Clinical trial NCT05215639: 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
Official title: Venetoclax AML Observational Real-World Study of Treatment-naïve Patients Ineligible for Intensive Chemotherapy in Switzerland & Austria
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute Myeloid Leukemia
Keywords: Acute Myeloid Leukemia
Venetoclax
Venclexta
Venclyxto
ABT-199
Cancer
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-01-31
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with acute myeloid leukemia (AML) treated with Venetoclax per approved local label in Switzerland \& Austria.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Achieving Overall Survival (OS)
timeFrame: Up to Month 24
Secondary outcomes:
measure: Percentage of Participants Achieving Composite Complete Remission
timeFrame: Up to Month 24
measure: Time to Transfusion Independence
timeFrame: Up to Month 24
measure: Change from Baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) Considered Minimally Clinical Important
timeFrame: Up to Month 24
measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Considered Minimally Clinical Important
timeFrame: Up to Month 24
measure: Treatment Patterns Venetoclax in Combination with Hypomethylating Agents (HMAs) and in Switzerland in combination with Low Dose Cytarabine (LDAC)
timeFrame: Up to Month 24
Other outcomes:
Locations:
city: Klagenfurt am Wörthersee
country: Austria
facility: Klinikum Klagenfurt am Wörthersee /ID# 247304
state: Kaernten
city: Sankt Poelten
country: Austria
facility: Universitaetsklinikum St. Poelten /ID# 247283
state: Niederoesterreich
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen /ID# 247284
state: Oberoesterreich
city: Graz
country: Austria
facility: Krankenhaus der Barmherzigen Brueder Graz /ID# 254121
state: Steiermark
city: Leoben
country: Austria
facility: Landeskrankenhaus Hochsteiermark, Standort Leoben /ID# 254174
state: Steiermark
city: Vienna
country: Austria
facility: Klinik Ottakring /ID# 247285
state: Wien
city: Wien
country: Austria
facility: Hanusch Krankenhaus /ID# 247282
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau AG /ID# 251598
state: Aargau
city: Baden
country: Switzerland
facility: Kantonsspital Baden /ID# 241896
state: Aargau
city: Basel
country: Switzerland
facility: Duplicate_Universitätsspital Basel /ID# 256509
state: Basel-Stadt
city: Luzern 16
country: Switzerland
facility: Luzerner Kantonsspital /ID# 239242
state: Luzern
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen /ID# 239233
state: Sankt Gallen
city: Bellinzona
country: Switzerland
facility: EOC Ospedale Regionale di Bellinzona e Valli /ID# 240663
state: Ticino
city: Brig
country: Switzerland
facility: Spitalzentrum Oberwallis /ID# 241897
state: Valais
city: Rennaz
country: Switzerland
facility: Hôpital du Chablais, Rennaz /ID# 241895
state: Vaud
city: Winterthur
country: Switzerland
facility: KSW Kantonsspital Winterthur /ID# 239852
state: Zuerich
city: Zurich
country: Switzerland
facility: Hirslanden Zürich /ID# 239239
state: Zuerich
city: Bern
country: Switzerland
facility: Inselspital, Universitaetsspital Bern /ID# 239241
city: Nyon
country: Switzerland
facility: Hôpital de Nyon /ID# 240720
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: