Oblimersen and Gemtuzumab Ozogamicin in Treating Older Patients With Relapsed Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT00017589|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 6, 2014
RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Oblimersen may help gemtuzumab ozogamicin kill more cancer cells by making cancer cells more sensitive to the drug.
PURPOSE: Phase II trial to study the effectiveness of combining oblimersen and gemtuzumab ozogamicin in treating older patients who have relapsed acute myeloid leukemia.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Biological: oblimersen sodium Drug: gemtuzumab ozogamicin||Phase 2|
- Determine the complete response rate of elderly patients with relapsed CD33-positive acute myeloid leukemia treated with oblimersen and gemtuzumab ozogamicin.
- Determine the overall response rate and duration of response of patients treated with this regimen.
- Determine the safety of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oblimersen IV continuously on days 1-7 and 15-22 and gemtuzumab ozogamicin IV over 2 hours on days 4 and 18.
Patients are followed monthly for 6 months.
PROJECTED ACCRUAL: A total of 20-100 patients will be accrued for this study within 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase II Study of Genasense (Bcl-2 Antisense) Combined With Mylotarg (Gemtuzumab Ozogamicin) in Elderly Patients With Relapsed Acute Myeloid Leukemia|
|Study Start Date :||December 2000|
|Actual Study Completion Date :||May 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00017589
|United States, New Jersey|
|Berkeley Heights, New Jersey, United States, 07922|
|Study Chair:||Stanley R. Frankel, MD||Genta Incorporated|