Trial Outcomes & Findings for A Study of 5-Azacitidine (Vidaza®) in Patients With Chronic Myelomonocytic Leukemia (NCT NCT01350947)
NCT ID: NCT01350947
Last Updated: 2016-06-13
Results Overview
Complete Hematologic Response is defined as: bone marrow evaluation shows \<= 5% myeloblasts with normal maturation of all cells lines; peripheral blood evaluation shows hemoglobin \>= 11 g/dL, neutrophils \>= 1000/mL, platelets \>= 100,000/mL, 0% blasts
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
24 months
Results posted on
2016-06-13
Participant Flow
Participant milestones
| Measure |
Arm 1 - 5-Azacitidine
All participants enrolled.
5-Azacitidine: Administered on Days 1-7 of each Cycle.
Subcutaneous administration:
To provide a homogeneous suspension, the contents of the syringe must be re-suspended by inverting the syringe 2-3 times and vigorously rolling the syringe between the palms for 30 seconds immediately prior to administration.
The 5-azacitidine suspension is administered subcutaneously.
Intravenous Administration:
5-Azacitidine solution is administered intravenously. Administer the total dose over a period of 10-40 minutes.
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of 5-Azacitidine (Vidaza®) in Patients With Chronic Myelomonocytic Leukemia
Baseline characteristics by cohort
| Measure |
All Patients
n=11 Participants
All participants enrolled.
5-Azacitidine: Administered on Days 1-7 of each Cycle.
Subcutaneous administration:
To provide a homogeneous suspension, the contents of the syringe must be re-suspended by inverting the syringe 2-3 times and vigorously rolling the syringe between the palms for 30 seconds immediately prior to administration.
The 5-azacitidine suspension is administered subcutaneously.
Intravenous Administration:
5-Azacitidine solution is administered intravenously. Administer the total dose over a period of 10-40 minutes.
|
|---|---|
|
Age, Continuous
|
69 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 monthsComplete Hematologic Response is defined as: bone marrow evaluation shows \<= 5% myeloblasts with normal maturation of all cells lines; peripheral blood evaluation shows hemoglobin \>= 11 g/dL, neutrophils \>= 1000/mL, platelets \>= 100,000/mL, 0% blasts
Outcome measures
| Measure |
Arm 1 - 5-Azacitidine
n=11 Participants
All participants enrolled.
5-Azacitidine: Administered on Days 1-7 of each Cycle.
Subcutaneous administration:
To provide a homogeneous suspension, the contents of the syringe must be re-suspended by inverting the syringe 2-3 times and vigorously rolling the syringe between the palms for 30 seconds immediately prior to administration.
The 5-azacitidine suspension is administered subcutaneously.
Intravenous Administration:
5-Azacitidine solution is administered intravenously. Administer the total dose over a period of 10-40 minutes.
|
|---|---|
|
Percentage of Patients With Complete Hematologic Response (According to IWG 2006 Criteria) in CMML Patients Treated With 5-azacitidine.
|
27 percentage of patients
|
Adverse Events
Arm 1 - 5-Azacitidine
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1 - 5-Azacitidine
n=11 participants at risk
All participants enrolled.
5-Azacitidine: Administered on Days 1-7 of each Cycle.
Subcutaneous administration:
To provide a homogeneous suspension, the contents of the syringe must be re-suspended by inverting the syringe 2-3 times and vigorously rolling the syringe between the palms for 30 seconds immediately prior to administration.
The 5-azacitidine suspension is administered subcutaneously.
Intravenous Administration:
5-Azacitidine solution is administered intravenously. Administer the total dose over a period of 10-40 minutes.
|
|---|---|
|
General disorders
Fatigue
|
9.1%
1/11 • Number of events 1
|
|
Blood and lymphatic system disorders
leukocytosis
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis
|
9.1%
1/11 • Number of events 1
|
|
Investigations
Thrombocytopenia
|
9.1%
1/11 • Number of events 1
|
|
Blood and lymphatic system disorders
Hematochezia
|
9.1%
1/11 • Number of events 1
|
|
Nervous system disorders
seizure
|
9.1%
1/11 • Number of events 1
|
|
General disorders
wound treatment
|
9.1%
1/11 • Number of events 1
|
Other adverse events
| Measure |
Arm 1 - 5-Azacitidine
n=11 participants at risk
All participants enrolled.
5-Azacitidine: Administered on Days 1-7 of each Cycle.
Subcutaneous administration:
To provide a homogeneous suspension, the contents of the syringe must be re-suspended by inverting the syringe 2-3 times and vigorously rolling the syringe between the palms for 30 seconds immediately prior to administration.
The 5-azacitidine suspension is administered subcutaneously.
Intravenous Administration:
5-Azacitidine solution is administered intravenously. Administer the total dose over a period of 10-40 minutes.
|
|---|---|
|
Gastrointestinal disorders
Abdominal Cramping
|
18.2%
2/11 • Number of events 2
|
|
Gastrointestinal disorders
abdominal pain
|
18.2%
2/11 • Number of events 2
|
|
Blood and lymphatic system disorders
Anemia
|
63.6%
7/11 • Number of events 22
|
|
Injury, poisoning and procedural complications
ankle sprain
|
9.1%
1/11 • Number of events 1
|
|
Metabolism and nutrition disorders
anorexia
|
18.2%
2/11 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
anthralgia
|
27.3%
3/11 • Number of events 3
|
|
Metabolism and nutrition disorders
back pain
|
18.2%
2/11 • Number of events 3
|
|
Infections and infestations
Bacteremia
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
bloating
|
9.1%
1/11 • Number of events 1
|
|
Blood and lymphatic system disorders
bloody discharge from urethra
|
9.1%
1/11 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
bone pain
|
9.1%
1/11 • Number of events 1
|
|
Eye disorders
Broken Blood Vessel of the Eye
|
9.1%
1/11 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
bruising
|
36.4%
4/11 • Number of events 4
|
|
Infections and infestations
cellulitis
|
18.2%
2/11 • Number of events 2
|
|
Injury, poisoning and procedural complications
chest lesion
|
9.1%
1/11 • Number of events 1
|
|
General disorders
chest pain
|
9.1%
1/11 • Number of events 1
|
|
General disorders
chills
|
9.1%
1/11 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
chloroma
|
9.1%
1/11 • Number of events 1
|
|
General disorders
cold sweats
|
9.1%
1/11 • Number of events 1
|
|
General disorders
cold symptoms
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
81.8%
9/11 • Number of events 10
|
|
General disorders
Cooler Lower Extremeties
|
9.1%
1/11 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.3%
3/11 • Number of events 3
|
|
Investigations
decreased neutrophil
|
9.1%
1/11 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
9.1%
1/11 • Number of events 1
|
|
Psychiatric disorders
Depression
|
27.3%
3/11 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
dermatitis
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
27.3%
3/11 • Number of events 3
|
|
Nervous system disorders
Dizziness
|
27.3%
3/11 • Number of events 3
|
|
Gastrointestinal disorders
dry mouth
|
9.1%
1/11 • Number of events 1
|
|
General disorders
dry nose
|
9.1%
1/11 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
27.3%
3/11 • Number of events 4
|
|
Gastrointestinal disorders
dyspepsia
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
dysphagia
|
9.1%
1/11 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
27.3%
3/11 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Ecchymoses
|
18.2%
2/11 • Number of events 3
|
|
Gastrointestinal disorders
epigastric pain
|
9.1%
1/11 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
27.3%
3/11 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
erythmea
|
9.1%
1/11 • Number of events 1
|
|
Eye disorders
eye irratation
|
9.1%
1/11 • Number of events 1
|
|
Eye disorders
eye swelling
|
9.1%
1/11 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
face burning
|
9.1%
1/11 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
27.3%
3/11 • Number of events 4
|
|
General disorders
Fatigue
|
45.5%
5/11 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
flank pain
|
18.2%
2/11 • Number of events 2
|
|
General disorders
flu like symptoms
|
18.2%
2/11 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
foot edema
|
9.1%
1/11 • Number of events 1
|
|
Renal and urinary disorders
frequent urination
|
9.1%
1/11 • Number of events 1
|
|
Nervous system disorders
headache
|
18.2%
2/11 • Number of events 2
|
|
Blood and lymphatic system disorders
Hematochezia
|
9.1%
1/11 • Number of events 1
|
|
Vascular disorders
hematoma
|
27.3%
3/11 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
9.1%
1/11 • Number of events 1
|
|
Injury, poisoning and procedural complications
hip pain
|
9.1%
1/11 • Number of events 1
|
|
Vascular disorders
Hot Flashes
|
9.1%
1/11 • Number of events 1
|
|
Metabolism and nutrition disorders
hyperglycema
|
9.1%
1/11 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
9.1%
1/11 • Number of events 1
|
|
Vascular disorders
hypotension
|
9.1%
1/11 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
9.1%
1/11 • Number of events 1
|
|
Investigations
increased creatinine
|
9.1%
1/11 • Number of events 1
|
|
General disorders
injection reaction
|
27.3%
3/11 • Number of events 5
|
|
Psychiatric disorders
insomnia
|
9.1%
1/11 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
itching
|
9.1%
1/11 • Number of events 1
|
|
Ear and labyrinth disorders
labyrinthitis
|
9.1%
1/11 • Number of events 1
|
|
Injury, poisoning and procedural complications
laceration
|
18.2%
2/11 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
leg pain
|
9.1%
1/11 • Number of events 2
|
|
Blood and lymphatic system disorders
leucocytosis
|
9.1%
1/11 • Number of events 1
|
|
Investigations
Leukopenia
|
63.6%
7/11 • Number of events 26
|
|
Musculoskeletal and connective tissue disorders
limited movement of limb
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
loose stool
|
9.1%
1/11 • Number of events 1
|
|
General disorders
malaise
|
18.2%
2/11 • Number of events 2
|
|
Gastrointestinal disorders
mouth sores
|
9.1%
1/11 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramps
|
9.1%
1/11 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
muscle weakness
|
9.1%
1/11 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
54.5%
6/11 • Number of events 11
|
|
Nervous system disorders
neuropathy
|
9.1%
1/11 • Number of events 3
|
|
Nervous system disorders
neutropenia
|
63.6%
7/11 • Number of events 59
|
|
Blood and lymphatic system disorders
neutropenic fever
|
9.1%
1/11 • Number of events 2
|
|
General disorders
Night Sweats
|
18.2%
2/11 • Number of events 2
|
|
General disorders
Nightmares
|
9.1%
1/11 • Number of events 1
|
|
General disorders
Nose Sore
|
9.1%
1/11 • Number of events 1
|
|
Cardiac disorders
Occasional palpitations
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
oral herpes lesion
|
9.1%
1/11 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
parovaria cyst
|
9.1%
1/11 • Number of events 1
|
|
Reproductive system and breast disorders
pelvic pain
|
9.1%
1/11 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
9.1%
1/11 • Number of events 1
|
|
Infections and infestations
port site infection
|
9.1%
1/11 • Number of events 1
|
|
Renal and urinary disorders
Prostatitis
|
9.1%
1/11 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
rash
|
18.2%
2/11 • Number of events 3
|
|
Ear and labyrinth disorders
ear lesion
|
9.1%
1/11 • Number of events 1
|
|
Infections and infestations
Rhinitis
|
9.1%
1/11 • Number of events 1
|
|
Infections and infestations
rhinovirus
|
9.1%
1/11 • Number of events 1
|
|
Injury, poisoning and procedural complications
scalp lesions
|
9.1%
1/11 • Number of events 1
|
|
Nervous system disorders
seizures
|
9.1%
1/11 • Number of events 1
|
|
Injury, poisoning and procedural complications
shin lesion
|
9.1%
1/11 • Number of events 1
|
|
Injury, poisoning and procedural complications
Sinus Infection
|
18.2%
2/11 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
9.1%
1/11 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
sore throat
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
stomach pain
|
9.1%
1/11 • Number of events 1
|
|
Nervous system disorders
syncope
|
9.1%
1/11 • Number of events 2
|
|
Cardiac disorders
tachycardia
|
9.1%
1/11 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
tendinitis
|
9.1%
1/11 • Number of events 1
|
|
Investigations
Thrombocytopenia
|
54.5%
6/11 • Number of events 40
|
|
Investigations
tooth infection
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
tooth pain
|
9.1%
1/11 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
torn ligament
|
9.1%
1/11 • Number of events 1
|
|
Nervous system disorders
tremor
|
9.1%
1/11 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
18.2%
2/11 • Number of events 2
|
|
Infections and infestations
Urinary Tract Infection
|
9.1%
1/11 • Number of events 1
|
|
Infections and infestations
viral conjunctivitis
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
27.3%
3/11 • Number of events 3
|
|
Investigations
Weight Gain
|
9.1%
1/11 • Number of events 1
|
|
General disorders
wound treatment
|
9.1%
1/11 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place