A Study to Assess Change in Disease State in Adult Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy in Switzerland and Austria Receiving Oral Venetoclax Tablets (VALOR)

Venetoclax AML Observational Real-World Study of Treatment-naïve Patients Ineligible for Intensive Chemotherapy in Switzerland & Austria

Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow and is the most common acute leukemia in adults. This study will evaluate how well Venetoclax works to treat AML in adult participants who are ineligible for intensive chemotherapy in Switzerland & Austria.

Venetoclax is a drug approved to treat acute myeloid leukemia. All study participants will receive Venetoclax as prescribed by their study doctor in accordance with approved local label. Adult participants with a new diagnosis of AML who are ineligible for intensive chemotherapy will be enrolled. Around 120 participants will be enrolled in the study in approximately 15 sites in Switzerland & Austria.

Participants will receive venetoclax tablets to be taken by mouth daily according to the approved local label. The duration of the study is approximately 24 months.

There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice and participants will be followed for 24 months.

Study Overview

• Status: Completed
• Conditions: Acute Myeloid Leukemia

• Study Type: Observational
• Enrollment (Actual): 124

Contacts and Locations

Study Locations

• Austria
  • Wien, Austria, 1140
    • Hanusch Krankenhaus /ID# 247282
  • Kaernten
    • Klagenfurt Am Woerthersee, Kaernten, Austria, 9020
      • Klinikum Klagenfurt am Woerthersee /ID# 247304
  • Niederoesterreich
    • Sankt Poelten, Niederoesterreich, Austria, 3100
      • Universitaetsklinikum St. Poelten /ID# 247283
  • Oberoesterreich
    • Linz, Oberoesterreich, Austria, 4010
      • Ordensklinikum Linz GmbH Elisabethinen /ID# 247284
  • Steiermark
    • Graz, Steiermark, Austria, 8020
      • Krankenhaus der Barmherzigen Brueder Graz /ID# 254121
    • Leoben, Steiermark, Austria, 8700
      • Landeskrankenhaus Hochsteiermark, Standort Leoben /ID# 254174
  • Wien
    • Vienna, Wien, Austria, 1160
      • Klinik Ottakring /ID# 247285
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital, Universitätsspital Bern /ID# 239241
  • Brig, Switzerland, 3900
    • Spitalzentrum Oberwallis /ID# 241897
  • Nyon, Switzerland, 1260
    • Hôpital de Nyon /ID# 240720
  • Rennaz, Switzerland, 1847
    • Hôpital du Chablais, Rennaz /ID# 241895
  • Zurich, Switzerland, 8032
    • Hirslanden Zürich /ID# 239239
  • Aargau
    • Aarau, Aargau, Switzerland, 5001
      • Kantonsspital Aarau AG /ID# 251598
    • Baden, Aargau, Switzerland, 5404
      • Kantonsspital Baden /ID# 241896
  • Basel-Stadt
    • Basel, Basel-Stadt, Switzerland, 4031
      • Universitätsspital Basel /ID# 256509
  • Luzern
    • Luzern 16, Luzern, Switzerland, 6000
      • Luzerner Kantonsspital /ID# 239242
  • Sankt Gallen
    • St. Gallen, Sankt Gallen, Switzerland, 9007
      • Kantonsspital St. Gallen /ID# 239233
  • Ticino
    • Bellinzona, Ticino, Switzerland, 6500
      • EOC Ospedale Regionale di Bellinzona e Valli /ID# 240663
  • Zuerich
    • Winterthur, Zuerich, Switzerland, 8400
      • KSW Kantonsspital Winterthur /ID# 239852

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult participants with acute myeloid leukemia (AML) treated with Venetoclax per approved local label in Switzerland & Austria.

Description

Inclusion Criteria:

• Newly-diagnosed AML and eligible to receive venetoclax as per local label.
• Physician has decided to initiate venetoclax treatment. The decision to treat with venetoclax is made by the physician in accordance with the local label prior to any decision to approach the patient to participate in this study.

Exclusion Criteria:

- Participating in an interventional clinical trial within 30 days prior to venetoclax treatment initiation.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Venetoclax Participants; Participants treated with Venetoclax in accordance with approved local label.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Overall Survival (OS)	OS is defined as the time from treatment initiation to death from any cause.	Up to Month 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Composite Complete Remission	Composite complete remission is defined as the proportion of participants with complete remission (CR) or complete remission with incomplete marrow recovery (CRi).	Up to Month 24
Time to Transfusion Independence	Time to transfusion independence is defined as the time between the date of first venetoclax intake and the absence of any Red Blood Cell (RBC) or platelet transfusion during any consecutive 8 and/or 16 weeks during the treatment period and percentage of participants achieving transfusion independence.	Up to Month 24
Change from Baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) Considered Minimally Clinical Important	The EQ-5D-5L is a standardized instrument used to measure health-related quality of life that can be used in a wide range of health conditions and treatments.	Up to Month 24
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Considered Minimally Clinical Important	The EORTC QLQ-C30 is 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.	Up to Month 24
Treatment Patterns Venetoclax in Combination with Hypomethylating Agents (HMAs) and in Switzerland in combination with Low Dose Cytarabine (LDAC)	Treatment patterns defined by the proportion of participants treated with venetoclax in combination with HMAs and in Switzerland in combination with LDAC.	Up to Month 24

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info.

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2021
• Primary Completion (Actual): November 14, 2023
• Study Completion (Actual): November 14, 2023

Study Registration Dates

• First Submitted: January 19, 2022
• First Submitted That Met QC Criteria: January 19, 2022
• First Posted (Actual): January 31, 2022

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Cancer; Acute Myeloid Leukemia; Venetoclax; ABT-199; Venclexta; Venclyxto
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
• Other Study ID Numbers: P21-937

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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