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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00085124 |
RATIONALE: Drugs used in chemotherapy, such as daunorubicin and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of daunorubicin and cytarabine by making cancer cells more sensitive to the drugs. It is not yet known whether daunorubicin and cytarabine are more effective with or without oblimersen in treating acute myeloid leukemia.
PURPOSE: This randomized phase III trial is studying daunorubicin, cytarabine, and oblimersen to see how well they work compared to daunorubicin and cytarabine in treating older patients with previously untreated acute myeloid leukemia.
Condition | Intervention | Phase |
Leukemia |
Drug: cytarabine Drug: daunorubicin hydrochloride Drug: oblimersen |
Phase III |
MedlinePlus related topics: | Cancer Leukemia, Adult Acute Leukemia, Adult Chronic |
ChemIDplus related topics: | Cytarabine Cytarabine hydrochloride Daunorubicin hydrochloride Daunorubicin Oblimersen sodium |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Phase III Study Of Daunorubicin And Cytarabine ± G3139 (Genesense ™, Oblimersen Sodium, NSC # 683428, IND # 58842), A BCL2 Antisense Oligodeoxynucleotide, In Previously Untreated Patients With Acute Myeloid Leukemia (AML) ≥ 60 Years |
Estimated Enrollment: | 500 |
Study Start Date: | December 2003 |
Show Detailed Description |
Ages Eligible for Study: | 60 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
No prior chemotherapy for leukemia or myelodysplasia except under the following conditions:
Endocrine therapy
Radiotherapy
Surgery
Other
Show 172 Study Locations |
Cancer and Leukemia Group B |
National Cancer Institute (NCI) |
Study Chair: | Guido Marcucci, MD | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Featured trial article 
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Study ID Numbers: | CDR0000367323, CALGB-10201 |
First Received: | June 10, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00085124 |
Health Authority: | United States: Federal Government |
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