Trial Outcomes & Findings for Interleukin-7 (CYT107) Treatment of Idiopathic CD4 Lymphocytopenia: Expansion of CD4 T Cells (ICICLE) (NCT NCT00839436)
NCT ID: NCT00839436
Last Updated: 2015-10-15
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
21 participants
Primary outcome timeframe
48 weeks per patient with a 3-4 year enrollment period
Results posted on
2015-10-15
Participant Flow
Participant milestones
| Measure |
3 mcg/kg Cohort
|
10 mcg/kg Cohort
|
20 mcg/kg Cohort
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
5
|
1
|
|
Overall Study
COMPLETED
|
2
|
4
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
3 mcg/kg Cohort
|
10 mcg/kg Cohort
|
20 mcg/kg Cohort
|
|---|---|---|---|
|
Overall Study
Developed exclusionary condition
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
|
Overall Study
Study drug no longer available
|
0
|
0
|
1
|
Baseline Characteristics
Interleukin-7 (CYT107) Treatment of Idiopathic CD4 Lymphocytopenia: Expansion of CD4 T Cells (ICICLE)
Baseline characteristics by cohort
| Measure |
3 mcg/kg Cohort
n=3 Participants
|
10 mcg/kg Cohort
n=5 Participants
|
20 mcg/kg Cohort
n=1 Participants
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Continuous
|
49 years
n=5 Participants
|
56 years
n=7 Participants
|
33 years
n=5 Participants
|
51 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
1 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
CD4 T cell count
|
13 cells/microliter
n=5 Participants
|
52 cells/microliter
n=7 Participants
|
15 cells/microliter
n=5 Participants
|
18 cells/microliter
n=4 Participants
|
PRIMARY outcome
Timeframe: 48 weeks per patient with a 3-4 year enrollment periodOutcome measures
| Measure |
3 mcg/kg Cohort
n=3 Participants
|
10 mcg/kg Cohort
n=5 Participants
|
20 mcg/kg Cohort
n=1 Participants
|
|---|---|---|---|
|
Adverse Events and Toxicities Associated With CYT107.
Grade 5 Adverse Events
|
0 Events
|
0 Events
|
0 Events
|
|
Adverse Events and Toxicities Associated With CYT107.
Grade 4 Adverse Events
|
0 Events
|
0 Events
|
0 Events
|
|
Adverse Events and Toxicities Associated With CYT107.
Grade 3 Adverse Events
|
3 Events
|
0 Events
|
0 Events
|
|
Adverse Events and Toxicities Associated With CYT107.
Grade 2 Adverse Events
|
21 Events
|
45 Events
|
0 Events
|
|
Adverse Events and Toxicities Associated With CYT107.
Grade 1 Adverse Events
|
103 Events
|
112 Events
|
8 Events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 48 weeks per patient with a 3-4 year enrollment periodOutcome measures
Outcome data not reported
Adverse Events
3 mcg/kg Cohort
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
10 mcg/kg Cohort
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
20 mcg/kg Cohort
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
3 mcg/kg Cohort
n=3 participants at risk
|
10 mcg/kg Cohort
n=5 participants at risk
|
20 mcg/kg Cohort
n=1 participants at risk
|
|---|---|---|---|
|
Immune system disorders
Systemic Lupus Erythematosis
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
0.00%
0/1
|
|
Gastrointestinal disorders
Gastroenteritis
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
0.00%
0/1
|
|
Immune system disorders
Acute hypersensitivity reaction
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
0.00%
0/1
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
0.00%
0/1
|
Other adverse events
| Measure |
3 mcg/kg Cohort
n=3 participants at risk
|
10 mcg/kg Cohort
n=5 participants at risk
|
20 mcg/kg Cohort
n=1 participants at risk
|
|---|---|---|---|
|
Investigations
lymphocyte count decreased
|
0.00%
0/3
|
0.00%
0/5
|
100.0%
1/1 • Number of events 1
|
|
Nervous system disorders
headache
|
66.7%
2/3 • Number of events 8
|
40.0%
2/5 • Number of events 2
|
100.0%
1/1 • Number of events 1
|
|
Blood and lymphatic system disorders
lymphadenopathy
|
66.7%
2/3 • Number of events 5
|
20.0%
1/5 • Number of events 3
|
100.0%
1/1 • Number of events 1
|
|
General disorders
pyrexia
|
0.00%
0/3
|
20.0%
1/5 • Number of events 3
|
100.0%
1/1 • Number of events 1
|
|
General disorders
injection site reaction
|
100.0%
3/3 • Number of events 6
|
100.0%
5/5 • Number of events 20
|
100.0%
1/1 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3
|
0.00%
0/5
|
100.0%
1/1 • Number of events 2
|
|
General disorders
feeling hot
|
0.00%
0/3
|
0.00%
0/5
|
100.0%
1/1 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
33.3%
1/3 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
hyperglycaemia
|
33.3%
1/3 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
hyperhydrosis
|
33.3%
1/3 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
muscle spasms
|
33.3%
1/3 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
rash
|
33.3%
1/3 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/1
|
|
General disorders
Localised oedema
|
66.7%
2/3 • Number of events 2
|
20.0%
1/5 • Number of events 1
|
0.00%
0/1
|
|
General disorders
injection site recall reaction
|
66.7%
2/3 • Number of events 5
|
20.0%
1/5 • Number of events 1
|
0.00%
0/1
|
|
Investigations
Blood bicarbonate abnormal
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
0.00%
0/1
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
0.00%
0/1
|
|
Psychiatric disorders
depression
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
0.00%
0/1
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
hyperlipidaemia
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
0.00%
0/1
|
|
Psychiatric disorders
insomnia
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
muscle strain
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
0.00%
0/1
|
|
Psychiatric disorders
panic disorder
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
0.00%
0/1
|
|
Investigations
platelet count decreased
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
0.00%
0/1
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
0.00%
0/1
|
|
Nervous system disorders
presyncope
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
procedural pain
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
0.00%
0/1
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
skin hyperpigmentation
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
skin ulcer
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
0.00%
0/1
|
|
Nervous system disorders
tremor
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
0.00%
0/1
|
|
Infections and infestations
vulvovaginal candidiasis
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
0.00%
0/1
|
|
General disorders
pain
|
33.3%
1/3 • Number of events 1
|
40.0%
2/5 • Number of events 2
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
hyponatraemia
|
33.3%
1/3 • Number of events 2
|
20.0%
1/5 • Number of events 2
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Number of events 3
|
20.0%
1/5 • Number of events 2
|
0.00%
0/1
|
|
Cardiac disorders
angina pectoris
|
0.00%
0/3
|
20.0%
1/5 • Number of events 2
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
contusion
|
0.00%
0/3
|
20.0%
1/5 • Number of events 2
|
0.00%
0/1
|
|
Gastrointestinal disorders
flatulence
|
0.00%
0/3
|
40.0%
2/5 • Number of events 2
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
hyperkalaemia
|
0.00%
0/3
|
20.0%
1/5 • Number of events 2
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
hypoalbuminaemia
|
0.00%
0/3
|
40.0%
2/5 • Number of events 2
|
0.00%
0/1
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.00%
0/3
|
20.0%
1/5 • Number of events 2
|
0.00%
0/1
|
|
Gastrointestinal disorders
tooth disorder
|
0.00%
0/3
|
40.0%
2/5 • Number of events 2
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.00%
0/3
|
40.0%
2/5 • Number of events 3
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
hypophosphataemia
|
0.00%
0/3
|
60.0%
3/5 • Number of events 3
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
night sweats
|
0.00%
0/3
|
20.0%
1/5 • Number of events 3
|
0.00%
0/1
|
|
General disorders
tenderness
|
33.3%
1/3 • Number of events 1
|
60.0%
3/5 • Number of events 4
|
0.00%
0/1
|
|
Cardiac disorders
palpitations
|
0.00%
0/3
|
40.0%
2/5 • Number of events 4
|
0.00%
0/1
|
|
Nervous system disorders
dizziness
|
33.3%
1/3 • Number of events 1
|
60.0%
3/5 • Number of events 6
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
33.3%
1/3 • Number of events 2
|
60.0%
3/5 • Number of events 6
|
0.00%
0/1
|
|
Gastrointestinal disorders
nausea
|
66.7%
2/3 • Number of events 2
|
40.0%
2/5 • Number of events 6
|
0.00%
0/1
|
|
Investigations
haemoglobin decreased
|
100.0%
3/3 • Number of events 13
|
40.0%
2/5 • Number of events 7
|
0.00%
0/1
|
|
General disorders
Chills
|
0.00%
0/3
|
40.0%
2/5 • Number of events 7
|
0.00%
0/1
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Number of events 1
|
80.0%
4/5 • Number of events 8
|
0.00%
0/1
|
|
General disorders
fatigue
|
66.7%
2/3 • Number of events 4
|
60.0%
3/5 • Number of events 8
|
0.00%
0/1
|
|
General disorders
injection site pruritis
|
0.00%
0/3
|
80.0%
4/5 • Number of events 12
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
acne
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
0.00%
0/1
|
|
Infections and infestations
alveolar osteitis
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
0.00%
0/1
|
|
Gastrointestinal disorders
anogenital dysplasia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
0.00%
0/1
|
|
Gastrointestinal disorders
apthous ulcer
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
arthropod bite
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
0.00%
0/1
|
|
Reproductive system and breast disorders
Breast discharge
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
0.00%
0/1
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
0.00%
0/1
|
|
Gastrointestinal disorders
colitis
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
0.00%
0/1
|
|
Gastrointestinal disorders
dry moutn
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
dry skin
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
eczema
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
0.00%
0/1
|
|
Ear and labyrinth disorders
external ear pain
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
0.00%
0/1
|
|
Eye disorders
eye pain
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
0.00%
0/1
|
|
Gastrointestinal disorders
gastritis
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
hiccups
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
hypocalaemia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
hypokalaemia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
0.00%
0/1
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
0.00%
0/1
|
|
Psychiatric disorders
libido increased
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
0.00%
0/1
|
|
General disorders
malaise
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
0.00%
0/1
|
|
Infections and infestations
Molluscum contagiosum
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal disorder
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
0.00%
0/1
|
|
Gastrointestinal disorders
Oesophagitis
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
osteoporosis
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
0.00%
0/1
|
|
Nervous system disorders
Parosmia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
pruritis
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
0.00%
0/1
|
|
Infections and infestations
pyuria
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
0.00%
0/1
|
|
Infections and infestations
sinusitis
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
0.00%
0/1
|
|
Surgical and medical procedures
supplementation therapy
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
tenosynovitis
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
0.00%
0/1
|
|
Gastrointestinal disorders
toothache
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
urticaria
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
0.00%
0/1
|
|
Eye disorders
vision blurred
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
0.00%
0/1
|
|
Gastrointestinal disorders
vomiting
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
0.00%
0/1
|
|
Investigations
Alanine aminotransferase increased
|
66.7%
2/3 • Number of events 2
|
0.00%
0/5
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
alopecia
|
33.3%
1/3 • Number of events 2
|
0.00%
0/5
|
0.00%
0/1
|
|
Investigations
Aspartate aminotransferase increased
|
66.7%
2/3 • Number of events 2
|
0.00%
0/5
|
0.00%
0/1
|
|
Gastrointestinal disorders
constipation
|
33.3%
1/3 • Number of events 2
|
0.00%
0/5
|
0.00%
0/1
|
|
Nervous system disorders
Dysgeusia
|
33.3%
1/3 • Number of events 2
|
0.00%
0/5
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
erythema
|
66.7%
2/3 • Number of events 2
|
0.00%
0/5
|
0.00%
0/1
|
|
Eye disorders
eye disorder
|
33.3%
1/3 • Number of events 2
|
0.00%
0/5
|
0.00%
0/1
|
|
Renal and urinary disorders
Haematuria
|
33.3%
1/3 • Number of events 2
|
0.00%
0/5
|
0.00%
0/1
|
|
Vascular disorders
hot flush
|
33.3%
1/3 • Number of events 2
|
0.00%
0/5
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
hypoglycaemia
|
33.3%
1/3 • Number of events 2
|
0.00%
0/5
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
33.3%
1/3 • Number of events 2
|
0.00%
0/5
|
0.00%
0/1
|
|
Renal and urinary disorders
proteinuria
|
33.3%
1/3 • Number of events 2
|
0.00%
0/5
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
66.7%
2/3 • Number of events 3
|
0.00%
0/5
|
0.00%
0/1
|
|
Gastrointestinal disorders
abdominal pain
|
66.7%
2/3 • Number of events 4
|
0.00%
0/5
|
0.00%
0/1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place