Daunorubicin Hydrochloride, Cytarabine and Oblimersen Sodium in Treating Patients With Previously Untreated Acute Myeloid Leukemia
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ClinicalTrials.gov Identifier: NCT00085124 |
Recruitment Status :
Completed
First Posted : June 11, 2004
Last Update Posted : June 5, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) Secondary Acute Myeloid Leukemia Untreated Adult Acute Myeloid Leukemia | Biological: oblimersen sodium Drug: cytarabine Drug: daunorubicin hydrochloride Other: laboratory biomarker analysis | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 500 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase III Study of Daunorubicin and Cytarabine +/- G3139 (Genasense, Oblimersen Sodium, NSC #683428, IND #58842), a BCL2 Antisense Oligodeoxynucleotide, in Previously Untreated Patients With Acute Myeloid Leukemia (AML) > / = 60 Years |
Study Start Date : | December 2003 |
Actual Primary Completion Date : | June 2007 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm I
Remission induction therapy: Patients receive oblimersen IV continuously on days 1-10, cytarabine IV continuously on days 4-10, and daunorubicin IV on days 4-6. Patients who achieve CR proceed to consolidation therapy. Patients who do not achieve CR receive a second course of induction therapy. Second remission induction therapy: Patients receive oblimersen IV continuously on days 1-8, cytarabine IV continuously on days 4-8, and daunorubicin IV on days 4-5. Patients who achieve CR proceed to consolidation therapy. Consolidation therapy: Patients receive oblimersen IV continuously on days 1-8 and high-dose cytarabine IV over 3 hours on days 4-8. Patients with a continuing CR receive a second course of consolidation therapy. |
Biological: oblimersen sodium
Given IV
Other Names:
Drug: cytarabine Given IV
Other Names:
Drug: daunorubicin hydrochloride Given IV
Other Names:
Other: laboratory biomarker analysis Correlative studies |
Experimental: Arm II
Remission induction therapy: Patients receive cytarabine IV continuously on days 1-7 and daunorubicin IV on days 1-3. Patients who achieve CR proceed to consolidation therapy. Patients who do not achieve CR receive a second course of induction therapy. Second remission induction therapy: Patients receive cytarabine IV continuously on days 1-5 and daunorubicin IV on days 1 and 2. Patients who achieve CR proceed to consolidation therapy. Consolidation therapy: Patients receive high-dose cytarabine IV over 3 hours on days 1-5. Patients with a continuing CR receive a second course of consolidation therapy. |
Drug: cytarabine
Given IV
Other Names:
Drug: daunorubicin hydrochloride Given IV
Other Names:
Other: laboratory biomarker analysis Correlative studies |
- Overall survival (OS) [ Time Frame: Up to 10 years ]
- Complete response (CR) rate [ Time Frame: Up to 10 years ]
- Median disease-free survival (DFS) [ Time Frame: Up to 10 years ]

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Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
-
DISEASE CHARACTERISTICS:
- Histologically confirmed acute myeloid leukemia
- No promyelocytic leukemia
- History of antecedent myelodysplasia allowed provided that the patient received no prior cytotoxic therapy for myelodysplastic syndromes
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PRIOR CONCURRENT THERAPY:
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Biologic therapy
- Prior growth factor and/or cytokine support allowed
- No concurrent routine or prophylactic myeloid growth factors
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Chemotherapy
- No prior chemotherapy for leukemia or myelodysplasia except under the following conditions:
- Emergency leukapheresis
- Emergency treatment for hyperleukocytosis with hydroxyurea
- No other concurrent chemotherapy
-
Endocrine therapy
- No concurrent hormones except steroids for adrenal failure or hormones for non-disease-related conditions allowed (e.g., insulin for diabetes)
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Radiotherapy
- Prior cranial radiotherapy for CNS leukostasis (1 dose only) allowed
- No concurrent palliative radiotherapy
- Surgery
- Not specified
-
Other
- Concurrent enrollment on CALGB-8461, CALGB-9665, and CALGB-9760 allowed
- No other concurrent investigational or commercial agents or therapies intended to treat the malignancy
-

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): NCT00085124
United States, Illinois | |
Cancer and Leukemia Group B | |
Chicago, Illinois, United States, 60606 | |
United States, Ohio | |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | |
Columbus, Ohio, United States, 43210 |
Principal Investigator: | Guido Marcucci | Cancer and Leukemia Group B |
Responsible Party: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00085124 |
Other Study ID Numbers: |
NCI-2012-02805 CALGB-10201 CDR367323 U10CA031946 ( U.S. NIH Grant/Contract ) |
First Posted: | June 11, 2004 Key Record Dates |
Last Update Posted: | June 5, 2013 |
Last Verified: | June 2013 |
Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms by Histologic Type Neoplasms Cytarabine Daunorubicin Oblimersen Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |