eligibility Criteria Details

Either previously untreated or relapsed indolent B-cell NHL:
Small lymphocytic lymphoma (SLL)
Lymphplasmacytic lymphoma (LPL)
Marginal zone lymphoma (MZL) or
Follicular lymphoma (FL)
Grades 1, 2, or 3A
CD20+ by previous or current biopsy
4 weeks since last cancer tx
12 weeks since last anti-CD20 therapy
ECOG PS 0-2
If prior rituxan, must have had CR/PR/SD for at least 6 months
If prior bendamustine, must have had CR/PR for at least 6 months
No prior allo or auto HCT
No CNS involvement
No HBV or known HIV

Objective

Primary- PK; Secondary- Safety, Extent of disease

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

CD20+ indolent B-cell lymphoma Grades 1, 2, or 3A

Dosing Frequency

ofatumumab IV, bendamustine IV

Control Agents

Study Protocol

Randomized