Clinical Trials List
Protocol NumberM15-889
NCT Number(ClinicalTrials.gov Identfier)NCT02980731
Completed
2016-12-13 - 2022-05-05
Phase III
Terminated3
ICD-10C91.10
Chronic lymphocytic leukemia of B-cell type not having achieved remission
Open-Label, Single Arm, Phase 3b, Multi-Center Study Evaluating the Impact of Venetoclax on the Quality of Life of Relapsed/Refractory Subjects With Chronic Lymphocytic Leukemia (CLL)
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Trial Applicant
AbbVie
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Sponsor
AbbVie
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Tzu-Ting Chen Division of Hematology & Oncology
- Ming-Yu Lien Division of Hematology & Oncology
- Che-Hung Lin Division of Hematology & Oncology
- Li-Yuan Bai Division of Hematology & Oncology
- Ching Yun Hsieh Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Jyh-Pyng Gau Division of Hematology & Oncology
- Po-Shen Ko Division of Hematology & Oncology
- San-Chi Chen Division of Hematology & Oncology
- Yao-Chung Liu Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
1 Terminated
Audit
None
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- Jih-Luh Tang Division of Hematology & Oncology
- MING YAO Division of Hematology & Oncology
- - - Division of Hematology & Oncology
- 劉家豪 Division of General Internal Medicine
- HSIN-AN HOU Division of Hematology & Oncology
- Chien-Chin Lin Division of Others -
- CHENG-HONG TSAI Division of Hematology & Oncology
- 劉高郎 Division of Radiology
- 陳尹愷 Division of General Internal Medicine
- Wen-Chien Chou Division of Others -
- Huai-Hsuan Huang Division of Hematology & Oncology
- 田豐銘 Division of Hematology & Oncology
- 徐思淳 Division of Others
- Tai-Chung Huang Division of Hematology & Oncology
- Chieh-Lung Cheng Division of Hematology & Oncology
- 林建廷 Division of General Internal Medicine
- - - Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
Condition/Disease
Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)
Objectives
Primary Objective:
The primary objective of this study is to evaluate the impact of venetoclax
monotherapy on the quality of life of subjects with relapsed or refractory chronic lymphocytic leukemia
(CLL) including those with the 17p deletion or TP53 mutation OR those who have received prior B-Cell
receptor inhibitor (BCRi) therapy. 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 Objectives:
The secondary objectives are to evaluate the 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.
The safety and tolerability of venetoclax in subjects with relapsed/refractory CLL will also be evaluated.
Test Drug
Venetoclax (ABT-199, GDC-0199)
Active Ingredient
Venetoclax
Dosage Form
Tablet
Dosage
10, 50 , 100
Endpoints
Primary Endpoint
The primary endpoint will be assessed by the GHS/QoL subscale of the EORTC
QLQ-C30. The primary endpoint will be the mean change from baseline to Week 48.
Scores will be calculated based on the scoring manual.
Secondary Endpoints
Secondary quality of life 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.
Key secondary efficacy endpoints will include 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).
The primary endpoint will be assessed by the GHS/QoL subscale of the EORTC
QLQ-C30. The primary endpoint will be the mean change from baseline to Week 48.
Scores will be calculated based on the scoring manual.
Secondary Endpoints
Secondary quality of life 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.
Key secondary efficacy endpoints will include 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).
Inclution Criteria
Main Inclusion:
A subject will be eligible for study participation if he/she meets all of the following 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 IWCLL NCI-WG guidelines and:
• has an indication for treatment according to the 2008 Modified IWCLL NCI-WG criteria
• has clinically measurable disease (lymphocytosis > 5 × 109
/L and/or palpable and measurable
nodes by physical exam and/or organomegaly assessed by physical exam)
In addition, patients:
• may harbor 17p deletion or TP53 mutation, assessed by a local laboratory in bone marrow or
peripheral blood AND/OR
• may have been previously treated with a B-cell receptor inhibitor
5. Adequate bone marrow function as follows:
• platelets ≥ 25,000/mm3 without any of the following:
o transfusion support within 14 days of Screening
o evidence of mucosal bleeding
o known history of major bleeding episode within 3 months of Screening
• hemoglobin ≥ 8.0 g/dL
A subject will be eligible for study participation if he/she meets all of the following 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 IWCLL NCI-WG guidelines and:
• has an indication for treatment according to the 2008 Modified IWCLL NCI-WG criteria
• has clinically measurable disease (lymphocytosis > 5 × 109
/L and/or palpable and measurable
nodes by physical exam and/or organomegaly assessed by physical exam)
In addition, patients:
• may harbor 17p deletion or TP53 mutation, assessed by a local laboratory in bone marrow or
peripheral blood AND/OR
• may have been previously treated with a B-cell receptor inhibitor
5. Adequate bone marrow function as follows:
• platelets ≥ 25,000/mm3 without any of the following:
o transfusion support within 14 days of Screening
o evidence of mucosal bleeding
o known history of major bleeding episode within 3 months of Screening
• hemoglobin ≥ 8.0 g/dL
Exclusion Criteria
Main Exclusion:
A subject will not be eligible for study participation if he/she meets any of the following 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.
A subject will not be eligible for study participation if he/she meets any of the following 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.
The Estimated Number of Participants
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Taiwan
15 participants
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Global
210 participants
