Study Evaluating Inotuzumab Ozogamicin In Acute Lymphocytic Leukemia

Completed · Phase 2

Conditions studied: Acute Lymphocytic Leukemia

In brief

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.

Key facts

Study ID

NCT01363297

Run by

Pfizer

People needed

72

Starts

2011-08-01

Expected to finish

2016-01-01

Last updated by the study team

2017-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with CD22-positive ALL with either refractory disease (i.e. disease progression or no response while receiving their most recent prior anti-cancer therapy), or relapsed disease (i.e. response to their most recent prior anti-cancer therapy with subsequent relapse). Subjects enrolled in the Phase 2 portion of the study must be due to receive salvage 2 or later therapy.
• Subjects with Philadelphia chromosome-positive (Ph+) ALL must have failed standard treatment with at least one tyrosine kinase inhibitor.
• Adequate renal and hepatic function, and negative pregnancy test for women of childbearing potential.

You may not qualify if…

• Subjects with isolated extramedullary relapse or active central nervous system (CNS) leukemia.
• Prior allogeneic hematopoietic stem cell transplant (HSCT) or other anti-CD22 immunotherapy within 4 months, or active graft versus host disease (GvHD) at study entry.
• Evidence or history of veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS).

Where it is running

• City of Hope National Medical Center — Duarte, California, United States
• Stanford Unversity Cancer Clinical Trials Office — Palo Alto, California, United States
• Stanford Unversity Hospital and Clinics, CTRU — Palo Alto, California, United States
• Stanford Cancer Institute — Stanford, California, United States
• Stanford University Hospital and Clinics — Stanford, California, United States
• The University of Chicago Medical Center — Chicago, Illinois, United States
• Massachusetts General Hospital (MGH) — Boston, Massachusetts, United States
• Brigham and Women's Hospital (BWH) — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Karmanos Cancer Institute at Farmington Hills — Farmington Hills, Michigan, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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