Study of the Use of Venetoclax in Patients With Chronic Lymphocytic Leukemia (CLL) Under Real-Life Setting
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|ClinicalTrials.gov Identifier: NCT03342144|
Recruitment Status : Recruiting
First Posted : November 14, 2017
Last Update Posted : May 20, 2021
|Condition or disease|
|Chronic Lymphocytic Leukemia (CLL)|
|Study Type :||Observational|
|Estimated Enrollment :||59 participants|
|Official Title:||Observational Study of the Use of Venetoclax in Patients With Chronic Lymphocytic Leukemia (CLL) Under Real-Life Setting in Austria, Germany and Switzerland|
|Actual Study Start Date :||December 4, 2017|
|Estimated Primary Completion Date :||December 31, 2024|
|Estimated Study Completion Date :||December 31, 2024|
Participants Receiving Venetoclax
Participants with Chronic Lymphocytic Leukemia (CLL) receiving venetoclax.
Participants Receiving Venetoclax + Rituximab
Participants with CLL receiving venetoclax in combination with rituximab.
- Percentage of Participants Achieving Best Overall Response Rate (ORR) [ Time Frame: Up to 12 months ]ORR is defined as the percentage of participants achieving partial response (PR) and complete response with incomplete regeneration of bone marrow (CRi) and complete response (CR) according to physician's assessment to therapy with venetoclax.
- Percentage of Participants Administering Venetoclax [ Time Frame: Up to 24 months ]Percentage of patients administering venetoclax throughout the study.
- Percentage of Participants with Disease Progression [ Time Frame: Up to 24 months ]Disease progression as defined in the study protocol.
- Overall Survival (OS) Rate [ Time Frame: Up to 24 months ]Percentage of patients with OS where OS is defined as the number of days from the date of entry in the study to the date of death.
- Progression-Free Survival (PFS) Rate [ Time Frame: Up to 24 months ]Percentage of patients with PFS where PFS is defined as the number of days from the date of entry in the study to the date of the first documented disease progression, start of a subsequent treatment regimen, or death due to any cause, whichever occurs first.
- Minimal Residual Disease (MRD) measurement on plasma circulating tumor Deoxyribo nucleic acid (DNA) (Switzerland Only) [ Time Frame: Up to 24 months ]MRD is defined as less than 1 clonal lymphocyte per 10000 leukocytes in peripheral blood or bone marrow.
- Percentage of Patients Achieving Complete Response (CR) [ Time Frame: Up to 24 months ]Complete Response as defined in the study protocol.
- Percentage of Patients Achieving Complete Response with Incomplete Regeneration of Bone Marrow (CRi) [ Time Frame: Up 24 months ]Incomplete regeneration of bone marrow (CRi) as defined in the study protocol.
- Percentage of Patients Achieving Partial Response (PR) [ Time Frame: Up to 24 months ]Partial response as defined in the study protocol.
- Percentage of Participants with Progressive Disease [ Time Frame: Up to 24 months ]Progressive disease as defined in the study protocol.
- Percentage of Patients with Stable Disease (SD) [ Time Frame: Up to 24 months ]SD is defined as percentage of all patients not having PD, but who do not meet the criteria for PR or CR.
- Quality of Life using EORTC QLQ-C30 Scores [ Time Frame: Up to 104 weeks ]European Organization for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire (QLQ) developed to assess the quality of life of cancer patients. and is based on multi-item and single-item scales. The core questionnaire contains 5 functional scales, 3 symptom scales, 1 global health status scale, as well as 6 single-item measures.
- QLQ-CLL 16/17 Scores [ Time Frame: Up to 104 weeks ]Quality of Life Questionnaire - Chronic Lymphocytic Leukemia (QLQ-CLL)16/17 is designed for patients with stage 0 to stage 4 chronic lymphocytic leukemia. It is used to assess 5 domains of health-related quality of life important in CLL: fatigue, side effects and symptoms of disease, infection and social activities or future illness-related concerns.
- European Quality of Life 5 Dimensions (EQ-5D-5L) including visual analogue scale (VAS) [ Time Frame: Up 24 months ]The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life. EQ-5D-5L questionnaire consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-5L questionnaire plus a VAS will be used to assess general health in 5 dimensions (mobility, self-care, usual activities, pain/discomfort anxiety/depression).
- Management of Venetoclax Therapy [ Time Frame: Up to 24 Months ]Management of venetoclax therapy includes time from blood sampling to laboratory result availability, changes in laboratory values, occurence of tumor lysis syndrome and possible interventions, length and reason for hospitalizations, duration of IV hydration, therapy modifications, supportive therapies other criteria described in the protocol.
- Health Resource Utilization (HRU) per year [ Time Frame: Up to 24 Months ]Health Resource Utilization (HRU) per year will be assessed.
- Clonal evolution and eradication of Tumor Protein p53 (TP53) mutated clones associated with treatment in relation to MRD negativity (Switzerland Only) [ Time Frame: Up to 24 months ]Clonal evolution and eradication of TP53 mutated clones associated with treatment in relation to MRD negativity is evaluated
- Value of MRD Assessment [ Time Frame: Up to 24 Months ]Value of MRD assessment by flow cytometry compared to comprehensive MRD assessment including flow cytometry plus NGS in peripheral blood as described in Annex II (Switzerland only).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03342144
|Contact: Johannes Huelsenbeck||+49 email@example.com|
|Contact: Bjoern Tewsfirstname.lastname@example.org|
|Study Director:||ABBVIE INC.||AbbVie|