A study evaluating venetoclax (ABT-199) in subjects with Chronic Lymphocytic Leukemia (CLL) whose cancer has come back or who had no response to previous cancer treatments including subjects who may be missing part of their chromosome 17 identified as 17p deletion, or TP53 gene mutation; or subjects who previously received treatment with B-cell receptor inhibitors.

• Register: EUCTR
• Last refreshed on: 2 May 2022
• Main ID: EUCTR2015-003667-11-BE
• Date of registration: 11/07/2016
• Prospective Registration: Yes
• Primary sponsor: AbbVie Deutschland GmbH & Co. KG
• Public title: A study evaluating venetoclax (ABT-199) in subjects with Chronic Lymphocytic Leukemia (CLL) whose cancer has come back or who had no response to previous cancer treatments including subjects who may be missing part of their chromosome 17 identified as 17p deletion, or TP53 gene mutation; or subjects who previously received treatment with B-cell receptor inhibitors.
• Scientific title: Open-Label, Single Arm, Phase 3B, Multi-Center Study Evaluating the Efficacy of Venetoclax (ABT 199) in Relapsed/Refractory Subjects with Chronic Lymphocytic Leukemia (CLL) (VENICE I)
• Date of first enrolment: 09/08/2016
• Target sample size: 250
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-003667-11
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Belgium, Canada, Denmark, Finland, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, Norway, Portugal, Puerto Rico, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States

Contacts

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie Ltd.

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie Ltd.

Key inclusion & exclusion 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 line of 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 × 10^9/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 (up to 60 subjects total will be enrolled in the study)
5. Adequate bone marrow function as follows:
• hemoglobin = 8.0 g/dL
• platelets = 25,000/mm^3 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

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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Chronic Lymphocytic Leukemia
MedDRA version: 21.1 Level: PT Classification code 10008958 Term: Chronic lymphocytic leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Product Name: Venetoclax
Product Code: ABT-199
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Venetoclax 10mg
Current Sponsor code: ABT-199
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-

Product Name: Venetoclax
Product Code: ABT-199
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Venetoclax 50mg
Current Sponsor code: ABT-199
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Product Name: Venetoclax
Product Code: ABT-199
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Venetoclax 100mg
Current Sponsor code: ABT-199
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Main Objective: The primary objective of this study to evaluate the efficacy of venetoclax monotherapy in subjects with relapsed or refractory chronic lymphocytic leukemia (CLL).

Primary end point(s): The primary efficacy endpoint will be measured by complete remission rate (CR+CRi) of the subjects who have not been previously treated with BCRi therapy as assessed by the investigator.

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 efficacy analyses.

Secondary Objective: The secondary objectives are to evaluate other efficacy parameters including the overall response rate (ORR), duration of overall response (DoR), time to progression (TTP), progression-free survival (PFS), overall survival (OS), Complete Remission rate in BCRi treated subjects.

Secondary Outcome(s)

Secondary end point(s): Key secondary efficacy endpoints:
Overall response rate, duration of response, time to progression, progression-free survival, overall survival, complete remission rate in B-Cell receptor inhibitor treated subjects.

Timepoint(s) of evaluation of this end point: The date the last enrolled subjects 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 efficacy analyses.

Secondary ID(s)

2015-003667-11-GR

M15-550

Source(s) of Monetary Support

AbbVie Inc.

Ethics review

Status: Approved
Approval date: 09/08/2016
Contact: