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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Participants | Participants with a confirmed diagnosis of CLL/SLL requiring first-line treatment, per international workshop on chronic lymphocytic leukemia (iwCLL) 2018 or at the discretion of the treating physician using ibrutinib plus venetoclax treatment in routine clinical practice will be enrolled in this study. No drug will be administered and only data available within routine clinical practice will be collected in this study. |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | 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]). | Up to approximately Week 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Factors Affecting the Physician Treatment Decision Using the Physician's Treatment Decision Questionnaire | 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. | At baseline |
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Inclusion Criteria
Exclusion Criteria
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The study will include adult participants with a confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) requiring first-line treatment, per international workshop on chronic lymphocytic leukemia (iwCLL) 2018 criteria or at the discretion of the treating physician using I+V treatment in routine clinical practice.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 844-434-4210 | Participate-In-This-Study1@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spitalul Universitar de Urgenta Bucuresti | Recruiting | Bucharest | 050098 | Romania |
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| Number of Participants with Factors Affecting Participant's Decision to Accept or Continue with the Proposed Treatment Using the Physician's Treatment Decision Questionnaire | 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. | At baseline |
| Overall Response Rate (ORR) By the End of Treatment Cycles | ORR is defined as the percentage of participants achieving the best response of complete or partial response (including CR, CRi, PR or PR-L). | Up to approximately Week 48 |
| Duration of response (DoR) | 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. | Up to approximately Week 60 |
| Progression-free survival (PFS) | PFS is measured from the start of I+V treatment to documented disease progression, relapse, or death due to any cause. | Up to approximately 4 years |
| Overall survival (OS) | OS is measured from the start of I+V treatment to date of death due to any cause. | Up to approximately 4 years |
| Time on treatment (TOT) | TOT is defined as time from the start of I+V treatment to the time of the end of treatment. | Up to approximately Week 60 |
| Time to Treatment Discontinuation (TTD) | TTD is defined as the time from the start of I+V treatment to the premature discontinuation of ibrutinib or venetoclax (whichever is earlier). | Up to approximately Week 60 |
| Time to Next Treatment (TTNT) | 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. | Up to approximately Week 60 |
| 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) | 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. | From Baseline up to approximately 4 years |
| Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Special Situations | 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. | Up to approximately 4 years |
| Number of Participants with Tumor Lysis Risk | 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. | At Baseline and After 12 Weeks |
| Number of Participants with Hospitalization for Venetoclax Ramp-up For The I+V Treatment | Participants with hospitalization for venetoclax ramp-up for The I+V treatment will be reported. | Up to approximately 4 years |
| Duration of Hospitalization | Duration of hospitalization is defined as number of days from the day of admission to discharge. | Up to approximately 4 years |
| Number of Emergency Room Visits | Emergency room visits, other than due to a serious adverse event following exposure to ibrutinib will be reported. | Up to approximately 4 years |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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