Acute Myeloid Leukemia Clinical Trial

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

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.

View Eligibility Criteria

Eligibility 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.

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

38

Study ID:

NCT00044733

Recruitment Status:

Completed

Sponsor:

Wyeth is now a wholly owned subsidiary of Pfizer

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There are 13 Locations for this study

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Little Rock Arkansas, 72211, United States

Hartford Connecticut, 06102, United States

Jacksonville Florida, 32209, United States

Honolulu Hawaii, 96813, United States

Olathe Kansas, 66061, United States

Camden New Jersey, 08103, United States

Trenton New Jersey, 08629, United States

Buffalo New York, 14215, United States

Rochester New York, 14642, United States

Canton Ohio, 44708, United States

Houston Texas, 77030, United States

Charleston West Virginia, 25304, United States

Madison Wisconsin, 53792, United States

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

38

Study ID:

NCT00044733

Recruitment Status:

Completed

Sponsor:


Wyeth is now a wholly owned subsidiary of Pfizer

How clear is this clinincal trial information?

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