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) (VENICE II)

AbbVie Deutschland GmbH & Co. KG0 sites200 target enrollmentStarted: July 28, 2017Last updated: January 17, 2022

Conditions

Trial Snapshot

No summary available.

•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:
•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
•hemoglobin = 8.0 g/dL
•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

•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.

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