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NCT00044733 Clinical Trial

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

Acute Myelogenous Leukemia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00044733
Other study ID # 0903X-100374
Secondary ID
Status Completed
Phase Phase 2
First received September 4, 2002
Last updated May 17, 2006
Start date March 2000
Est. completion date September 2004

Study information
Verified date May 2006
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Other known NCT identifiers
  • NCT00053274

Recruitment information / eligibility
Status Completed
Enrollment 38
Est. completion date September 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

Masking: Open Label

Related Conditions & MeSH terms

Intervention

Drug:
• Mylotarg (gemtuzumab ozogamicin) Injection

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

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