Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Lymphoma

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoma, Mantle-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Lymphoma, Non-Hodgkin

Lymphosarcoma

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Mantle Cell Lymphoma

Chromosome 17p Deletion

All Drugs and Chemicals

Amino Acids

Ibrutinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

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.

Ibrutinib capsule administered orally at a dose of 420 mg for CLL participants.

Ibrutinib 420 mg

Ibrutinib capsule administered orally at a dose of 560 mg for MCL participants.

Ibrutinib 560 mg

Johnson & Johnson Private Limited Clinical Trial

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).

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

A Prospective, Multicenter, Open Label Single Arm Phase IV Clinical Trial to Assess Safety of ImbruvicaTM (Ibrutinib Capsules 140 mg) in Indian Patients With Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma Who Have Received at Least One Prior Therapy or Chronic Lymphocytic Leukemia With 17p Deletion

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.

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.

Johnson & Johnson Private Limited

Safety analysis set included all participants who had signed the ICF and received at least one dose of 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.

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

India

Region of Enrollment

Sr. Medical Advisor

Safety analysis set included all participants who had signed the informed consent form (ICF) and received at least one dose of ibrutinib.

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs)

Overall Study

Spots Global Cancer Trial Database 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

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial