Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 54179060LYM4005 | Other Identifier | Johnson & Johnson Private Limited |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary purpose of this study is to evaluate the post-marketing safety of ImbruvicaTM (ibrutinib capsule 140 milligram [mg]) under actual conditions of use, and to understand the incidence of adverse events (AEs) (serious and non-serious AEs).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibrutinib | Experimental | Participants will receive ibrutinib 420 milligram (mg) (three 140 mg capsules) as a single daily dose for chronic lymphocytic leukemia (CLL) and 560 mg (four 140 mg capsules) as a single daily dose for mantle cell lymphoma (MCL) for up to 12 months or till disease progression, whichever is earlier. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibrutinib 420 mg | Drug | Ibrutinib capsule administered orally at a dose of 420 mg for CLL participants. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Any AE occurred at or after the initial administration of study drug up to maximum of 30 days after last dose was considered as treatment emergent. | Day 1 up to 30 days after last dose of study drug (up to 13 months) |
| Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was an AE which resulted in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Any AE occurred at or after the initial administration of study drug up to maximum of 30 days after last dose was considered as treatment emergent. | Day 1 up to 30 days after last dose of study drug (up to 13 months) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Private Limited Clinical Trial | Johnson & Johnson Private Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Avron Hospitals Pvt. Ltd | Ahmedabad | 380013 | India | |||
| Post Graduate Institute of Medical Education And Research PGIMER |
Since the aim of the study was to assess the safety of Imbruvica (Ibrutinib 140 milligrams [mg]), combined data of enrolled participants with either chronic lymphocytic leukemia (CLL) or mantle cell lymphoma (MCL) was collected and analyzed as planned in the protocol.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ibrutinib | Enrolled participants were prescribed ibrutinib as per locally approved prescribing information: a single daily dose of ibrutinib 420 mg (3 capsules of 140 mg) for participants with CLL and ibrutinib 560 mg (4 capsules of 140 mg) for participants with MCL, for up to 12 months or till disease progression, whichever was earlier. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 22, 2022 | Apr 30, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Ibrutinib 560 mg | Drug | Ibrutinib capsule administered orally at a dose of 560 mg for MCL participants. |
|
|
| Chandigarh |
| 160012 |
| India |
| Basavatarakam Indo-American Hospital | Hyderabad | 500034 | India |
| Bhagwan Mahaveer Cancer Hospital & Research Centre | Jaipur | 302017 | India |
| Cytecare Hospitals Pvt. Ltd | Karnataka | 560064 | India |
| Apollo Multispeciality Hospital Ltd | Kolkata | 700019 | India |
| Tata Medical Center | Kolkata | 700156 | India |
| Jawaharlal Institute of Postgraduate Medical Education and Research | Puducherry | 605008 | India |
| Deenanath Mangeshkar Hospital and Research Centre | Pune | 411004 | India |
| Noble Hospital Pvt Ltd | Pune | 411013 | India |
| Participants With CLL |
|
| Participants With MCL |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ibrutinib | Enrolled participants were prescribed ibrutinib as per locally approved prescribing information: a single daily dose of ibrutinib 420 mg (3 capsules of 140 mg) for participants with CLL and ibrutinib 560 mg (4 capsules of 140 mg) for participants with MCL, for up to 12 months or till disease progression, whichever was earlier. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Any AE occurred at or after the initial administration of study drug up to maximum of 30 days after last dose was considered as treatment emergent. | Safety analysis set included all participants who had signed the informed consent form (ICF) and received at least one dose of ibrutinib. | Posted | Count of Participants | Participants | Day 1 up to 30 days after last dose of study drug (up to 13 months) |
|
|
| ||||||||||||||||||||||||||
| Primary | Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was an AE which resulted in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Any AE occurred at or after the initial administration of study drug up to maximum of 30 days after last dose was considered as treatment emergent. | Safety analysis set included all participants who had signed the ICF and received at least one dose of ibrutinib. | Posted | Count of Participants | Participants | Day 1 up to 30 days after last dose of study drug (up to 13 months) |
|
|
Day 1 up to 30 days after last dose of study drug (up to 13 months)
Safety analysis set included all participants who had signed the ICF and received at least one dose of ibrutinib.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ibrutinib | Enrolled participants were prescribed ibrutinib as per locally approved prescribing information: a single daily dose of ibrutinib 420 mg (3 capsules of 140 mg) for participants with CLL and ibrutinib 560 mg (4 capsules of 140 mg) for participants with MCL, for up to 12 months or till disease progression, whichever was earlier. | 10 | 75 | 23 | 75 | 55 | 75 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Acute Coronary Syndrome | Cardiac disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Cardio-Respiratory Arrest | Cardiac disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Disease Progression | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hepatic Function Abnormal | Hepatobiliary disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Brain Abscess | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Bronchopulmonary Aspergillosis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Cerebral Aspergillosis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Oral Candidiasis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Sinusitis Fungal | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Tumour Lysis Syndrome | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Generalised Tonic-Clonic Seizure | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Conjunctival Haemorrhage | Eye disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Mouth Ulceration | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Mucosal Inflammation | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Neuropathy Peripheral | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 25.0 | Non-systematic Assessment |
|
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Medical Advisor | Johnson & Johnson Private Limited | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 6, 2023 | Apr 30, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
Not provided
Not provided
| ID | Term |
|---|---|
| C551803 | ibrutinib |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|