Decitabine and Cytarabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia, High Risk Myelodysplastic Syndrome, or Myeloproliferative Neoplasm

Completed · Not applicable

Conditions studied: Chronic Myelomonocytic Leukemia-2, Myelodysplastic Syndrome, Myeloproliferative Neoplasm, Untreated Adult Acute Myeloid Leukemia

In brief

This clinical trial studies decitabine and cytarabine in treating older patients with newly diagnosed acute myeloid leukemia, myelodysplastic syndrome that is likely to come back or spread to other places in the body, or myeloproliferative neoplasm. Drugs used in chemotherapy, such as decitabine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving decitabine and cytarabine may work better than standard therapies in treating cancers of the bone marrow and blood cells, such as acute myeloid leukemia, myelodysplastic syndrome, or myeloproliferative neoplasm.

Key facts

Study ID

NCT02121418

Run by

University of Washington

People needed

12

Starts

2014-06-01

Expected to finish

2018-02-14

Last updated by the study team

2018-04-13

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Newly-diagnosed AML by World Health Organization (WHO) criteria (>= 20% myeloid blasts by morphology in either blood or marrow)
• High-risk myelodysplastic syndrome (MDS) or myeloproliferative neoplasm (MPN) including chronic myelomonocytic leukemia 2 (CMML2) as defined by 10-19% myeloid blasts in either blood or marrow
• Patients may have received azacitidine, decitabine, or lenalidomide but no "cytotoxic therapy" such as ara-C or anthracyclines; data suggest that failure to respond to azacitidine reduces probability of response to 3+7; hence in the interest of having a relatively homogeneous population, while patients who have received and failed azacitidine or decitabine will be eligible for this study, they will be analyzed separately from patients who have not received these drugs
• Treatment related mortality (TRM) score < 22.9; patients with TRM scores > 13.1, in whom the risk of death within 28 days of beginning induction therapy has averaged 41%, will preferentially be placed on protocol 2642
• Provision of written informed consent
• Note, unlike pharmaceutical company sponsored protocols eligibility is not conditioned on bilirubin, creatinine, or absence of other malignancy within the past 2-3 years; the TRM score incorporates creatinine and thus a high creatinine can in principle be offset by favorable values for the other covariates in the TRM score; bilirubin was not a covariate in the TRM; furthermore, in the doses we are using, dose adjustment of decitabine or ara-C is not indicated in the presence of renal or hepatic abnormalities; our broad eligibility criteria may increase the likelihood that our results will be generalizable; the inability to reproduce results of early phase AML studies has been a problem in the past

Where it is running

• Bozeman Deaconess Hospital — Bozeman, Montana, United States
• Kadlec Clinic Hematology and Oncology — Kennewick, Washington, United States
• EvergreenHealth Medical Center — Kirkland, Washington, United States
• Skagit Valley Hospital — Mount Vernon, Washington, United States
• Olympic Medical Center — Port Angeles, Washington, United States
• Group Health Cooperative — Redmond, Washington, United States
• Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States
• Multicare Health System — Tacoma, Washington, United States
• Wenatchee Valley Hospital and Clinics — Wenatchee, Washington, United States

Full record on ClinicalTrials.gov

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