A Study Evaluating the Impact of Venetoclax on the Quality of Life for Subjects With Relapsed (Your Cancer Has Come Back) or Refractory (no Response to Previous Cancer Treatments) Chronic Lymphocytic Leukemia (CLL) While Receiving Venetoclax Monotherapy (a Single Agent).
Condition: Chronic Lymphocytic Leukemia (CLL)
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Venetoclax
Intervention description: Venetoclax tablets were to be taken orally once daily with a meal and water in the morning at approximately the same time each day. Tablets were to be swallowed whole and not chewed, crushed, or broken prior to swallowing.
Intervention MeSH terms: Venetoclax
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 210.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Relapsed CLL; Refractory CLL; 17p deletion; TP53 gene; B-Cell receptor inhibitor (BCRi); European Organization of Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30); Overall response rate (ORR); Duration of overall response (DOR); Complete remission rate (CR + CRi); Progression-free survival (PFS); Overall survival (OS)

Summary:

      The purpose of this open-label, single-arm study was to evaluate the impact of venetoclax on
      the quality of life of participants including those with with relapsed/refractory (R/R)
      chronic lymphocytic leukemia (CLL; a type of cancer affecting the blood and the bone marrow)
      with or without the 17p deletion or TP53 mutation, including participants with an unknown
      status, as well as R/R CLL participants who had been previously treated with B-cell receptor
      inhibitor (BCRi) therapy. The starting dose of venetoclax was 20 mg once daily. The dose must
      have been gradually increased over a period of 5 weeks up to the daily dose of 400 mg.
      Participants may have continued receiving venetoclax for up to 2 years. After the treatment
      period, participants may have continued on into a 2-year follow-up period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eastern Cooperative Oncology Group (ECOG) performance score of ≤ 2

          -  Participant has relapsed/refractory disease (received at least one prior therapy)

          -  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)

               -  with or without 17p deletion or TP53 mutation

               -  may have been previously treated with a prior B-cell receptor inhibitor therapy

          -  Adequate bone marrow function

        Exclusion Criteria:

          -  Participant has developed Richter's transformation or Prolymphocytic leukemia (PLL)

          -  Participant has previously received venetoclax

          -  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

          -  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

          -  Prior allogeneic stem cell transplant