Trial Outcomes & Findings for Study of Ibrutinib in Subjects With Acute Myeloid Leukemia (NCT NCT02351037)
NCT ID: NCT02351037
Last Updated: 2018-08-14
Results Overview
Dohner's 2000 Criteria for AML: Complete Response (CR), Bone marrow blasts \< 5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \> 1.0 x 109/L (1000/µL); platelet count \>100 x 109/L (100 000/µL); independence of red cell transfusions; CR with Incomplete Recovery (CRi), All CR criteria except for residual neutropenia (\< 1.0 x 109/L \[1000/µL\]) or thrombocytopenia (\<100 x 109/L \[100 000/µL\]) ; Morphologic leukemia-free state, Bone marrow blasts \< 5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required; Partial Remission (PR), All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%; Relapse, Bone marrow blasts \> 5%; or reappearance of blasts in the blood; or development of extramedullary disease.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
When the last subject enrolled completes approximately 12 months of treatment.
Results posted on
2018-08-14
Participant Flow
Participant milestones
| Measure |
Ibrutinib Monotherapy Cohort
Up to 33 response evaluable subjects will receive ibrutinib 560 mg once daily on a continuous basis.
Ibrutinib: Subjects will receive ibrutinib 560 mg once daily on a continuing basis.
|
Ibrutinib + LD-AraC Combination Cohort
Up to 25-28 additional response evaluable subjects (for a total of 34 subjects) will receive ibrutinib 560 mg once daily on a continuous basis starting 2 days prior to first cytarabine dose (20 mg BID sc) for 10 days of a 28-day cycle.
Ibrutinib + LD-AraC: Subjects will receive ibrutinib 560 mg once daily on a continuous basis starting 2 days prior to first cytarabine dose (20 mg BID sc) for 10 days of a 28-day cycle.
|
Ibrutinib+Azacitidine Combination Cohort
Up to 34 response evaluable subjects will receive ibrutinib 560 mg once daily on a continuous basis starting 1 day prior to first azacitidine dose + azacitidine 75mg/m2 IV once daily Days 1-7 of a 28-day cycle (with an option to increase to 100mg/m2 after 2 cycles).
Ibrutinib+Azacitidine: Subjects will receive ibrutinib 560 mg once daily on a continuous basis starting 1 day prior to first azacitidine dose + azacitidine 75 mg/m2 IV once daily on Days 1-7 of a 28-day cycle (with an option to increase to 100 mg/m2 after 2 cycles).
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
21
|
8
|
|
Overall Study
COMPLETED
|
7
|
21
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Ibrutinib in Subjects With Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Ibrutinib Monotherapy Cohort
n=7 Participants
Up to 33 response evaluable subjects will receive ibrutinib 560 mg once daily on a continuous basis.
Ibrutinib: Subjects will receive ibrutinib 560 mg once daily on a continuing basis.
|
Ibrutinib + LD-AraC Combination Cohort
n=21 Participants
Up to 25-28 additional response evaluable subjects (for a total of 34 subjects) will receive ibrutinib 560 mg once daily on a continuous basis starting 2 days prior to first cytarabine dose (20 mg BID sc) for 10 days of a 28-day cycle.
Ibrutinib + LD-AraC: Subjects will receive ibrutinib 560 mg once daily on a continuous basis starting 2 days prior to first cytarabine dose (20 mg BID sc) for 10 days of a 28-day cycle.
|
Ibrutinib+Azacitidine Combination Cohort
n=8 Participants
Up to 34 response evaluable subjects will receive ibrutinib 560 mg once daily on a continuous basis starting 1 day prior to first azacitidine dose + azacitidine 75mg/m2 IV once daily Days 1-7 of a 28-day cycle (with an option to increase to 100mg/m2 after 2 cycles).
Ibrutinib+Azacitidine: Subjects will receive ibrutinib 560 mg once daily on a continuous basis starting 1 day prior to first azacitidine dose + azacitidine 75 mg/m2 IV once daily on Days 1-7 of a 28-day cycle (with an option to increase to 100 mg/m2 after 2 cycles).
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
15 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
21 Participants
n=483 Participants
|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 11.7 • n=93 Participants
|
70 years
STANDARD_DEVIATION 9.1 • n=4 Participants
|
58 years
STANDARD_DEVIATION 12.4 • n=27 Participants
|
67 years
STANDARD_DEVIATION 11.1 • n=483 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
16 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
20 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
31 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
33 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=93 Participants
|
21 participants
n=4 Participants
|
8 participants
n=27 Participants
|
36 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: When the last subject enrolled completes approximately 12 months of treatment.Dohner's 2000 Criteria for AML: Complete Response (CR), Bone marrow blasts \< 5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \> 1.0 x 109/L (1000/µL); platelet count \>100 x 109/L (100 000/µL); independence of red cell transfusions; CR with Incomplete Recovery (CRi), All CR criteria except for residual neutropenia (\< 1.0 x 109/L \[1000/µL\]) or thrombocytopenia (\<100 x 109/L \[100 000/µL\]) ; Morphologic leukemia-free state, Bone marrow blasts \< 5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required; Partial Remission (PR), All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%; Relapse, Bone marrow blasts \> 5%; or reappearance of blasts in the blood; or development of extramedullary disease.
Outcome measures
| Measure |
Ibrutinib Monotherapy Cohort
n=7 Participants
Up to 33 response evaluable subjects will receive ibrutinib 560 mg once daily on a continuous basis.
Ibrutinib: Subjects will receive ibrutinib 560 mg once daily on a continuing basis.
|
Ibrutinib + LD-AraC Combination Cohort
n=21 Participants
Up to 25-28 additional response evaluable subjects (for a total of 34 subjects) will receive ibrutinib 560 mg once daily on a continuous basis starting 2 days prior to first cytarabine dose (20 mg BID sc) for 10 days of a 28-day cycle.
Ibrutinib + LD-AraC: Subjects will receive ibrutinib 560 mg once daily on a continuous basis starting 2 days prior to first cytarabine dose (20 mg BID sc) for 10 days of a 28-day cycle.
|
Ibrutinib+Azacitidine Combination Cohort
n=8 Participants
Up to 34 response evaluable subjects will receive ibrutinib 560 mg once daily on a continuous basis starting 1 day prior to first azacitidine dose + azacitidine 75mg/m2 IV once daily Days 1-7 of a 28-day cycle (with an option to increase to 100mg/m2 after 2 cycles).
Ibrutinib+Azacitidine: Subjects will receive ibrutinib 560 mg once daily on a continuous basis starting 1 day prior to first azacitidine dose + azacitidine 75 mg/m2 IV once daily on Days 1-7 of a 28-day cycle (with an option to increase to 100 mg/m2 after 2 cycles).
|
|---|---|---|---|
|
Efficacy of Ibrutinib Monotherapy or in Combination With Either LD-AraC or Azacitidine Using the Overall Remission Rate (Defined as Proportion of Subjects Achieving a CR or CRi) According to the LeukemiaNet Guidelines
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 30 days following the last dose of study drug.Number of Participants with Adverse Events and number of patients with lab abnormalities.The safety profile of ibrutinib was evaluated based on the incidence of adverse events (AEs) as well as clinically significant laboratory abnormalities and vital signs, and other malignancies. The safety evaluations performed in this study were standard and/or were required based on the safety data available from other clinical and preclinical settings.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: When the last subject enrolled completes approximately 12 months of treatmentTo evaluate clinical efficacy by assessing relapse-free survival (RFS), event-free survival (EFS) and overall survival (OS).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: When the last subject enrolled completes approximately 12 months of treatmentTo evaluate clinical benefit defined as CR, CRi, morphologic leukemia-free state, and partial remission (PR).
Outcome measures
Outcome data not reported
Adverse Events
Ibrutinib Monotherapy Cohort
Serious events: 4 serious events
Other events: 7 other events
Deaths: 7 deaths
Ibrutinib + LD-AraC Combination Cohort
Serious events: 21 serious events
Other events: 21 other events
Deaths: 21 deaths
Ibrutinib+Azacitidine Combination Cohort
Serious events: 8 serious events
Other events: 8 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Ibrutinib Monotherapy Cohort
n=7 participants at risk
Up to 33 response evaluable subjects will receive ibrutinib 560 mg once daily on a continuous basis.
Ibrutinib: Subjects will receive ibrutinib 560 mg once daily on a continuing basis.
|
Ibrutinib + LD-AraC Combination Cohort
n=21 participants at risk
Up to 25-28 additional response evaluable subjects (for a total of 34 subjects) will receive ibrutinib 560 mg once daily on a continuous basis starting 2 days prior to first cytarabine dose (20 mg BID sc) for 10 days of a 28-day cycle.
Ibrutinib + LD-AraC: Subjects will receive ibrutinib 560 mg once daily on a continuous basis starting 2 days prior to first cytarabine dose (20 mg BID sc) for 10 days of a 28-day cycle.
|
Ibrutinib+Azacitidine Combination Cohort
n=8 participants at risk
Up to 34 response evaluable subjects will receive ibrutinib 560 mg once daily on a continuous basis starting 1 day prior to first azacitidine dose + azacitidine 75mg/m2 IV once daily Days 1-7 of a 28-day cycle (with an option to increase to 100mg/m2 after 2 cycles).
Ibrutinib+Azacitidine: Subjects will receive ibrutinib 560 mg once daily on a continuous basis starting 1 day prior to first azacitidine dose + azacitidine 75 mg/m2 IV once daily on Days 1-7 of a 28-day cycle (with an option to increase to 100 mg/m2 after 2 cycles).
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
14.3%
1/7 • 2 years, 4 months
|
28.6%
6/21 • 2 years, 4 months
|
50.0%
4/8 • 2 years, 4 months
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/7 • 2 years, 4 months
|
4.8%
1/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/7 • 2 years, 4 months
|
4.8%
1/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/7 • 2 years, 4 months
|
9.5%
2/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/7 • 2 years, 4 months
|
4.8%
1/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7 • 2 years, 4 months
|
4.8%
1/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Gastrointestinal disorders
Small intestine obstruction
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
General disorders
Fatigue
|
0.00%
0/7 • 2 years, 4 months
|
4.8%
1/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
General disorders
Asthenia
|
0.00%
0/7 • 2 years, 4 months
|
9.5%
2/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/7 • 2 years, 4 months
|
4.8%
1/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/7 • 2 years, 4 months
|
38.1%
8/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Infections and infestations
Bacteraemia
|
14.3%
1/7 • 2 years, 4 months
|
4.8%
1/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/7 • 2 years, 4 months
|
14.3%
3/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Infections and infestations
Cellulitis
|
0.00%
0/7 • 2 years, 4 months
|
9.5%
2/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/7 • 2 years, 4 months
|
4.8%
1/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Infections and infestations
Cellulitis orbital
|
0.00%
0/7 • 2 years, 4 months
|
4.8%
1/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Infections and infestations
Influenza
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Infections and infestations
Septic embolus
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Infections and infestations
Pseudomonal sepsis
|
0.00%
0/7 • 2 years, 4 months
|
4.8%
1/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Infections and infestations
Septic shock
|
0.00%
0/7 • 2 years, 4 months
|
4.8%
1/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Infections and infestations
Vulvitis
|
14.3%
1/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/7 • 2 years, 4 months
|
4.8%
1/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/7 • 2 years, 4 months
|
4.8%
1/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/7 • 2 years, 4 months
|
4.8%
1/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/7 • 2 years, 4 months
|
9.5%
2/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Metabolism and nutrition disorders
Failure to thrive
|
14.3%
1/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
42.9%
3/7 • 2 years, 4 months
|
42.9%
9/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Nervous system disorders
Seizure
|
0.00%
0/7 • 2 years, 4 months
|
4.8%
1/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/7 • 2 years, 4 months
|
4.8%
1/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/7 • 2 years, 4 months
|
9.5%
2/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/7 • 2 years, 4 months
|
9.5%
2/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/7 • 2 years, 4 months
|
4.8%
1/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/7 • 2 years, 4 months
|
14.3%
3/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.00%
0/7 • 2 years, 4 months
|
4.8%
1/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/7 • 2 years, 4 months
|
4.8%
1/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/7 • 2 years, 4 months
|
4.8%
1/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/7 • 2 years, 4 months
|
4.8%
1/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/7 • 2 years, 4 months
|
4.8%
1/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
General disorders
Pyrexia
|
0.00%
0/7 • 2 years, 4 months
|
4.8%
1/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/7 • 2 years, 4 months
|
4.8%
1/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/7 • 2 years, 4 months
|
4.8%
1/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Infections and infestations
Lung infection
|
14.3%
1/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
Other adverse events
| Measure |
Ibrutinib Monotherapy Cohort
n=7 participants at risk
Up to 33 response evaluable subjects will receive ibrutinib 560 mg once daily on a continuous basis.
Ibrutinib: Subjects will receive ibrutinib 560 mg once daily on a continuing basis.
|
Ibrutinib + LD-AraC Combination Cohort
n=21 participants at risk
Up to 25-28 additional response evaluable subjects (for a total of 34 subjects) will receive ibrutinib 560 mg once daily on a continuous basis starting 2 days prior to first cytarabine dose (20 mg BID sc) for 10 days of a 28-day cycle.
Ibrutinib + LD-AraC: Subjects will receive ibrutinib 560 mg once daily on a continuous basis starting 2 days prior to first cytarabine dose (20 mg BID sc) for 10 days of a 28-day cycle.
|
Ibrutinib+Azacitidine Combination Cohort
n=8 participants at risk
Up to 34 response evaluable subjects will receive ibrutinib 560 mg once daily on a continuous basis starting 1 day prior to first azacitidine dose + azacitidine 75mg/m2 IV once daily Days 1-7 of a 28-day cycle (with an option to increase to 100mg/m2 after 2 cycles).
Ibrutinib+Azacitidine: Subjects will receive ibrutinib 560 mg once daily on a continuous basis starting 1 day prior to first azacitidine dose + azacitidine 75 mg/m2 IV once daily on Days 1-7 of a 28-day cycle (with an option to increase to 100 mg/m2 after 2 cycles).
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/7 • 2 years, 4 months
|
4.8%
1/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Blood and lymphatic system disorders
Anaemia
|
28.6%
2/7 • 2 years, 4 months
|
23.8%
5/21 • 2 years, 4 months
|
50.0%
4/8 • 2 years, 4 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/7 • 2 years, 4 months
|
9.5%
2/21 • 2 years, 4 months
|
62.5%
5/8 • 2 years, 4 months
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
28.6%
2/7 • 2 years, 4 months
|
9.5%
2/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
37.5%
3/8 • 2 years, 4 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
14.3%
1/7 • 2 years, 4 months
|
4.8%
1/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/7 • 2 years, 4 months
|
4.8%
1/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/7 • 2 years, 4 months
|
4.8%
1/21 • 2 years, 4 months
|
25.0%
2/8 • 2 years, 4 months
|
|
Eye disorders
Vision blurred
|
0.00%
0/7 • 2 years, 4 months
|
14.3%
3/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Gastrointestinal disorders
Diarrhoea
|
42.9%
3/7 • 2 years, 4 months
|
47.6%
10/21 • 2 years, 4 months
|
37.5%
3/8 • 2 years, 4 months
|
|
Gastrointestinal disorders
Nausea
|
42.9%
3/7 • 2 years, 4 months
|
38.1%
8/21 • 2 years, 4 months
|
37.5%
3/8 • 2 years, 4 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/7 • 2 years, 4 months
|
28.6%
6/21 • 2 years, 4 months
|
25.0%
2/8 • 2 years, 4 months
|
|
Gastrointestinal disorders
Vomiting
|
28.6%
2/7 • 2 years, 4 months
|
14.3%
3/21 • 2 years, 4 months
|
25.0%
2/8 • 2 years, 4 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7 • 2 years, 4 months
|
19.0%
4/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/7 • 2 years, 4 months
|
14.3%
3/21 • 2 years, 4 months
|
25.0%
2/8 • 2 years, 4 months
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/7 • 2 years, 4 months
|
9.5%
2/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/7 • 2 years, 4 months
|
4.8%
1/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/7 • 2 years, 4 months
|
4.8%
1/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
14.3%
1/7 • 2 years, 4 months
|
4.8%
1/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
General disorders
Fatigue
|
28.6%
2/7 • 2 years, 4 months
|
57.1%
12/21 • 2 years, 4 months
|
25.0%
2/8 • 2 years, 4 months
|
|
General disorders
Oedema peripheral
|
42.9%
3/7 • 2 years, 4 months
|
47.6%
10/21 • 2 years, 4 months
|
37.5%
3/8 • 2 years, 4 months
|
|
General disorders
Pyrexia
|
14.3%
1/7 • 2 years, 4 months
|
28.6%
6/21 • 2 years, 4 months
|
25.0%
2/8 • 2 years, 4 months
|
|
General disorders
Asthenia
|
0.00%
0/7 • 2 years, 4 months
|
33.3%
7/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
General disorders
Chills
|
0.00%
0/7 • 2 years, 4 months
|
23.8%
5/21 • 2 years, 4 months
|
37.5%
3/8 • 2 years, 4 months
|
|
General disorders
Malaise
|
0.00%
0/7 • 2 years, 4 months
|
9.5%
2/21 • 2 years, 4 months
|
25.0%
2/8 • 2 years, 4 months
|
|
General disorders
Injection site bruising
|
14.3%
1/7 • 2 years, 4 months
|
9.5%
2/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
General disorders
Pain
|
14.3%
1/7 • 2 years, 4 months
|
9.5%
2/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Infections and infestations
Pneumonia
|
14.3%
1/7 • 2 years, 4 months
|
23.8%
5/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/7 • 2 years, 4 months
|
9.5%
2/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Injury, poisoning and procedural complications
Fall
|
28.6%
2/7 • 2 years, 4 months
|
23.8%
5/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Injury, poisoning and procedural complications
Contusion
|
14.3%
1/7 • 2 years, 4 months
|
9.5%
2/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Injury, poisoning and procedural complications
Skin Abrasion
|
14.3%
1/7 • 2 years, 4 months
|
9.5%
2/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/7 • 2 years, 4 months
|
9.5%
2/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
1/7 • 2 years, 4 months
|
4.8%
1/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.3%
1/7 • 2 years, 4 months
|
52.4%
11/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/7 • 2 years, 4 months
|
33.3%
7/21 • 2 years, 4 months
|
37.5%
3/8 • 2 years, 4 months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
42.9%
3/7 • 2 years, 4 months
|
19.0%
4/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
14.3%
1/7 • 2 years, 4 months
|
23.8%
5/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/7 • 2 years, 4 months
|
23.8%
5/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
14.3%
1/7 • 2 years, 4 months
|
9.5%
2/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Metabolism and nutrition disorders
Dehydration
|
14.3%
1/7 • 2 years, 4 months
|
9.5%
2/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/7 • 2 years, 4 months
|
19.0%
4/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
28.6%
2/7 • 2 years, 4 months
|
9.5%
2/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
14.3%
1/7 • 2 years, 4 months
|
9.5%
2/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
0.00%
0/7 • 2 years, 4 months
|
9.5%
2/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/7 • 2 years, 4 months
|
14.3%
3/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/7 • 2 years, 4 months
|
9.5%
2/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/7 • 2 years, 4 months
|
4.8%
1/21 • 2 years, 4 months
|
25.0%
2/8 • 2 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
1/7 • 2 years, 4 months
|
4.8%
1/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
14.3%
1/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/7 • 2 years, 4 months
|
19.0%
4/21 • 2 years, 4 months
|
25.0%
2/8 • 2 years, 4 months
|
|
Nervous system disorders
Headache
|
28.6%
2/7 • 2 years, 4 months
|
4.8%
1/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/7 • 2 years, 4 months
|
9.5%
2/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/7 • 2 years, 4 months
|
23.8%
5/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Psychiatric disorders
Agitation
|
0.00%
0/7 • 2 years, 4 months
|
19.0%
4/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/7 • 2 years, 4 months
|
9.5%
2/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Psychiatric disorders
Insomnia
|
28.6%
2/7 • 2 years, 4 months
|
14.3%
3/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/7 • 2 years, 4 months
|
9.5%
2/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Renal and urinary disorders
Urinary retention
|
14.3%
1/7 • 2 years, 4 months
|
9.5%
2/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/7 • 2 years, 4 months
|
9.5%
2/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.3%
1/7 • 2 years, 4 months
|
38.1%
8/21 • 2 years, 4 months
|
25.0%
2/8 • 2 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • 2 years, 4 months
|
19.0%
4/21 • 2 years, 4 months
|
62.5%
5/8 • 2 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
14.3%
1/7 • 2 years, 4 months
|
9.5%
2/21 • 2 years, 4 months
|
25.0%
2/8 • 2 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
14.3%
1/7 • 2 years, 4 months
|
19.0%
4/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/7 • 2 years, 4 months
|
14.3%
3/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/7 • 2 years, 4 months
|
14.3%
3/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/7 • 2 years, 4 months
|
4.8%
1/21 • 2 years, 4 months
|
25.0%
2/8 • 2 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/7 • 2 years, 4 months
|
9.5%
2/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
28.6%
2/7 • 2 years, 4 months
|
14.3%
3/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/7 • 2 years, 4 months
|
14.3%
3/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/7 • 2 years, 4 months
|
14.3%
3/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/7 • 2 years, 4 months
|
4.8%
1/21 • 2 years, 4 months
|
25.0%
2/8 • 2 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
25.0%
2/8 • 2 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/7 • 2 years, 4 months
|
9.5%
2/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Vascular disorders
Hypotension
|
14.3%
1/7 • 2 years, 4 months
|
28.6%
6/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/7 • 2 years, 4 months
|
9.5%
2/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/7 • 2 years, 4 months
|
4.8%
1/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Cardiac disorders
Cardiac failure congestive
|
14.3%
1/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Endocrine disorders
Thyroid cyst
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Eye disorders
Scleral haemorrhage
|
14.3%
1/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
14.3%
1/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
General disorders
Catheter site erythema
|
14.3%
1/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
General disorders
Catheter site haemorrhage
|
14.3%
1/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
General disorders
Catheter site pain
|
14.3%
1/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
General disorders
Chest pain
|
14.3%
1/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
General disorders
Injection site pain
|
14.3%
1/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
General disorders
Mass
|
14.3%
1/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
General disorders
Adverse drug reaction
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
General disorders
Feeling hot
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Infections and infestations
Gingivitis
|
14.3%
1/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Infections and infestations
Sinusitis
|
14.3%
1/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Infections and infestations
Granulicatella infection
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Infections and infestations
Upper respiratory fungal infection
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Infections and infestations
Viral sepsis
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Injury, poisoning and procedural complications
Vascular access site occlusion
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Investigations
Lymphocyte count decreased
|
14.3%
1/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Investigations
Blood creatinine decreased
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Investigations
White blood cell count decreased
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Metabolism and nutrition disorders
Gout
|
14.3%
1/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
14.3%
1/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Nervous system disorders
Loss of consciousness
|
14.3%
1/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Nervous system disorders
Lethargy
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Nervous system disorders
Presyncope
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Nervous system disorders
Somnolence
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Product Issues
Device occlusion
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Psychiatric disorders
Delirium
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Psychiatric disorders
Dysphoria
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Renal and urinary disorders
Urinary incontinence
|
14.3%
1/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
14.3%
1/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Erythema multiform
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
0.00%
0/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
12.5%
1/8 • 2 years, 4 months
|
|
Vascular disorders
Flushing
|
14.3%
1/7 • 2 years, 4 months
|
0.00%
0/21 • 2 years, 4 months
|
0.00%
0/8 • 2 years, 4 months
|
Additional Information
Priyanka Mandava, Director of Clinical Operations
Pharmacyclics
Phone: 408-215-3776
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 1. Institution/Investigator will not publish without Sponsor prior review and approval 2. Institution/Investigator will not publish until after the completion of the study or until 12 months after results are received
- Publication restrictions are in place
Restriction type: OTHER