Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Mantle-Cell
Conditions
Brief summary
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).
Interventions
DRUGIbrutinib 420 mg
Ibrutinib capsule administered orally at a dose of 420 mg for CLL participants.
DRUGIbrutinib 560 mg
Ibrutinib capsule administered orally at a dose of 560 mg for MCL participants.
Sponsors
Johnson & Johnson Private Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chronic lymphocytic leukemia (CLL) or mantle cell lymphoma (MCL) participants being newly initiated on Imbruvica treatment (ibrutinib capsule 140 milligram \[mg\]) based on independent clinical judgment of treating physicians as per locally approved prescribing information * Must give a written informed consent indicating that they understand the purpose and are willing to participate in the study and allowing data collection and source data verification in accordance with regulatory requirements
Exclusion criteria
* Participants who are not eligible to receive Imbruvica as per the locally approved prescribing information * Participants participating or planning to participate in any interventional drug trial during the course of this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Day 1 up to 30 days after last dose of study drug (up to 13 months) | 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. |
| Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) | Day 1 up to 30 days after last dose of study drug (up to 13 months) | 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. |
Countries
India
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 75 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Death | 10 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Progressive Disease | 1 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Ibrutinib |
|---|---|
| Age, Continuous | 61.9 years STANDARD_DEVIATION 11.81 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 75 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 75 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment India | 75 Participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 10 / 75 |
| other Total, other adverse events | 55 / 75 |
| serious Total, serious adverse events | 23 / 75 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ibrutinib | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 62 Participants |
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ibrutinib | Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) | 23 Participants |