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

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

Study Description

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)

Study Design

• 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

Groups and Cohorts

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Contacts

Contact: Johannes Huelsenbeck; +49 611-1720-3036; johannes.huelsenbeck@abbvie.com

Contact: Bjoern Tews; bjoern.tews@abbvie.com

Locations

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

• Study Director: AbbVie Inc.; AbbVie

More Information

Additional Information:

Related Info 

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT03342144 History of Changes
• Other Study ID Numbers: P17-132
• First Posted: November 14, 2017
• Last Update Posted: February 28, 2019
• Last Verified: February 2019

Individual Participant Data (IPD) Sharing Statement:

• 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:

Chronic Lymphocytic Leukemia (CLL); Cancer; Leukemia; venetoclax

Additional relevant MeSH terms:

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