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A Study of 5-Azacitidine (Vidaza®) in Patients With Chronic Myelomonocytic Leukemia

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ClinicalTrials.gov Identifier: NCT01350947
Recruitment Status : Completed
First Posted : May 10, 2011
Results First Posted : October 29, 2015
Last Update Posted : June 13, 2016
Sponsor:
Collaborator:
Celgene
Information provided by (Responsible Party):
University of Utah

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Myelomonocytic Leukemia
Intervention Drug: 5-Azacitidine
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1 - 5-Azacitidine
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 11
Completed 11
Not Completed 0
Arm/Group Title All Patients
Hide Arm/Group Description

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 Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 11 participants
69
(56 to 85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
5
  45.5%
Male
6
  54.5%
1.Primary Outcome
Title Percentage of Patients With Complete Hematologic Response (According to IWG 2006 Criteria) in CMML Patients Treated With 5-azacitidine.
Hide Description 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
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - 5-Azacitidine
Hide Arm/Group Description:

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 Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: percentage of patients
27
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1 - 5-Azacitidine
Hide Arm/Group Description

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.

All-Cause Mortality
Arm 1 - 5-Azacitidine
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Arm 1 - 5-Azacitidine
Affected / at Risk (%) # Events
Total   2/11 (18.18%)    
Blood and lymphatic system disorders   
leukocytosis  1/11 (9.09%)  1
Hematochezia  1/11 (9.09%)  1
Gastrointestinal disorders   
Mucositis  1/11 (9.09%)  1
General disorders   
Fatigue  1/11 (9.09%)  1
wound treatment  1/11 (9.09%)  1
Investigations   
Thrombocytopenia  1/11 (9.09%)  1
Nervous system disorders   
seizure  1/11 (9.09%)  1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm 1 - 5-Azacitidine
Affected / at Risk (%) # Events
Total   11/11 (100.00%)    
Blood and lymphatic system disorders   
Anemia  7/11 (63.64%)  22
bloody discharge from urethra  1/11 (9.09%)  1
Hematochezia  1/11 (9.09%)  1
leucocytosis  1/11 (9.09%)  1
neutropenic fever  1/11 (9.09%)  2
Cardiac disorders   
Occasional palpitations  1/11 (9.09%)  1
tachycardia  1/11 (9.09%)  1
Ear and labyrinth disorders   
labyrinthitis  1/11 (9.09%)  1
ear lesion  1/11 (9.09%)  1
Eye disorders   
Broken Blood Vessel of the Eye  1/11 (9.09%)  1
eye irratation  1/11 (9.09%)  1
eye swelling  1/11 (9.09%)  1
Gastrointestinal disorders   
Abdominal Cramping  2/11 (18.18%)  2
abdominal pain  2/11 (18.18%)  2
bloating  1/11 (9.09%)  1
Constipation  9/11 (81.82%)  10
Diarrhea  3/11 (27.27%)  3
dry mouth  1/11 (9.09%)  1
dyspepsia  1/11 (9.09%)  1
dysphagia  1/11 (9.09%)  1
epigastric pain  1/11 (9.09%)  1
loose stool  1/11 (9.09%)  1
mouth sores  1/11 (9.09%)  1
Nausea  6/11 (54.55%)  11
oral herpes lesion  1/11 (9.09%)  1
stomach pain  1/11 (9.09%)  1
tooth pain  1/11 (9.09%)  1
Vomiting  3/11 (27.27%)  3
General disorders   
chest pain  1/11 (9.09%)  1
chills  1/11 (9.09%)  1
cold sweats  1/11 (9.09%)  1
cold symptoms  1/11 (9.09%)  1
Cooler Lower Extremeties  1/11 (9.09%)  1
dry nose  1/11 (9.09%)  1
Fatigue  5/11 (45.45%)  5
flu like symptoms  2/11 (18.18%)  2
injection reaction  3/11 (27.27%)  5
malaise  2/11 (18.18%)  2
Night Sweats  2/11 (18.18%)  2
Nightmares  1/11 (9.09%)  1
Nose Sore  1/11 (9.09%)  1
wound treatment  1/11 (9.09%)  1
Infections and infestations   
Bacteremia  1/11 (9.09%)  1
cellulitis  2/11 (18.18%)  2
port site infection  1/11 (9.09%)  1
Rhinitis  1/11 (9.09%)  1
rhinovirus  1/11 (9.09%)  1
Urinary Tract Infection  1/11 (9.09%)  1
viral conjunctivitis  1/11 (9.09%)  1
Injury, poisoning and procedural complications   
ankle sprain  1/11 (9.09%)  1
chest lesion  1/11 (9.09%)  1
Fall  3/11 (27.27%)  4
hip pain  1/11 (9.09%)  1
laceration  2/11 (18.18%)  3
scalp lesions  1/11 (9.09%)  1
shin lesion  1/11 (9.09%)  1
Sinus Infection  2/11 (18.18%)  2
Investigations   
decreased neutrophil  1/11 (9.09%)  1
increased creatinine  1/11 (9.09%)  1
Leukopenia  7/11 (63.64%)  26
Thrombocytopenia  6/11 (54.55%)  40
tooth infection  1/11 (9.09%)  1
Weight Gain  1/11 (9.09%)  1
Metabolism and nutrition disorders   
anorexia  2/11 (18.18%)  2
back pain  2/11 (18.18%)  3
Dehydration  1/11 (9.09%)  1
hyperglycema  1/11 (9.09%)  1
Hypomagnesemia  1/11 (9.09%)  1
Musculoskeletal and connective tissue disorders   
anthralgia  3/11 (27.27%)  3
bone pain  1/11 (9.09%)  1
flank pain  2/11 (18.18%)  2
foot edema  1/11 (9.09%)  1
leg pain  1/11 (9.09%)  2
limited movement of limb  1/11 (9.09%)  1
Muscle Cramps  1/11 (9.09%)  1
muscle weakness  1/11 (9.09%)  1
tendinitis  1/11 (9.09%)  1
torn ligament  1/11 (9.09%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
chloroma  1/11 (9.09%)  1
parovaria cyst  1/11 (9.09%)  1
Nervous system disorders   
Dizziness  3/11 (27.27%)  3
Dysgeusia  3/11 (27.27%)  4
headache  2/11 (18.18%)  2
neuropathy  1/11 (9.09%)  3
neutropenia  7/11 (63.64%)  59
seizures  1/11 (9.09%)  1
syncope  1/11 (9.09%)  2
tremor  1/11 (9.09%)  1
Psychiatric disorders   
Depression  3/11 (27.27%)  4
insomnia  1/11 (9.09%)  1
Renal and urinary disorders   
frequent urination  1/11 (9.09%)  1
Prostatitis  1/11 (9.09%)  1
Reproductive system and breast disorders   
pelvic pain  1/11 (9.09%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  3/11 (27.27%)  3
dyspnea  3/11 (27.27%)  3
Epistaxis  3/11 (27.27%)  4
Hemoptysis  1/11 (9.09%)  1
Hypoxia  1/11 (9.09%)  1
Nasal Congestion  1/11 (9.09%)  1
Pneumonia  1/11 (9.09%)  1
Sleep apnea  1/11 (9.09%)  1
sore throat  1/11 (9.09%)  1
Upper Respiratory Infection  2/11 (18.18%)  2
Skin and subcutaneous tissue disorders   
bruising  4/11 (36.36%)  4
dermatitis  1/11 (9.09%)  1
Ecchymoses  2/11 (18.18%)  3
erythmea  1/11 (9.09%)  1
face burning  1/11 (9.09%)  1
itching  1/11 (9.09%)  1
rash  2/11 (18.18%)  3
Vascular disorders   
hematoma  3/11 (27.27%)  3
Hot Flashes  1/11 (9.09%)  1
hypotension  1/11 (9.09%)  1
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mark Wade
Organization: Huntsman Cancer Institute
Phone: 801-213-5746
EMail: mark.wade@hci.utah.edu
Layout table for additonal information
Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT01350947    
Other Study ID Numbers: HCI47081
First Submitted: April 29, 2011
First Posted: May 10, 2011
Results First Submitted: September 28, 2015
Results First Posted: October 29, 2015
Last Update Posted: June 13, 2016