An Open-label, Phase 2 Study of ACP-196 (Acalabrutinib) in Subjects With Mantle Cell Lymphoma

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: NCT02213926

Recruitment Status : Active, not recruiting

First Posted : August 12, 2014

Results First Posted : October 19, 2018

Last Update Posted : January 23, 2024

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Acerta Pharma BV

Study Type	Interventional
Study Design	Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Mantle Cell Lymphoma (MCL)
Intervention	Drug: ACP-196 (acalabrutinib)
Enrollment	124

Participant Flow

Recruitment Details
Pre-assignment Details	For the ACE-LY-004 program, Study Terminated by Sponsor refers to the following: Patients receiving treatment benefits will continue to be provided with study medication in the Post Final Analysis Management of the trial. No further data collection for analysis and reporting will be completed after the final Analysis.


Arm/Group Title	ACP-196 100 mg BID
Arm/Group Description	subjects with relapsed/refractory M...
Arm/Group Description	subjects with relapsed/refractory MCL
Period Title: Overall Study
Started	124
Completed	0
Not Completed	124
Reason Not Completed
Death	59
Withdrawal by Subject	10
study terminated by sponsor	51
Lost to Follow-up	3
SITE CLOSURE - PI RETIREMENT	1

Baseline Characteristics

Arm/Group Title		ACP-196 100 mg BID
Arm/Group Description		subjects with relapsed/refractory M...
Arm/Group Description		subjects with relapsed/refractory MCL
Overall Number of Baseline Participants		124
Baseline Analysis Population Description		...
Baseline Analysis Population Description		The analysis population included All Treated Subjects.
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	124 participants
		67.1 (10.5)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	124 participants
	Female	25 20.2%
	Male	99 79.8%
Race/Ethnicity, Customized Measure Type: Number Unit of measure: Participants	Number Analyzed	124 participants
Hispanic or Latino		4
Not Hispanic or Latino		90
Not Reported		30
Race/Ethnicity, Customized Measure Type: Number Unit of measure: Participants	Number Analyzed	124 participants
American Indian or Alaska Native		0
Asian		0
Black or African American		3
Native Hawaiian or Other Pacific Islander		0
White		92
Not Reported		29
Region of Enrollment Measure Type: Number Unit of measure: Participants	Number Analyzed	124 participants
Australia		2
Belgium		2
France		26
Italy		8
Netherlands		5
Poland		19
Spain		4
United Kingdom		13
USA		45

Outcome Measures

1.Primary Outcome


Title	Overall Response Rate (ORR) of ACP-196 (Acalabrutinib) in Subjects With Previously Treated MCL.
Description	The overall response rate (ORR) is defined as the proportion of subjec...
Description	The overall response rate (ORR) is defined as the proportion of subjects achieving either a partial remission (response) (PR) or complete response (CR) according to the Lugano Classification for NHL (Cheson 2014) as assessed by investigators, where SD stands for Stable Disease, PD for Progressive Disease and NE for Not Evaluable.
Time Frame	From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months. 1 cycle =28 days

Outcome Measure Data

Analysis Population Description

The analysis population included all treated subjects.


Arm/Group Title	ACP-196 (Acalabrutinib)
Arm/Group Description:	ACP-196 (acalabrutinib) 100 mg BID
Arm/Group Description:	ACP-196 (acalabrutinib) 100 mg BID
Overall Number of Participants Analyzed	124
Measure Type: Count of Participants Unit of Measure: Participants
CR	59 47.6%
PR	42 33.9%
SD	10 8.1%
PD	10 8.1%
NE	3 2.4%

Adverse Events

Time Frame	From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months.
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	ACP-196 100 mg BID
Arm/Group Description	Description (Arm-group)
Arm/Group Description	Description (Arm-group)
All-Cause Mortality
	ACP-196 100 mg BID
	Affected / at Risk (%)
Total	59/124 (47.58%)
Serious Adverse Events Serious Adverse Events
	ACP-196 100 mg BID
	Affected / at Risk (%)	# Events
Total	62/124 (50.00%)
Blood and lymphatic system disorders
Anaemia ^† 1	6/124 (4.84%)	9
Febrile neutropenia ^† 1	1/124 (0.81%)	1
Haemolytic anaemia ^† 1	1/124 (0.81%)	1
Leukostasis syndrome ^† 1	1/124 (0.81%)	1
Cardiac disorders
Acute coronary syndrome ^† 1	1/124 (0.81%)	1
Acute myocardial infarction ^† 1	1/124 (0.81%)	1
Cardiac failure ^† 1	1/124 (0.81%)	1
Cardio-respiratory arrest ^† 1	1/124 (0.81%)	1
Coronary artery disease ^† 1	1/124 (0.81%)	1
Gastrointestinal disorders
Abdominal pain ^† 1	1/124 (0.81%)	1
Colitis ^† 1	2/124 (1.61%)	3
Diarrhoea ^† 1	1/124 (0.81%)	1
Gastrointestinal haemorrhage ^† 1	2/124 (1.61%)	2
Inguinal hernia ^† 1	1/124 (0.81%)	1
Inguinal hernia strangulated ^† 1	1/124 (0.81%)	1
Intestinal obstruction ^† 1	1/124 (0.81%)	1
Nausea ^† 1	1/124 (0.81%)	1
Pancreatitis acute ^† 1	1/124 (0.81%)	1
Umbilical hernia ^† 1	1/124 (0.81%)	1
Vomiting ^† 1	2/124 (1.61%)	2
General disorders
Chest pain ^† 1	1/124 (0.81%)	1
General physical health deterioration ^† 1	4/124 (3.23%)	4
Non-cardiac chest pain ^† 1	1/124 (0.81%)	1
Peripheral swelling ^† 1	1/124 (0.81%)	1
Pyrexia ^† 1	2/124 (1.61%)	2
Hepatobiliary disorders
Cholecystitis ^† 1	1/124 (0.81%)	1
Cholelithiasis ^† 1	1/124 (0.81%)	1
Jaundice extrahepatic obstructive ^† 1	1/124 (0.81%)	1
Infections and infestations
Arthritis bacterial ^† 1	1/124 (0.81%)	1
Bacteraemia ^† 1	1/124 (0.81%)	1
Catheter site infection ^† 1	1/124 (0.81%)	1
Clostridium difficile infection ^† 1	1/124 (0.81%)	2
Escherichia infection ^† 1	1/124 (0.81%)	2
Gastroenteritis viral ^† 1	1/124 (0.81%)	1
Lower respiratory tract infection ^† 1	1/124 (0.81%)	1
Lower respiratory tract infection bacterial ^† 1	1/124 (0.81%)	1
Paronychia ^† 1	1/124 (0.81%)	1
Pharyngitis ^† 1	1/124 (0.81%)	1
Pneumonia ^† 1	8/124 (6.45%)	8
Pseudomonal bacteraemia ^† 1	1/124 (0.81%)	1
Respiratory syncytial virus infection ^† 1	1/124 (0.81%)	1
Respiratory tract infection ^† 1	1/124 (0.81%)	1
Sepsis ^† 1	2/124 (1.61%)	2
Streptococcal bacteraemia ^† 1	1/124 (0.81%)	1
Upper respiratory tract infection ^† 1	2/124 (1.61%)	2
Urinary tract infection ^† 1	1/124 (0.81%)	2
Urinary tract infection bacterial ^† 1	1/124 (0.81%)	1
Urosepsis ^† 1	1/124 (0.81%)	1
Injury, poisoning and procedural complications
Ankle fracture ^† 1	1/124 (0.81%)	1
Fall ^† 1	1/124 (0.81%)	1
Humerus fracture ^† 1	1/124 (0.81%)	1
Incisional hernia ^† 1	1/124 (0.81%)	1
Radius fracture ^† 1	1/124 (0.81%)	1
Subdural haematoma ^† 1	1/124 (0.81%)	1
Tibia fracture ^† 1	1/124 (0.81%)	1
Transfusion reaction ^† 1	1/124 (0.81%)	1
Investigations
General physical condition abnormal ^† 1	1/124 (0.81%)	1
Metabolism and nutrition disorders
Decreased appetite ^† 1	1/124 (0.81%)	1
Lactic acidosis ^† 1	1/124 (0.81%)	1
Tumour lysis syndrome ^† 1	2/124 (1.61%)	2
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	1/124 (0.81%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma ^† 1	1/124 (0.81%)	1
Diffuse large b-cell lymphoma ^† 1	1/124 (0.81%)	1
Hodgkin's disease ^† 1	1/124 (0.81%)	1
Invasive ductal breast carcinoma ^† 1	1/124 (0.81%)	1
Metastases to meninges ^† 1	1/124 (0.81%)	1
Myelodysplastic syndrome ^† 1	1/124 (0.81%)	1
Non-small cell lung cancer ^† 1	1/124 (0.81%)	1
Squamous cell carcinoma of skin ^† 1	1/124 (0.81%)	1
Nervous system disorders
Autoimmune encephalopathy ^† 1	1/124 (0.81%)	1
Headache ^† 1	1/124 (0.81%)	1
Ischaemic stroke ^† 1	1/124 (0.81%)	1
Psychiatric disorders
Psychotic disorder ^† 1	1/124 (0.81%)	2
Suicide attempt ^† 1	1/124 (0.81%)	1
Renal and urinary disorders
Haematuria ^† 1	1/124 (0.81%)	2
Hydronephrosis ^† 1	1/124 (0.81%)	1
Reproductive system and breast disorders
Prostatitis ^† 1	1/124 (0.81%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnoea ^† 1	1/124 (0.81%)	1
Interstitial lung disease ^† 1	1/124 (0.81%)	1
Pleural effusion ^† 1	1/124 (0.81%)	1
Pulmonary embolism ^† 1	1/124 (0.81%)	1
Pulmonary fibrosis ^† 1	1/124 (0.81%)	1
Skin and subcutaneous tissue disorders
Acute febrile neutrophilic dermatosis ^† 1	1/124 (0.81%)	1
Vascular disorders
Aortic stenosis ^† 1	1/124 (0.81%)	1
Hypotension ^† 1	1/124 (0.81%)	1
Peripheral ischaemia ^† 1	1/124 (0.81%)	1
1 Term from vocabulary, MedDRA 23.0 † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	ACP-196 100 mg BID
	Affected / at Risk (%)	# Events
Total	122/124 (98.39%)
Blood and lymphatic system disorders
Anaemia ^† 1	16/124 (12.90%)	25
Haemolysis ^† 1	1/124 (0.81%)	1
Haemorrhagic diathesis ^† 1	1/124 (0.81%)	1
Increased tendency to bruise ^† 1	3/124 (2.42%)	3
Iron deficiency anaemia ^† 1	1/124 (0.81%)	1
Leukocytosis ^† 1	1/124 (0.81%)	1
Leukopenia ^† 1	1/124 (0.81%)	1
Lymph node pain ^† 1	1/124 (0.81%)	1
Neutropenia ^† 1	14/124 (11.29%)	18
Pancytopenia ^† 1	1/124 (0.81%)	1
Splenomegaly ^† 1	2/124 (1.61%)	2
Thrombocytopenia ^† 1	7/124 (5.65%)	11
Cardiac disorders
Angina pectoris ^† 1	1/124 (0.81%)	1
Aortic valve incompetence ^† 1	1/124 (0.81%)	1
Atrial fibrillation ^† 1	3/124 (2.42%)	3
Atrioventricular block complete ^† 1	1/124 (0.81%)	1
Bradycardia ^† 1	1/124 (0.81%)	1
Extrasystoles ^† 1	1/124 (0.81%)	1
Mitral valve incompetence ^† 1	2/124 (1.61%)	2
Pericardial effusion ^† 1	1/124 (0.81%)	1
Right ventricular enlargement ^† 1	1/124 (0.81%)	1
Sinus arrest ^† 1	1/124 (0.81%)	1
Sinus tachycardia ^† 1	1/124 (0.81%)	1
Tachycardia ^† 1	2/124 (1.61%)	2
Tricuspid valve incompetence ^† 1	1/124 (0.81%)	1
Ventricular extrasystoles ^† 1	1/124 (0.81%)	1
Ear and labyrinth disorders
Deafness ^† 1	1/124 (0.81%)	1
Hypoacusis ^† 1	2/124 (1.61%)	2
Otorrhoea ^† 1	1/124 (0.81%)	1
Tinnitus ^† 1	1/124 (0.81%)	1
Vertigo ^† 1	4/124 (3.23%)	4
Vertigo positional ^† 1	2/124 (1.61%)	3
Endocrine disorders
Hyperparathyroidism ^† 1	1/124 (0.81%)	1
Eye disorders
Cataract ^† 1	4/124 (3.23%)	5
Chalazion ^† 1	1/124 (0.81%)	2
Conjunctival haemorrhage ^† 1	1/124 (0.81%)	1
Dry eye ^† 1	5/124 (4.03%)	7
Eye discharge ^† 1	1/124 (0.81%)	1
Eye pain ^† 1	1/124 (0.81%)	1
Eye pruritus ^† 1	1/124 (0.81%)	1
Eyelid rash ^† 1	1/124 (0.81%)	1
Lacrimation increased ^† 1	7/124 (5.65%)	13
Ocular hyperaemia ^† 1	1/124 (0.81%)	1
Periorbital swelling ^† 1	1/124 (0.81%)	1
Scleral hyperaemia ^† 1	1/124 (0.81%)	1
Vision blurred ^† 1	8/124 (6.45%)	11
Gastrointestinal disorders
Abdominal discomfort ^† 1	1/124 (0.81%)	1
Abdominal distension ^† 1	3/124 (2.42%)	3
Abdominal pain ^† 1	14/124 (11.29%)	21
Abdominal pain lower ^† 1	1/124 (0.81%)	1
Abdominal pain upper ^† 1	10/124 (8.06%)	11
Aerophagia ^† 1	1/124 (0.81%)	1
Constipation ^† 1	20/124 (16.13%)	26
Dental caries ^† 1	1/124 (0.81%)	1
Diarrhoea ^† 1	47/124 (37.90%)	76
Dry mouth ^† 1	3/124 (2.42%)	3
Dyspepsia ^† 1	3/124 (2.42%)	3
Dysphagia ^† 1	2/124 (1.61%)	2
Flatulence ^† 1	3/124 (2.42%)	3
Food poisoning ^† 1	1/124 (0.81%)	1
Gastric ulcer ^† 1	1/124 (0.81%)	1
Gastritis ^† 1	1/124 (0.81%)	1
Gastrointestinal mucosa hyperaemia ^† 1	1/124 (0.81%)	1
Gastrointestinal polyp ^† 1	1/124 (0.81%)	1
Gastrointestinal sounds abnormal ^† 1	1/124 (0.81%)	1
Gastrooesophageal reflux disease ^† 1	5/124 (4.03%)	8
Glossodynia ^† 1	1/124 (0.81%)	1
Haematochezia ^† 1	1/124 (0.81%)	1
Haemorrhoids ^† 1	1/124 (0.81%)	1
Hiatus hernia ^† 1	1/124 (0.81%)	1
Hyperchlorhydria ^† 1	1/124 (0.81%)	1
Inguinal hernia ^† 1	3/124 (2.42%)	3
Intestinal obstruction ^† 1	1/124 (0.81%)	1
Irritable bowel syndrome ^† 1	1/124 (0.81%)	1
Large intestine polyp ^† 1	1/124 (0.81%)	1
Nausea ^† 1	27/124 (21.77%)	49
Odynophagia ^† 1	1/124 (0.81%)	1
Oesophageal spasm ^† 1	1/124 (0.81%)	1
Oesophagitis ^† 1	1/124 (0.81%)	1
Oral pain ^† 1	2/124 (1.61%)	4
Proctalgia ^† 1	1/124 (0.81%)	1
Rectal haemorrhage ^† 1	1/124 (0.81%)	1
Stomatitis ^† 1	9/124 (7.26%)	17
Tooth disorder ^† 1	1/124 (0.81%)	1
Toothache ^† 1	1/124 (0.81%)	1
Vomiting ^† 1	18/124 (14.52%)	30
General disorders
Asthenia ^† 1	22/124 (17.74%)	35
Chest discomfort ^† 1	1/124 (0.81%)	1
Chest pain ^† 1	2/124 (1.61%)	2
Chills ^† 1	4/124 (3.23%)	4
Crepitations ^† 1	1/124 (0.81%)	1
Facial pain ^† 1	1/124 (0.81%)	1
Fatigue ^† 1	37/124 (29.84%)	70
Gait disturbance ^† 1	1/124 (0.81%)	1
General physical health deterioration ^† 1	3/124 (2.42%)	3
Influenza like illness ^† 1	6/124 (4.84%)	10
Malaise ^† 1	1/124 (0.81%)	1
Nodule ^† 1	2/124 (1.61%)	3
Non-cardiac chest pain ^† 1	4/124 (3.23%)	4
Oedema ^† 1	2/124 (1.61%)	2
Oedema peripheral ^† 1	11/124 (8.87%)	16
Pain ^† 1	4/124 (3.23%)	4
Peripheral swelling ^† 1	7/124 (5.65%)	8
Pyrexia ^† 1	19/124 (15.32%)	26
Sensation of foreign body ^† 1	1/124 (0.81%)	1
Suprapubic pain ^† 1	1/124 (0.81%)	1
Swelling ^† 1	2/124 (1.61%)	2
Vessel puncture site haematoma ^† 1	1/124 (0.81%)	2
Hepatobiliary disorders
Cholelithiasis ^† 1	1/124 (0.81%)	1
Drug-induced liver injury ^† 1	1/124 (0.81%)	1
Hepatic steatosis ^† 1	1/124 (0.81%)	1
Hepatotoxicity ^† 1	1/124 (0.81%)	1
Immune system disorders
Contrast media allergy ^† 1	1/124 (0.81%)	1
Food allergy ^† 1	1/124 (0.81%)	1
Hypersensitivity ^† 1	1/124 (0.81%)	2
Hypogammaglobulinaemia ^† 1	2/124 (1.61%)	2
Seasonal allergy ^† 1	1/124 (0.81%)	1
Infections and infestations
Acute sinusitis ^† 1	1/124 (0.81%)	1
Bronchitis ^† 1	11/124 (8.87%)	12
Bronchitis viral ^† 1	1/124 (0.81%)	1
Catheter site infection ^† 1	1/124 (0.81%)	1
Cellulitis ^† 1	2/124 (1.61%)	2
Chronic sinusitis ^† 1	2/124 (1.61%)	2
Clostridium difficile infection ^† 1	1/124 (0.81%)	1
Conjunctivitis ^† 1	4/124 (3.23%)	4
Cystitis ^† 1	1/124 (0.81%)	1
Cytomegalovirus viraemia ^† 1	1/124 (0.81%)	1
Dacryocystitis ^† 1	1/124 (0.81%)	1
Dermatitis infected ^† 1	1/124 (0.81%)	1
Ear infection ^† 1	1/124 (0.81%)	1
Erysipelas ^† 1	1/124 (0.81%)	1
Eye infection ^† 1	2/124 (1.61%)	2
Fungal infection ^† 1	2/124 (1.61%)	2
Fungal skin infection ^† 1	1/124 (0.81%)	2
Furuncle ^† 1	1/124 (0.81%)	1
Gastroenteritis ^† 1	1/124 (0.81%)	1
Gastrointestinal infection ^† 1	1/124 (0.81%)	1
Gastrointestinal viral infection ^† 1	1/124 (0.81%)	1
Helicobacter gastritis ^† 1	1/124 (0.81%)	1
Herpes dermatitis ^† 1	1/124 (0.81%)	1
Herpes simplex ^† 1	1/124 (0.81%)	1
Herpes zoster ^† 1	10/124 (8.06%)	10
Infection ^† 1	1/124 (0.81%)	1
Influenza ^† 1	7/124 (5.65%)	7
Jc virus infection ^† 1	1/124 (0.81%)	1
Laryngitis ^† 1	4/124 (3.23%)	5
Localised infection ^† 1	3/124 (2.42%)	3
Lower respiratory tract infection ^† 1	6/124 (4.84%)	13
Lower respiratory tract infection bacterial ^† 1	1/124 (0.81%)	1
Mastoiditis ^† 1	1/124 (0.81%)	1
Nasopharyngitis ^† 1	10/124 (8.06%)	14
Ophthalmic herpes zoster ^† 1	1/124 (0.81%)	1
Oral herpes ^† 1	3/124 (2.42%)	3
Otitis externa ^† 1	1/124 (0.81%)	1
Otosalpingitis ^† 1	1/124 (0.81%)	1
Parainfluenzae virus infection ^† 1	1/124 (0.81%)	1
Peripheral nerve infection ^† 1	1/124 (0.81%)	1
Pharyngitis ^† 1	2/124 (1.61%)	2
Pneumocystis jirovecii pneumonia ^† 1	1/124 (0.81%)	1
Pneumonia ^† 1	8/124 (6.45%)	9
Pulpitis dental ^† 1	1/124 (0.81%)	1
Respiratory tract infection ^† 1	3/124 (2.42%)	3
Rhinitis ^† 1	6/124 (4.84%)	6
Rhinovirus infection ^† 1	1/124 (0.81%)	1
Sinusitis ^† 1	16/124 (12.90%)	25
Skin infection ^† 1	1/124 (0.81%)	1
Streptococcal bacteraemia ^† 1	1/124 (0.81%)	1
Tonsillitis ^† 1	1/124 (0.81%)	1
Tracheitis ^† 1	2/124 (1.61%)	2
Upper respiratory tract infection ^† 1	20/124 (16.13%)	30
Urinary tract infection ^† 1	5/124 (4.03%)	13
Vascular device infection ^† 1	1/124 (0.81%)	1
Viral infection ^† 1	2/124 (1.61%)	2
Viral upper respiratory tract infection ^† 1	1/124 (0.81%)	1
Injury, poisoning and procedural complications
Anaemia postoperative ^† 1	1/124 (0.81%)	1
Animal bite ^† 1	2/124 (1.61%)	2
Arthropod bite ^† 1	2/124 (1.61%)	2
Contusion ^† 1	16/124 (12.90%)	23
Fall ^† 1	6/124 (4.84%)	6
Hand fracture ^† 1	1/124 (0.81%)	2
Head injury ^† 1	1/124 (0.81%)	1
Infusion related reaction ^† 1	3/124 (2.42%)	3
Ligament sprain ^† 1	1/124 (0.81%)	1
Muscle strain ^† 1	1/124 (0.81%)	1
Periorbital haematoma ^† 1	1/124 (0.81%)	1
Post procedural haemorrhage ^† 1	1/124 (0.81%)	1
Procedural pain ^† 1	1/124 (0.81%)	1
Radius fracture ^† 1	1/124 (0.81%)	1
Skin abrasion ^† 1	1/124 (0.81%)	1
Skin laceration ^† 1	1/124 (0.81%)	1
Tendon rupture ^† 1	1/124 (0.81%)	1
Tibia fracture ^† 1	1/124 (0.81%)	1
Tooth fracture ^† 1	1/124 (0.81%)	1
Vaccination complication ^† 1	1/124 (0.81%)	1
Wound ^† 1	1/124 (0.81%)	1
Investigations
Alanine aminotransferase increased ^† 1	1/124 (0.81%)	1
Blood bilirubin increased ^† 1	2/124 (1.61%)	2
Blood cholesterol increased ^† 1	1/124 (0.81%)	1
Blood creatinine increased ^† 1	3/124 (2.42%)	5
Blood iron decreased ^† 1	1/124 (0.81%)	1
Blood pressure increased ^† 1	1/124 (0.81%)	1
Blood urea increased ^† 1	1/124 (0.81%)	1
Breath sounds abnormal ^† 1	2/124 (1.61%)	2
Neutrophil count decreased ^† 1	4/124 (3.23%)	5
Platelet count decreased ^† 1	3/124 (2.42%)	3
Serum ferritin decreased ^† 1	1/124 (0.81%)	1
Thyroxine decreased ^† 1	1/124 (0.81%)	1
Transaminases increased ^† 1	1/124 (0.81%)	1
Weight decreased ^† 1	4/124 (3.23%)	6
Weight increased ^† 1	1/124 (0.81%)	1
Metabolism and nutrition disorders
Decreased appetite ^† 1	8/124 (6.45%)	12
Dehydration ^† 1	3/124 (2.42%)	4
Hypercalcaemia ^† 1	1/124 (0.81%)	1
Hyperkalaemia ^† 1	5/124 (4.03%)	6
Hyperuricaemia ^† 1	5/124 (4.03%)	6
Hypocalcaemia ^† 1	1/124 (0.81%)	1
Hypokalaemia ^† 1	6/124 (4.84%)	8
Hypomagnesaemia ^† 1	4/124 (3.23%)	4
Hyponatraemia ^† 1	2/124 (1.61%)	4
Hypophosphataemia ^† 1	1/124 (0.81%)	2
Iron deficiency ^† 1	1/124 (0.81%)	1
Tumour lysis syndrome ^† 1	1/124 (0.81%)	1
Vitamin b12 deficiency ^† 1	1/124 (0.81%)	1
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	13/124 (10.48%)	16
Back pain ^† 1	14/124 (11.29%)	15
Bone pain ^† 1	2/124 (1.61%)	2
Flank pain ^† 1	3/124 (2.42%)	3
Groin pain ^† 1	2/124 (1.61%)	2
Joint swelling ^† 1	3/124 (2.42%)	3
Limb discomfort ^† 1	1/124 (0.81%)	1
Muscle contracture ^† 1	1/124 (0.81%)	1
Muscle spasms ^† 1	9/124 (7.26%)	12
Muscular weakness ^† 1	3/124 (2.42%)	3
Musculoskeletal chest pain ^† 1	3/124 (2.42%)	3
Musculoskeletal pain ^† 1	11/124 (8.87%)	11
Musculoskeletal stiffness ^† 1	2/124 (1.61%)	2
Myalgia ^† 1	27/124 (21.77%)	49
Neck pain ^† 1	4/124 (3.23%)	4
Osteoporosis ^† 1	1/124 (0.81%)	1
Pain in extremity ^† 1	8/124 (6.45%)	9
Tendon pain ^† 1	1/124 (0.81%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma ^† 1	5/124 (4.03%)	6
Haemangioma of skin ^† 1	1/124 (0.81%)	1
Malignant melanoma ^† 1	2/124 (1.61%)	2
Skin papilloma ^† 1	1/124 (0.81%)	1
Squamous cell carcinoma ^† 1	1/124 (0.81%)	1
Squamous cell carcinoma of skin ^† 1	2/124 (1.61%)	3
Tumour ulceration ^† 1	1/124 (0.81%)	1
Nervous system disorders
Aphasia ^† 1	1/124 (0.81%)	1
Balance disorder ^† 1	2/124 (1.61%)	2
Burning sensation ^† 1	2/124 (1.61%)	2
Carotid arteriosclerosis ^† 1	1/124 (0.81%)	1
Carotid artery stenosis ^† 1	1/124 (0.81%)	1
Disturbance in attention ^† 1	2/124 (1.61%)	2
Dizziness ^† 1	18/124 (14.52%)	21
Dizziness postural ^† 1	1/124 (0.81%)	3
Dysgeusia ^† 1	1/124 (0.81%)	1
Encephalopathy ^† 1	1/124 (0.81%)	1
Headache ^† 1	48/124 (38.71%)	60
Hypoaesthesia ^† 1	7/124 (5.65%)	9
Intention tremor ^† 1	1/124 (0.81%)	1
Memory impairment ^† 1	9/124 (7.26%)	12
Migraine ^† 1	1/124 (0.81%)	1
Neuralgia ^† 1	3/124 (2.42%)	4
Neuropathy peripheral ^† 1	2/124 (1.61%)	2
Paraesthesia ^† 1	10/124 (8.06%)	11
Peripheral sensory neuropathy ^† 1	2/124 (1.61%)	2
Presyncope ^† 1	3/124 (2.42%)	3
Resting tremor ^† 1	1/124 (0.81%)	2
Sciatica ^† 1	4/124 (3.23%)	4
Sensory loss ^† 1	1/124 (0.81%)	1
Somnolence ^† 1	2/124 (1.61%)	2
Syncope ^† 1	5/124 (4.03%)	5
Tremor ^† 1	2/124 (1.61%)	2
Product Issues
Device occlusion ^† 1	1/124 (0.81%)	1
Psychiatric disorders
Confusional state ^† 1	1/124 (0.81%)	1
Delirium ^† 1	1/124 (0.81%)	1
Depression ^† 1	4/124 (3.23%)	4
Insomnia ^† 1	9/124 (7.26%)	9
Mental status changes ^† 1	1/124 (0.81%)	1
Sleep disorder ^† 1	4/124 (3.23%)	4
Renal and urinary disorders
Acute kidney injury ^† 1	2/124 (1.61%)	2
Bladder spasm ^† 1	1/124 (0.81%)	1
Dysuria ^† 1	1/124 (0.81%)	1
Haematuria ^† 1	2/124 (1.61%)	4
Pollakiuria ^† 1	4/124 (3.23%)	4
Renal failure ^† 1	2/124 (1.61%)	2
Renal injury ^† 1	1/124 (0.81%)	1
Strangury ^† 1	1/124 (0.81%)	1
Urinary incontinence ^† 1	1/124 (0.81%)	3
Urinary retention ^† 1	2/124 (1.61%)	2
Reproductive system and breast disorders
Adnexa uteri pain ^† 1	1/124 (0.81%)	1
Pelvic pain ^† 1	2/124 (1.61%)	2
Prostatitis ^† 1	1/124 (0.81%)	1
Respiratory, thoracic and mediastinal disorders
Bronchiectasis ^† 1	1/124 (0.81%)	1
Bronchitis chronic ^† 1	1/124 (0.81%)	1
Bronchostenosis ^† 1	1/124 (0.81%)	1
Catarrh ^† 1	1/124 (0.81%)	1
Cough ^† 1	29/124 (23.39%)	38
Dysphonia ^† 1	2/124 (1.61%)	2
Dyspnoea ^† 1	18/124 (14.52%)	26
Dyspnoea exertional ^† 1	5/124 (4.03%)	5
Emphysema ^† 1	1/124 (0.81%)	1
Epistaxis ^† 1	9/124 (7.26%)	9
Interstitial lung disease ^† 1	1/124 (0.81%)	1
Middle lobe syndrome ^† 1	1/124 (0.81%)	1
Nasal congestion ^† 1	5/124 (4.03%)	6
Nasal obstruction ^† 1	2/124 (1.61%)	2
Nasal polyps ^† 1	1/124 (0.81%)	1
Organising pneumonia ^† 1	1/124 (0.81%)	1
Oropharyngeal pain ^† 1	5/124 (4.03%)	8
Paranasal sinus discomfort ^† 1	2/124 (1.61%)	2
Paranasal sinus hypersecretion ^† 1	2/124 (1.61%)	2
Pharyngeal erythema ^† 1	1/124 (0.81%)	1
Pleural effusion ^† 1	4/124 (3.23%)	4
Pleurisy ^† 1	1/124 (0.81%)	1
Productive cough ^† 1	5/124 (4.03%)	10
Pulmonary air leakage ^† 1	1/124 (0.81%)	1
Rales ^† 1	2/124 (1.61%)	4
Rhinitis allergic ^† 1	1/124 (0.81%)	1
Rhinorrhoea ^† 1	6/124 (4.84%)	8
Sinus congestion ^† 1	1/124 (0.81%)	1
Sinus pain ^† 1	1/124 (0.81%)	2
Sneezing ^† 1	1/124 (0.81%)	1
Sputum discoloured ^† 1	2/124 (1.61%)	2
Tachypnoea ^† 1	1/124 (0.81%)	1
Throat irritation ^† 1	1/124 (0.81%)	1
Upper respiratory tract congestion ^† 1	2/124 (1.61%)	2
Upper-airway cough syndrome ^† 1	3/124 (2.42%)	3
Wheezing ^† 1	1/124 (0.81%)	1
Skin and subcutaneous tissue disorders
Actinic keratosis ^† 1	1/124 (0.81%)	1
Alopecia ^† 1	1/124 (0.81%)	1
Blood blister ^† 1	1/124 (0.81%)	1
Dermatitis ^† 1	1/124 (0.81%)	1
Dermatitis acneiform ^† 1	1/124 (0.81%)	1
Dermatitis allergic ^† 1	1/124 (0.81%)	1
Dermatitis contact ^† 1	1/124 (0.81%)	1
Drug eruption ^† 1	1/124 (0.81%)	1
Dry skin ^† 1	1/124 (0.81%)	1
Ecchymosis ^† 1	4/124 (3.23%)	5
Eczema ^† 1	2/124 (1.61%)	2
Erythema ^† 1	7/124 (5.65%)	7
Hyperhidrosis ^† 1	4/124 (3.23%)	4
Hyperkeratosis ^† 1	1/124 (0.81%)	1
Intertrigo ^† 1	1/124 (0.81%)	1
Night sweats ^† 1	2/124 (1.61%)	2
Perioral dermatitis ^† 1	1/124 (0.81%)	2
Petechiae ^† 1	11/124 (8.87%)	14
Pruritus ^† 1	6/124 (4.84%)	6
Purpura ^† 1	6/124 (4.84%)	7
Rash ^† 1	18/124 (14.52%)	31
Rash erythematous ^† 1	4/124 (3.23%)	4
Rash maculo-papular ^† 1	1/124 (0.81%)	1
Rash papular ^† 1	1/124 (0.81%)	1
Rash pruritic ^† 1	2/124 (1.61%)	3
Skin exfoliation ^† 1	1/124 (0.81%)	1
Skin lesion ^† 1	3/124 (2.42%)	4
Stasis dermatitis ^† 1	1/124 (0.81%)	1
Urticaria ^† 1	2/124 (1.61%)	2
Vascular disorders
Aortic stenosis ^† 1	1/124 (0.81%)	1
Arterial disorder ^† 1	1/124 (0.81%)	1
Deep vein thrombosis ^† 1	1/124 (0.81%)	1
Flushing ^† 1	1/124 (0.81%)	1
Haematoma ^† 1	8/124 (6.45%)	8
Hot flush ^† 1	2/124 (1.61%)	2
Hypertension ^† 1	4/124 (3.23%)	5
Hypotension ^† 1	6/124 (4.84%)	6
Lymphoedema ^† 1	2/124 (1.61%)	2
Peripheral arterial occlusive disease ^† 1	1/124 (0.81%)	1
Peripheral artery aneurysm ^† 1	1/124 (0.81%)	1
Peripheral venous disease ^† 1	1/124 (0.81%)	2
Thrombophlebitis superficial ^† 1	1/124 (0.81%)	1
Thrombosed varicose vein ^† 1	1/124 (0.81%)	1
Varicose vein ^† 1	1/124 (0.81%)	1
1 Term from vocabulary, MedDRA 23.0 † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT 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.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Global Clinical Lead
Organization:	AstraZeneca Clinical -Study Information Center
Phone:	1-877-240-9479
EMail:	information.center@astrazeneca.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wang M, Rule S, Zinzani PL, Goy A, Casasnovas O, Smith SD, Damaj G, Doorduijn J, Lamy T, Morschhauser F, Panizo C, Shah B, Davies A, Eek R, Dupuis J, Jacobsen E, Kater AP, Le Gouill S, Oberic L, Robak T, Covey T, Dua R, Hamdy A, Huang X, Izumi R, Patel P, Rothbaum W, Slatter JG, Jurczak W. Acalabrutinib in relapsed or refractory mantle cell lymphoma (ACE-LY-004): a single-arm, multicentre, phase 2 trial. Lancet. 2018 Feb 17;391(10121):659-667. doi: 10.1016/S0140-6736(17)33108-2. Epub 2017 Dec 11.

Layout table for additonal information

Responsible Party:	Acerta Pharma BV
ClinicalTrials.gov Identifier:	NCT02213926
Other Study ID Numbers:	ACE-LY-004 2014-002117-28 ( EudraCT Number )
First Submitted:	August 5, 2014
First Posted:	August 12, 2014
Results First Submitted:	August 16, 2018
Results First Posted:	October 19, 2018
Last Update Posted:	January 23, 2024

To Top