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

Completed · Phase 2

Conditions studied: Acute Myelogenous Leukemia

In brief

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.

Key facts

Study ID

NCT00044733

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

People needed

38

Starts

2000-03-01

Expected to finish

2004-09-01

Last updated by the study team

2006-05-18

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Study site — Little Rock, Arkansas, United States
• Study site — Hartford, Connecticut, United States
• Study site — Jacksonville, Florida, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Olathe, Kansas, United States
• Study site — Camden, New Jersey, United States
• Study site — Trenton, New Jersey, United States
• Study site — Buffalo, New York, United States
• Study site — Rochester, New York, United States
• Study site — Canton, Ohio, United States
• Study site — Houston, Texas, United States
• Study site — Charleston, West Virginia, United States
• Study site — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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