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

Sponsor
AbbVie (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03342144
Collaborator
(none)
350
67
84.9
5.2
0.1

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated 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 :
    Dec 4, 2017
    Anticipated Primary Completion Date :
    Dec 31, 2024
    Anticipated Study Completion Date :
    Dec 31, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Primary Outcome Measures

    1. Percentage of Participants Achieving Best Overall Response Rate (ORR) [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [Up to 36 months]

      Partial response as defined in the study protocol.

    22. Percentage of Participants Receiving Venetoclax Monotherapy with Progressive Disease [Up to 24 months]

      Progressive disease as defined in the study protocol.

    23. Percentage of Participants Receiving Venetoclax Combination with Obinutuzumab with Progressive Disease [Up to 24 months]

      Progressive disease as defined in the study protocol.

    24. Percentage of Participants Receiving Venetoclax Combination with Rituximab with Progressive Disease [Up to 36 months]

      Progressive disease as defined in the study protocol.

    25. Percentage of Participants Receiving Venetoclax Monotherapy with Stable Disease (SD) [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) [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) [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 [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 [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) [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 [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 [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) [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 [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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Universitaetsklinikum St. Poelten /ID# 221152 Sankt Poelten Niederoesterreich Austria 3100
    2 Medizinische Universitaet Graz /ID# 221155 Graz Steiermark Austria 8036
    3 Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 221153 Salzburg Austria 5020
    4 Hanusch Krankenhaus /ID# 221151 Wien Austria 1140
    5 Stauferklinikum Schwaebisch Gmuend /ID# 201518 Mutlangen Baden-Wuerttemberg Germany 73557
    6 Onkologische Praxis /ID# 201545 Stuttgart Baden-Wuerttemberg Germany 70174
    7 Schwarzwald-Baar-Klinikum /ID# 208176 Villingen-Schwenningen Baden-Wuerttemberg Germany 78052
    8 MVZ am Klinikum Aschaffenburg Onkologie /ID# 201548 Aschaffenburg Bayern Germany 63739
    9 Studienzentrum Aschaffenburg /ID# 204125 Aschaffenburg Bayern Germany 63739
    10 Haematologisch-Onkologische Praxis im Zentrum Augsburg /ID# 200950 Augsburg Bayern Germany 86150
    11 Onkologie am Segelfliegerdamm /ID# 202603 Berlin Bayern Germany 12487
    12 Onkologie Hof /ID# 201531 Hof Bayern Germany 95028
    13 Praxis Dr. Stauch /ID# 202611 Kronach Bayern Germany 96317
    14 VK&K Studien GbR /ID# 202614 Landshut Bayern Germany 84036
    15 Haemato-Onkologie /ID# 205236 Muenchen Bayern Germany 81241
    16 Praxis Dres. Krober/Stosiek /ID# 206729 Regensburg Berlin Germany 93053
    17 Praxis Dr. Kreher /ID# 202604 Bad Liebenwerda Brandenburg Germany 04924
    18 Praxis Dres. Kiehl/Stein /ID# 210052 Frankfurt (Oder) Brandenburg Germany 15236
    19 MVZ f. Blut- u.Krebserkrankungen /ID# 206704 Potsdam Brandenburg Germany 14467
    20 Centrum für Haematologie /ID# 206701 Frankfurt am Main Hessen Germany 60389
    21 MVZ Dres. Cordes & Partner /ID# 202598 Frankfurt am Main Hessen Germany 60596
    22 Praxis Dres. Tebbe/Mayer /ID# 206730 Kassel Hessen Germany 34125
    23 Onkologische Kooperation Harz /ID# 201550 Goslar Niedersachsen Germany 38642
    24 OAZ Hannover /ID# 201538 Hannover Niedersachsen Germany 30171
    25 Onkolologische Praxis Oldenburg /ID# 202607 Oldenburg Niedersachsen Germany 26121
    26 MVZ der Paracelsus-Klinik /ID# 201541 Osnabrück Niedersachsen Germany 49076
    27 Med. Studiengesellschaft Nord West GmbH /ID# 201535 Westerstede Niedersachsen Germany 26655
    28 Praxis Dres. Plewe/Losem /ID# 202606 Neuss Nordrhein-Westfalen Germany 41462
    29 Hämatologie und Onkologie /ID# 205247 Kaiserslautern Rheinland-Pfalz Germany 67655
    30 Onkozentrum Dresden /ID# 202599 Dresden Sachsen Germany 01127
    31 BAG Freiberg-Richter, Jacobasch, Illmer, Wolf /ID# 201532 Dresden Sachsen Germany 01307
    32 Friedrich-Ebert-Krankenhaus GmbH /ID# 206206 Neumuenster Schleswig-Holstein Germany 24534
    33 Drs. Tanzer, Chirca, Stoeberl /ID# 202613 Bad Reichenhall Germany 83435
    34 MVZ Klinikum Mittelbaden GmbH /ID# 206207 Baden-Baden Germany 76532
    35 Praxis für Hämatologie und Onkologie /ID# 241763 Berlin Germany 10117
    36 Onkologische Schwerpunktpraxis /ID# 200953 Berlin Germany 10707
    37 Praxis am Volkspark /ID# 243195 Berlin Germany 10715
    38 Ambulantes Tumorzentrum Bremerhaven /ID# 224353 Bremerhaven Germany 27576
    39 Pioh Dres. Draube & Partner /ID# 239507 Cologne Germany 50674
    40 Praxis Dres. Prange-Krex/Mohm /ID# 210049 Dresden Germany 01307
    41 Internistische Schwerpunktpraxen, Erlangen /ID# 200949 Erlangen Germany 91052
    42 Klinikum Frankfurt Hoechst /ID# 210048 Frankfurt Germany 65929
    43 Praxis fuer interdisziplinaere Onkolologie und Haematologie /ID# 206999 Freiburg im Breisgau Germany 79110
    44 MVZ Onkologie GmbH /ID# 212376 Hagen Germany 58095
    45 Onkomedic GbR /ID# 218354 Halle (Saale) Germany 06110
    46 OncoResearch Lerchenfeld GmbH /ID# 205237 Hamburg Germany 22081
    47 Onkologische Gemeinschaftspraxis /ID# 205239 Hamburg Germany 22767
    48 Evangelisches Krankenhaus Hamm /ID# 206703 Hamm Germany 59063
    49 Studienbüro Kamal und Dorn GBR /ID# 234105 Hanover Germany 30625
    50 Klinikum Idar-Oberstein GmbH /ID# 210046 Idar-Oberstein Germany 55743
    51 Praxis Fuchs/Koehler /ID# 243215 Langen (Hessen) Germany 63225
    52 Luebecker Oncology Practice /ID# 200952 Luebeck Germany 23562
    53 Praxis Dr. Klaproth/Cura /ID# 216413 Neunkirchen Germany 66538
    54 Bruederkrankenhaus St. Josef Paderborn /ID# 202600 Paderborn Germany 33098
    55 Onkologische Praxis GbR /ID# 206705 Porta Westfalica Germany 32457
    56 Praxis Dres. Decker/Lakner/Leithäuser /ID# 206208 Rostock Germany 18057
    57 Diakonieklinikum Schwaebisch Hall /ID# 206205 Schwaebisch Hall Germany 74523
    58 MVZ am Schlossgarten GmbH /ID# 210043 Schwetzingen Germany 68723
    59 Kantonsspital Aarau AG /ID# 210034 Aarau Aargau Switzerland 5001
    60 Spital Thun /ID# 233714 Thun Bern Switzerland 3600
    61 Luzerner Kantonsspital /ID# 210029 Luzern 16 Luzern Switzerland 6000
    62 Réseau Hospitalier Neuchâtelois /ID# 227865 Neuchâtel Neuchatel Switzerland 2000
    63 Kantonsspital St. Gallen /ID# 223037 St. Gallen Sankt Gallen Switzerland 9007
    64 Kantonsspital Münsterlingen /ID# 210035 Münsterlingen Thurgau Switzerland 8596
    65 EOC Ospedale Regionale di Bellinzona e Valli /ID# 208782 Bellinzona Ticino Switzerland 6500
    66 KSW Kantonsspital Winterthur /ID# 211068 Winterthur Zuerich Switzerland 8400
    67 Inselspital, Universitätsspital Bern /ID# 210031 Bern Switzerland 3010

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: ABBVIE INC., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT03342144
    Other Study ID Numbers:
    • P17-132
    First Posted:
    Nov 14, 2017
    Last Update Posted:
    Jul 12, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 12, 2022