Trial Outcomes & Findings for Study of Decitabine for Treatment of Older Patients With Acute Myeloid Leukemia (AML) (NCT NCT00358644)
NCT ID: NCT00358644
Last Updated: 2013-05-20
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
1 year
Results posted on
2013-05-20
Participant Flow
Participant milestones
| Measure |
Decitabine 20 mg/m2 Intravenous
Decitabine 20 mg/m2 Intravenous on Days 1-5 of each 28 day cycle
|
|---|---|
|
Overall Study
STARTED
|
55
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
50
|
Reasons for withdrawal
| Measure |
Decitabine 20 mg/m2 Intravenous
Decitabine 20 mg/m2 Intravenous on Days 1-5 of each 28 day cycle
|
|---|---|
|
Overall Study
Progressive Disease
|
21
|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
Death
|
11
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Physician Decision
|
6
|
|
Overall Study
Patient not eligible for study
|
1
|
Baseline Characteristics
Study of Decitabine for Treatment of Older Patients With Acute Myeloid Leukemia (AML)
Baseline characteristics by cohort
| Measure |
Decitabine 20 mg/m2 Intravenous
n=55 Participants
Decitabine 20 mg/m2 Intravenous on Days 1-5 of each 28 day cycle
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
48 Participants
n=5 Participants
|
|
Age Continuous
|
73.0 years
STANDARD_DEVIATION 6.84 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
50 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
|
|
Region of Enrollment
United States
|
55 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Intent-to-Treat (ITT)
Outcome measures
| Measure |
Decitabine 20 mg/m2 Intravenous
n=55 Participants
Decitabine 20 mg/m2 Intravenous on Days 1-5 of each 28 day cycle
|
|---|---|
|
Complete Response = Morphologic Complete Remission (mCR)
|
13 Participants
|
Adverse Events
Decitabine 20 mg/m2 Intravenous
Serious events: 40 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Decitabine 20 mg/m2 Intravenous
n=55 participants at risk
Decitabine 20 mg/m2 Intravenous on Days 1-5 of each 28 day cycle
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.8%
1/55
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
23.6%
13/55
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.3%
4/55
|
|
Cardiac disorders
Angina Pectoris
|
1.8%
1/55
|
|
Blood and lymphatic system disorders
Atrial Fibrillation
|
3.6%
2/55
|
|
Cardiac disorders
Myocardial Infarction
|
1.8%
1/55
|
|
Gastrointestinal disorders
Caecitis
|
1.8%
1/55
|
|
Gastrointestinal disorders
Diarrhea
|
5.5%
3/55
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
1.8%
1/55
|
|
Gastrointestinal disorders
Nausea
|
1.8%
1/55
|
|
Gastrointestinal disorders
Toothache
|
1.8%
1/55
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
1.8%
1/55
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
1/55
|
|
General disorders
Catheter Thrombosis
|
1.8%
1/55
|
|
General disorders
Chest Pain
|
1.8%
1/55
|
|
General disorders
Disease Progression
|
16.4%
9/55
|
|
General disorders
Mucosal Inflammation
|
1.8%
1/55
|
|
General disorders
Performance Status Decreased
|
5.5%
3/55
|
|
General disorders
Pyrexia
|
7.3%
4/55
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
1.8%
1/55
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
1.8%
1/55
|
|
Infections and infestations
Alpha Haemolytic Streptococcal Infection
|
1.8%
1/55
|
|
Infections and infestations
Bacteraemia
|
10.9%
6/55
|
|
Infections and infestations
Catheter Site Infection
|
1.8%
1/55
|
|
Infections and infestations
Cellulitis
|
1.8%
1/55
|
|
Infections and infestations
Clostridium Difficile Colitis
|
7.3%
4/55
|
|
Infections and infestations
Enterocolitis Infectious
|
1.8%
1/55
|
|
Infections and infestations
Fungaemia
|
1.8%
1/55
|
|
Infections and infestations
Fungal Sepsis
|
1.8%
1/55
|
|
Infections and infestations
Gingival Infection
|
1.8%
1/55
|
|
Infections and infestations
Groin Abscess
|
1.8%
1/55
|
|
Infections and infestations
Lobar Pneumonia
|
1.8%
1/55
|
|
Infections and infestations
Pneumonia
|
12.7%
7/55
|
|
Infections and infestations
Pneumonia Fungal
|
1.8%
1/55
|
|
Infections and infestations
Pneumonia Klebsiella
|
1.8%
1/55
|
|
Infections and infestations
Pneumonia Primary Atypical
|
1.8%
1/55
|
|
Infections and infestations
Pseudomonal Bacteraemia
|
1.8%
1/55
|
|
Infections and infestations
Sepsis
|
14.5%
8/55
|
|
Infections and infestations
Staphylococcal Bacteraemia
|
5.5%
3/55
|
|
Infections and infestations
Staphylococcal Infection
|
1.8%
1/55
|
|
Infections and infestations
Staphylococcal Sepsis
|
1.8%
1/55
|
|
Infections and infestations
Streptococcal Bacteraemia
|
1.8%
1/55
|
|
Infections and infestations
Tonsillitis
|
1.8%
1/55
|
|
Infections and infestations
Tooth Abscess
|
1.8%
1/55
|
|
Infections and infestations
Urinary Tract Infection
|
7.3%
4/55
|
|
Infections and infestations
Urosepsis
|
1.8%
1/55
|
|
Injury, poisoning and procedural complications
Haemolytic Transfusion Reaction
|
1.8%
1/55
|
|
Injury, poisoning and procedural complications
Subdural Haemorrhage
|
1.8%
1/55
|
|
Investigations
Blood Creatinine Increased
|
1.8%
1/55
|
|
Metabolism and nutrition disorders
Acidosis
|
1.8%
1/55
|
|
Metabolism and nutrition disorders
Dehydration
|
1.8%
1/55
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.8%
1/55
|
|
Metabolism and nutrition disorders
Malnutrition
|
1.8%
1/55
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
1.8%
1/55
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukaemia
|
1.8%
1/55
|
|
Nervous system disorders
Haemorrhage Intracranial
|
1.8%
1/55
|
|
Psychiatric disorders
Mental Status Changes
|
3.6%
2/55
|
|
Renal and urinary disorders
Renal Failure
|
3.6%
2/55
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
1.8%
1/55
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.6%
2/55
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.8%
1/55
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Haemorrhage
|
1.8%
1/55
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
1.8%
1/55
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
5.5%
3/55
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
1.8%
1/55
|
|
Vascular disorders
Embolism
|
1.8%
1/55
|
|
Vascular disorders
Hypotension
|
3.6%
2/55
|
Other adverse events
| Measure |
Decitabine 20 mg/m2 Intravenous
n=55 participants at risk
Decitabine 20 mg/m2 Intravenous on Days 1-5 of each 28 day cycle
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
25.5%
14/55
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
30.9%
17/55
|
|
Blood and lymphatic system disorders
Leukopenia
|
12.7%
7/55
|
|
Blood and lymphatic system disorders
Lymphopenia
|
7.3%
4/55
|
|
Blood and lymphatic system disorders
Neutropenia
|
25.5%
14/55
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
21.8%
12/55
|
|
Cardiac disorders
Atrial Fibrillation
|
7.3%
4/55
|
|
Cardiac disorders
Sinus Tachycardia
|
5.5%
3/55
|
|
Cardiac disorders
Tachycardia
|
9.1%
5/55
|
|
Ear and labyrinth disorders
Ear Pain
|
5.5%
3/55
|
|
Eye disorders
Conjuntival Haemorrhage
|
5.5%
3/55
|
|
Gastrointestinal disorders
Abdominal Pain
|
14.5%
8/55
|
|
Gastrointestinal disorders
Constipation
|
41.8%
23/55
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
22/55
|
|
Gastrointestinal disorders
Gingival Bleeding
|
5.5%
3/55
|
|
Gastrointestinal disorders
Nausea
|
50.9%
28/55
|
|
Gastrointestinal disorders
Oral Pain
|
9.1%
5/55
|
|
Gastrointestinal disorders
Stomatitis
|
7.3%
4/55
|
|
Gastrointestinal disorders
Toothache
|
5.5%
3/55
|
|
Gastrointestinal disorders
Vomiting
|
29.1%
16/55
|
|
General disorders
Asthenia
|
30.9%
17/55
|
|
General disorders
Catheter Site Pain
|
5.5%
3/55
|
|
General disorders
Chills
|
23.6%
13/55
|
|
General disorders
Disease Progression
|
16.4%
9/55
|
|
General disorders
Fatigue
|
67.3%
37/55
|
|
General disorders
Mucosal Inflammation
|
20.0%
11/55
|
|
General disorders
Oedema
|
20.0%
11/55
|
|
General disorders
Oedema Peripheral
|
36.4%
20/55
|
|
General disorders
Pain
|
18.2%
10/55
|
|
General disorders
Performance Status Decreased
|
9.1%
5/55
|
|
General disorders
Pyrexia
|
43.6%
24/55
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
5.5%
3/55
|
|
Infections and infestations
Bacteraemia
|
12.7%
7/55
|
|
Infections and infestations
Candidiasis
|
5.5%
3/55
|
|
Infections and infestations
Cellulitis
|
5.5%
3/55
|
|
Infections and infestations
Clostridium Difficile Colitis
|
9.1%
5/55
|
|
Infections and infestations
Pneumonia
|
16.4%
9/55
|
|
Infections and infestations
Sepsis
|
14.5%
8/55
|
|
Infections and infestations
Staphylococcal Bacteraemia
|
5.5%
3/55
|
|
Infections and infestations
Urinary Tract Infection
|
12.7%
7/55
|
|
Injury, poisoning and procedural complications
Contusion
|
14.5%
8/55
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
14.5%
8/55
|
|
Investigations
Alanine Aminotransferase Increased
|
7.3%
4/55
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
7.3%
4/55
|
|
Investigations
Blood Creatinine Increased
|
10.9%
6/55
|
|
Investigations
International Normalised Ratio Increased
|
10.9%
6/55
|
|
Investigations
Weight Decreased
|
5.5%
3/55
|
|
Metabolism and nutrition disorders
Anorexia
|
16.4%
9/55
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
16.4%
9/55
|
|
Metabolism and nutrition disorders
Fluid Overload
|
9.1%
5/55
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
9.1%
5/55
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.5%
3/55
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
16.4%
9/55
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
18.2%
10/55
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
29.1%
16/55
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
18.2%
10/55
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
10.9%
6/55
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
10.9%
6/55
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.7%
7/55
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
14.5%
8/55
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
12.7%
7/55
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
5.5%
3/55
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
5.5%
3/55
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
14.5%
8/55
|
|
Nervous system disorders
Dizziness
|
27.3%
15/55
|
|
Nervous system disorders
Headache
|
23.6%
13/55
|
|
Nervous system disorders
Hypoaesthesia
|
5.5%
3/55
|
|
Psychiatric disorders
Anxiety
|
9.1%
5/55
|
|
Psychiatric disorders
Depression
|
9.1%
5/55
|
|
Psychiatric disorders
Insomnia
|
18.2%
10/55
|
|
Renal and urinary disorders
Renal Failure
|
9.1%
5/55
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
29.1%
16/55
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
40.0%
22/55
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
7.3%
4/55
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.5%
3/55
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.3%
4/55
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
7.3%
4/55
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal Sinus Hypersecretion
|
7.3%
4/55
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
18.2%
10/55
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
5.5%
3/55
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
7.3%
4/55
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
7.3%
4/55
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.5%
3/55
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
9.1%
5/55
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.5%
3/55
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
7.3%
4/55
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
9.1%
5/55
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
9.1%
5/55
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
5.5%
3/55
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.5%
8/55
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
5.5%
3/55
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
7.3%
4/55
|
|
Vascular disorders
Hypertension
|
9.1%
5/55
|
|
Vascular disorders
Hypotension
|
16.4%
9/55
|
Additional Information
Eisai Call Center
Eisai Inc.
Phone: 888-422-4743
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place