Study Evaluating Inotuzumab Ozogamicin In Acute Lymphocytic Leukemia
Public ClinicalTrials.gov record NCT01363297. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-label, Phase 1/2 Study Of Inotuzumab Ozogamicin In Subjects With Relapsed Or Refractory Cd22-positive Acute Lymphocytic Leukemia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The Phase 1 portion of this study will assess the safety, tolerability and efficacy at increasing dose levels of inotuzumab ozogamicin in subjects with CD22-positive relapsed or refractory adult acute lymphocytic leukemia (ALL) in order to select the recommended phase 2 dose (RP2D) and schedule. The Phase 2 portion of the study will evaluate the efficacy of inotuzumab ozogamicin as measured by hematologic remission rate (CR + CRi) in patients in second or later salvage status.
Study identification
- NCT ID
- NCT01363297
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 72 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2011
- Primary completion
- Jul 31, 2014
- Completion
- Dec 31, 2015
- Last update posted
- Apr 12, 2017
2011 – 2016
United States locations
- U.S. sites
- 15
- U.S. states
- 7
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | 91010-3000 | — |
| Stanford Unversity Cancer Clinical Trials Office | Palo Alto | California | 94304 | — |
| Stanford Unversity Hospital and Clinics, CTRU | Palo Alto | California | 94304 | — |
| Stanford Cancer Institute | Stanford | California | 94305 | — |
| Stanford University Hospital and Clinics | Stanford | California | 94305 | — |
| The University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| Massachusetts General Hospital (MGH) | Boston | Massachusetts | 02114 | — |
| Brigham and Women's Hospital (BWH) | Boston | Massachusetts | 02115 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Karmanos Cancer Institute at Farmington Hills | Farmington Hills | Michigan | 48334 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01363297, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 12, 2017 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01363297 live on ClinicalTrials.gov.