Study on Decitabine, Cytarabine, and Daunorubicin for Treating Acute Myeloid Leukemia
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT01627041
This clinical trial is testing how well a combination of chemotherapy drugs, including decitabine, cytarabine, and daunorubicin, works in treating patients with acute myeloid leukemia (AML). The study aims to find out if adding decitabine can make the other drugs more effective in killing cancer cells.
Patient Parameters
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Program Overview
This study is exploring whether adding the drug decitabine to the standard chemotherapy treatment with daunorubicin and cytarabine can improve outcomes for patients with acute myeloid leukemia (AML). Chemotherapy drugs work by stopping cancer cells from growing or dividing. Decitabine might help the other drugs work better by making cancer cells more sensitive to treatment. The study will compare low-dose and high-dose decitabine to see which is more effective when combined with the other drugs.
Description
The main goal of this study is to determine if using decitabine before the standard chemotherapy regimen (known as '7+3' induction chemotherapy) is beneficial for patients with acute myeloid leukemia (AML). Researchers want to see if this approach can lead to a complete remission rate of 50% or higher. They will also assess the safety and potential side effects of using decitabine in this way.
The study involves two groups of patients. In the first group, patients receive the standard chemotherapy treatment with daunorubicin and cytarabine. In the second group, patients receive decitabine for a few days before starting the same chemotherapy treatment. If patients do not achieve complete remission after the first round of treatment, they may receive a second round.
Participants will have blood, bone marrow, and oral cell samples collected for analysis before and after treatment. These samples will help researchers study the effects of decitabine on DNA and cancer cells.
After completing the treatment, patients will be monitored for up to 10 years to track their health and any long-term effects of the treatment.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with acute myeloid leukemia (AML) as defined by specific medical criteria.
- Have a less-than-favorable risk group based on certain genetic markers.
- Be in good overall health with a performance status score of 2 or lower, meaning able to carry out light work.
- Have normal heart function as shown by specific tests.
- Have liver and kidney function within specified limits.
- Not be pregnant or nursing, and agree to use effective birth control during the study.
- Understand the study and agree to sign a written informed consent document.
Exclusion Criteria
- Have received chemotherapy or radiation within the last two weeks, except for hydroxyurea.
- Be taking other investigational drugs.
- Have a history of allergic reactions to similar drugs.
- Have uncontrolled illnesses that pose a high risk for treatment, such as serious infections or heart problems.
- Have HIV with a CD4 count below 200 cells/μL.
- Have a psychiatric disorder or social situation that prevents understanding the study or following its requirements.
- Have central nervous system involvement by AML, unless approved by the study investigator.
- Have a high number of leukemia cells in the blood, unless controlled by specific treatments.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Lafayette Family Cancer Center-EMMC | 04412 | Brewer | Maine |
| Roswell Park Cancer Institute | 14263 | Buffalo | New York |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | 10032 | New York | New York |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| NYP/Weill Cornell Medical Center | 10065 | New York | New York |
| Montefiore Medical Center-Weiler Hospital | 10461 | The Bronx | New York |
| Montefiore Medical Center - Moses Campus | 10467 | The Bronx | New York |
| Case Western Reserve University | 44106 | Cleveland | Ohio |
| Ohio State University Comprehensive Cancer Center | 43210 | Columbus | Ohio |
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