Trial Outcomes & Findings for Azacitidine and Etanercept in Treating Patients With Myelodysplastic Syndromes (NCT NCT00118287)
NCT ID: NCT00118287
Last Updated: 2017-05-24
Results Overview
Count of participants with a hematologic improvement (erythroid, platelet, or neutrophil response), assessed at 3 months.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
32 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2017-05-24
Participant Flow
Participant milestones
| Measure |
Treatment (Chemotherapy, Chemoprotection)
Patients receive etanercept SC twice weekly during weeks 1 and 2 and azacitidine SC or IV over 10-40 minutes on days 1-7. Treatment repeats every 28 days for at least 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
azacitidine: Given SC or IV
etanercept: Given SC
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Treatment (Chemotherapy, Chemoprotection)
Patients receive etanercept SC twice weekly during weeks 1 and 2 and azacitidine SC or IV over 10-40 minutes on days 1-7. Treatment repeats every 28 days for at least 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
azacitidine: Given SC or IV
etanercept: Given SC
|
|---|---|
|
Overall Study
Intracranial haemorrhage
|
1
|
|
Overall Study
Muscle pain
|
1
|
Baseline Characteristics
Azacitidine and Etanercept in Treating Patients With Myelodysplastic Syndromes
Baseline characteristics by cohort
| Measure |
Treatment (Chemotherapy, Chemoprotection)
n=32 Participants
Patients receive etanercept SC twice weekly during weeks 1 and 2 and azacitidine SC or IV over 10-40 minutes on days 1-7. Treatment repeats every 28 days for at least 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
azacitidine: Given SC or IV
etanercept: Given SC
|
|---|---|
|
Age, Continuous
|
69 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsCount of participants with a hematologic improvement (erythroid, platelet, or neutrophil response), assessed at 3 months.
Outcome measures
| Measure |
Treatment (Chemotherapy, Chemoprotection)
n=32 Participants
Patients receive etanercept SC twice weekly during weeks 1 and 2 and azacitidine SC or IV over 10-40 minutes on days 1-7. Treatment repeats every 28 days for at least 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
azacitidine: Given SC or IV
etanercept: Given SC
|
|---|---|
|
Frequency of Hematologic Responses, as Defined by International Working Group (IWG) Criteria
Erythroid response
|
14 Participants
|
|
Frequency of Hematologic Responses, as Defined by International Working Group (IWG) Criteria
Platelet response
|
8 Participants
|
|
Frequency of Hematologic Responses, as Defined by International Working Group (IWG) Criteria
Neutrophil response
|
1 Participants
|
|
Frequency of Hematologic Responses, as Defined by International Working Group (IWG) Criteria
No response
|
7 Participants
|
|
Frequency of Hematologic Responses, as Defined by International Working Group (IWG) Criteria
Withdrawn from study
|
2 Participants
|
Adverse Events
Treatment (Chemotherapy, Chemoprotection)
Serious events: 5 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Chemotherapy, Chemoprotection)
n=32 participants at risk
Patients receive etanercept SC twice weekly during weeks 1 and 2 and azacitidine SC or IV over 10-40 minutes on days 1-7. Treatment repeats every 28 days for at least 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
azacitidine: Given SC or IV
etanercept: Given SC
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
3.1%
1/32
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis and fever
|
3.1%
1/32
|
|
Cardiac disorders
Cardiopulmonary arrest resulting in death
|
3.1%
1/32
|
|
Blood and lymphatic system disorders
Splenic rupture with splenectomy
|
3.1%
1/32
|
|
Hepatobiliary disorders
Gall Bladder removal with benign mass
|
3.1%
1/32
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary nodule
|
3.1%
1/32
|
|
Infections and infestations
Endocarditis
|
3.1%
1/32
|
|
Nervous system disorders
CNS hemorrhages
|
9.4%
3/32
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.1%
1/32
|
Other adverse events
| Measure |
Treatment (Chemotherapy, Chemoprotection)
n=32 participants at risk
Patients receive etanercept SC twice weekly during weeks 1 and 2 and azacitidine SC or IV over 10-40 minutes on days 1-7. Treatment repeats every 28 days for at least 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
azacitidine: Given SC or IV
etanercept: Given SC
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
59.4%
19/32
|
|
Musculoskeletal and connective tissue disorders
Arthritis, Joint pain
|
15.6%
5/32
|
|
Cardiac disorders
Atrial fibrillation/flutter
|
9.4%
3/32
|
|
Skin and subcutaneous tissue disorders
Bleeding from cuts
|
6.2%
2/32
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
18.8%
6/32
|
|
Vascular disorders
Hematoma
|
6.2%
2/32
|
|
Blood and lymphatic system disorders
Coagulopathy
|
9.4%
3/32
|
|
Cardiac disorders
Congestive heart failure
|
18.8%
6/32
|
|
Metabolism and nutrition disorders
Dehydration, 1 with diarrhea
|
6.2%
2/32
|
|
Gastrointestinal disorders
Diverticulitis
|
6.2%
2/32
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea on exertion
|
9.4%
3/32
|
|
Cardiac disorders
Elevated cardiac enzymes
|
9.4%
3/32
|
|
General disorders
Mouth/Gum Bleeding
|
6.2%
2/32
|
|
General disorders
Fatigue
|
34.4%
11/32
|
|
General disorders
Weakness
|
6.2%
2/32
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
21.9%
7/32
|
|
Hepatobiliary disorders
Gallstones
|
6.2%
2/32
|
|
Hepatobiliary disorders
Hematuria
|
28.1%
9/32
|
|
Skin and subcutaneous tissue disorders
Hives, urticaria
|
9.4%
3/32
|
|
Investigations
Hyperbilirubinemia
|
9.4%
3/32
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.2%
2/32
|
|
Metabolism and nutrition disorders
Hyponatremia
|
25.0%
8/32
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
21.9%
7/32
|
|
Gastrointestinal disorders
Ileus
|
6.2%
2/32
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
34.4%
11/32
|
|
Blood and lymphatic system disorders
Leukopenia
|
46.9%
15/32
|
|
Blood and lymphatic system disorders
Lymphopenia
|
50.0%
16/32
|
|
Investigations
Neutropenia
|
53.1%
17/32
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusions
|
6.2%
2/32
|
|
Gastrointestinal disorders
Rectal or GI bleeding
|
18.8%
6/32
|
|
Renal and urinary disorders
Renal failure
|
6.2%
2/32
|
|
Investigations
Thrombocytopenia
|
53.1%
17/32
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
6.2%
2/32
|
|
Musculoskeletal and connective tissue disorders
Compression fractures
|
6.2%
2/32
|
|
Cardiac disorders
Hypertension
|
6.2%
2/32
|
|
Skin and subcutaneous tissue disorders
Squamos cell carcinoma removal
|
6.2%
2/32
|
|
Musculoskeletal and connective tissue disorders
Gout
|
6.2%
2/32
|
|
Cardiac disorders
Hypotension
|
12.5%
4/32
|
|
Blood and lymphatic system disorders
Transfusion reaction
|
9.4%
3/32
|
|
Musculoskeletal and connective tissue disorders
Limited upper extremity function, after injury
|
6.2%
2/32
|
|
Blood and lymphatic system disorders
Petechia
|
6.2%
2/32
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
2/32
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
6.2%
2/32
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place