Ofatumumab With or Without Bendamustine for Patients With Mantle Cell Lymphoma Ineligible for Autologous Stem Cell Transplant

PHASE2CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

September 12, 2023

Study Completion Date

September 12, 2023

Conditions
Mantle Cell Lymphoma
Interventions
BIOLOGICAL

Ofatumumab (This arm is closed)

Ofatumumab Day 1 Week 1: 1000 mg, Day 2 week 1: 1000mg. Patients who exhibit a baseline leukocytosis ≥ 20,000 will receive 300 mg of ofatumumab on day 1, week 1. Thereafter, they can receive the 1000 mg dose Ofatumumab Day 1, Weeks 2-4: 1000 mg Will reassess 8-10 weeks after conclusion of treatment with CT CAP, and following this q 12 wks for 2 yrs, then q 6mo until POD or for a maximum of 5 years

OTHER

Ofatumumab + Bendamustine

Ofatumumab day 1 + Bendamustine 90 mg/m2 days 1 \& 2 x 6 cycles q 28 days Cycle 1, day 1: Ofatumumab 1000 mg followed by Bendamustine 90 mg/m2. Patients who exhibit a leukocytosis ≥ 20,000 will receive 300 mg of ofatumumab on day 1, week 1. Thereafter, they can receive the 1000 mg dose. Cycle 1, day 2: Ofatumumab 1000mg followed by Bendamustine 90 mg/m2 Cycles 2-6: Ofatumumab 1000 mg day 1, Bendamustine 90 mg/m2 days 1 and 2 Will reassess 4-6 weeks after conclusion of treatment with CT CAP, and following this q 12 wks for 2 yrs, then q 6mo until POD or for a maximum of 5 years

Trial Locations (6)

10065

Memorial Sloan Kettering Cancer Center, New York

10591

Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center, Sleepy Hollow

10604

Memorial Sloan Kettering West Harrison, Harrison

11570

Memorial Sloan Kettering Cancer Center at Mercy Medical Center, Rockville Centre

11725

Memorial Sloan Kettering Cancer Center @ Suffolk, Commack

07920

Memorial Sloan Kettering Cancer Center at Basking Ridge, Basking Ridge

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT01437709 - Ofatumumab With or Without Bendamustine for Patients With Mantle Cell Lymphoma Ineligible for Autologous Stem Cell Transplant | Biotech Hunter | Biotech Hunter