Study Evaluating Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia After Stem Cell Transplant - Full Text View

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

MedlinePlus related topics:

Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

ChemIDplus related topics:

Gemtuzumab ozogamicin

U.S. FDA Resources

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)

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

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

Keywords provided by Wyeth:

Leukemia

Stem Cell Transplant

Study placed in the following topic categories:

Antibodies, Monoclonal

Signs and Symptoms

Leukemia

Antibodies

Acute myelogenous leukemia

Leukemia, Myeloid

Gemtuzumab

Leukemia, Myeloid, Acute

Acute myelocytic leukemia

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Immunologic Factors

Antineoplastic Agents

Therapeutic Uses

Physiological Effects of Drugs

Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2008

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