Study Evaluating Inotuzumab Ozogamicin (CMC-544) Plus Rituximab In Diffuse Large B-Cell Non-Hodgkin's Lymphoma

Completed · Phase 2

Conditions studied: Lymphoma, B-Cell

In brief

The purpose of this study is to evaluate inotuzumab ozogamicin in combination with rituximab prior to an autologous stem cell transplant (aSCT) in patients with relapsed/refractory diffuse large B-cell Non-Hodgkin's lymphoma.

Key facts

Study ID

NCT00867087

Run by

Pfizer

People needed

64

Starts

2009-06-08

Expected to finish

2012-10-31

Last updated by the study team

2017-12-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• CD20/CD22-positive diffuse large B-cell NHL that has relapsed after 1 or 2 prior therapies; one prior therapy must include anthracyclines and one must include rituximab in combination with chemotherapy
• Relapsed/disease progression within 12 months after start of prior therapy and/or secondary International Prognostic Index (sIPI) score greater than 1
• Eligible for autologous stem cell transplant (aSCT)

You may not qualify if…

• Prior allogeneic hematopoietic stem cell transplant
• Within 6 months prior to test article: autologous transplant, treatment with anti-CD22 antibodies, radio-immunotherapy
• Veno-occlusive disease or sinusoidal obstruction syndrome, chronic liver disease, systemic vasculitides, current or chronic hepatitis B or C infection

Where it is running

• Loyola University Medical Center, Foster G. McGraw Hospital and Satellites — Maywood, Illinois, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• Siteman Cancer Center — City of Saint Peters, Missouri, United States
• Barnes-Jewish Hospital — St Louis, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• John Theurer Cancer Center (JTCC) at Hackensack University Medical Center (HUMC) — Hackensack, New Jersey, United States
• John Theurer Cancer Center (JTCC) at Hackensack University Medical Center (HUMC) — Hackensack, New Jersey, United States
• Hackensack University Medical CenteR — Hackensack, New Jersey, United States
• John Theurer Cancer Center (JTCC) at Hackensack University Medical Center (HUMC) — Hackensack, New Jersey, United States
• John Theurer Cancer Center, Hackensack University Medical Center — Hackensack, New Jersey, United States
• Memorial Sloan - Kettering Cancer Center — New York, New York, United States
• Penn State Milton S Hershey Medical Center — Hershey, Pennsylvania, United States
• UT Southwestern University Hospital - St. Paul — Dallas, Texas, United States
• Zale Lipshy University Hospital — Dallas, Texas, United States
• UT Southwestern Medical Center — Dallas, Texas, United States
• The University of Texas, M. D. Anderson Cancer Center — Houston, Texas, United States
• University of Texas, MD Anderson Cancer Center — Houston, Texas, United States
• Methodist Healthcare System of — San Antonio, Texas, United States
• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States
• Pharmaceutical Research Center — Madison, Wisconsin, United States
• CHRU de Lille Hopital Claude Huriez — Lille, France
• Institut Paoli Calmettes — Marseille, France
• CHU Saint-Eloi — Montpellier, France
• Hopital Saint Louis — Paris, France

Full record on ClinicalTrials.gov

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