N/A
N=12
Decitabine and Cytarabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia, High Risk Myelodysplastic Syndrome, or Myeloproliferative Neoplasm
Chronic Myelomonocytic Leukemia-2 · Myelodysplastic Syndrome · Myeloproliferative Neoplasm · Untreated Adult Acute Myeloid Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT02121418 ↗Enrolled (actual)
12
Serious AEs
91.7%
Results posted
Apr 2018
Primary outcome: Primary: Overall Survival of Patients Over Age 60 With Newly Diagnosed AML/High Risk MDS — 7 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cytarabine (Drug); Decitabine (Drug); Laboratory Biomarker Analysis (Other)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival of Patients Over Age 60 With Newly Diagnosed AML/High Risk MDS |
7 | — |
| SECONDARY Response Rate |
4; 3 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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 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
Data sourced from ClinicalTrials.gov (NCT02121418). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.