Combination of Pentostatin, Bendamustine and Ofatumumab for Treatment of Chronic Lymphocytic Leukemia and Lymphoma

PHASE1TerminatedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

May 25, 2011

Primary Completion Date

April 8, 2016

Study Completion Date

May 10, 2018

Conditions
Chronic Lymphocytic LeukemiaB-Cell Non-Hodgkin's Lymphoma
Interventions
DRUG

Bendamustine

Bendamustine at the dose of 50 mg/m2 (or 70 or 90 or 40 mg/m2 depending on the dose level) daily on day 1 and 2.

DRUG

Pentostatin

Pentostatin 4 mg/m2 on day 1 of each cycle. For patients with estimated or measured glomerular filtration rate (GFR) 30 to 60 ml/min/m2 pentostatin will be administered at the reduced dose of 2 mg/m2 on day 1 of each cycle.

DRUG

Ofatumumab

Ofatumumab 300 mg on day 2 of first cycle. Subsequently, from cycle 2 to 6, ofatumumab 1000 mg on day 2 will be administered.

Trial Locations (1)

19107

Thomas Jefferson University, Philadelphia

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

collaborator

Novartis

INDUSTRY

lead

Sidney Kimmel Cancer Center at Thomas Jefferson University

OTHER