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Trial record 15 of 67 for:    Venetoclax AND CRi

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

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ClinicalTrials.gov Identifier: NCT03342144
Recruitment Status : Recruiting
First Posted : November 14, 2017
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
An observational study to assess the effectiveness, health economic‐relevant costs and patient reported outcomes in patients with Chronic lymphocytic leukemia (CLL) receiving venetoclax as prescribed at the discretion of the physician and in accordance with local clinical practice and label.

Condition or disease
Chronic Lymphocytic Leukemia (CLL)

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Study Type : Observational
Estimated Enrollment : 250 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, 2021
Estimated Study Completion Date : December 31, 2021


Group/Cohort
Participants Receiving Venetoclax
Participants with Chronic Lymphocytic Leukemia (CLL) receiving venetoclax.



Primary Outcome Measures :
  1. Percentage of Patients Achieving 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. Progression-Free Survival (PFS) Rate [ Time Frame: Up to 24 months ]
    Percentage of patients 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.

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

  3. 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.

  4. Percentage of Patients 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.

  5. 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).

  6. 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 patients 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.

  7. Percentage of Patients with Progressive Disease (PD) [ Time Frame: Up to 24 months ]
    Progressive disease as defined in the study protocol.

  8. Percentage of Patients Achieving Partial Response (PR) [ Time Frame: Up to 24 months ]
    Partial response as defined in the study protocol.

  9. Percentage of Patients Administering Venetoclax [ Time Frame: Up to 24 months ]
    Percentage of patients administering venetoclax throughout the study.

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

  11. Percentage of Patients Achieving Complete Response (CR) [ Time Frame: Up to 24 months ]
    Complete Response as defined in the study protocol.

  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. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic lymphocytic leukemia (CLL) administering venetoclax per the local label.
Criteria

Inclusion Criteria:

  • Patient 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 patients, 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 patients, who have failed both chemoimmunotherapy and a B‐cell receptor pathway inhibitor.

Exclusion Criteria:

  • None

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


Contacts
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Contact: Johannes Huelsenbeck +49 611-1720-3036 johannes.huelsenbeck@abbvie.com
Contact: Bjoern Tews bjoern.tews@abbvie.com

Locations
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Germany
Onkologische Praxis /ID# 201545 Recruiting
Stuttgart, Baden-Wuerttemberg, Germany, 70174
Medizinisches Versorgungszentrum (MVZ) /ID# 201548 Recruiting
Aschaffenburg, Bayern, Germany, 63739
Studienzentrum Aschaffenburg /ID# 204125 Recruiting
Aschaffenburg, Bayern, Germany, 63739
Praxis Dres. Hornberger & Kollegen /ID# 202613 Recruiting
Bad Reichenhall, Bayern, Germany, 83435
Onkologie am Segelfliegerdamm /ID# 202603 Recruiting
Berlin, Bayern, Germany, 12487
Onkologie Hof /ID# 201531 Recruiting
Hof, Bayern, Germany, 95028
Praxis Dr. Vehling-Kaiser /ID# 202614 Recruiting
Landshut, Bayern, Germany, 84028
Hämato-Onkologie /ID# 205236 Recruiting
Munich, Bayern, Germany, 81241
Praxis Dres. Kröber/Stosiek /ID# 206729 Recruiting
Ratisbon, Berlin, Germany, 93053
Praxis Dr. Kreher /ID# 202604 Recruiting
Bad Liebenwerda, Brandenburg, Germany, 04924
MVZ f. Blut- u.Krebserkrankungen /ID# 206704 Recruiting
Potsdam, Brandenburg, Germany, 14467
MVZ Dres. Cordes & Partner /ID# 202598 Recruiting
Frankfurt am Main, Hessen, Germany, 60596
OAZ Hannover /ID# 201538 Recruiting
Hanover, Niedersachsen, Germany, 30171
Onkolologische Praxis Oldenburg /ID# 202607 Recruiting
Oldenburg, Niedersachsen, Germany, 26121
MVZ der Paracelsus-Klinik /ID# 201541 Recruiting
Osnabrück, Niedersachsen, Germany, 49076
Med. Studiengesellschaft Nord West GmbH /ID# 201535 Recruiting
Westerstede, Niedersachsen, Germany, 26655
Praxis Dres. Plewe/Losem /ID# 202606 Recruiting
Neuss, Nordrhein-Westfalen, Germany, 41462
Onkozentrum Dresden /ID# 202599 Recruiting
Dresden, Sachsen, Germany, 01127
BAG Freiberg-Richter /ID# 201532 Recruiting
Dresden, Sachsen, Germany, 01307
Onkologische Schwerpunktpraxis /ID# 200953 Recruiting
Berlin, Germany, 10707
Internistische Schwerpunktprax /ID# 200949 Recruiting
Erlangen, Germany, 91052
Luebecker Oncology Practice /ID# 200952 Recruiting
Luebeck, Germany, 23562
Stauferklinikum Schwaebisch Gm /ID# 201518 Recruiting
Mutlangen, Germany, 73557
Onkologische Praxis GbR /ID# 206705 Recruiting
Porta Westfalica, Germany, 32457
Praxis Dres. Decker/Lakner/Leithäuser /ID# 206208 Recruiting
Rostock, Germany, 18057
Switzerland
Kantonsspital Aarau /ID# 210034 Recruiting
Aarau, Switzerland, 5001
Ospedale San Giovanni /ID# 208782 Recruiting
Bellinzona, Switzerland, 6500
Inselspital, Universitaetsklinik /ID# 210031 Recruiting
Bern, Switzerland, 3010
Luzerner Kantonsspital /ID# 210029 Recruiting
Luzern, Switzerland, 6000
Kantonsspital Muensterlingen /ID# 210035 Recruiting
Münsterlingen, Switzerland, 8596
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03342144     History of Changes
Other Study ID Numbers: P17-132
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
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
Additional relevant MeSH terms:
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Venetoclax
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
Antineoplastic Agents