Chronic Lymphocytic Leukemia MedDRA version: 20.0 Level: PT Classification code 10008958 Term: Chronic lymphocytic leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years. 2. Eastern Cooperative Oncology Group (ECOG) performance score of = 2. 3. Subject has relapsed/refractory disease (received at least one prior therapy). 4. Diagnosis of CLL that meets published 2008 Modified International Workshop on CLL National Cancer Institute – Working Group (IWCLL NCI-WG) Guidelines and: • has an indication for treatment according to the 2008 Modified IWCLL NCI-WG Guidelines • has clinically measurable disease (lymphocytosis > 5 × 109/L and/or palpable and measurable nodes by physical exam and/or organomegaly assessed by physical exam) • subjects with or without the 17p deletion or TP53 mutation are eligible • subjects who have received prior B-cell receptor inhibitor therapy are also eligible 5. Adequate bone marrow function as follows: • hemoglobin = 8.0 g/dL • platelets = 25,000/mm3 without any of the following: - transfusion support within 14 days of Screening - evidence of mucosal bleeding - known history of major bleeding episode within 3 months of Screening Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120
Exclusion criteria
Exclusion criteria: 1. Subject has developed Richter's transformation or Prolymphocytic leukemia (PLL) 2. Subject has previously received venetoclax. 3. History of active malignancies other than CLL within the past 2 years prior to first dose of venetoclax, with the exception of: • adequately treated in situ carcinoma of the cervix uteri • adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin • previous malignancy confined and surgically resected (or treated with other modalities) with curative intent. 4. Active and uncontrolled autoimmune cytopenias (within 2 weeks prior to Screening), including autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP), despite low dose corticosteroids. 5. Prior allogeneic stem cell transplant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study to evaluate the impact of venetoclax monotherapy on the quality of life of subjects with relapsed or refractory chronic lymphocytic leukemia (CLL). Quality of life will be assessed by the Global Health Status/Quality of Life (GHS/QoL) subscale of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30);Secondary Objective: The secondary objectives are to evaluate impact of venetoclax monotherapy on quality of life based on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Chronic Lymphocytic Leukemia Module (EORTC QLQ-CLL16), EuroQoL 5 Dimension 5 Level Questionnaire (EQ-5D-5L), and the remaining subscales/items from the EORTC QLQ-C30; overall response rate (ORR); complete remission rate (CR + CRi); duration of overall response (DOR), time to progression (TTP), duration of progression-free survival (PFS); overall survival (OS); and CR rate in BCRi treated subjects.;Primary end point(s): The primary endpoint will be assessed by the GHS/QoLL subscale of the EORTC QLQ-C30. The primary endpoint will be the mean change from baseline (within 72 hours prior to the first does of venetoclax) to Week 48. Scores will be calculated based on the scoring manual.;Timepoint(s) of evaluation of this end point: The date the last enrolled subject has completed their Week 48 disease assessment or after all enrolled subjects have discontinued venetoclax, whichever is earlier, will be defined as the data "cutoff" date for the analyses. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints will include all multi-item scales and single-item scales from the EORTC QLQ-C30, EORTC QLQ-CLL16 and EQ-5D-5L. Scores will be calculated based on the scoring manual for each instrument. The secondary efficacy endpoints will include the Complete Remission Rate (CR+CRi), Overall Response Rate (ORR), Duration of Overall Response (DOR), Time to Progression (TTP), Duration of Progression-Free Survival (PFS) and Overall Survival (OS).;Timepoint(s) of evaluation of this end point: The date the last enrolled subject has completed their Week 48 disease assessment, or after all enrolled subjects have discontinued venetoclax, whichever is earlier, will be defined as the data "cutoff" date for the analyses. | — |
Countries
Argentina, Australia, Bulgaria, Colombia, Hong Kong, Hungary, Mexico, New Zealand, Poland, Romania, Russian Federation, Taiwan
Contacts
Public ContactEU Clinical Trials Helpdesk
AbbVie Ltd.
Outcome results
None listed