Study Evaluating Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia After Stem Cell Transplant

This study has been completed.

First Received: September 4, 2002 Last Updated: May 17, 2006 History of Changes

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00044733

Purpose

The primary objective of this study is to evaluate the safety of gemtuzumab ozogamicin in relapsed CD33-positive AML patients who received HSCT. If the MTD dose is not reached, 9 mg/m2 will be the maximum tested dose. A secondary objective is to assess efficacy in terms of the number of patients attaining a complete (CR) or morphological (CRp) remission.

Condition	Intervention	Phase
Acute Myelogenous Leukemia	Drug: Mylotarg (gemtuzumab ozogamicin) Injection	Phase II

Study Type:	Interventional
Study Design:	Open Label
Official Title:	A Dose-Finding Study of the Safety of Gemtuzumab Ozogamicin as Single Agent Treatment of Patients With Relapsed Acute Myelogenous Leukemia After Autologous or Allogenic Hematopoietic Stem Cell Transplant (HSCT)

Resource links provided by NLM:

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

Drug Information available for: Gemtuzumab ozogamicin

U.S. FDA Resources

Further study details as provided by Wyeth:

Estimated Enrollment:	38
Study Start Date:	March 2000
Estimated Study Completion Date:	September 2004

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Patients with CD33+ AML who have experienced relapse after autologous or allogeneic HSCT. Flow cytometry, performed at the study site, must demonstrate that the patient has AML that is CD33 positive, based on local laboratory criteria (Patients with history of MDS pretransplant will be eligible if their proportion of myeloblasts by marrow aspirate exceeds 5% at time of evaluation for Gemtuzumab Ozogamicin treatment)
The patient must be greater than or equal to 60 days post-HCST
Patients of all ages may be entered in this study

Exclusion Criteria

Peripheral white blood count (WBC) greater than or equal to 30,000/uL at the time of initial Gemtuzumab Ozogamicin administration. (In order to reduce the peripheral blood count, patients may be treated with Hydroxyurea. Hydroxyurea must be discontinued 24 hours prior to Gemtuzumab Ozogamicin administration.)
Known active central nervous system (CNS) or testicular leukemia at time of study entry.
Prior therapy with anti-CD33 antibodies.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00044733

Locations

United States, Arkansas

Little Rock, Arkansas, United States, 72211
United States, Connecticut

Hartford, Connecticut, United States, 06102
United States, Florida

Jacksonville, Florida, United States, 32209
United States, Hawaii

Honolulu, Hawaii, United States, 96813
United States, Kansas

Olathe, Kansas, United States, 66061
United States, New Jersey

Camden, New Jersey, United States, 08103

Trenton, New Jersey, United States, 08629
United States, New York

Rochester, New York, United States, 14642

Buffalo, New York, United States, 14215
United States, Ohio

Canton, Ohio, United States, 44708
United States, Texas

Houston, Texas, United States, 77030
United States, West Virginia

Charleston, West Virginia, United States, 25304
United States, Wisconsin

Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor, MD

Wyeth

More Information

No publications provided

Study ID Numbers:	0903X-100374
Study First Received:	September 4, 2002
Last Updated:	May 17, 2006
ClinicalTrials.gov Identifier:	NCT00044733 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Leukemia
Stem Cell Transplant

Additional relevant MeSH terms:

Antibodies, Monoclonal
Leukemia
Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Antineoplastic Agents

Therapeutic Uses
Physiological Effects of Drugs
Leukemia, Myeloid
Gemtuzumab
Leukemia, Myeloid, Acute
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009