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 survivalCR 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
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