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

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00044733

Collaborator

(none)

Enrollment

Locations

Duration (Months)

2.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Mar 1, 2000

Study Completion Date :

Sep 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	City	State	Country	Postal Code
1	Little Rock	Arkansas	United States	72211
2	Hartford	Connecticut	United States	06102
3	Jacksonville	Florida	United States	32209
4	Honolulu	Hawaii	United States	96813
5	Olathe	Kansas	United States	66061
6	Camden	New Jersey	United States	08103
7	Trenton	New Jersey	United States	08629
8	Buffalo	New York	United States	14215
9	Rochester	New York	United States	14642
10	Canton	Ohio	United States	44708
11	Houston	Texas	United States	77030
12	Charleston	West Virginia	United States	25304
13	Madison	Wisconsin	United States	53792