Study Evaluating Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia After Stem Cell Transplant
NCT00044733
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Adult Trials: 18+ Years
- 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
- 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.
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Study Evaluating Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia After Stem Cell Transplant | |||
| Official Title ICMJE | 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) | |||
| 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. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 2 | |||
| Study Design ICMJE | Masking: None (Open Label) | |||
| Condition ICMJE | Acute Myelogenous Leukemia | |||
| Intervention ICMJE | Drug: Mylotarg (gemtuzumab ozogamicin) Injection | |||
| Study Arms ICMJE | Not Provided | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Enrollment ICMJE | 38 | |||
| Original Enrollment ICMJE | Not Provided | |||
| Study Completion Date ICMJE | September 2004 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | Child, Adult, Older Adult | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00044733 | |||
| Other Study ID Numbers ICMJE | 0903X-100374 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Not Provided | |||
| Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Verification Date | May 2006 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||