Trial Outcomes & Findings for A Phase II Open-Label Study of High-Dose Cytarabine and Clofarabine in Adult Patients With Refractory or Relapsed Acute Myelogenous Leukemia or Refractory or Relapsed Acute Lymphoblastic Leukemia (NCT NCT01656031)
NCT ID: NCT01656031
Last Updated: 2017-06-20
Results Overview
Response to the therapy is measured by a defined improvement in Neutrophil and platlet counts, along with improved cellularity of bone marrow biopsy (\>20% with maturation of all cell lines), \<5% blasts, auer rods must not be detectable and extramedullary leukemia or soft tissue involvment must not be present.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
39 participants
Primary outcome timeframe
5 weeks
Results posted on
2017-06-20
Participant Flow
Recruiment began 02/28/2005 and ended 08/06/2008.
Participant milestones
| Measure |
High-dose Cytarabine and Clofarabine
high-dose cytarabine administered intravenously over 3 hours followed by clofarabine administered intravenously over 2 hours daily for 5 consecutive days
|
|---|---|
|
Overall Study
STARTED
|
39
|
|
Overall Study
COMPLETED
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase II Open-Label Study of High-Dose Cytarabine and Clofarabine in Adult Patients With Refractory or Relapsed Acute Myelogenous Leukemia or Refractory or Relapsed Acute Lymphoblastic Leukemia
Baseline characteristics by cohort
| Measure |
High-dose Cytarabine and Clofarabine
n=39 Participants
high-dose cytarabine administered intravenously over 3 hours followed by clofarabine administered intravenously over 2 hours daily for 5 consecutive days
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=93 Participants
|
|
Age, Continuous
|
53.4 years
STANDARD_DEVIATION 15.9 • n=93 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 5 weeksResponse to the therapy is measured by a defined improvement in Neutrophil and platlet counts, along with improved cellularity of bone marrow biopsy (\>20% with maturation of all cell lines), \<5% blasts, auer rods must not be detectable and extramedullary leukemia or soft tissue involvment must not be present.
Outcome measures
| Measure |
High-Dose Cytarabine and Clofarabine
n=39 Participants
|
|---|---|
|
Measure Patient Response to High-dose Cytarabine Followed by Clofarabine in Adult Patients With Relapsed or Refractory AML
|
17 participants
|
Adverse Events
High-Dose Cytarabine and Clofarabine
Serious events: 39 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
High-Dose Cytarabine and Clofarabine
n=39 participants at risk
|
|---|---|
|
Investigations
low Platelets
|
100.0%
39/39 • Number of events 39
|
|
Investigations
Low WBC
|
100.0%
39/39 • Number of events 39
|
|
Investigations
Low ANC
|
97.4%
38/39 • Number of events 38
|
|
Investigations
Low Hemoglobin
|
94.9%
37/39 • Number of events 37
|
|
Investigations
hypokalemia
|
66.7%
26/39 • Number of events 26
|
|
Investigations
Lymphopenia
|
59.0%
23/39 • Number of events 23
|
|
Investigations
serum glutamic pyruvic transaminase
|
59.0%
23/39 • Number of events 23
|
|
Investigations
serum glutamic oxaloacetic transaminase
|
56.4%
22/39 • Number of events 22
|
|
Infections and infestations
Infection with high grade neutropenia
|
38.5%
15/39 • Number of events 15
|
|
Investigations
hypophosphatemia
|
35.9%
14/39 • Number of events 14
|
|
Investigations
hyperglycemia
|
30.8%
12/39 • Number of events 12
|
|
Investigations
Acidosis
|
28.2%
11/39 • Number of events 11
|
|
Investigations
Febrile neutropenia
|
28.2%
11/39 • Number of events 11
|
|
Investigations
Hypoxia
|
23.1%
9/39 • Number of events 9
|
|
Investigations
hyponatremia
|
23.1%
9/39 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
23.1%
9/39 • Number of events 9
|
|
Investigations
hyperbilirubinemia
|
20.5%
8/39 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
17.9%
7/39 • Number of events 7
|
|
Investigations
hypocalcemia
|
2.6%
1/39 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
17.9%
7/39 • Number of events 7
|
|
Infections and infestations
Lung Infection with high grade neutropenia
|
15.4%
6/39 • Number of events 6
|
|
Investigations
Bicarbonate serum-low
|
15.4%
6/39 • Number of events 6
|
|
Cardiac disorders
Hypotension
|
15.4%
6/39 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Pain: Skin
|
10.3%
4/39 • Number of events 4
|
|
Investigations
Lipase
|
10.3%
4/39 • Number of events 4
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
10.3%
4/39 • Number of events 4
|
|
Investigations
Alkalosis
|
10.3%
4/39 • Number of events 4
|
|
Investigations
Partial Thromboplastin Time
|
10.3%
4/39 • Number of events 4
|
|
Infections and infestations
Infection - Other
|
10.3%
4/39 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhea
|
10.3%
4/39 • Number of events 4
|
|
Infections and infestations
Urinary Infection with high grade neutropenia
|
7.7%
3/39 • Number of events 3
|
|
Infections and infestations
infection associated with Lymphopenia
|
7.7%
3/39 • Number of events 3
|
|
Investigations
hyperuricemia
|
7.7%
3/39 • Number of events 3
|
|
General disorders
Confusion
|
7.7%
3/39 • Number of events 3
|
|
Vascular disorders
Edema: viscera
|
7.7%
3/39 • Number of events 3
|
|
Investigations
hyperkalemia
|
7.7%
3/39 • Number of events 3
|
|
Investigations
hypoalbuminemia
|
7.7%
3/39 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
3/39 • Number of events 3
|
|
Infections and infestations
Blood Infection with high grade neutropenia
|
5.1%
2/39 • Number of events 2
|
|
Infections and infestations
Urinary with low grade neutropenia
|
5.1%
2/39 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
hemorrhage/bleeding into skin or mucosa
|
5.1%
2/39 • Number of events 2
|
|
Immune system disorders
Allergic reaction
|
5.1%
2/39 • Number of events 2
|
|
Infections and infestations
Colitis infectious
|
5.1%
2/39 • Number of events 2
|
|
Cardiac disorders
Atrial fibrillation
|
5.1%
2/39 • Number of events 2
|
|
Investigations
hypernatremia
|
5.1%
2/39 • Number of events 2
|
|
Investigations
hypermagnesemia
|
5.1%
2/39 • Number of events 2
|
|
General disorders
Fatigue
|
5.1%
2/39 • Number of events 2
|
|
Nervous system disorders
Neuropathy: motor
|
5.1%
2/39 • Number of events 2
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
5.1%
2/39 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome
|
5.1%
2/39 • Number of events 2
|
|
Renal and urinary disorders
Renal failure
|
5.1%
2/39 • Number of events 2
|
|
General disorders
Anorexia
|
5.1%
2/39 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
5.1%
2/39 • Number of events 2
|
|
Infections and infestations
Urinary tract infection
|
2.6%
1/39 • Number of events 1
|
|
Infections and infestations
Urinary tract Infection with high grade neutropenia
|
2.6%
1/39 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Upper airway Infection with high grade neutropenia
|
2.6%
1/39 • Number of events 1
|
|
Infections and infestations
Trachea Infection with high grade neutropenia
|
2.6%
1/39 • Number of events 1
|
|
Infections and infestations
Skin Infection with high grade neutropenia
|
2.6%
1/39 • Number of events 1
|
|
Infections and infestations
Nose Infection with high grade neutropenia
|
2.6%
1/39 • Number of events 1
|
|
Infections and infestations
Brain Infection with high grade neutropenia
|
2.6%
1/39 • Number of events 1
|
|
Infections and infestations
Bone Infection with high grade neutropenia
|
2.6%
1/39 • Number of events 1
|
|
Vascular disorders
"Hemorrhage, pulmonary/upper respiratory"
|
2.6%
1/39 • Number of events 1
|
|
Vascular disorders
"Hemorrhage, Vagina"
|
2.6%
1/39 • Number of events 1
|
|
Vascular disorders
"Hemorrhage, Bladder"
|
2.6%
1/39 • Number of events 1
|
|
Nervous system disorders
Tremor
|
2.6%
1/39 • Number of events 1
|
|
General disorders
Syncope (fainting)
|
2.6%
1/39 • Number of events 1
|
|
Infections and infestations
Mucositis/stomatitis Oral cavity
|
2.6%
1/39 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
2.6%
1/39 • Number of events 1
|
|
Vascular disorders
"Hemorrhage, Lung"
|
2.6%
1/39 • Number of events 1
|
|
General disorders
Pain: Rectum
|
2.6%
1/39 • Number of events 1
|
|
Infections and infestations
Lung infection
|
2.6%
1/39 • Number of events 1
|
|
Cardiac disorders
Pericardial effusion (non-malignant)
|
2.6%
1/39 • Number of events 1
|
|
General disorders
Pain
|
2.6%
1/39 • Number of events 1
|
|
General disorders
Pain: Esophagus
|
2.6%
1/39 • Number of events 1
|
|
Gastrointestinal disorders
functional obstruction of bowel
|
2.6%
1/39 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemorrhage Stomach
|
2.6%
1/39 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
2.6%
1/39 • Number of events 1
|
|
General disorders
Pain: Face
|
2.6%
1/39 • Number of events 1
|
|
General disorders
Death not associated with any term
|
2.6%
1/39 • Number of events 1
|
|
General disorders
Pain: Chest wall
|
2.6%
1/39 • Number of events 1
|
|
General disorders
Pain: Chest/thorax
|
2.6%
1/39 • Number of events 1
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
2.6%
1/39 • Number of events 1
|
|
Eye disorders
Cataract
|
2.6%
1/39 • Number of events 1
|
|
Investigations
Iron overload
|
2.6%
1/39 • Number of events 1
|
|
Investigations
Amylase
|
2.6%
1/39 • Number of events 1
|
|
Cardiac disorders
Atrial tachycardia
|
2.6%
1/39 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.6%
1/39 • Number of events 1
|
|
General disorders
Pain: Abdomen
|
2.6%
1/39 • Number of events 1
|
|
General disorders
Depression
|
2.6%
1/39 • Number of events 1
|
|
General disorders
Mood alteration: Agitation
|
2.6%
1/39 • Number of events 1
|
|
Vascular disorders
Edema: limb
|
2.6%
1/39 • Number of events 1
|
|
Vascular disorders
Edema: head and neck
|
2.6%
1/39 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.6%
1/39 • Number of events 1
|
|
Cardiac disorders
Cardiac Arrhythmia - Other
|
2.6%
1/39 • Number of events 1
|
|
Investigations
hypomagnesemia
|
2.6%
1/39 • Number of events 1
|
|
Investigations
hypoglycemia
|
2.6%
1/39 • Number of events 1
|
|
Nervous system disorders
Neuropathy: sensory
|
2.6%
1/39 • Number of events 1
|
|
Investigations
Creatinine
|
2.6%
1/39 • Number of events 1
|
|
Investigations
Alkaline phosphatase
|
2.6%
1/39 • Number of events 1
|
Other adverse events
| Measure |
High-Dose Cytarabine and Clofarabine
n=39 participants at risk
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
76.9%
30/39 • Number of events 30
|
|
Gastrointestinal disorders
Vomiting
|
56.4%
22/39 • Number of events 22
|
|
Gastrointestinal disorders
Diarrhea
|
79.5%
31/39 • Number of events 31
|
|
General disorders
Anorexia
|
53.8%
21/39 • Number of events 21
|
|
Investigations
Alkaline phosphatase
|
69.2%
27/39 • Number of events 27
|
|
Investigations
Creatinine
|
43.6%
17/39 • Number of events 17
|
|
Investigations
Proteinuria
|
20.5%
8/39 • Number of events 8
|
|
General disorders
Hair loss
|
10.3%
4/39 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
13/39 • Number of events 13
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
20.5%
8/39 • Number of events 8
|
|
General disorders
Hypertension
|
15.4%
6/39 • Number of events 6
|
|
Cardiac disorders
Hypotension
|
30.8%
12/39 • Number of events 12
|
|
Cardiac disorders
Neuropathy: sensory
|
17.9%
7/39 • Number of events 7
|
|
Nervous system disorders
Pain
|
10.3%
4/39 • Number of events 4
|
|
General disorders
Insomnia
|
35.9%
14/39 • Number of events 14
|
|
General disorders
Rigors/chills
|
38.5%
15/39 • Number of events 15
|
|
General disorders
Fatigue
|
48.7%
19/39 • Number of events 19
|
|
Investigations
hyperglycemia
|
69.2%
27/39 • Number of events 27
|
|
Investigations
hypoglycemia
|
12.8%
5/39 • Number of events 5
|
|
Investigations
hypocalcemia
|
69.2%
27/39 • Number of events 27
|
|
Investigations
hypomagnesemia
|
76.9%
30/39 • Number of events 30
|
|
Investigations
hyponatremia
|
46.2%
18/39 • Number of events 18
|
|
Investigations
hypokalemia
|
30.8%
12/39 • Number of events 12
|
|
Investigations
Bicarbonate serum-low
|
48.7%
19/39 • Number of events 19
|
|
Investigations
hypoalbuminemia
|
79.5%
31/39 • Number of events 31
|
|
Investigations
hyperbilirubinemia
|
48.7%
19/39 • Number of events 19
|
|
Investigations
serum glutamic pyruvic transaminase
|
38.5%
15/39 • Number of events 15
|
|
Investigations
hypophosphatemia
|
17.9%
7/39 • Number of events 7
|
|
Gastrointestinal disorders
Constipation
|
20.5%
8/39 • Number of events 8
|
|
General disorders
Pain: Head/headache
|
51.3%
20/39 • Number of events 20
|
|
Investigations
serum glutamic oxaloacetic transaminase
|
41.0%
16/39 • Number of events 16
|
|
Investigations
hypermagnesemia
|
12.8%
5/39 • Number of events 5
|
|
Investigations
hypernatremia
|
46.2%
18/39 • Number of events 18
|
|
General disorders
Dysphagia
|
10.3%
4/39 • Number of events 4
|
|
General disorders
Fever without neutropenia
|
12.8%
5/39 • Number of events 5
|
|
General disorders
Urinary frequency/urgency
|
15.4%
6/39 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.1%
9/39 • Number of events 9
|
|
Vascular disorders
Edema: limb
|
43.6%
17/39 • Number of events 17
|
|
Vascular disorders
Edema: viscera
|
17.9%
7/39 • Number of events 7
|
|
Vascular disorders
Confusion
|
20.5%
8/39 • Number of events 8
|
|
General disorders
Pruritus/itching
|
15.4%
6/39 • Number of events 6
|
|
General disorders
Anxiety
|
25.6%
10/39 • Number of events 10
|
|
General disorders
Depression
|
17.9%
7/39 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
46.2%
18/39 • Number of events 18
|
|
Skin and subcutaneous tissue disorders
Pain: Abdomen
|
15.4%
6/39 • Number of events 6
|
|
Investigations
Partial Thromboplastin Time
|
48.7%
19/39 • Number of events 19
|
|
Investigations
Pain: Joint
|
12.8%
5/39 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
33.3%
13/39 • Number of events 13
|
|
Cardiac disorders
Atrial fibrillation
|
12.8%
5/39 • Number of events 5
|
|
General disorders
Pain: Back
|
12.8%
5/39 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.3%
4/39 • Number of events 4
|
|
Vascular disorders
Hemorrhage respiratory
|
10.3%
4/39 • Number of events 4
|
|
Gastrointestinal disorders
Flatulence
|
10.3%
4/39 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
17.9%
7/39 • Number of events 7
|
|
General disorders
Pain: Muscle
|
10.3%
4/39 • Number of events 4
|
|
General disorders
Pain: Extremity-limb
|
20.5%
8/39 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Pain: Skin
|
12.8%
5/39 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Pericardial effusion (non-malignant)
|
23.1%
9/39 • Number of events 9
|
|
Cardiac disorders
hemorrhage/bleeding into skin or mucosa
|
12.8%
5/39 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Allergic rhinitis
|
12.8%
5/39 • Number of events 5
|
|
Cardiac disorders
Sinus tachycardia
|
35.9%
14/39 • Number of events 14
|
|
Cardiac disorders
Vitreous hemorrhage
|
10.3%
4/39 • Number of events 4
|
|
General disorders
Psychosis
|
12.8%
5/39 • Number of events 5
|
|
Infections and infestations
Mucositis/stomatitis Oral cavity
|
15.4%
6/39 • Number of events 6
|
|
Eye disorders
Conjunctiva with neutropenia
|
7.7%
3/39 • Number of events 3
|
|
General disorders
Pain: Bone
|
7.7%
3/39 • Number of events 3
|
|
General disorders
Ataxia
|
7.7%
3/39 • Number of events 3
|
|
Investigations
hyperuricemia
|
7.7%
3/39 • Number of events 3
|
|
General disorders
Dry mouth
|
7.7%
3/39 • Number of events 3
|
|
Investigations
hyperkalemia
|
7.7%
3/39 • Number of events 3
|
|
Investigations
hypercalcemia
|
7.7%
3/39 • Number of events 3
|
|
General disorders
Taste alteration
|
7.7%
3/39 • Number of events 3
|
|
General disorders
Dizziness
|
7.7%
3/39 • Number of events 3
|
|
Nervous system disorders
Neuropathy: motor
|
7.7%
3/39 • Number of events 3
|
|
Infections and infestations
Stomatitis/Pharygitis
|
7.7%
3/39 • Number of events 3
|
|
Vascular disorders
Hemorrhage/Bleeding - Other
|
7.7%
3/39 • Number of events 3
|
|
Vascular disorders
Hemorrhage GU: Urinary
|
5.1%
2/39 • Number of events 2
|
|
Eye disorders
blurred vision
|
5.1%
2/39 • Number of events 2
|
|
General disorders
Tremor
|
5.1%
2/39 • Number of events 2
|
|
General disorders
Dental problems
|
5.1%
2/39 • Number of events 2
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia: Sinus bradycardia
|
5.1%
2/39 • Number of events 2
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia: Sinus arrhythmia
|
5.1%
2/39 • Number of events 2
|
|
General disorders
photophobia
|
5.1%
2/39 • Number of events 2
|
|
Cardiac disorders
Palpitations
|
5.1%
2/39 • Number of events 2
|
|
Vascular disorders
Osteonecrosis
|
5.1%
2/39 • Number of events 2
|
|
General disorders
Pain: Neck
|
5.1%
2/39 • Number of events 2
|
|
General disorders
Muscle weakness
|
5.1%
2/39 • Number of events 2
|
|
Vascular disorders
Hemorrhage GI: Oral cavity
|
5.1%
2/39 • Number of events 2
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
5.1%
2/39 • Number of events 2
|
|
General disorders
Pain: Chest wall
|
5.1%
2/39 • Number of events 2
|
|
General disorders
Pain: Cardiac/heart
|
5.1%
2/39 • Number of events 2
|
|
General disorders
Mood alteration: Agitation
|
5.1%
2/39 • Number of events 2
|
|
General disorders
Heartburn/dyspepsia
|
5.1%
2/39 • Number of events 2
|
|
Vascular disorders
Edema: head and neck
|
5.1%
2/39 • Number of events 2
|
|
General disorders
Sweating
|
5.1%
2/39 • Number of events 2
|
|
General disorders
Urinary retention (including neurogenic bladder)
|
5.1%
2/39 • Number of events 2
|
|
Investigations
Low Hemoglobin
|
5.1%
2/39 • Number of events 2
|
Additional Information
Dr. Bayard Powell
Comprehensive Cancer Center of Wake Forest University
Phone: 336-716-7970
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place