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Completed Phase 2 Interventional Results available

Study Evaluating Inotuzumab Ozogamicin In Acute Lymphocytic Leukemia

ClinicalTrials.gov ID: NCT01363297

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.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 3:23 AM EDT

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
Lead sponsor
Pfizer
Industry
Enrollment
72 participants

Conditions and interventions

Interventions

Drug

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
Aug 2011 (Type not available)
Primary completion
Aug 2014 (Actual)
Completion
Jan 2016 (Actual)
Last update posted
Apr 13, 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 13, 2017 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01363297 live on ClinicalTrials.gov.

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