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Study of Ibrutinib in Subjects With Acute Myeloid Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02351037
Recruitment Status : Terminated (Study data do not support development in AML.)
First Posted : January 30, 2015
Results First Posted : August 14, 2018
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Pharmacyclics LLC.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acute Myeloid Leukemia (AML)
Interventions Drug: Ibrutinib
Drug: Ibrutinib + LD-AraC
Drug: Ibrutinib+Azacitidine
Enrollment 36
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ibrutinib Monotherapy Cohort Ibrutinib + LD-AraC Combination Cohort Ibrutinib+Azacitidine Combination Cohort
Hide Arm/Group Description

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.

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.

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).

Period Title: Overall Study
Started 7 21 8
Completed 7 21 8
Not Completed 0 0 0
Arm/Group Title Ibrutinib Monotherapy Cohort Ibrutinib + LD-AraC Combination Cohort Ibrutinib+Azacitidine Combination Cohort Total
Hide Arm/Group Description

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.

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.

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 of all reporting groups
Overall Number of Baseline Participants 7 21 8 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 21 participants 8 participants 36 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
  57.1%
5
  23.8%
6
  75.0%
15
  41.7%
>=65 years
3
  42.9%
16
  76.2%
2
  25.0%
21
  58.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 21 participants 8 participants 36 participants
67  (11.7) 70  (9.1) 58  (12.4) 67  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 21 participants 8 participants 36 participants
Female
3
  42.9%
7
  33.3%
6
  75.0%
16
  44.4%
Male
4
  57.1%
14
  66.7%
2
  25.0%
20
  55.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 21 participants 8 participants 36 participants
Hispanic or Latino
1
  14.3%
2
   9.5%
2
  25.0%
5
  13.9%
Not Hispanic or Latino
6
  85.7%
19
  90.5%
6
  75.0%
31
  86.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 21 participants 8 participants 36 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   4.8%
0
   0.0%
1
   2.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  14.3%
1
   4.8%
0
   0.0%
2
   5.6%
White
6
  85.7%
19
  90.5%
8
 100.0%
33
  91.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 21 participants 8 participants 36 participants
7 21 8 36
1.Primary Outcome
Title 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
Hide Description 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.
Time Frame When the last subject enrolled completes approximately 12 months of treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ibrutinib Monotherapy Cohort Ibrutinib + LD-AraC Combination Cohort Ibrutinib+Azacitidine Combination Cohort
Hide Arm/Group Description:

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.

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.

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 Number of Participants Analyzed 7 21 8
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   4.8%
0
   0.0%
2.Primary Outcome
Title Safety and Tolerability of Ibrutinib Monotherapy or in Combination With Either LD-AraC or Azacitidine
Hide Description 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.
Time Frame Up to 30 days following the last dose of study drug.
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Relapse-free Survival (RFS), Event-free Survival (EFS) and Overall Survival (OS)
Hide Description To evaluate clinical efficacy by assessing relapse-free survival (RFS), event-free survival (EFS) and overall survival (OS).
Time Frame When the last subject enrolled completes approximately 12 months of treatment
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Clinical Benefit Rate - as Defined as the Proportion of Subjects Who Achieve CR, CRi, Morphologic Leukemia-free State, or Partial Remission (PR)
Hide Description To evaluate clinical benefit defined as CR, CRi, morphologic leukemia-free state, and partial remission (PR).
Time Frame When the last subject enrolled completes approximately 12 months of treatment
Outcome Measure Data Not Reported
Time Frame 2 years, 4 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ibrutinib Monotherapy Cohort Ibrutinib + LD-AraC Combination Cohort Ibrutinib+Azacitidine Combination Cohort
Hide Arm/Group Description

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.

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.

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).

All-Cause Mortality
Ibrutinib Monotherapy Cohort Ibrutinib + LD-AraC Combination Cohort Ibrutinib+Azacitidine Combination Cohort
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/7 (100.00%)   21/21 (100.00%)   8/8 (100.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Ibrutinib Monotherapy Cohort Ibrutinib + LD-AraC Combination Cohort Ibrutinib+Azacitidine Combination Cohort
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/7 (57.14%)   21/21 (100.00%)   8/8 (100.00%) 
Blood and lymphatic system disorders       
Febrile neutropenia * 1  1/7 (14.29%)  6/21 (28.57%)  4/8 (50.00%) 
Anaemia * 1  0/7 (0.00%)  1/21 (4.76%)  0/8 (0.00%) 
Thrombocytopenia * 1  0/7 (0.00%)  1/21 (4.76%)  0/8 (0.00%) 
Leukocytosis * 1  0/7 (0.00%)  2/21 (9.52%)  0/8 (0.00%) 
Cardiac disorders       
Atrial flutter * 1  0/7 (0.00%)  1/21 (4.76%)  0/8 (0.00%) 
Cardiac arrest * 1  0/7 (0.00%)  1/21 (4.76%)  0/8 (0.00%) 
Atrial fibrillation * 1  0/7 (0.00%)  1/21 (4.76%)  1/8 (12.50%) 
Gastrointestinal disorders       
Diarrhoea * 1  0/7 (0.00%)  1/21 (4.76%)  0/8 (0.00%) 
Abdominal pain * 1  0/7 (0.00%)  1/21 (4.76%)  0/8 (0.00%) 
Stomatitis * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
Small intestine obstruction * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
Haematemesis * 1  0/7 (0.00%)  1/21 (4.76%)  0/8 (0.00%) 
General disorders       
Fatigue * 1  0/7 (0.00%)  1/21 (4.76%)  0/8 (0.00%) 
Asthenia * 1  0/7 (0.00%)  2/21 (9.52%)  1/8 (12.50%) 
Multiple organ dysfunction syndrome * 1  0/7 (0.00%)  1/21 (4.76%)  0/8 (0.00%) 
Pyrexia * 1  0/7 (0.00%)  1/21 (4.76%)  0/8 (0.00%) 
Infections and infestations       
Pneumonia * 1  0/7 (0.00%)  8/21 (38.10%)  1/8 (12.50%) 
Bacteraemia * 1  1/7 (14.29%)  1/21 (4.76%)  0/8 (0.00%) 
Pneumonia fungal * 1  0/7 (0.00%)  3/21 (14.29%)  0/8 (0.00%) 
Cellulitis * 1  0/7 (0.00%)  2/21 (9.52%)  0/8 (0.00%) 
Sepsis * 1  0/7 (0.00%)  1/21 (4.76%)  0/8 (0.00%) 
Cellulitis orbital * 1  0/7 (0.00%)  1/21 (4.76%)  0/8 (0.00%) 
Escherichia sepsis * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
Influenza * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
Septic embolus * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
Pseudomonal sepsis * 1  0/7 (0.00%)  1/21 (4.76%)  0/8 (0.00%) 
Septic shock * 1  0/7 (0.00%)  1/21 (4.76%)  0/8 (0.00%) 
Vulvitis * 1  1/7 (14.29%)  0/21 (0.00%)  0/8 (0.00%) 
Escherichia bacteraemia * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
Lung infection * 1  1/7 (14.29%)  0/21 (0.00%)  0/8 (0.00%) 
Injury, poisoning and procedural complications       
Fall * 1  0/7 (0.00%)  1/21 (4.76%)  0/8 (0.00%) 
Transfusion reaction * 1  0/7 (0.00%)  1/21 (4.76%)  0/8 (0.00%) 
Metabolism and nutrition disorders       
Hyponatraemia * 1  0/7 (0.00%)  1/21 (4.76%)  0/8 (0.00%) 
Dehydration * 1  0/7 (0.00%)  2/21 (9.52%)  1/8 (12.50%) 
Failure to thrive * 1  1/7 (14.29%)  0/21 (0.00%)  0/8 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Acute myeloid leukaemia * 1  3/7 (42.86%)  9/21 (42.86%)  0/8 (0.00%) 
Nervous system disorders       
Cerebrovascular accident * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
Seizure * 1  0/7 (0.00%)  1/21 (4.76%)  0/8 (0.00%) 
Syncope * 1  0/7 (0.00%)  1/21 (4.76%)  0/8 (0.00%) 
Haemorrhage intracranial * 1  0/7 (0.00%)  1/21 (4.76%)  0/8 (0.00%) 
Psychiatric disorders       
Confusional state * 1  0/7 (0.00%)  2/21 (9.52%)  0/8 (0.00%) 
Renal and urinary disorders       
Acute kidney injury * 1  0/7 (0.00%)  2/21 (9.52%)  0/8 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Pleural effusion * 1  0/7 (0.00%)  1/21 (4.76%)  0/8 (0.00%) 
Respiratory failure * 1  0/7 (0.00%)  3/21 (14.29%)  1/8 (12.50%) 
Pulmonary alveolar haemorrhage * 1  0/7 (0.00%)  1/21 (4.76%)  0/8 (0.00%) 
Respiratory arrest * 1  0/7 (0.00%)  1/21 (4.76%)  0/8 (0.00%) 
1
Term from vocabulary, MedDRA (19.0)
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ibrutinib Monotherapy Cohort Ibrutinib + LD-AraC Combination Cohort Ibrutinib+Azacitidine Combination Cohort
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/7 (100.00%)   21/21 (100.00%)   8/8 (100.00%) 
Blood and lymphatic system disorders       
Febrile neutropenia * 1  0/7 (0.00%)  1/21 (4.76%)  1/8 (12.50%) 
Anaemia * 1  2/7 (28.57%)  5/21 (23.81%)  4/8 (50.00%) 
Thrombocytopenia * 1  0/7 (0.00%)  2/21 (9.52%)  5/8 (62.50%) 
Increased tendency to bruise * 1  2/7 (28.57%)  2/21 (9.52%)  1/8 (12.50%) 
Leukopenia * 1  0/7 (0.00%)  0/21 (0.00%)  3/8 (37.50%) 
Neutropenia * 1  1/7 (14.29%)  1/21 (4.76%)  1/8 (12.50%) 
Cardiac disorders       
Atrial fibrillation * 1  0/7 (0.00%)  1/21 (4.76%)  1/8 (12.50%) 
Sinus tachycardia * 1  0/7 (0.00%)  1/21 (4.76%)  2/8 (25.00%) 
Cardiac failure congestive * 1  1/7 (14.29%)  0/21 (0.00%)  0/8 (0.00%) 
Sinus bradycardia * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
Endocrine disorders       
Thyroid cyst * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
Eye disorders       
Vision blurred * 1  0/7 (0.00%)  3/21 (14.29%)  0/8 (0.00%) 
Scleral haemorrhage * 1  1/7 (14.29%)  0/21 (0.00%)  0/8 (0.00%) 
Gastrointestinal disorders       
Diarrhoea * 1  3/7 (42.86%)  10/21 (47.62%)  3/8 (37.50%) 
Nausea * 1  3/7 (42.86%)  8/21 (38.10%)  3/8 (37.50%) 
Constipation * 1  0/7 (0.00%)  6/21 (28.57%)  2/8 (25.00%) 
Vomiting * 1  2/7 (28.57%)  3/21 (14.29%)  2/8 (25.00%) 
Abdominal pain * 1  0/7 (0.00%)  4/21 (19.05%)  1/8 (12.50%) 
Stomatitis * 1  0/7 (0.00%)  3/21 (14.29%)  2/8 (25.00%) 
Abdominal distension * 1  0/7 (0.00%)  2/21 (9.52%)  1/8 (12.50%) 
Dysphagia * 1  0/7 (0.00%)  1/21 (4.76%)  1/8 (12.50%) 
Gastrointestinal haemorrhage * 1  0/7 (0.00%)  1/21 (4.76%)  1/8 (12.50%) 
Gastrooesophageal reflux disease * 1  1/7 (14.29%)  1/21 (4.76%)  0/8 (0.00%) 
Abdominal pain upper * 1  1/7 (14.29%)  0/21 (0.00%)  0/8 (0.00%) 
Abdominal discomfort * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
Flatulence * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
General disorders       
Fatigue * 1  2/7 (28.57%)  12/21 (57.14%)  2/8 (25.00%) 
Oedema peripheral * 1  3/7 (42.86%)  10/21 (47.62%)  3/8 (37.50%) 
Pyrexia * 1  1/7 (14.29%)  6/21 (28.57%)  2/8 (25.00%) 
Asthenia * 1  0/7 (0.00%)  7/21 (33.33%)  0/8 (0.00%) 
Chills * 1  0/7 (0.00%)  5/21 (23.81%)  3/8 (37.50%) 
Malaise * 1  0/7 (0.00%)  2/21 (9.52%)  2/8 (25.00%) 
Injection site bruising * 1  1/7 (14.29%)  2/21 (9.52%)  0/8 (0.00%) 
Pain * 1  1/7 (14.29%)  2/21 (9.52%)  0/8 (0.00%) 
Catheter site erythema * 1  1/7 (14.29%)  0/21 (0.00%)  0/8 (0.00%) 
Catheter site haemorrhage * 1  1/7 (14.29%)  0/21 (0.00%)  0/8 (0.00%) 
Catheter site pain * 1  1/7 (14.29%)  0/21 (0.00%)  0/8 (0.00%) 
Chest pain * 1  1/7 (14.29%)  0/21 (0.00%)  0/8 (0.00%) 
Injection site pain * 1  1/7 (14.29%)  0/21 (0.00%)  0/8 (0.00%) 
Mass * 1  1/7 (14.29%)  0/21 (0.00%)  0/8 (0.00%) 
Adverse drug reaction * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
Feeling hot * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
Hepatobiliary disorders       
Hepatic function abnormal * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
Immune system disorders       
Drug hypersensitivity * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
Infections and infestations       
Pneumonia * 1  1/7 (14.29%)  5/21 (23.81%)  1/8 (12.50%) 
Bacteraemia * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
Upper respiratory tract infection * 1  0/7 (0.00%)  2/21 (9.52%)  1/8 (12.50%) 
Gingivitis * 1  1/7 (14.29%)  0/21 (0.00%)  0/8 (0.00%) 
Sinusitis * 1  1/7 (14.29%)  0/21 (0.00%)  0/8 (0.00%) 
Escherichia infection * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
Granulicatella infection * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
Staphylococcal infection * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
Upper respiratory fungal infection * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
Urinary tract infection * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
Viral sepsis * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
Injury, poisoning and procedural complications       
Fall * 1  2/7 (28.57%)  5/21 (23.81%)  0/8 (0.00%) 
Contusion * 1  1/7 (14.29%)  2/21 (9.52%)  0/8 (0.00%) 
Skin Abrasion * 1  1/7 (14.29%)  2/21 (9.52%)  0/8 (0.00%) 
Transfusion reaction * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
Procedural pain * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
Vascular access complication * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
Vascular access site occlusion * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
Investigations       
Alanine aminotransferase increased * 1  0/7 (0.00%)  2/21 (9.52%)  0/8 (0.00%) 
Aspartate aminotransferase increased * 1  1/7 (14.29%)  1/21 (4.76%)  0/8 (0.00%) 
Lymphocyte count decreased * 1  1/7 (14.29%)  0/21 (0.00%)  0/8 (0.00%) 
Blood creatinine decreased * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
White blood cell count decreased * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
Metabolism and nutrition disorders       
Decreased appetite * 1  1/7 (14.29%)  11/21 (52.38%)  1/8 (12.50%) 
Hypomagnesaemia * 1  0/7 (0.00%)  7/21 (33.33%)  3/8 (37.50%) 
Hypoalbuminaemia * 1  3/7 (42.86%)  4/21 (19.05%)  1/8 (12.50%) 
Hypokalaemia * 1  1/7 (14.29%)  5/21 (23.81%)  1/8 (12.50%) 
Hyponatraemia * 1  0/7 (0.00%)  5/21 (23.81%)  0/8 (0.00%) 
Hypophosphataemia * 1  1/7 (14.29%)  2/21 (9.52%)  1/8 (12.50%) 
Dehydration * 1  1/7 (14.29%)  2/21 (9.52%)  0/8 (0.00%) 
Hyperkalaemia * 1  0/7 (0.00%)  4/21 (19.05%)  0/8 (0.00%) 
Hypocalcaemia * 1  2/7 (28.57%)  2/21 (9.52%)  0/8 (0.00%) 
Hyperuricaemia * 1  1/7 (14.29%)  2/21 (9.52%)  0/8 (0.00%) 
Tumor lysis syndrome * 1  0/7 (0.00%)  2/21 (9.52%)  0/8 (0.00%) 
Gout * 1  1/7 (14.29%)  0/21 (0.00%)  0/8 (0.00%) 
Hypernatraemia * 1  1/7 (14.29%)  0/21 (0.00%)  0/8 (0.00%) 
Acidosis * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
Fluid overload * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  0/7 (0.00%)  3/21 (14.29%)  0/8 (0.00%) 
Muscle spasms * 1  0/7 (0.00%)  2/21 (9.52%)  1/8 (12.50%) 
Pain in extremity * 1  0/7 (0.00%)  1/21 (4.76%)  2/8 (25.00%) 
Back pain * 1  1/7 (14.29%)  1/21 (4.76%)  0/8 (0.00%) 
Pain in jaw * 1  1/7 (14.29%)  0/21 (0.00%)  1/8 (12.50%) 
Myalgia * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
Neck pain * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
Nervous system disorders       
Dizziness * 1  0/7 (0.00%)  4/21 (19.05%)  2/8 (25.00%) 
Headache * 1  2/7 (28.57%)  1/21 (4.76%)  1/8 (12.50%) 
Dysarthria * 1  0/7 (0.00%)  2/21 (9.52%)  0/8 (0.00%) 
Loss of consciousness * 1  1/7 (14.29%)  0/21 (0.00%)  0/8 (0.00%) 
Lethargy * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
Paraesthesia * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
Presyncope * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
Somnolence * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
Product Issues       
Device occlusion * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
Psychiatric disorders       
Anxiety * 1  0/7 (0.00%)  5/21 (23.81%)  1/8 (12.50%) 
Agitation * 1  0/7 (0.00%)  4/21 (19.05%)  1/8 (12.50%) 
Confusional state * 1  0/7 (0.00%)  2/21 (9.52%)  1/8 (12.50%) 
Insomnia * 1  2/7 (28.57%)  3/21 (14.29%)  0/8 (0.00%) 
Delirium * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
Dysphoria * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
Renal and urinary disorders       
Acute kidney injury * 1  0/7 (0.00%)  2/21 (9.52%)  1/8 (12.50%) 
Urinary retention * 1  1/7 (14.29%)  2/21 (9.52%)  0/8 (0.00%) 
Haematuria * 1  0/7 (0.00%)  2/21 (9.52%)  0/8 (0.00%) 
Urinary incontinence * 1  1/7 (14.29%)  0/21 (0.00%)  0/8 (0.00%) 
Oliguria * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
Reproductive system and breast disorders       
Pelvic pain * 1  1/7 (14.29%)  0/21 (0.00%)  0/8 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea * 1  1/7 (14.29%)  8/21 (38.10%)  2/8 (25.00%) 
Cough * 1  1/7 (14.29%)  4/21 (19.05%)  5/8 (62.50%) 
Epistaxis * 1  1/7 (14.29%)  2/21 (9.52%)  2/8 (25.00%) 
Hypoxia * 1  1/7 (14.29%)  4/21 (19.05%)  0/8 (0.00%) 
Pleural effusion * 1  0/7 (0.00%)  3/21 (14.29%)  1/8 (12.50%) 
Haemoptysis * 1  0/7 (0.00%)  3/21 (14.29%)  0/8 (0.00%) 
Oropharyngeal pain * 1  0/7 (0.00%)  1/21 (4.76%)  2/8 (25.00%) 
Pulmonary oedema * 1  0/7 (0.00%)  2/21 (9.52%)  0/8 (0.00%) 
Acute respiratory distress syndrome * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
Lung infiltration * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
Skin and subcutaneous tissue disorders       
Petechiae * 1  2/7 (28.57%)  3/21 (14.29%)  0/8 (0.00%) 
Ecchymosis * 1  0/7 (0.00%)  3/21 (14.29%)  1/8 (12.50%) 
Night sweats * 1  0/7 (0.00%)  3/21 (14.29%)  0/8 (0.00%) 
Rash maculo-papular * 1  0/7 (0.00%)  1/21 (4.76%)  2/8 (25.00%) 
Drug eruption * 1  0/7 (0.00%)  0/21 (0.00%)  2/8 (25.00%) 
Skin hyperpigmentation * 1  0/7 (0.00%)  2/21 (9.52%)  0/8 (0.00%) 
Dermatitis acneiform * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
Dry skin * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
Erythema multiform * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
Hirsutism * 1  0/7 (0.00%)  0/21 (0.00%)  1/8 (12.50%) 
Vascular disorders       
Hypotension * 1  1/7 (14.29%)  6/21 (28.57%)  1/8 (12.50%) 
Hypertension * 1  0/7 (0.00%)  2/21 (9.52%)  1/8 (12.50%) 
Deep vein thrombosis * 1  0/7 (0.00%)  1/21 (4.76%)  1/8 (12.50%) 
Flushing * 1  1/7 (14.29%)  0/21 (0.00%)  0/8 (0.00%) 
1
Term from vocabulary, MedDRA (19.0)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
  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
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Priyanka Mandava, Director of Clinical Operations
Organization: Pharmacyclics
Phone: 408-215-3776
EMail: psingh@pcyc.com
Layout table for additonal information
Responsible Party: Pharmacyclics LLC.
ClinicalTrials.gov Identifier: NCT02351037     History of Changes
Other Study ID Numbers: PCYC-1131-CA
First Submitted: January 16, 2015
First Posted: January 30, 2015
Results First Submitted: April 4, 2018
Results First Posted: August 14, 2018
Last Update Posted: August 14, 2018