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

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NCT00044733

Last updated on May 11, 2018
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FOR MORE INFORMATION
Study Location
Little Rock, Arkansas, 72211 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Acute Myelogenous Leukemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0+
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00044733
Pfizer
Completed
Study Evaluating Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia After Stem Cell Transplant

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Study Evaluating Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia After Stem Cell Transplant
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)
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.
Not Provided
Interventional
Phase 2
Masking: None (Open Label)
Acute Myelogenous Leukemia
Drug: Mylotarg (gemtuzumab ozogamicin) Injection
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
September 2004
Not Provided

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.
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00044733
0903X-100374
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
May 2006

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]zer.com



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