Decitabine and Cytarabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia, High Risk Myelodysplastic Syndrome, or Myeloproliferative Neoplasm
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| ClinicalTrials.gov Identifier: NCT02121418 |
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Recruitment Status :
Completed
First Posted : April 23, 2014
Results First Posted : April 13, 2018
Last Update Posted : April 13, 2018
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Sponsor:
University of Washington
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Pamela S Becker, University of Washington
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Myelomonocytic Leukemia-2 Myelodysplastic Syndrome Myeloproliferative Neoplasm Untreated Adult Acute Myeloid Leukemia | Drug: Cytarabine Drug: Decitabine Other: Laboratory Biomarker Analysis | Not Applicable |
PRIMARY OBJECTIVES:
I. Examine whether a combination of decitabine given for 10 days (days 1-10), rather than the usual 5 days, plus "standard dose cytarabine (ara-C) (100 mg/m^2 daily days 1-7) might improve 6-month survival probability from the historical 65% to 80% in patients age >= 60 with newly diagnosed acute myeloid leukemia (AML).
II. Test whether this combination might maintain complete response (CR) rate at our historic 45% in these patients.
III. Study factors that lead physicians to escalate or maintain ara-C doses in those patients who have had an "intermediate response" short of CR to the first 2 cycles of the combination.
IV. While maintaining awareness of confounding covariates, examine the effect of such dose escalation on CR rate.
OUTLINE:
Patients receive decitabine intravenously (IV) daily on days 1-10 and cytarabine IV once daily (QD) on days 1-7. Treatment repeats every 28-35 days for 2 courses in the absence of disease progression or unacceptable toxicity. After course 3, patients achieving remission will receive 1-2 more courses of therapy at the same dose. Patients in remission with significant side effects will receive decitabine and cytarabine at decreased doses. Patients not achieving remission will not receive any more treatment.
After completion of study treatment, patients are followed up for 6 months and then periodically.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 12 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Decitabine Plus Cytarabine for Induction of Remission in Newly Diagnosed Elderly Acute Myeloid Leukemia (AML) and Advanced Myelodysplastic Syndrome (MDS) |
| Study Start Date : | June 2014 |
| Actual Primary Completion Date : | February 8, 2017 |
| Actual Study Completion Date : | February 14, 2018 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Familial acute myeloid leukemia with mutated CEBPA
Cytogenetically normal acute myeloid leukemia
Core binding factor acute myeloid leukemia
| Arm | Intervention/treatment |
|---|---|
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Experimental: Treatment (decitabine, cytarabine)
Patients receive decitabine IV daily on days 1-10 and cytarabine IV QD on days 1-7. Treatment repeats every 28-35 days for 2 courses in the absence of disease progression or unacceptable toxicity. After course 3, patients achieving remission will receive 1-2 more courses of therapy at the same dose. Patients in remission with significant side effects will receive decitabine and cytarabine at decreased doses. Patients not achieving remission will not receive any more treatment.
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Drug: Cytarabine
Given IV
Other Names:
Drug: Decitabine Given IV
Other Names:
Other: Laboratory Biomarker Analysis Correlative studies |
Primary Outcome Measures :
- Overall Survival of Patients Over Age 60 With Newly Diagnosed AML/High Risk MDS [ Time Frame: At 6 months ]Compared to historical data of a completed Southwestern Oncology Group (SWOG) trial of azacitidine and gemtuzumab ozogamicin.
Secondary Outcome Measures :
- Response Rate [ Time Frame: Up to 2 years ]Rate of Complete Response or Complete Response with Incomplete Count Recovery
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| Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 < 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
Information from the National Library of Medicine
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): NCT02121418
Locations
| United States, Montana | |
| Bozeman Deaconess Hospital | |
| Bozeman, Montana, United States, 59715 | |
| United States, Washington | |
| Kadlec Clinic Hematology and Oncology | |
| Kennewick, Washington, United States, 99336 | |
| EvergreenHealth Medical Center | |
| Kirkland, Washington, United States, 98033 | |
| Skagit Valley Hospital | |
| Mount Vernon, Washington, United States, 98274 | |
| Olympic Medical Center | |
| Port Angeles, Washington, United States, 98362 | |
| Group Health Cooperative | |
| Redmond, Washington, United States, 98052 | |
| Fred Hutch/University of Washington Cancer Consortium | |
| Seattle, Washington, United States, 98109 | |
| Multicare Health System | |
| Tacoma, Washington, United States, 98415 | |
| Wenatchee Valley Hospital and Clinics | |
| Wenatchee, Washington, United States, 98801 | |
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Pamela Becker | Fred Hutch/University of Washington Cancer Consortium |
Study Documents (Full-Text)
Documents provided by Pamela S Becker, University of Washington:
Documents provided by Pamela S Becker, University of Washington:
Study Protocol and Statistical Analysis Plan [PDF] March 22, 2017
| Responsible Party: | Pamela S Becker, Principal Investigator, University of Washington |
| ClinicalTrials.gov Identifier: | NCT02121418 |
| Other Study ID Numbers: |
9019 NCI-2014-00769 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 9019 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium ) P30CA015704 ( U.S. NIH Grant/Contract ) |
| First Posted: | April 23, 2014 Key Record Dates |
| Results First Posted: | April 13, 2018 |
| Last Update Posted: | April 13, 2018 |
| Last Verified: | April 2018 |
Additional relevant MeSH terms:
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Leukemia Neoplasms Leukemia, Myeloid Leukemia, Myeloid, Acute Preleukemia Leukemia, Myelomonocytic, Chronic Leukemia, Myelomonocytic, Juvenile Myelodysplastic Syndromes Myeloproliferative Disorders Syndrome Disease Pathologic Processes Neoplasms by Histologic Type Bone Marrow Diseases Hematologic Diseases |
Precancerous Conditions Myelodysplastic-Myeloproliferative Diseases Cytarabine Decitabine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Enzyme Inhibitors |