Trial Outcomes & Findings for Does Maitake Mushroom Extract Enhance Hematopoiesis in Myelodysplastic Patients? (NCT NCT01099917)
NCT ID: NCT01099917
Last Updated: 2016-05-19
Results Overview
The main criterion for study response is ability of the study agent to show a statistically significant improvement in neutrophil count and neutrophil function (as measured by the respiratory burst test). Changes in neutrophil counts will also be described as defined by the International Working Group (IWG) criteria for response in MDS patients
COMPLETED
PHASE2
45 participants
baseline and week 12
2016-05-19
Participant Flow
Participant milestones
| Measure |
Maitake
This is a phase II trial examining hematopoietic response in Myelodisplastic Patients.
|
|---|---|
|
Overall Study
STARTED
|
45
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
27
|
Reasons for withdrawal
| Measure |
Maitake
This is a phase II trial examining hematopoietic response in Myelodisplastic Patients.
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Not Treated
|
24
|
Baseline Characteristics
Does Maitake Mushroom Extract Enhance Hematopoiesis in Myelodysplastic Patients?
Baseline characteristics by cohort
| Measure |
Maitake
n=21 Participants
This is a phase II trial examining hematopoietic response in Myelodisplastic Patients.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and week 12The main criterion for study response is ability of the study agent to show a statistically significant improvement in neutrophil count and neutrophil function (as measured by the respiratory burst test). Changes in neutrophil counts will also be described as defined by the International Working Group (IWG) criteria for response in MDS patients
Outcome measures
| Measure |
Maitake
n=18 Participants
This is a phase II trial examining hematopoietic response in Myelodisplastic Patients.
|
|---|---|
|
Changes in Neutrophil Counts
|
-0.3 cells/mm^3
Interval -0.5 to 0.0
|
Adverse Events
Maitake
Serious adverse events
| Measure |
Maitake
n=21 participants at risk
This is a phase II trial examining hematopoietic response in Myelodisplastic Patients.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
4.8%
1/21 • Number of events 1
|
|
General disorders
Aphonia
|
4.8%
1/21 • Number of events 1
|
|
Nervous system disorders
Confusion
|
4.8%
1/21 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.8%
1/21 • Number of events 1
|
|
Nervous system disorders
Edema cerebral
|
4.8%
1/21 • Number of events 1
|
|
Eye disorders
Eye disorders - Other
|
4.8%
1/21 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
4.8%
1/21 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukocytosis
|
4.8%
1/21 • Number of events 1
|
|
Infections and infestations
Lung infection
|
4.8%
1/21 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
4.8%
1/21 • Number of events 1
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
4.8%
1/21 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.8%
1/21 • Number of events 1
|
|
Nervous system disorders
Stroke
|
4.8%
1/21 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
4.8%
1/21 • Number of events 1
|
Other adverse events
| Measure |
Maitake
n=21 participants at risk
This is a phase II trial examining hematopoietic response in Myelodisplastic Patients.
|
|---|---|
|
Blood and lymphatic system disorders
Blood bilirubin increased
|
9.5%
2/21
|
|
General disorders
Headache
|
19.0%
4/21
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
19.0%
4/21
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
9.5%
2/21 • Number of events 2
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
47.6%
10/21
|
|
General disorders
Pain in extremity
|
9.5%
2/21
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
42.9%
9/21 • Number of events 9
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
52.4%
11/21
|
Additional Information
Dr. Barrie Cassileth
Memorial Sloan Kettering Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place