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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00044733
First received: September 4, 2002
Last updated: May 17, 2006
Last verified: May 2006
History of Changes
  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 2

Study Type: Interventional
Study Design: Masking: 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:

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

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
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
Investigators
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00044733     History of Changes
Obsolete Identifiers: NCT00053274
Other Study ID Numbers: 0903X-100374
Study First Received: September 4, 2002
Last Updated: May 17, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Leukemia
Stem Cell Transplant

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
 Gemtuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013