VALOR: 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

Sponsor

AbbVie (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05215639

Collaborator

(none)

120

Enrollment

Locations

48.1

Anticipated Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia

Study Design

Study Type:

Observational

Anticipated Enrollment :

120 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 27, 2021

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Venetoclax Participants Participants treated with Venetoclax in accordance with approved local label.

Outcome Measures

Primary Outcome Measures

Percentage of Participants Achieving Overall Survival (OS) [Up to Month 24]
OS is defined as the time from treatment initiation to death from any cause.

Secondary Outcome Measures

Percentage of Participants Achieving Composite Complete Remission [Up to Month 24]
Composite complete remission is defined as the proportion of participants with complete remission (CR) or complete remission with incomplete marrow recovery (CRi).
Time to Transfusion Independence [Up to Month 24]
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.
Change from Baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) Considered Minimally Clinical Important [Up to Month 24]
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.
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Considered Minimally Clinical Important [Up to Month 24]
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.
Treatment Patterns Venetoclax in Combination with Hypomethylating Agents (HMAs) and in Switzerland in combination with Low Dose Cytarabine (LDAC) [Up to Month 24]
Treatment patterns defined by the proportion of participants treated with venetoclax in combination with HMAs and in Switzerland in combination with LDAC.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Luzerner Kantonsspital /ID# 239242	Luzern 16	Luzern	Switzerland	6000
2	Kantonsspital St. Gallen /ID# 239233	St. Gallen	Sankt Gallen	Switzerland	9007
3	EOC Ospedale Regionale di Bellinzona e Valli /ID# 240663	Bellinzona	Ticino	Switzerland	6500
4	KSW Kantonsspital Winterthur /ID# 239852	Winterthur	Zuerich	Switzerland	8400
5	Kantonsspital Baden /ID# 241896	Baden		Switzerland	5404
6	Inselspital, Universitätsspital Bern /ID# 239241	Bern		Switzerland	3010
7	Spitalzentrum Oberwallis /ID# 241897	Brig		Switzerland	3900
8	Hôpital de Nyon /ID# 240720	Nyon		Switzerland	1260
9	Hôpital du Chablais, Rennaz /ID# 241895	Rennaz		Switzerland	1847
10	Hirslanden Zürich /ID# 239239	Zurich		Switzerland	8032