Trial Outcomes & Findings for A Study to Assess Safety of ImbruvicaTM in Indian Participants With Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma Who Have Received at Least One Prior Therapy or Chronic Lymphocytic Leukemia With 17p Deletion (NCT NCT03190330)
NCT ID: NCT03190330
Last Updated: 2025-05-25
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
75 participants
Primary outcome timeframe
Day 1 up to 30 days after last dose of study drug (up to 13 months)
Results posted on
2025-05-25
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
75
|
|
Overall Study
Participants With CLL
|
67
|
|
Overall Study
Participants With MCL
|
8
|
|
Overall Study
COMPLETED
|
55
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Death
|
10
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Progressive Disease
|
1
|
Baseline Characteristics
A Study to Assess Safety of ImbruvicaTM in Indian Participants With Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma Who Have Received at Least One Prior Therapy or Chronic Lymphocytic Leukemia With 17p Deletion
Baseline characteristics by cohort
| Measure |
Ibrutinib
n=75 Participants
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.
|
|---|---|
|
Age, Continuous
|
61.9 years
STANDARD_DEVIATION 11.81 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
75 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
75 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
India
|
75 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to 30 days after last dose of study drug (up to 13 months)Population: Safety analysis set included all participants who had signed the informed consent form (ICF) and received at least one dose of ibrutinib.
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.
Outcome measures
| Measure |
Ibrutinib
n=75 Participants
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.
|
|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
62 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to 30 days after last dose of study drug (up to 13 months)Population: Safety analysis set included all participants who had signed the ICF and received at least one dose of ibrutinib.
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.
Outcome measures
| Measure |
Ibrutinib
n=75 Participants
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.
|
|---|---|
|
Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs)
|
23 Participants
|
Adverse Events
Ibrutinib
Serious events: 23 serious events
Other events: 55 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Ibrutinib
n=75 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
1.3%
1/75 • 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.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.3%
1/75 • 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.
|
|
Cardiac disorders
Acute Coronary Syndrome
|
1.3%
1/75 • 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.
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
2.7%
2/75 • 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.
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.3%
1/75 • 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.
|
|
General disorders
Death
|
1.3%
1/75 • 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.
|
|
General disorders
Disease Progression
|
1.3%
1/75 • 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.
|
|
General disorders
Non-Cardiac Chest Pain
|
1.3%
1/75 • 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.
|
|
General disorders
Pyrexia
|
5.3%
4/75 • 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.
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
1.3%
1/75 • 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.
|
|
Infections and infestations
Brain Abscess
|
1.3%
1/75 • 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.
|
|
Infections and infestations
Bronchopulmonary Aspergillosis
|
1.3%
1/75 • 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.
|
|
Infections and infestations
Cellulitis
|
1.3%
1/75 • 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.
|
|
Infections and infestations
Cerebral Aspergillosis
|
1.3%
1/75 • 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.
|
|
Infections and infestations
Covid-19
|
4.0%
3/75 • 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.
|
|
Infections and infestations
Oral Candidiasis
|
1.3%
1/75 • 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.
|
|
Infections and infestations
Pneumonia
|
1.3%
1/75 • 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.
|
|
Infections and infestations
Respiratory Tract Infection
|
1.3%
1/75 • 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.
|
|
Infections and infestations
Sepsis
|
1.3%
1/75 • 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.
|
|
Infections and infestations
Sinusitis Fungal
|
1.3%
1/75 • 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.
|
|
Infections and infestations
Varicella
|
1.3%
1/75 • 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.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
1.3%
1/75 • 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.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.3%
1/75 • 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.
|
|
Metabolism and nutrition disorders
Tumour Lysis Syndrome
|
1.3%
1/75 • 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.
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
1.3%
1/75 • 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.
|
|
Nervous system disorders
Generalised Tonic-Clonic Seizure
|
1.3%
1/75 • 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.
|
|
Nervous system disorders
Seizure
|
1.3%
1/75 • 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.
|
Other adverse events
| Measure |
Ibrutinib
n=75 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
16.0%
12/75 • 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.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
2.7%
2/75 • 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.
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.3%
4/75 • 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.
|
|
Ear and labyrinth disorders
Vertigo
|
5.3%
4/75 • 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.
|
|
Eye disorders
Conjunctival Haemorrhage
|
2.7%
2/75 • 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.
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.3%
4/75 • 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.
|
|
Gastrointestinal disorders
Constipation
|
5.3%
4/75 • 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.0%
6/75 • 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.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.7%
2/75 • 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.
|
|
Gastrointestinal disorders
Mouth Ulceration
|
5.3%
4/75 • 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.
|
|
Gastrointestinal disorders
Nausea
|
4.0%
3/75 • 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.
|
|
Gastrointestinal disorders
Stomatitis
|
5.3%
4/75 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
10.7%
8/75 • 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.
|
|
General disorders
Fatigue
|
9.3%
7/75 • 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.
|
|
General disorders
Mucosal Inflammation
|
2.7%
2/75 • 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.
|
|
General disorders
Non-Cardiac Chest Pain
|
2.7%
2/75 • 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.
|
|
General disorders
Pain
|
2.7%
2/75 • 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.
|
|
General disorders
Pyrexia
|
10.7%
8/75 • 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.
|
|
Infections and infestations
Covid-19
|
4.0%
3/75 • 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.
|
|
Infections and infestations
Furuncle
|
6.7%
5/75 • 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.
|
|
Infections and infestations
Pneumonia
|
5.3%
4/75 • 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.
|
|
Infections and infestations
Urinary Tract Infection
|
5.3%
4/75 • 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.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
8.0%
6/75 • 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.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.7%
2/75 • 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.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
4.0%
3/75 • 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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
5/75 • 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.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.3%
4/75 • 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.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
4.0%
3/75 • 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.
|
|
Nervous system disorders
Dizziness
|
4.0%
3/75 • 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.
|
|
Nervous system disorders
Headache
|
9.3%
7/75 • 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.
|
|
Nervous system disorders
Neuropathy Peripheral
|
2.7%
2/75 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.7%
8/75 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.7%
2/75 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.7%
2/75 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
2.7%
2/75 • 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.
|
|
Skin and subcutaneous tissue disorders
Blister
|
2.7%
2/75 • 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.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
4.0%
3/75 • 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.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
5/75 • 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.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
5.3%
4/75 • 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.
|
|
Vascular disorders
Hypertension
|
6.7%
5/75 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER