Trial Outcomes & Findings for Low-Dose Decitabine in Myelodysplastic Syndrome Post Azacytidine Failure (NCT NCT00113321)
NCT ID: NCT00113321
Last Updated: 2012-08-07
Results Overview
Participants with Overall Response, categorized as 'Complete Response' to represent remission or 'No Complete Response' for lack of remission. Response evaluation after completing one course of therapy (8-12 weeks), then bone marrow aspiration to document remission every 1-3 courses.
TERMINATED
PHASE2
16 participants
Blood tests baseline and after completing 8-12 weeks of therapy
2012-08-07
Participant Flow
Recruitment Period 3/28/05 - 11/7/08; all patients were registered at The University of Texas M.D. Anderson Cancer Center.
Study was terminated due to low accrual.
Participant milestones
| Measure |
Decitabine
20 mg/m2 by vein (IV) over 1 hour daily x 5 days.
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Low-Dose Decitabine in Myelodysplastic Syndrome Post Azacytidine Failure
Baseline characteristics by cohort
| Measure |
Decitabine
n=16 Participants
20 mg/m2 by vein (IV) over 1 hour daily x 5 days.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
|
Age Continuous
|
75 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood tests baseline and after completing 8-12 weeks of therapyPopulation: Treated population (16 patients); No further analysis done since study terminated early due to low accrual.
Participants with Overall Response, categorized as 'Complete Response' to represent remission or 'No Complete Response' for lack of remission. Response evaluation after completing one course of therapy (8-12 weeks), then bone marrow aspiration to document remission every 1-3 courses.
Outcome measures
| Measure |
Decitabine
n=16 Participants
20 mg/m2 by vein (IV) over 1 hour daily x 5 days.
|
|---|---|
|
Overall Response
Complete Response
|
3 Participants
|
|
Overall Response
No Complete Response
|
13 Participants
|
Adverse Events
Decitabine
Serious adverse events
| Measure |
Decitabine
n=16 participants at risk
20 mg/m2 by vein (IV) over 1 hour daily x 5 days.
|
|---|---|
|
General disorders
Death
|
18.8%
3/16 • Number of events 3 • 2 years 1 month
|
|
Infections and infestations
Febrile Neutropenia
|
12.5%
2/16 • Number of events 3 • 2 years 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.2%
1/16 • Number of events 1 • 2 years 1 month
|
|
Cardiac disorders
Elevated Cardiac Triponin
|
6.2%
1/16 • Number of events 1 • 2 years 1 month
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow (Other) - Spleen
|
6.2%
1/16 • Number of events 1 • 2 years 1 month
|
Other adverse events
| Measure |
Decitabine
n=16 participants at risk
20 mg/m2 by vein (IV) over 1 hour daily x 5 days.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.2%
1/16 • Number of events 1 • 2 years 1 month
|
|
Metabolism and nutrition disorders
Elevated Alanine transaminase (ALT)
|
18.8%
3/16 • Number of events 3 • 2 years 1 month
|
|
Gastrointestinal disorders
Anorexia
|
43.8%
7/16 • Number of events 7 • 2 years 1 month
|
|
Metabolism and nutrition disorders
Elevated aspartate aminotransferase (AST)
|
43.8%
7/16 • Number of events 7 • 2 years 1 month
|
|
Metabolism and nutrition disorders
Elevated Bilirubin
|
6.2%
1/16 • Number of events 1 • 2 years 1 month
|
|
Gastrointestinal disorders
Constipation
|
6.2%
1/16 • Number of events 1 • 2 years 1 month
|
|
Metabolism and nutrition disorders
Elevated Creatinine
|
6.2%
1/16 • Number of events 1 • 2 years 1 month
|
|
Infections and infestations
Febrile Neutropenia
|
6.2%
1/16 • Number of events 1 • 2 years 1 month
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
12.5%
2/16 • Number of events 2 • 2 years 1 month
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory (0ther)
|
6.2%
1/16 • Number of events 1 • 2 years 1 month
|
|
Gastrointestinal disorders
Mucositis
|
6.2%
1/16 • Number of events 1 • 2 years 1 month
|
|
Gastrointestinal disorders
Nausea
|
31.2%
5/16 • Number of events 5 • 2 years 1 month
|
|
General disorders
Pain
|
6.2%
1/16 • Number of events 1 • 2 years 1 month
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
4/16 • Number of events 4 • 2 years 1 month
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
2/16 • Number of events 2 • 2 years 1 month
|
Additional Information
Hagop Kantarjian, M.D., Professor
The University of Texas M. D. Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place