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| Sponsor: | Genta Incorporated |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00017589 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Leukemia |
Biological: oblimersen sodium Drug: gemtuzumab ozogamicin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| 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 |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed CD33+ acute myeloid leukemia (AML)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
More Information
| Study ID Numbers: | CDR0000068721, GENTA-GA210, UCCRC-10928 |
| Study First Received: | June 6, 2001 |
| Last Updated: | April 4, 2009 |
| ClinicalTrials.gov Identifier: | NCT00017589 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent adult acute myeloid leukemia |
|
Antibodies, Monoclonal Leukemia Neoplasms Neoplasms by Histologic Type Immunologic Factors Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Leukemia, Myeloid Gemtuzumab Leukemia, Myeloid, Acute Pharmacologic Actions |