Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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 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.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

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

FieldValue
Enrollment Target 103 participants
Start Date 2010-03
Est. Completion 2014-03
Phase Phase 1

Sponsor

Pfizer

1,845 total trials

What the Registry Record Tells You About NCT01055496

The ClinicalTrials.gov registry entry for NCT01055496 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 103 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 198-participant average among 31 other Lymphoma, B-Cell trials with a reported enrollment target (48% lower). The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 9 distinct geographic areas - top geographies include 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.

Similar trials for Lymphoma, B-Cell

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.