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

Acute Myeloid Leukemia Clinical Trial

— VALOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05215639
• Other study ID #: P21-937
• Status: Completed
• Start date: December 27, 2021
• Est. completion date: November 14, 2023

Study information

• Verified date: December 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: November 14, 2023
• Est. primary completion date: November 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Locations

Country	Name	City	State
Austria	Krankenhaus der Barmherzigen Brueder Graz /ID# 254121	Graz	Steiermark
Austria	Klinikum Klagenfurt am Woerthersee /ID# 247304	Klagenfurt Am Woerthersee	Kaernten
Austria	Landeskrankenhaus Hochsteiermark, Standort Leoben /ID# 254174	Leoben	Steiermark
Austria	Ordensklinikum Linz GmbH Elisabethinen /ID# 247284	Linz	Oberoesterreich
Austria	Universitaetsklinikum St. Poelten /ID# 247283	Sankt Poelten	Niederoesterreich
Austria	Klinik Ottakring /ID# 247285	Vienna	Wien
Austria	Hanusch Krankenhaus /ID# 247282	Wien
Switzerland	Kantonsspital Aarau AG /ID# 251598	Aarau	Aargau
Switzerland	Kantonsspital Baden /ID# 241896	Baden	Aargau
Switzerland	Universitätsspital Basel /ID# 256509	Basel	Basel-Stadt
Switzerland	EOC Ospedale Regionale di Bellinzona e Valli /ID# 240663	Bellinzona	Ticino
Switzerland	Inselspital, Universitätsspital Bern /ID# 239241	Bern
Switzerland	Spitalzentrum Oberwallis /ID# 241897	Brig
Switzerland	Luzerner Kantonsspital /ID# 239242	Luzern 16	Luzern
Switzerland	Hôpital de Nyon /ID# 240720	Nyon
Switzerland	Hôpital du Chablais, Rennaz /ID# 241895	Rennaz
Switzerland	Kantonsspital St. Gallen /ID# 239233	St. Gallen	Sankt Gallen
Switzerland	KSW Kantonsspital Winterthur /ID# 239852	Winterthur	Zuerich
Switzerland	Hirslanden Zürich /ID# 239239	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

Austria,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

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