Chemotherapy Plus Ofatumumab Followed by G-CSF for Mobilization of Peripheral Blood Stem Cells in Patients With Non-Hodgkin's Lymphomas

PHASE2CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

August 22, 2011

Primary Completion Date

July 21, 2019

Study Completion Date

July 21, 2019

Conditions
Lymphoma
Interventions
DRUG

Ofatumumab

1000 mg by vein on Day 1 and 2000 mg by vein on Day 8

DRUG

Ifosfamide

3.33 gm/m2 by vein on Days 2, 3, and 4 continuously.

DRUG

Etoposide

150 mg/m2 by vein over 2 hours every 12 hours Days 2, 3, and 4 for 6 doses.

DRUG

Mesna

"2 gm/m2 by vein over 1 hour on Day 2 (given before Ifosfamide starts)~2.66 gm/m2/day by vein continuous infusion given over 24 hours daily for 3 days starting on Day 2 (together with Ifosfamide)~After Ifosfamide/Mesna, 2 gm/m2 by vein given over 12 hours for one dose."

DRUG

G-CSF

6 mcg/kg subcutaneously twice a day on day 6 (rounded off to the nearest vial) until completion of apheresis.

PROCEDURE

Stem Cell Collection

Blood stem cells will be collected when blood counts have returned to normal (about 10-16 days after chemotherapy). Stem cell collection takes about 4 hours each time.

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER

NCT01329900 - Chemotherapy Plus Ofatumumab Followed by G-CSF for Mobilization of Peripheral Blood Stem Cells in Patients With Non-Hodgkin's Lymphomas | Biotech Hunter | Biotech Hunter