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Study Evaluating Chemotherapy in Combination With Inotuzumab Ozogamicin In Subjects With Non-Hodgkin's Lymphoma
NCT01055496 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01055496
The ClinicalTrials.gov registry entry for NCT01055496 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 103 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 769 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01055496 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Other, Washington, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01055496?
This trial is sponsored by Pfizer, which has 769 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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