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Study of the Use of Venetoclax in Participants With Chronic Lymphocytic Leukemia (CLL) Under Real-Life Setting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03342144
Recruitment Status : Active, not recruiting
First Posted : November 14, 2017
Last Update Posted : June 7, 2023
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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Brief Summary:
An observational study to assess the effectiveness, health economic-relevant costs and participant reported outcomes in participants with Chronic lymphocytic leukemia (CLL) receiving venetoclax as a monotherapy or in combination with rituximab or obinutuzumab as prescribed at the discretion of the physician and in accordance with local clinical practice and label.

Condition or disease
Chronic Lymphocytic Leukemia (CLL)

Study Design
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Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of the Use of Venetoclax in Patients With Chronic Lymphocytic Leukemia (CLL) Under Real-Life Setting in Austria, Germany and Switzerland
Actual Study Start Date : December 4, 2017
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Venetoclax

Groups and Cohorts
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Group/Cohort
Participants Receiving Venetoclax
Participants with Chronic Lymphocytic Leukemia (CLL) receiving venetoclax.
Participants Receiving Venetoclax + Rituximab
Participants with CLL receiving venetoclax in combination with rituximab.
Participants Receiving Venetoclax + Obinutuzumab
Participants with CLL receiving venetoclax in combination with obinutuzumab.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants Achieving Best Overall Response Rate (ORR) [ Time Frame: Up to 12 months ]
    ORR is defined as the percentage of participants achieving partial response (PR) and complete response with incomplete regeneration of bone marrow (CRi) and complete response (CR) according to physician's assessment to therapy with venetoclax.


Secondary Outcome Measures :
  1. Percentage of Participants Still on Venetoclax Monotherapy [ Time Frame: Up to 24 months ]
    Percentage of participants still on venetoclax monotherapy throughout the study.

  2. Percentage of Participants Still on Venetoclax in Combination with Rituximab [ Time Frame: Up to 24 months ]
    Percentage of participants still on venetoclax in combination with rituximab throughout the study.

  3. Percentage of Participants Receiving Venetoclax Monotherapy with Disease Progression [ Time Frame: Up to 24 months ]
    Disease progression as defined in the study protocol in participants receiving venetoclax monotherapy.

  4. Percentage of Participants Receiving Venetoclax in Combination with Obinutuzumab with Disease Progression [ Time Frame: Up to 24 months ]
    Disease progression as defined in the study protocol in participants receiving venetoclax in combination with obinutuzumab.

  5. Percentage of Participants Receiving Venetoclax in Combination with Rituximab with Disease Progression [ Time Frame: Up to 36 months ]
    Disease progression as defined in the study protocol in participants receiving venetoclax in combination with rituximab.

  6. Overall Survival (OS) Rate in Participants Receiving Venetoclax Monotherapy [ Time Frame: Up to 24 months ]
    Percentage of participants with OS where OS is defined as the number of days from the date of entry in the study to the date of death.

  7. Overall Survival (OS) Rate in Participants Receiving Venetoclax in Combination with Obinutuzumab [ Time Frame: Up to 24 months ]
    Percentage of participants with OS where OS is defined as the number of days from the date of entry in the study to the date of death.

  8. Overall Survival (OS) Rate in Participants Receiving Venetoclax in Combination with Rituximab [ Time Frame: Up to 36 months ]
    Percentage of participants with OS where OS is defined as the number of days from the date of entry in the study to the date of death.

  9. Progression-Free Survival (PFS) Rate in Participants Receiving Venetoclax Monotherapy [ Time Frame: Up to 24 months ]
    Percentage of participants with PFS where PFS is defined as the number of days from the date of entry in the study to the date of the first documented disease progression, start of a subsequent treatment regimen, or death due to any cause, whichever occurs first.

  10. Progression-Free Survival (PFS) Rate in Participants Receiving Venetoclax in Combination with Obinutuzumab [ Time Frame: Up to 24 months ]
    Percentage of participants with PFS where PFS is defined as the number of days from the date of entry in the study to the date of the first documented disease progression, start of a subsequent treatment regimen, or death due to any cause, whichever occurs first.

  11. Progression-Free Survival (PFS) Rate in Participants Receiving Venetoclax in Combination with Rituximab [ Time Frame: Up to 36 months ]
    Percentage of participants with PFS where PFS is defined as the number of days from the date of entry in the study to the date of the first documented disease progression, start of a subsequent treatment regimen, or death due to any cause, whichever occurs first.

  12. Minimal Residual Disease (MRD) measurement on plasma circulating tumor Deoxyribo nucleic acid (DNA) (Switzerland Only) [ Time Frame: Up to 24 months ]
    MRD is defined as less than 1 clonal lymphocyte per 10000 leukocytes in peripheral blood or bone marrow.

  13. Percentage of Participants Receiving Venetoclax Monotherapy and Achieving Complete Response (CR) [ Time Frame: Up to 24 months ]
    Complete Response as defined in the study protocol.

  14. Percentage of Participants Receiving Venetoclax in Combination with Obinutuzumab and Achieving Complete Response (CR) [ Time Frame: Up to 24 months ]
    Complete Response as defined in the study protocol.

  15. Percentage of Participants Receiving Venetoclax in Combination with Rituximab and Achieving Complete Response (CR) [ Time Frame: Up to 36 months ]
    Complete Response as defined in the study protocol.

  16. Percentage of Participants Receiving Venetoclax Monotherapy and Achieving Complete Response with Incomplete Regeneration of Bone Marrow (CRi) [ Time Frame: Up 24 months ]
    Incomplete regeneration of bone marrow (CRi) as defined in the study protocol.

  17. Percentage of Participants Receiving Venetoclax Combination with Obinutuzumab and Achieving Complete Response with Incomplete Regeneration of Bone Marrow (CRi) [ Time Frame: Up 24 months ]
    Incomplete regeneration of bone marrow (CRi) as defined in the study protocol.

  18. Percentage of Participants Receiving Venetoclax Combination with Rituximab and Achieving Complete Response with Incomplete Regeneration of Bone Marrow (CRi) [ Time Frame: Up 36 months ]
    Incomplete regeneration of bone marrow (CRi) as defined in the study protocol.

  19. Percentage of Participants Receiving Venetoclax Monotherapy and Achieving Partial Response (PR) [ Time Frame: Up to 24 months ]
    Partial response as defined in the study protocol.

  20. Percentage of Participants Receiving Venetoclax Combination with Obinutuzumab and Achieving Partial Response (PR) [ Time Frame: Up to 24 months ]
    Partial response as defined in the study protocol.

  21. Percentage of Participants Receiving Venetoclax Combination with Rituximab and Achieving Partial Response (PR) [ Time Frame: Up to 36 months ]
    Partial response as defined in the study protocol.

  22. Percentage of Participants Receiving Venetoclax Monotherapy with Progressive Disease [ Time Frame: Up to 24 months ]
    Progressive disease as defined in the study protocol.

  23. Percentage of Participants Receiving Venetoclax Combination with Obinutuzumab with Progressive Disease [ Time Frame: Up to 24 months ]
    Progressive disease as defined in the study protocol.

  24. Percentage of Participants Receiving Venetoclax Combination with Rituximab with Progressive Disease [ Time Frame: Up to 36 months ]
    Progressive disease as defined in the study protocol.

  25. Percentage of Participants Receiving Venetoclax Monotherapy with Stable Disease (SD) [ Time Frame: Up to 24 months ]
    SD is defined as percentage of all participants not having PD, but who do not meet the criteria for PR or CR.

  26. Percentage of Participants Receiving Venetoclax Combination with Obinutuzumab with Stable Disease (SD) [ Time Frame: Up to 24 months ]
    SD is defined as percentage of all participants not having PD, but who do not meet the criteria for PR or CR.

  27. Percentage of Participants Receiving Venetoclax Combination with Rituximab with Stable Disease (SD) [ Time Frame: Up to 36 months ]
    SD is defined as percentage of all participants not having PD, but who do not meet the criteria for PR or CR.

  28. Quality of Life using EORTC QLQ-C30 Scores [ Time Frame: Up to 104 weeks ]
    European Organization for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire (QLQ) developed to assess the quality of life of cancer patients. and is based on multi-item and single-item scales. The core questionnaire contains 5 functional scales, 3 symptom scales, 1 global health status scale, as well as 6 single-item measures.

  29. QLQ-CLL 16/17 Scores [ Time Frame: Up to 104 weeks ]
    Quality of Life Questionnaire - Chronic Lymphocytic Leukemia (QLQ-CLL)16/17 is designed for participants with stage 0 to stage 4 chronic lymphocytic leukemia. It is used to assess 5 domains of health-related quality of life important in CLL: fatigue, side effects and symptoms of disease, infection and social activities or future illness-related concerns.

  30. European Quality of Life 5 Dimensions (EQ-5D-5L) including visual analogue scale (VAS) [ Time Frame: Up 24 months ]
    The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life. EQ-5D-5L questionnaire consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-5L questionnaire plus a VAS will be used to assess general health in 5 dimensions (mobility, self-care, usual activities, pain/discomfort anxiety/depression).

  31. Management of Venetoclax Therapy [ Time Frame: Up to 24 Months ]
    Management of venetoclax therapy includes time from blood sampling to laboratory result availability, changes in laboratory values, occurence of tumor lysis syndrome and possible interventions, length and reason for hospitalizations, duration of IV hydration, therapy modifications, supportive therapies other criteria described in the protocol.

  32. Health Resource Utilization (HRU) per year [ Time Frame: Up to 24 Months ]
    Health Resource Utilization (HRU) per year will be assessed.

  33. Clonal evolution and eradication of Tumor Protein p53 (TP53) mutated clones associated with treatment in relation to MRD negativity (Switzerland Only) [ Time Frame: Up to 24 months ]
    Clonal evolution and eradication of TP53 mutated clones associated with treatment in relation to MRD negativity is evaluated

  34. Value of MRD Assessment [ Time Frame: Up to 24 Months ]
    Value of MRD assessment by flow cytometry compared to comprehensive MRD assessment including flow cytometry plus NGS in peripheral blood as described in Annex II (Switzerland only).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with chronic lymphocytic leukemia (CLL) administering venetoclax per the local label.
Criteria

Inclusion Criteria:

  • Participant with chronic lymphocytic leukemia (CLL) administering venetoclax and who meets the following conditions as specified in the label for venetoclax:
  • Venetoclax monotherapy for the treatment of CLL in the presence of deletion chromosome 17 (del[17p]) or tumor protein p53 (TP53) mutation in adult participants, who are unsuitable for or have failed to a B-cell receptor pathway inhibitor.
  • Venetoclax monotherapy for the treatment of CLL in the absence of del(17p) or TP53 mutation in adult participants, who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.
  • Venetoclax in combination with rituximab for the treatment of adult participants with CLL who have received at least one prior therapy.
  • Venetoclax in combination with obinutuzumab for previously untreated adult participants with CLL.

Exclusion Criteria:

- None

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03342144


Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
More Information
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Additional Information:

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03342144    
Other Study ID Numbers: P17-132
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: June 7, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
Chronic Lymphocytic Leukemia (CLL)
Cancer
Leukemia
venetoclax
rituximab
 obinutuzumab
ABT-199
venclexta
venclyxto
Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Chronic Disease
Disease Attributes
Pathologic Processes