Study Evaluating Inotuzumab Ozogamicin (CMC-544) Plus Rituximab In Diffuse Large B-Cell Non-Hodgkin's Lymphoma
NCT00867087
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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)
- 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
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Duarte, California
- San Diego, California
- Chicago, Illinois
- Boston, Massachusetts
- Saint Louis, Missouri
- Buffalo, New York
- Cleveland, Ohio
- Aichi,
- Kanagawa,
- Tokyo,
- Tokyo,
- Maywood, Illinois
- Boston, Massachusetts
- Ann Arbor, Michigan
- Saint Louis, Missouri
- Saint Louis, Missouri
- Saint Peters, Missouri
- Hackensack, New Jersey
- Hackensack, New Jersey
- Hackensack, New Jersey
- Hackensack, New Jersey
- Hackensack, New Jersey
- New York, New York
- Hershey, Pennsylvania
- Dallas, Texas
- Dallas, Texas
- Dallas, Texas
- Houston, Texas
- Houston, Texas
- San Antonio, Texas
- Madison, Wisconsin
- Madison, Wisconsin
- Lille,
- Marseille,
- Montpellier Cedex 5,
- Paris,
- Pessac,
- Pierre-Benite cedex 114,
- Pierre-benite Cedex,
- Strasbourg,
- Berlin,
- Seoul, Gangnam-gu
- Seoul, Seoul/korea
- Seoul,
- Singapore,
- Manchester,
- Manchester,
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Study Evaluating Inotuzumab Ozogamicin (CMC-544) Plus Rituximab In Diffuse Large B-Cell Non-Hodgkin's Lymphoma | |||
Official Title ICMJE | An Open-label, Single-arm, Phase 2 Study Of Inotuzumab Ozogamicin Plus Rituximab In Subjects With Relapsed/Refractory Cd22-positive Diffuse Large B-cell Lymphoma, Eligible For Autologous Stem Cell Transplantation | |||
Brief Summary | 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Non-Randomized Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Lymphoma, B-Cell | |||
Intervention ICMJE |
| |||
Study Arms ICMJE | Experimental: Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2
Inotuzumab ozogamicin, in combination with rituximab, will be administered to patients with relapsed/refractory diffuse large B-cell Non-Hodgkin's lymphoma prior to an autologous stem cell transplant (aSCT). Interventions:
| |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 64 | |||
Original Estimated Enrollment ICMJE | 60 | |||
Actual Study Completion Date ICMJE | October 31, 2012 | |||
Actual Primary Completion Date | October 31, 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | France, Germany, Korea, Republic of, Singapore, United Kingdom, United States | |||
Removed Location Countries | Hong Kong, Japan, Mexico, Poland | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00867087 | |||
Other Study ID Numbers ICMJE | 3129K5-2005 B1931001 ( Other Identifier: Alias Study Number ) 2008-007802-12 ( EudraCT Number ) | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | UCB Pharma | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | October 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |