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No longer recruiting (closed or complete)Last updated: 31 January 2024

VENICE II: This phase III trial is trying to determine the impact an oral chemotherapy (Venetoclax) has in the treatment and quality of life of people diagnosed with Chronic Lymphocytic Leukaemia (CLL)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)

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18 - 99

Trial acronym

VENICE II

Clinical summary

Summary

Participants will receive oral Venetoclax 20mg administered once daily, beginning with a dose-titration phase and then escalated up to 400mg once daily.

Conditions

This trial is treating people with Chronic Lymphocytic Leukaemia (CLL)

Eligibility

Inclusion

  • 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

  • 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

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

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No longer recruiting (closed or complete) hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

AbbVie

Scientific Title

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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