NCT01437709 is a Phase 2 clinical trial of Ofatumumab (This arm is closed) in Mantle Cell Lymphoma, sponsored by Memorial Sloan Kettering Cancer Center.

Who is sponsoring NCT01437709?

NCT01437709 is sponsored by Memorial Sloan Kettering Cancer Center.

What drugs are being tested in NCT01437709?

Interventions in NCT01437709: Ofatumumab (This arm is closed), Ofatumumab + Bendamustine.

What condition does NCT01437709 study?

NCT01437709 studies Mantle Cell Lymphoma.

Is NCT01437709 still recruiting?

NCT01437709 is currently completed. Last updated 13 February 2025.

Are results published for NCT01437709?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-02-13 · How we verify

NCT01437709

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Results posted Last updated 13 February 2025

What this trial tests

Phase 2 trial testing Ofatumumab (This arm is closed) in Mantle Cell Lymphoma in 30 participants. Completed in 12 September 2023.

Timeline

1 September 2011

Primary endpoint
12 September 2023

12 September 2023

Quick facts

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	1 September 2011
Primary completion	12 September 2023
Estimated completion	12 September 2023
Sites	6 locations across United States

Drugs / interventions tested

Ofatumumab (This arm is closed) — full drug profile →
Ofatumumab + Bendamustine — full drug profile →

Conditions studied

Mantle Cell Lymphoma — all drugs for Mantle Cell Lymphoma →

Sponsor

Memorial Sloan Kettering Cancer Center — full company profile →

Who can join

18 and older, any sex, with Mantle Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Single Agent Efficacy (as Determined by Response Rate)
Time frame: 2 years
of the monoclonal antibody ofatumumab alone in low risk patients. Assessments prior to each cycle of immunotherapy or chemoimmunotherapy: (every 4 weeks)
the Efficacy (as Determined by Response Rate) of the Combination Ofatumumab + Bendamustine
Time frame: 2 years
in high risk patients. Assessments prior to each cycle of immunotherapy or chemoimmunotherapy: (every 4 weeks)

Sponsor's own description

This study is being done to understand how to treat Mantle Cell Lymphoma (MCL). The goals of treatment are to control the lymphoma with the least amount of side effects. In many cases, MCL is treated with an antibody plus chemotherapy. An antibody is a laboratory-produced substance created to attach to proteins on the cancer cells, eventually destroying them. Chemotherapy is medicine that specifically destroys cancer cells. The purpose of this study is to find out what effects, good and/or bad, the drugs Ofatumumab and Bendamustine have on this type of cancer. Patients in this study will either receive Ofatumumab alone, or Ofatumumab combined with Bendamustine.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Mantle cell lymphoma in the era of precision medicine-diagnosis, biomarkers and therapeutic agents.
Inamdar AA, Goy A, Ayoub NM, Attia C, et al · · 2016 · cited 42× · PMID 27119356 · DOI 10.18632/oncotarget.8961
Current trials for frontline therapy of mantle cell lymphoma.
Steiner RE, Romaguera J, Wang M. · · 2018 · cited 13× · PMID 29374487 · DOI 10.1186/s13045-018-0556-x
Ofatumumab plus HyperCVAD/HD-MA induction leads to high rates of minimal residual disease negativity in patients with newly diagnosed mantle cell lymphoma: Results of a phase 2 study.
Torka P, Akhtar OS, Reddy NM, Baysal BE, et al · · 2022 · cited 3× · PMID 35157306 · DOI 10.1002/cncr.34106

Verify or expand the search:

Other recruiting trials for Mantle Cell Lymphoma

Currently open trials in the same condition.

NCT07377578 — A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cel · Phase 3 · recruiting
NCT07285044 — The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Tr · Phase 2 · recruiting
NCT06839053 — Sonrotoclax, Rituximab, and Zanubrutinib in Treating Participants With Chronic Lymphocytic Leukemia, Small Lymphocytic L · Phase 2 · recruiting
NCT06357676 — Glofitamab Plus Ibrutinib With Obinutuzumab for the Treatment of Patients With Mantle Cell Lymphoma, IGNITE MCL Trial · Phase 1, PHASE2 · recruiting
NCT06854003 — BRAZAN: A Randomized Phase 2 Study of Bendamustine, Rituximab, Cytarabine (AraC) Induction With Zanubrutinib (BRAZAN) Fo · Phase 2 · recruiting

Other Memorial Sloan Kettering Cancer Center trials

Trials by the same sponsor.

NCT07566377 — Cord Blood Transplantation in Children and Young Adults With Blood Cancer · Phase 2 · recruiting
NCT07507643 — A Study of Methylprednisolone in People Having Liver Surgery · Phase 3 · recruiting
NCT07483307 — A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer · Phase 2 · recruiting
NCT07459673 — HERizon-Breast: A ctDNA-Guided Adaptive Study of Sequential Anti-HER2 Therapies and CNS Prophylaxis to Induce Long-Term · Phase 2 · recruiting
NCT07449195 — A Study Comparing Two Optical Coherence Tomography Devices in People With Ocular Tumors · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01437709 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center
Last refreshed: 13 February 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01437709.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing