Leukemia, Lymphocytic, Chronic, B-Cell
Conditions
Brief summary
The purpose of this study is to see how well Ibrutinib and Venetoclax (I+V) treatment works (effectiveness) for participants with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) when it is used in routine, everyday medical care.
Interventions
None listed
Sponsors
Janssen Research & Development, LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) requiring treatment according to international workshop on chronic lymphocytic leukemia (iwCLL) 2018 guidelines * Intented for the treatment with fixed-duration ibrutinib plus venetoclax treatment (I+V) according to the approved indication. Decision to start I+V treatment must have been taken before and independently of participant's inclusion in the study * Participant must sign an informed consent form (ICF) allowing source data verification in accordance with local requirements * Is able to read, understand, and complete the PRO instruments in local language and comply with completion of all patient-reported outcome (PRO) instruments
Exclusion criteria
* Has a history of CLL/SLL treatment * Has received an investigational medicinal product (including investigational vaccines) or used an invasive investigational medical device within 30 days before the start of the study or the first data collection time point * Is currently enrolled or plans to participate in an interventional clinical study (participation in a non-Janssen sponsored non-interventional study or registry is allowed) * Falls under any restrictions or limitations preventing treatment with I+V as per the current approved label of ibrutinib or venetoclax in Romania
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | Up to approximately Week 60 | The ORR is defined as the percentage of participants achieving the best response of complete or partial response (including complete response \[CR\], complete response with incomplete hematological recovery \[CRi\], partial response \[PR\] or partial response with lymphocytosis \[PR-L\]). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Factors Affecting the Physician Treatment Decision Using the Physician's Treatment Decision Questionnaire | At baseline | Participants with factors affecting the physicians treatment decision using the physician's treatment decision questionnaire (European Organization for Research and Treatment of Cancer \[EORTC\] Quality of Life Questionnaire\]) will be reported. |
| Number of Participants with Factors Affecting Participant's Decision to Accept or Continue with the Proposed Treatment Using the Physician's Treatment Decision Questionnaire | At baseline | Participants with factors affecting the participant's decision to accept or continue with the proposed treatment using the physician's treatment decision questionnaire (EORTC Quality of Life Questionnaire) will be reported. |
| Overall Response Rate (ORR) By the End of Treatment Cycles | Up to approximately Week 48 | ORR is defined as the percentage of participants achieving the best response of complete or partial response (including CR, CRi, PR or PR-L). |
| Duration of response (DoR) | Up to approximately Week 60 | DoR is defined as time (in months ) from the first date of achieving complete or partial response (including CR, CRi, PR, or PR-L) to the date of first documented evidence of progressive disease (PD) or death. |
| Progression-free survival (PFS) | Up to approximately 4 years | PFS is measured from the start of I+V treatment to documented disease progression, relapse, or death due to any cause. |
| Overall survival (OS) | Up to approximately 4 years | OS is measured from the start of I+V treatment to date of death due to any cause. |
| Time on treatment (TOT) | Up to approximately Week 60 | TOT is defined as time from the start of I+V treatment to the time of the end of treatment. |
| Time to Treatment Discontinuation (TTD) | Up to approximately Week 60 | TTD is defined as the time from the start of I+V treatment to the premature discontinuation of ibrutinib or venetoclax (whichever is earlier). |
| Time to Next Treatment (TTNT) | Up to approximately Week 60 | TTNT is measured from the start of I+V treatment to the start of subsequent chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) treatment where applicable. |
| Change from Baseline in Health-Related Quality of Life as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chronic lymphocytic leukemia 17 (EORTC QLQ-CLL17) | From Baseline up to approximately 4 years | The EORTC QLQ-CLL17, comprising 17 questions, was developed to supplement the core questionnaire and to specifically assess the health status of participants with CLL. It comprises 17 items grouped into 3 multi-item scales: 1) symptom burden, 2) physical condition/fatigue, and 3) worries/fears about health and functioning. Each question is rated using a 4-point response scale ("not at all," "a little," "quite a bit," and "very much"). The scores of each subscale are calculated and then transformed to a 0 to 100 scale. Higher scores represent higher levels of symptom burden, physical condition/fatigue, or worries/fears about health and functioning. |
| Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Special Situations | Up to approximately 4 years | An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. Number of participants with AEs, all serious AEs, and all special situations (for example, medication error, overdosing, abuse, lack of effect, unexpected benefits following exposure to ibrutinib etc.) will be reported. |
| Number of Participants with Tumor Lysis Risk | At Baseline and After 12 Weeks | Number of participants with tumor lysis risk (absolute lymphocyte count \[ALC\] and lymph node diameter) will be reported. Tumor lysis will be categorized as: 1) high: any lymph node with largest diameter greater than or equal to (\>=) 10 centimeter (cm) or any lymph node with largest diameter \>=5 cm and ALC \>=25 gram/liter (G/L); 2) intermediate: any lymph node \>=5 cm to less than (\<) 10 cm or ALC \>=25 G/L; and 3) low: all lymph nodes \<5 cm and ALC \<25 G/L. |
| Number of Participants with Hospitalization for Venetoclax Ramp-up For The I+V Treatment | Up to approximately 4 years | Participants with hospitalization for venetoclax ramp-up for The I+V treatment will be reported. |
| Duration of Hospitalization | Up to approximately 4 years | Duration of hospitalization is defined as number of days from the day of admission to discharge. |
| Number of Emergency Room Visits | Up to approximately 4 years | Emergency room visits, other than due to a serious adverse event following exposure to ibrutinib will be reported. |
Countries
Romania
Contacts
CONTACTStudy Contact
STUDY_DIRECTORJanssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Outcome results
None listed