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NCT01055496 · ClinicalTrials.gov registry record · Phase 1
Study Evaluating Chemotherapy in Combination With Inotuzumab Ozogamicin In Subjects With Non-Hodgkin's Lymphoma
A Phase 1 study of Lymphoma, B-Cell, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 103
- Enrollment target
- 20
- Study locations
NCT01055496: Completed Phase 1 study of Lymphoma, B-Cell, sponsored by Pfizer.
NCT01055496 is a Phase 1 study of Lymphoma, B-Cell that has completed, run by Pfizer. The registered enrollment target is 103 participants, below the 198-participant average among 31 other Lymphoma, B-Cell trials with a reported enrollment target (48% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01055496, a Phase 1 study of Lymphoma, B-Cell, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 103 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
DLT was defined as: febrile neutropenia, Grade (Gr) 4 neutropenia ≥7 days, Gr 4 thrombocytopenia ≥7 days, Gr 3/4 thrombocytopenia associated with bleeding requiring a transfusion, Gr 3/4 non-hematologic toxicity (except alopecia) ≥7 days or treatment-related and clinically significant irrespective of duration, ≥Gr 3 QTc prolongation, Gr 4 alanine or aspartate aminotransferase, Gr 2 hyperbilirubinemia (greater than (\>)1.5 x upper normal limit) \>7 days, delayed recovery from a treatment-related
Conditions Studied
Interventions
- DRUG inotuzumab ozogamicin+rituximab +cyclophosphamide+vincristine+prednisone
- DRUG inotuzumab ozogamicin+rituximab+gemcitabine+cisplatinum+dexamethasone
Study Locations (20)
Other
- UZ Gent - Ghent
- UZ Gasthuisberg - Leuven
- Hopital Saint-Louis -Universite Paris VII - Paris
- Hospital Saint-Louis - Service d'Hemato-Oncologie - Paris
- Centre Hospitalier Lyon Sud - Service d'Hematologie - Pierre-Bénite
- Prince of Wales Hospital - Hong Kong
Washington
- Northwest Medical Specialties, PLLC - Federal Way
- Northwest Medical Specialties, PLLC - Gig Harbor
- Northwest Medical Specialties, PLLC - Lakewood
- Rainier Physicians, PC - Puyallup
- Northwest Medical Specialties PLLC - Tacoma
Florida
- Davis Cancer Pavillion and Shands Medical Plaza - Gainesville
- Shands Cancer Hospital At The University Of Florida - Gainesville
- Shands Hospital at the University of Florida - Gainesville
Pennsylvania
- Fox Chase Cancer Center - Philadelphia
Texas
- The University of Texas MD Anderson Cancer Center - Houston
Alberta
- Cross Cancer Institute - Edmonton
Nova Scotia
- Queen Elizabeth Health Sciences Centre - Halifax
Ontario
- Princess Margaret Cancer Centre - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2010-03 |
| Est. Completion | 2014-03 |
| Phase | Phase 1 |
What the finished NCT01055496 record still lists
NCT01055496 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 198-participant average among 31 other Lymphoma, B-Cell trials with a reported enrollment target (48% lower).
The record links to 1 condition, with Lymphoma, B-Cell appearing as the primary indexed condition, and to 2 interventions - of which inotuzumab ozogamicin+rituximab +cyclophosphamide+vincristine+prednisone is the first listed.
NCT01055496 names 20 study sites across 9 states, led by Other, Washington, Florida.
Frequently Asked Questions
What is clinical trial NCT01055496 about?
NCT01055496 is a clinical study titled "Study Evaluating Chemotherapy in Combination With Inotuzumab Ozogamicin In Subjects With Non-Hodgkin's Lymphoma". 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-C...
What is the current status of trial NCT01055496?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 103 participants. The study started on 2010-03. Estimated completion is 2014-03.
What conditions does trial NCT01055496 study?
This clinical trial studies the following conditions: Lymphoma, B-Cell.
What interventions are being tested in trial NCT01055496?
The interventions under investigation include: inotuzumab ozogamicin+rituximab +cyclophosphamide+vincristine+prednisone (DRUG), inotuzumab ozogamicin+rituximab+gemcitabine+cisplatinum+dexamethasone (DRUG).
Who is sponsoring clinical trial NCT01055496?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01055496 being conducted?
This trial has 20 study locations across Florida, Pennsylvania, Texas, Washington, Alberta. 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 NCT01055496's enrollment target sits among peer trials
103 12th of 31 higher than 20 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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