Trial Outcomes & Findings for Liposomal Vincristine Plus Dexamethasone in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (NCT NCT00144963)
NCT ID: NCT00144963
Last Updated: 2019-12-12
Results Overview
Subjects had to receive at least 1 course consisting of 4 weekly infusions of VSLI at the assigned drug dose with a minimum 2 weeks of observation after the last VSLI dose to be included in the evaluation of the MTD.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
36 participants
Primary outcome timeframe
6 weeks
Results posted on
2019-12-12
Participant Flow
Participant milestones
| Measure |
VSLI
Vincristine Sulfate Liposomes Injection (VSLI)
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Liposomal Vincristine Plus Dexamethasone in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
Baseline characteristics by cohort
| Measure |
VSLI
n=36 Participants
Vincristine Sulfate Liposomes Injection (VSLI)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
36.3 years
STANDARD_DEVIATION 13.83 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: This study was designed to define the MTD of VSLI. Up to 7 sequential escalating dose cohorts (1.5, 1.825, 2.0, 2.25, 2.4, 2.6, and 2.8 mg/m2) were planned, with at least 3 subjects in each cohort. Escalation to the next higher dose cohort was allowed to proceed only if no nonhematologic DLT was observed.
Subjects had to receive at least 1 course consisting of 4 weekly infusions of VSLI at the assigned drug dose with a minimum 2 weeks of observation after the last VSLI dose to be included in the evaluation of the MTD.
Outcome measures
| Measure |
VSLI
n=26 Participants
Vincristine Sulfate Liposomes Injection (VSLI)
|
|---|---|
|
MTD of VSLI
|
2.25 mg/m2
|
Adverse Events
VSLI
Serious events: 33 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VSLI
n=36 participants at risk
Vincristine Sulfate Liposomes Injection (VSLI)
|
|---|---|
|
Psychiatric disorders
mental status changes
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Cardiac disorders
cardiac arrest
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Infections and infestations
Bacteraemia
|
47.2%
17/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Infections and infestations
Pneumonia, fungal
|
8.3%
3/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Infections and infestations
pneumonia
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Blood and lymphatic system disorders
febrile neutropenia
|
33.3%
12/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Blood and lymphatic system disorders
neutropenia
|
8.3%
3/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
General disorders
pyrexia
|
27.8%
10/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Gastrointestinal disorders
abdominal pain
|
11.1%
4/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Gastrointestinal disorders
oesophagitis
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Metabolism and nutrition disorders
dehydration
|
8.3%
3/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Metabolism and nutrition disorders
failure to thrive
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Metabolism and nutrition disorders
hyperglycemia
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Vascular disorders
hypotension
|
19.4%
7/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Investigations
alanine aminotransferase increased
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Investigations
aspartate aminotransferase increased
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Respiratory, thoracic and mediastinal disorders
respiratory distress
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Nervous system disorders
peripheral neuropathy
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Psychiatric disorders
confusional state
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
Other adverse events
| Measure |
VSLI
n=36 participants at risk
Vincristine Sulfate Liposomes Injection (VSLI)
|
|---|---|
|
Metabolism and nutrition disorders
hyperglycaemia
|
41.7%
15/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Metabolism and nutrition disorders
hypokalaemia
|
27.8%
10/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Metabolism and nutrition disorders
decreased appetite
|
25.0%
9/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Metabolism and nutrition disorders
hypomagnesaemia
|
25.0%
9/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Metabolism and nutrition disorders
dehydration
|
22.2%
8/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Metabolism and nutrition disorders
hypocalcaemia
|
16.7%
6/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Metabolism and nutrition disorders
hyperphosphataemia
|
8.3%
3/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Metabolism and nutrition disorders
hyponatraemia
|
8.3%
3/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Metabolism and nutrition disorders
hypophosphataemia
|
8.3%
3/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Metabolism and nutrition disorders
failure to thrive
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Metabolism and nutrition disorders
hyperkalaemia
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Metabolism and nutrition disorders
hyperuricaemia
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Metabolism and nutrition disorders
metabolic acidosis
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Blood and lymphatic system disorders
anaemia
|
47.2%
17/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Blood and lymphatic system disorders
febrile neutropenia
|
38.9%
14/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Blood and lymphatic system disorders
neutropenia
|
36.1%
13/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
36.1%
13/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Blood and lymphatic system disorders
leukopenia
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
General disorders
fatigue
|
61.1%
22/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
General disorders
pyrexia
|
50.0%
18/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
General disorders
chills
|
33.3%
12/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
General disorders
oedema peripheral
|
19.4%
7/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
General disorders
oedema
|
13.9%
5/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
General disorders
asthenia
|
11.1%
4/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
General disorders
chest pain
|
11.1%
4/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
General disorders
pain
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Nervous system disorders
neuropathy peripheral
|
52.8%
19/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Nervous system disorders
dizziness
|
27.8%
10/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Nervous system disorders
headache
|
25.0%
9/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Nervous system disorders
paraesthesia
|
22.2%
8/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Nervous system disorders
hypoaesthesia
|
11.1%
4/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Nervous system disorders
peripheral sensory neuropathy
|
11.1%
4/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Nervous system disorders
encephalopathy
|
8.3%
3/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Nervous system disorders
peripheral motor neuropathy
|
8.3%
3/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Nervous system disorders
dysgeusia
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Nervous system disorders
neuralgia
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Nervous system disorders
tremor
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Gastrointestinal disorders
constipation
|
66.7%
24/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Gastrointestinal disorders
nausea
|
47.2%
17/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Gastrointestinal disorders
abdominal pain
|
44.4%
16/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Gastrointestinal disorders
diarrhoea
|
41.7%
15/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Gastrointestinal disorders
abdominal distension
|
22.2%
8/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Gastrointestinal disorders
gatrooesophageal reflux disease
|
19.4%
7/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Gastrointestinal disorders
vomitting
|
16.7%
6/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Gastrointestinal disorders
abdominal discomfort
|
8.3%
3/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Gastrointestinal disorders
dyspepsia
|
8.3%
3/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Gastrointestinal disorders
dry mouth
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Gastrointestinal disorders
gingival bleeding
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Gastrointestinal disorders
oesophagitis
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Gastrointestinal disorders
pancreatitis
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Gastrointestinal disorders
rectal haemorrhage
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
36.1%
13/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Musculoskeletal and connective tissue disorders
bone pain
|
33.3%
12/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
16.7%
6/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Musculoskeletal and connective tissue disorders
muscular weakness
|
16.7%
6/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Musculoskeletal and connective tissue disorders
back pain
|
11.1%
4/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
11.1%
4/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Musculoskeletal and connective tissue disorders
muscle spasms
|
8.3%
3/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Musculoskeletal and connective tissue disorders
flank pain
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Musculoskeletal and connective tissue disorders
myopathy
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Infections and infestations
bacteraemia
|
25.0%
9/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Infections and infestations
staphylococcal bacteraemia
|
11.1%
4/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Infections and infestations
pneumonia
|
8.3%
3/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Infections and infestations
pneumonia fungal
|
8.3%
3/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Infections and infestations
bacterial infection
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Infections and infestations
enterococcal bacteraemia
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Infections and infestations
sepsis
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Infections and infestations
urinary tract infection
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Investigations
alanine aminotransferase increased
|
25.0%
9/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Investigations
aspartate aminotransferase increased
|
22.2%
8/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Investigations
blood lactate dehydrogenase increased
|
16.7%
6/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Investigations
blood alkaline phosphatase increased
|
11.1%
4/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Investigations
blood urea increased
|
11.1%
4/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
30.6%
11/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea
|
22.2%
8/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Respiratory, thoracic and mediastinal disorders
hiccups
|
13.9%
5/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Respiratory, thoracic and mediastinal disorders
oropharyngeal pain
|
11.1%
4/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
11.1%
4/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
8.3%
3/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Respiratory, thoracic and mediastinal disorders
pleuritic pain
|
8.3%
3/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Respiratory, thoracic and mediastinal disorders
rhinitis alergic
|
8.3%
3/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Respiratory, thoracic and mediastinal disorders
atelectasis
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Respiratory, thoracic and mediastinal disorders
dysphonia
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Respiratory, thoracic and mediastinal disorders
epistasis
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Respiratory, thoracic and mediastinal disorders
respiratory distress
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Respiratory, thoracic and mediastinal disorders
rhinorrhoea
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Respiratory, thoracic and mediastinal disorders
sinus congestion
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Psychiatric disorders
insomnia
|
44.4%
16/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Psychiatric disorders
anxiety
|
19.4%
7/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Psychiatric disorders
confusional state
|
19.4%
7/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Psychiatric disorders
mental status change
|
11.1%
4/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Psychiatric disorders
depression
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Psychiatric disorders
sleep disorder
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Skin and subcutaneous tissue disorders
rash
|
13.9%
5/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Skin and subcutaneous tissue disorders
petechiae
|
11.1%
4/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Skin and subcutaneous tissue disorders
dry skin
|
8.3%
3/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Skin and subcutaneous tissue disorders
ecchymosis
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Skin and subcutaneous tissue disorders
erythema
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Skin and subcutaneous tissue disorders
hyperhidrosis
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Skin and subcutaneous tissue disorders
night sweats
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Vascular disorders
hypotension
|
33.3%
12/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Vascular disorders
hypertension
|
13.9%
5/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Cardiac disorders
tachycardia
|
25.0%
9/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Cardiac disorders
cardiac arrest
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Cardiac disorders
sinus tachycardia
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Eye disorders
vision blurred
|
13.9%
5/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Hepatobiliary disorders
hyperbilirubinaemia
|
8.3%
3/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Injury, poisoning and procedural complications
contusion
|
8.3%
3/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
|
Reproductive system and breast disorders
vaginal haemorrhage
|
5.6%
2/36 • start of dosing until 30 days after permanent discontinuation of study treatment or until permanent discontinuation of study treatment and initiation of a subsequent anti-leukemia therapy
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60