Study Evaluating Chemotherapy in Combination With Inotuzumab Ozogamicin In Subjects With Non-Hodgkin's Lymphoma

Completed · Phase 1

Conditions studied: Lymphoma, B-Cell

In brief

This is a phase 1 trial designed to evaluate safety and tolerability of chemotherapy in combination with inotuzumab ozogamicin, an investigational product, in adults with CD22-positive non-Hodgkin's lymphoma. The trial will involve two arms. In one arm, subjects will receive chemotherapy regimen R-CVP (rituximab, cyclophosphamide, vincristine and prednisone). In the other arm, subjects will receive R-GDP (rituximab, gemcitabine, cisplatinum and dexamethasone). Subjects in both arms will also receive inotuzumab ozogamicin.

Key facts

Study ID

NCT01055496

Run by

Pfizer

People needed

103

Starts

2010-03-01

Expected to finish

2014-03-01

Last updated by the study team

2019-08-02

Who can join

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

You may qualify if…

• Dose escalation cohorts: subjects with diagnosis of CD22-positive Non-Hodgkin's Lymphoma (NHL) who have had at least 1 prior anticancer treatment, including prior treatment with rituximab and chemotherapy.
• Expanded maximum tolerated dose (MTD) confirmation and preliminary efficacy cohorts: subjects with diagnosis of CD22-positive NHL who have had at least 1 prior anticancer treatment, including prior treatment with rituximab and chemotherapy or newly diagnosed subjects who are not candidates for anthracycline-based therapy.
• At least 1 measurable disease lesion that is > 1 cm in the longest transverse diameter, with a product of the diameters > 2.25 cm2 by CT or magnetic resonance imaging (MRI).

You may not qualify if…

• Candidate for potentially curative therapy such as stem cell transplantation.
• Prior allogeneic hematopoietic stem cell transplantation (HSCT).
• Prior autologous transplantation, radioimmunotherapy, or other anti CD22 immunotherapy <= 6 months before the first dose of investigational product.
• More than 3 previous combination chemotherapy (2 or more cytotoxics) anticancer regimens.

Where it is running

• Davis Cancer Pavillion and Shands Medical Plaza — Gainesville, Florida, United States
• Shands Cancer Hospital At The University Of Florida — Gainesville, Florida, United States
• Shands Hospital at the University of Florida — Gainesville, Florida, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Northwest Medical Specialties, PLLC — Federal Way, Washington, United States
• Northwest Medical Specialties, PLLC — Gig Harbor, Washington, United States
• Northwest Medical Specialties, PLLC — Lakewood, Washington, United States
• Rainier Physicians, PC — Puyallup, Washington, United States
• Northwest Medical Specialties PLLC — Tacoma, Washington, United States
• UZ Gent — Ghent, Belgium
• UZ Gasthuisberg — Leuven, Belgium
• Cross Cancer Institute — Edmonton, Alberta, Canada
• Queen Elizabeth Health Sciences Centre — Halifax, Nova Scotia, Canada
• Princess Margaret Cancer Centre — Toronto, Ontario, Canada
• Hopital Saint-Louis -Universite Paris VII — Paris, France
• Hospital Saint-Louis - Service d'Hemato-Oncologie — Paris, France
• Centre Hospitalier Lyon Sud - Service d'Hematologie — Pierre-Bénite, France
• Prince of Wales Hospital — Hong Kong, Hong Kong
• Nagoya Daini Red Cross Hospital — Nagoya, Aichi-ken, Japan
• National Cancer Center Hospital — Chuo-ku, Tokyo, Japan
• Cancer Institute Hospital, Japanese Foundation For Cancer Research — Koto-Ku, Tokyo, Japan
• Singapore General Hospital — Singapore, Singapore
• Samsung Medical Center — Seoul, South Korea
• Nuffield Hospital — Eastleigh, Hants, United Kingdom

Full record on ClinicalTrials.gov

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