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

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)

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.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment

38

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arkansas
      • Little Rock, Arkansas, United States, 72211
    • Connecticut
      • Hartford, Connecticut, United States, 06102
    • Florida
      • Jacksonville, Florida, United States, 32209
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
    • Kansas
      • Olathe, Kansas, United States, 66061
    • New Jersey
      • Camden, New Jersey, United States, 08103
      • Trenton, New Jersey, United States, 08629
    • New York
      • Buffalo, New York, United States, 14215
      • Rochester, New York, United States, 14642
    • Ohio
      • Canton, Ohio, United States, 44708
    • Texas
      • Houston, Texas, United States, 77030
    • West Virginia
      • Charleston, West Virginia, United States, 25304
    • Wisconsin
      • Madison, Wisconsin, United States, 53792

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2000

Study Completion

September 1, 2004

Study Registration Dates

First Submitted

September 4, 2002

First Submitted That Met QC Criteria

September 5, 2002

First Posted (Estimate)

September 6, 2002

Study Record Updates

Last Update Posted (Estimate)

May 18, 2006

Last Update Submitted That Met QC Criteria

May 17, 2006

Last Verified

May 1, 2006

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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