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). (VENICE II)

AbbVie

Status and phase: Completed; Phase 3

Conditions: Chronic Lymphocytic Leukemia (CLL)

Treatments: Drug: Venetoclax

Study type: Interventional

Funder types: Industry

Identifiers

NCT02980731

M15-889

2016-001097-15 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 210 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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210 participants in 1 patient group

Venetoclax

Experimental group

Description:

Venetoclax was administered orally once daily (QD) for a planned duration of up to 2 years or until disease progression; median time on treatment was 127 weeks. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.

Treatment:

Drug: Venetoclax