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).

Study Identifier
M15-889
CT.gov Identifier
NCT02980731
EudraCT Identifier
2016-001097-15
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol
Available Language(s): English
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Statistical Analysis Plan
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Scientific Result Summary
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Plain Language Summary
Available Language(s): English, Bulgarian, Chinese (Taiwan), Hungarian, Polish, Russian
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Study Details

Medical Condition
  • Blood Cancer - Chronic Lymphocytic Leukemia (CLL)
    • Study Drug
  • Venetoclax
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18 - 99 Years
    Inclusion and Exclusion 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

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Hospital Italiano La Plata /ID# 150812
    La Plata, Buenos Aires, Argentina, 1902
    Status
    Not applicable
    Location
    Fundaleu /Id# 150811
    Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina, 1114
    Status
    Not applicable
    Location
    Cemic /Id# 150810
    Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina, 1431
    Status
    Not applicable
    Location
    Sanatorio Allende /ID# 150813
    Córdoba, Argentina, 5000
    Status
    Not applicable
    Location
    St George Hospital /ID# 154212
    Kogarah, New South Wales, Australia, 2217
    Status
    Not applicable
    Location
    Liverpool Hospital /ID# 154950
    Liverpool, New South Wales, Australia, 2170
    Status
    Not applicable
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