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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00044733
Recruitment Status : Completed
First Posted : September 6, 2002
Last Update Posted : May 18, 2006
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
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 or disease Intervention/treatment Phase
Acute Myelogenous Leukemia Drug: Mylotarg (gemtuzumab ozogamicin) Injection Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 38 participants
Masking: None (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)
Study Start Date : March 2000
Study Completion Date : September 2004

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00044733

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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
Buffalo, New York, United States, 14215
Rochester, New York, United States, 14642
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 is now a wholly owned subsidiary of Pfizer
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Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer

Layout table for additonal information Identifier: NCT00044733    
Obsolete Identifiers: NCT00053274
Other Study ID Numbers: 0903X-100374
First Posted: September 6, 2002    Key Record Dates
Last Update Posted: May 18, 2006
Last Verified: May 2006
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Stem Cell Transplant
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Antineoplastic Agents, Immunological
Antineoplastic Agents