Health Condition 1: null- Chronic Lymphocytic Leukemia (CLL) and Mantle Cell Lymphoma (MCL)
Conditions
Interventions
Intervention1: Ibrutinib: No study treatment will be administered as a part of this study. Participants in this observational study with confirmed diagnosis of CLL and MCL receiving ibrutinib treatmen
Sponsors
Johnson and Johnson Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Must have a confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) or Mantle Cell Lymphoma (MCL) CLL or MCL participants being newly initiated on Imbruvica treatment (ibrutinib capsule 140 mg) based on independent clinical judgment of treating physicians
Exclusion criteria
Exclusion criteria: Any contraindications to ibrutinib use according to the current version of the Prescribing information in India
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate (ORR) Time to Progression (TTP) Percentage of Participants with Complete Response (CR) Percentage of Participants with Partial Response (PR) Percentage of Participants with Stable Disease (SD) Percentage of Participants with Progressive Disease (PD) Timepoint: Up to 14 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Median time to Response with Ibrutinib Change from Baseline in Hemoglobin Levels Change from Baseline in Platelet Counts Number of Participants with Response to Ibrutinib by Prior Lines of Therapy Number of Participants with Hematological and Non-hematological Adverse Drug Reactions (ADR)Timepoint: Up to 14 months | — |
Countries
India
Contacts
Public ContactDr Prashant Narang
Johnson and Johnson Private Limited
Outcome results
None listed