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

Information source: University of Washington
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(15;17)(q22;q12); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Chronic Myelomonocytic Leukemia; de Novo Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable; Previously Treated Myelodysplastic Syndromes; Untreated Adult Acute Myeloid Leukemia

Intervention: decitabine (Drug); cytarabine (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: University of Washington

Official(s) and/or principal investigator(s):
Pamela Becker, Principal Investigator, Affiliation: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

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.

Clinical Details

Official title: Decitabine Plus Cytarabine for Induction of Remission in Newly Diagnosed Elderly Acute Myeloid Leukemia (AML) and Advanced Myelodysplastic Syndrome (MDS)

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Overall survival

CR rate

Detailed description: 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 ara-C (cytarabine) (100 mg/m2 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 periodically.

Eligibility

Minimum age: 60 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Bozeman Deaconess Cancer Center, Bozeman, Montana 59715, United States; Not yet recruiting
Jack O. Hensold, Phone: 406-585-5070
Jack O. Hensold, Principal Investigator

Kadlec Clinic Hematology and Oncology, Kennewick, Washington 99336, United States; Not yet recruiting
Thomas A. Rado, Phone: 509-783-0144
Thomas A. Rado, Principal Investigator

EvergreenHealth Medical Center, Kirkland, Washington 98033, United States; Not yet recruiting
Aimee D. Kohn, Phone: 425-899-3953
Aimee D. Kohn, Principal Investigator

Skagit Valley Hospital, Mount Vernon, Washington 98274, United States; Not yet recruiting
Kiarash Kojouri, Phone: 360-428-2146
Kiarash Kojouri, Principal Investigator

Olympic Medical Center, Port Angeles, Washington 98362, United States; Not yet recruiting
Thomas D. Kummet, Phone: 360-683-9895
Thomas D. Kummet, Principal Investigator

Group Health Cooperative, Redmond, Washington 98052, United States; Not yet recruiting
Eric Y. Chen, Phone: 425-502-3690
Eric Y. Chen, Principal Investigator

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington 98109, United States; Recruiting
Pamela S. Becker, Phone: 206-543-3360
Pamela S. Becker, Principal Investigator

Multicare Health System, Tacoma, Washington 98415, United States; Not yet recruiting
John A. Keech, Phone: 253-403-1677
John A. Keech, Principal Investigator

Wenatchee Valley Medical Center, Wenatchee, Washington 98801, United States; Not yet recruiting
Mitchell A. Garrison, Phone: 509-663-8711
Mitchell A. Garrison, Principal Investigator

Additional Information

Starting date: June 2014
Last updated: March 23, 2015

Page last updated: August 20, 2015

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