Daunorubicin Hydrochloride, Cytarabine and Oblimersen Sodium in Treating Patients With Previously… (NCT00085124) | Clinical Trial Compass
CompletedPhase 3
Daunorubicin Hydrochloride, Cytarabine and Oblimersen Sodium in Treating Patients With Previously Untreated Acute Myeloid Leukemia
United States500 participantsStarted 2003-12
Plain-language summary
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. 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.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* PRIOR CONCURRENT THERAPY:
* Biologic therapy
* Prior growth factor and/or cytokine support allowed
* No concurrent routine or prophylactic myeloid growth factors
* 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)
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.