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Trial record 73 of 4360 for:    bone tumors AND NOT metastatic

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
Recruitment Status : Completed
First Posted : April 23, 2014
Results First Posted : April 13, 2018
Last Update Posted : April 13, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Pamela S Becker, University of Washington

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Chronic Myelomonocytic Leukemia-2
Myelodysplastic Syndrome
Myeloproliferative Neoplasm
Untreated Adult Acute Myeloid Leukemia
Interventions Drug: Cytarabine
Drug: Decitabine
Other: Laboratory Biomarker Analysis
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Decitabine, Cytarabine)
Hide Arm/Group Description 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. 12 patients were consented and treated.
Period Title: Overall Study
Started 12
Completed 12
Not Completed 0
Arm/Group Title Treatment (Decitabine, Cytarabine)
Hide Arm/Group Description 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. 12 patients were consented and treated.
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
0
   0.0%
Between 18 and 65 years
0
   0.0%
>=65 years
12
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
3
  25.0%
Male
9
  75.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Hispanic or Latino
1
   8.3%
Not Hispanic or Latino
9
  75.0%
Unknown or Not Reported
2
  16.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
American Indian or Alaska Native
1
   8.3%
Asian
1
   8.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
8
  66.7%
More than one race
1
   8.3%
Unknown or Not Reported
1
   8.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
1.Primary Outcome
Title Overall Survival of Patients Over Age 60 With Newly Diagnosed AML/High Risk MDS
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Decitabine, Cytarabine)
Hide Arm/Group Description:
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. 12 patients were consented and treated.
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: participants
7
2.Secondary Outcome
Title Response Rate
Hide Description Rate of Complete Response or Complete Response with Incomplete Count Recovery
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Decitabine, Cytarabine)
Hide Arm/Group Description:
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. 12 patients were consented and treated.
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: participants
Complete Respnose 4
Complete Response with Incomplete Count Recovery 3
Time Frame 2 years
Adverse Event Reporting Description Other [not including serious] adverse events were not addressed.
 
Arm/Group Title Treatment (Decitabine, Cytarabine)
Hide Arm/Group Description 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. 12 patients were consented and treated.
All-Cause Mortality
Treatment (Decitabine, Cytarabine)
Affected / at Risk (%)
Total   9/12 (75.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Decitabine, Cytarabine)
Affected / at Risk (%) # Events
Total   11/12 (91.67%)    
Blood and lymphatic system disorders   
Hypertension   1/12 (8.33%)  1
Cardiac disorders   
Syncope   1/12 (8.33%)  1
Afibrillation   1/12 (8.33%)  1
Gastrointestinal disorders   
Diarrhea   1/12 (8.33%)  1
Esophagogastric mucosal junction ulcer   1/12 (8.33%)  1
General disorders   
Fatigue   1/12 (8.33%)  1
Hepatobiliary disorders   
Bacterial Liver Abscess   1/12 (8.33%)  1
Infections and infestations   
Febrile Neutropenia   4/12 (33.33%)  5
Pneumonia   6/12 (50.00%)  6
MRSA Bacteremia   1/12 (8.33%)  1
Staph Bacteremia   2/12 (16.67%)  2
Bacteremia   1/12 (8.33%)  1
C. Difficile Diarrhea   1/12 (8.33%)  1
Pyomyositis of B/L calf   1/12 (8.33%)  1
Clostridium Ramosum bacteremia   1/12 (8.33%)  1
Rothia Bacteremia   1/12 (8.33%)  1
Oral mucositis   1/12 (8.33%)  1
Diverticulitis   1/12 (8.33%)  1
Investigations   
Hyponatremia   1/12 (8.33%)  1
Hypokalemia   1/12 (8.33%)  1
Hyperbilirubinemia   1/12 (8.33%)  1
Musculoskeletal and connective tissue disorders   
Muscle Weakness   2/12 (16.67%)  2
Hypoxia   1/12 (8.33%)  1
Skin and subcutaneous tissue disorders   
Right cheek cellulitis   1/12 (8.33%)  1
Rash   1/12 (8.33%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Decitabine, Cytarabine)
Affected / at Risk (%) # Events
Total   0/0    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Pamela Becker
Organization: University of Washington
Phone: 206-606-7273
Responsible Party: Pamela S Becker, University of Washington
ClinicalTrials.gov Identifier: NCT02121418     History of Changes
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 Submitted: April 21, 2014
First Posted: April 23, 2014
Results First Submitted: February 8, 2018
Results First Posted: April 13, 2018
Last Update Posted: April 13, 2018