An interventional study of Cytarabine and Decitabine in Chronic Myelomonocytic Leukemia-2, Myelodysplastic Syndrome and Myeloproliferative Neoplasm, sponsored by University of Washington. Completed at 9 sites in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2018-04-13.
Sponsored by University of Washington · Not applicable, Interventional, and Treatment
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.
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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 12 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
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Inclusion Criteria:
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.
Drug: Cytarabine · Drug: Decitabine · Other: Laboratory Biomarker Analysis
Given IV
Also known as: .beta.-Cytosine arabinoside, 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-.beta.-D-Arabinofuranosylcytosine, 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-Beta-D-arabinofuranosylcytosine, 1.beta.-D-Arabinofuranosylcytosine, 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-, 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-, Alexan, Ara-C, ARA-cell, Arabine, Arabinofuranosylcytosine, Arabinosylcytosine, Aracytidine, Aracytin, Aracytine, Beta-Cytosine Arabinoside, CHX-3311, Cytarabinum, Cytarbel, Cytosar, Cytosar-U, Cytosine Arabinoside, Cytosine-.beta.-arabinoside, Cytosine-beta-arabinoside, Erpalfa, Starasid, Tarabine PFS, U 19920, U-19920, Udicil, WR-28453
Given IV
Also known as: 5-Aza-2'-deoxycytidine, Dacogen, Decitabine for Injection, Deoxyazacytidine, Dezocitidine
Correlative studies
Overall Survival of Patients Over Age 60 With Newly Diagnosed AML/High Risk MDS
Compared to historical data of a completed Southwestern Oncology Group (SWOG) trial of azacitidine and gemtuzumab ozogamicin.
Time frame: At 6 months
Response Rate
Rate of Complete Response or Complete Response with Incomplete Count Recovery
Time frame: Up to 2 years
| Milestone | Treatment (Decitabine, Cytarabine) |
|---|---|
| Started | 12 |
| Completed | 12 |
| Not completed | 0 |
Compared to historical data of a completed Southwestern Oncology Group (SWOG) trial of azacitidine and gemtuzumab ozogamicin.
| participants | Treatment (Decitabine, Cytarabine) |
|---|---|
| Overall Survival of Patients Over Age 60 With Newly Diagnosed AML/High Risk MDS | 7 |
Rate of Complete Response or Complete Response with Incomplete Count Recovery
| participants | Treatment (Decitabine, Cytarabine) |
|---|---|
| Complete Respnose | 4 |
| Complete Response with Incomplete Count Recovery | 3 |
Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (Decitabine, Cytarabine) | 9/12 (75%) | 11/12 (91.7%) | — |
| Event | Treatment (Decitabine, Cytarabine) |
|---|---|
| PneumoniaInfections and infestations | 6/12 |
| Febrile NeutropeniaInfections and infestations | 4/12 |
| Staph BacteremiaInfections and infestations | 2/12 |
| Muscle WeaknessMusculoskeletal and connective tissue disorders | 2/12 |
| MRSA BacteremiaInfections and infestations | 1/12 |
| HyponatremiaInvestigations | 1/12 |
| HypertensionBlood and lymphatic system disorders | 1/12 |
| HypokalemiaInvestigations | 1/12 |
| Right cheek cellulitisSkin and subcutaneous tissue disorders | 1/12 |
| Bacterial Liver AbscessHepatobiliary disorders | 1/12 |
| Age, Categorical(Participants) | Treatment (Decitabine, Cytarabine) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 0 |
| >=65 years | 12 |
| Sex: Female, Male(Participants) | Treatment (Decitabine, Cytarabine) |
|---|---|
| Female | 3 |
| Male | 9 |
| Ethnicity (NIH/OMB)(Participants) | Treatment (Decitabine, Cytarabine) |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 9 |
| Unknown or Not Reported | 2 |
| Race (NIH/OMB)(Participants) | Treatment (Decitabine, Cytarabine) |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 8 |
| More than one race | 1 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Treatment (Decitabine, Cytarabine) |
|---|---|
| United States | 12 |
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