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NCT00867087 · ClinicalTrials.gov registry record · Phase 2
Study Evaluating Inotuzumab Ozogamicin (CMC-544) Plus Rituximab In Diffuse Large B-Cell Non-Hodgkin's Lymphoma
A Phase 2 study of Lymphoma, B-Cell, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 64
- Enrollment target
- 20
- Study locations
NCT00867087: Completed Phase 2 study of Lymphoma, B-Cell, sponsored by Pfizer.
NCT00867087 is a Phase 2 study of Lymphoma, B-Cell that has completed, run by Pfizer. The registered enrollment target is 64 participants, below the 199-participant average among 31 other Lymphoma, B-Cell trials with a reported enrollment target (68% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00867087, a Phase 2 study of Lymphoma, B-Cell, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 64 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Response criteria based on National Cancer Institute (NCI) International Response Criteria for non-Hodgkin's lymphoma. CR: no detectable clinical \& radiographic evidence of disease/disease-related symptoms; lymph nodes/nodal masses regressed to normal size (less than or equal to \[≤\] 1.5 cm in greatest transverse diameter for nodes greater than \[\>\] 1.5 cm pre-therapy); spleen \& other organs (if enlarged pre-therapy) regressed in size \& spleen not palpable on physical examination; repeat b
Conditions Studied
Interventions
- DRUG rituximab
- DRUG inotuzumab ozogamicin (CMC-544)
Study Locations (20)
Texas
- UT Southwestern University Hospital - St. Paul - Dallas
- Zale Lipshy University Hospital - Dallas
- UT Southwestern Medical Center - Dallas
- The University of Texas, M. D. Anderson Cancer Center - Houston
- University of Texas, MD Anderson Cancer Center - Houston
- Methodist Healthcare System of - San Antonio
New Jersey
- John Theurer Cancer Center (JTCC) at Hackensack University Medical Center (HUMC) - Hackensack
- John Theurer Cancer Center (JTCC) at Hackensack University Medical Center (HUMC) - Hackensack
- Hackensack University Medical CenteR - Hackensack
- John Theurer Cancer Center (JTCC) at Hackensack University Medical Center (HUMC) - Hackensack
- John Theurer Cancer Center, Hackensack University Medical Center - Hackensack
Missouri
- Siteman Cancer Center - City of Saint Peters
- Barnes-Jewish Hospital - St Louis
- Washington University School of Medicine - St Louis
Illinois
- Loyola University Medical Center, Foster G. McGraw Hospital and Satellites - Maywood
Massachusetts
- Tufts Medical Center - Boston
Michigan
- University of Michigan Comprehensive Cancer Center - Ann Arbor
New York
- Memorial Sloan - Kettering Cancer Center - New York
Pennsylvania
- Penn State Milton S Hershey Medical Center - Hershey
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2009-06-08 |
| Est. Completion | 2012-10-31 |
| Phase | Phase 2 |
What the finished NCT00867087 record still lists
NCT00867087 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 199-participant average among 31 other Lymphoma, B-Cell trials with a reported enrollment target (68% lower).
The record links to 1 condition, with Lymphoma, B-Cell appearing as the primary indexed condition, and to 2 interventions - of which rituximab is the first listed.
NCT00867087 names 20 study sites across 9 states, led by Texas, New Jersey, Missouri.
Frequently Asked Questions
What is clinical trial NCT00867087 about?
NCT00867087 is a clinical study titled "Study Evaluating Inotuzumab Ozogamicin (CMC-544) Plus Rituximab In Diffuse Large B-Cell Non-Hodgkin's Lymphoma". 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.
What is the current status of trial NCT00867087?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 64 participants. The study started on 2009-06-08. Estimated completion is 2012-10-31.
What conditions does trial NCT00867087 study?
This clinical trial studies the following conditions: Lymphoma, B-Cell.
What interventions are being tested in trial NCT00867087?
The interventions under investigation include: rituximab (DRUG), inotuzumab ozogamicin (CMC-544) (DRUG).
Who is sponsoring clinical trial NCT00867087?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00867087 being conducted?
This trial has 20 study locations across Illinois, Massachusetts, Michigan, Missouri, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00867087's enrollment target sits among peer trials
64 13th of 31 higher than 19 of 31 other Lymphoma, B-Cell trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphoma, B-Cell trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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