CHOP and Campath-1H in Previously Untreated Aggressive T/NK-Cell Lymphomas

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

March 31, 2004

Primary Completion Date

August 31, 2012

Study Completion Date

October 31, 2016

Conditions
Non-Hodgkin's Lymphoma
Interventions
DRUG

CHOP

CHOP will be given 60-120 minutes following SQ administration of Alemtuzumab as follows: cyclophosphamide 750 mg/m2 IV on day 1, doxorubicin 50 mg/m2 IV on day 1, vincristine 1.4 mg/m2 (maximum dose = 2 mg) IV on day 1, and prednisone 100 mg PO on days 1-5.

DRUG

Alemtuzumab

Single agent Alemtuzumab given subcutaneously (SQ) on week #1. Dose escalation will occur during the first week of therapy, starting with 3 mg of Alemtuzumab administered SQ on day 1. If well tolerated, this will be followed by 10 mg SQ on day 3 and 30 mg (split into 2 injection sites) on day 5.

PROCEDURE

Plasma Samples

Plasma samples will be obtained for Alemtuzumab pharmacokinetics (PK) during the first week of single agent Alemtuzumab stepped up dosing and subsequently before and after the 5th and the 8th Alemtuzumab/CHOP dose.

Trial Locations (1)

43210

Ohio State University, Columbus

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

lead

Ohio State University Comprehensive Cancer Center

OTHER