A Study of Oral Venetoclax Tablets and Oral Azacitidine Versus Oral Azacitidine as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy

Acute Myeloid Leukemia (AML) Clinical Trial

— VIALE-M  

Official title:

A Multicenter, Phase 3 Study of Venetoclax and Oral Azacitidine Versus Oral Azacitidine as Maintenance Therapy for Patients With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy (VIALE-M)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04102020
• Other study ID #: M19-708
• Secondary ID: 2019-002217-19
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 26, 2020
• Est. completion date: April 30, 2025

Study information

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

Clinical Trial Summary

This study will be conducted in two parts. Part 1 will be the Dose Confirmation portion to determine recommended Phase 3 dose (RPTD) of venetoclax in combination with AZA. Part 3 will be the Dose Finding portion to determine RPTD of venetoclax in combination with CC-486. Part 2 and Part 3 Randomization of the study were removed.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 112
• Est. completion date: April 30, 2025
• Est. primary completion date: September 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of newly diagnosed acute myeloid leukemia (AML).
• Participant meets the following disease activity criteria:
• Confirmation of AML by World Health Organization (WHO) criteria (2016) and have confirmed complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following completion of intensive induction and consolidation chemotherapies.
• Achieved first CR + CRi within 120 days of first dose of study drug or be no more than 75 days since last dose of intensive conventional (including both induction and consolidation) chemotherapies.
• AML has intermediate or poor risk cytogenetics per National Comprehensive Cancer Network (NCCN) 2016 criteria.
• Eastern Cooperative Oncology Group (ECOG) performance status <= 2.
• Participant must have adequate hematologic, renal, and liver function laboratory values as described in the protocol.

Exclusion Criteria:

• History of acute promyelocytic leukemia (APL).
• History of active central nervous system involvement with acute myeloid leukemia (AML).

Related Conditions & MeSH terms

• Acute Myeloid Leukemia (AML)
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Venetoclax
Tablet: Oral
• Azacitidine
Subcutaneous (SC) or intravenous (IV) injection
• CC-486
Tablet; Oral

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital /ID# 238754	Adelaide	South Australia
Australia	Box Hill Hospital /ID# 217622	Box Hill	Victoria
Australia	Barwon Health /ID# 217921	Geelong	Victoria
Australia	St George Hospital /ID# 215416	Kogarah	New South Wales
Australia	Liverpool Hospital /ID# 215415	Liverpool	New South Wales
Australia	Perth Blood Institute Ltd /ID# 217531	Nedlands	Western Australia
Australia	Shoalhaven District Memorial Hospital /ID# 221973	Nowra	New South Wales
Australia	Gold coast University Hospital /ID# 214650	SouthPort	Queensland
Australia	Toowoomba Hospital /ID# 217922	Toowoomba	Queensland
Australia	Wollongong Hospital /ID# 216071	Wollongong	New South Wales
Australia	Princess Alexandra Hospital /ID# 238753	Woolloongabba	Queensland
Canada	Tom Baker Cancer Centre /ID# 214625	Calgary	Alberta
Canada	University of Alberta Hospital - Division of Hematology /ID# 215656	Edmonton	Alberta
Canada	Juravinski Cancer Centre /ID# 214623	Hamilton	Ontario
Canada	London Health Sciences Center- University Hospital /ID# 216055	London	Ontario
Canada	McGill University Health Center Research Institute /ID# 215984	Montreal	Quebec
Canada	Ottawa Hospital Research Institute /ID# 214627	Ottawa	Ontario
Canada	Princess Margaret Cancer Centre /ID# 214624	Toronto	Ontario
China	Beijing Friendship Hospital /ID# 216455	Beijing	Beijing
China	Chinese PLA General Hospital /ID# 216286	Beijing	Beijing
China	Peking University International Hospital /ID# 217439	Beijing
China	West China Hospital, Sichuan University /ID# 216606	Chengdu	Sichuan
China	Guangdong Provincial People's Hospital /ID# 216284	Guangzhou	Guangdong
China	Nanfang Hospital of Southern Medical University /ID# 215565	Guangzhou	Guangdong
China	The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 215564	Hangzhou	Zhejiang
China	Shanghai Tongji Hospital /ID# 218800	Shanghai	Shanghai
China	Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 215558	Tianjin	Tianjin
China	Tongji Hospital Tongji Medical College of HUST /ID# 216456	Wuhan	Hubei
China	Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 218046	Wuhan	Hubei
China	Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 216283	Xi'an	Shaanxi
China	Henan Cancer Hospital /ID# 215566	Zhengzhou	Henan
Czechia	Fakultni Nemocnice Brno /ID# 214807	Brno
Czechia	Fakultni nemocnice Ostrava /ID# 214809	Ostrava
Czechia	Ustav hematologie a krevni transfuze /ID# 215137	Praha
France	Chu Angers /Id# 215151	Angers
France	Centre Hospitalier de la Cote Basque /ID# 216185	Bayonne	Pyrenees-Atlantiques
France	Hopital Avicenne - APHP /ID# 215152	Bobigny	Ile-de-France
France	Hopital Henri Mondor /ID# 215159	Creteil
France	Centre Hospitalier de Versailles André Mignot /ID# 215157	Le Chesnay
France	Centre Hospitalier du Mans /ID# 215148	Le Mans CEDEX 9	Sarthe
France	CHRU Lille - Hopital Claude Huriez /ID# 217474	Lille	Hauts-de-France
France	CHU de Nantes - Hotel Dieu /ID# 217367	Nantes	Pays-de-la-Loire
France	CHU de Nice - Hôpital Archet 1 /ID# 217368	Nice	Alpes-Maritimes
France	CHU Bordeaux - Hopital Haut Leveque /ID# 215150	Pessac	Gironde
France	CHRU Tours - Hopital Bretonneau /ID# 216186	Tours CEDEX 9	Indre-et-Loire
France	Institut Gustave Roussy /ID# 215158	Villejuif Cedex	Val-de-Marne
Germany	Klinikum Chemnitz gGmbH /ID# 216073	Chemnitz
Germany	Universitaetsklinikum Halle (Saale) /ID# 221109	Halle (Saale)
Germany	Universitaetsklinikum Leipzig /ID# 214440	Leipzig	Sachsen
Germany	Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 215173	Lübeck	Schleswig-Holstein
Germany	Universitaetsklinikum Giessen und Marburg /ID# 214734	Marburg
Greece	General University Hospital of Alexandroupolis /ID# 213870	Alexandroupolis
Greece	General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 213872	Athens
Greece	General Hospital of Athens Laiko /ID# 213869	Athens	Attiki
Greece	University General Hospital Attikon /ID# 214298	Athens	Attiki
Greece	University General Hospital of Heraklion PA.G.N.I /ID# 214075	Heraklion	Kriti
Greece	University General Hospital of Patras /ID# 213871	RION Patras Achaia
Hungary	Semmelweis Egyetem /ID# 214423	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont /ID# 214422	Debrecen	Hajdu-Bihar
Hungary	Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 214426	Kaposvár	Somogy
Hungary	Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 214425	Nyiregyhaza	Szabolcs-Szatmar-Bereg
Hungary	Markusovszky Egyetemi Oktatokorhaz /ID# 215644	Szombathely	Vas
Israel	Hadassah Medical Center-Hebrew University /ID# 239700	Jerusalem	Yerushalayim
Israel	Shaare Zedek Medical Center /ID# 239699	Jerusalem
Israel	Rabin Medical Center /ID# 239696	Petakh Tikva
Israel	Tel Aviv Sourasky Medical Center /ID# 239698	Tel Aviv-Yafo	Tel-Aviv
Italy	Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 213944	Ancona
Italy	IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 213948	Bologna
Italy	ASST Spedali civili di Brescia /ID# 214580	Brescia
Italy	A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 214802	Catania
Italy	Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 214826	Milan
Italy	ASST Grande Ospedale Metropolitano Niguarda /ID# 213946	Milano
Italy	Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 213947	Napoli
Italy	Azienda Ospedaliera Universitaria Federico II /ID# 214278	Napoli
Italy	Ospedale S.Eugenio /ID# 214277	Rome
Italy	A.O.U. Citta della Salute e della Scienza di Torino /ID# 214505	Turin
Japan	Kyushu University Hospital /ID# 215286	Fukuoka-shi	Fukuoka
Japan	National Hospital Organization Kyushu Cancer Center /ID# 214841	Fukuoka-shi	Fukuoka
Japan	Saitama Medical University International Medical Center /ID# 214823	Hidaka-shi	Saitama
Japan	National Hospital Organization Mito Medical Center /ID# 214699	Higashi Ibaraki-gun	Ibaraki
Japan	Nagasaki University Hospital /ID# 214916	Nagasaki-shi	Nagasaki
Japan	Aichi Cancer Center Hospital /ID# 215284	Nagoya-shi	Aichi
Japan	Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 215680	Nagoya-shi	Aichi
Japan	Okayama University Hospital /ID# 214840	Okayama-shi	Okayama
Japan	Osaka Metropolitan University Hospital /ID# 215225	Osaka-shi	Osaka
Japan	Kindai University Hospital /ID# 214915	Osakasayama-shi	Osaka
Japan	Hokkaido University Hospital /ID# 215938	Sapporo-shi	Hokkaido
Japan	Tohoku University Hospital /ID# 214669	Sendai-shi	Miyagi
Japan	NTT Medical Center Tokyo /ID# 214959	Shinagawa-ku	Tokyo
Japan	Yamagata University Hospital /ID# 214698	Yamagata-shi	Yamagata
Japan	University of Fukui Hospital /ID# 215283	Yoshida-gun	Fukui
Korea, Republic of	Pusan National University Hospital /ID# 213941	Busan
Korea, Republic of	Seoul National University Bundang Hospital /ID# 215549	Seongnam	Gyeonggido
Korea, Republic of	Samsung Medical Center /ID# 213940	Seoul
Korea, Republic of	Seoul National University Hospital /ID# 213943	Seoul
Puerto Rico	Pan American Center for Oncology Trials, LLC /ID# 214953	Rio Piedras
Russian Federation	MMCC Kommunarka /ID# 215223	Moscow
Russian Federation	P. Hertsen Moscow Oncology Research Institute /ID# 214312	Moscow
Russian Federation	Nizhny Novgorod Regional Clinical Hospital named N.A. Semashko /ID# 214309	Nizhniy Novgorod	Nizhegorodskaya Oblast
Russian Federation	Clinic of Immunopathology, SRIFCI /ID# 217937	Novosibirsk
Russian Federation	Almazov National Medical Research Centre /ID# 214306	Sankt-Peterburg
Russian Federation	Academician I.P. Pavlov First St. Petersburg State Medical University /ID# 215393	St. Petersburg	Sankt-Peterburg
Russian Federation	Regional Clinical Hospital of Yaroslavl /ID# 214318	Yaroslavl
Spain	Hospital Santa Creu i Sant Pau /ID# 214714	Barcelona
Spain	Hospital Universitario Reina Sofia /ID# 214786	Cordoba
Spain	Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 214715	Hospitalet de Llobregat	Barcelona
Spain	Hospital Universitario 12 de Octubre /ID# 214789	Madrid
Spain	Hospital Universitario Fundacion Jimenez Diaz /ID# 214933	Madrid
Spain	Hospital Universitario Infanta Leonor /ID# 214843	Madrid
Spain	Hospital Universitario Ramon y Cajal /ID# 214684	Madrid
Spain	MD Anderson Madrid /ID# 214477	Madrid
Spain	Hospital Universitario Virgen de la Victoria /ID# 214713	Malaga
Spain	Hospital Universitario de Navarra /ID# 214788	Pamplona	Navarra
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 213953	Kaohsiung
Taiwan	China Medical University Hospital /ID# 213952	Taichung
Taiwan	National Taiwan University Hospital /ID# 213939	Taipei City
Taiwan	Linkou Chang Gung Memorial Hospital /ID# 213951	Taoyuan City
Turkey	Ankara Univ Medical Faculty /ID# 214239	Ankara
Turkey	Gulhane Askeri Tip Academy /ID# 214242	Ankara
Turkey	Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 215525	Istanbul
Turkey	Erciyes University Medical Fac /ID# 214240	Melikgazi	Kayseri
Turkey	Karadeniz University /ID# 214241	Trabzon
United Kingdom	University Hospitals Birmingham NHS Foundation Trust /ID# 215910	Birmingham
United Kingdom	University Hospitals Bristol /ID# 215911	Bristol	Bristol, City Of
United Kingdom	Cardiff & Vale University Health Board /ID# 215906	Cardiff	Wales
United Kingdom	Leicester Royal Infirmary /ID# 215924	Leicester	England
United Kingdom	Barts Health NHS Trust /ID# 215909	London	London, City Of
United Kingdom	Guys and St Thomas NHS Foundation Trust /ID# 215908	London	London, City Of
United Kingdom	University College London Hospitals NHS Foundation Trust /ID# 215921	London
United States	St. Alphonsus Regional Medical /ID# 216424	Boise	Idaho
United States	Massachusetts General Hospital /ID# 217307	Boston	Massachusetts
United States	Tufts Medical Center /ID# 216110	Boston	Massachusetts
United States	Rush University Medical Center /ID# 218815	Chicago	Illinois
United States	Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 214584	Dallas	Texas
United States	Colorado Blood Cancer Institute /ID# 214280	Denver	Colorado
United States	Compassionate Cancer Care Research Group - Fountain Valley /ID# 216156	Fountain Valley	California
United States	Prisma Health Cancer Institute-Faris Road /ID# 216066	Greenville	South Carolina
United States	St Francis Cancer Center /ID# 216115	Greenville	South Carolina
United States	The John Theurer Cancer /ID# 215191	Hackensack	New Jersey
United States	University of Texas MD Anderson Cancer Center /ID# 225201	Houston	Texas
United States	University of Kentucky Markey Cancer Center /ID# 215048	Lexington	Kentucky
United States	University of California, Los Angeles /ID# 219149	Los Angeles	California
United States	Norton Cancer Institute /ID# 216401	Louisville	Kentucky
United States	Mitchell Cancer Institute /ID# 216443	Mobile	Alabama
United States	Tennessee Oncology-Nashville Centennial /ID# 218757	Nashville	Tennessee
United States	Rutgers Cancer Institute of New Jersey /ID# 239708	New Brunswick	New Jersey
United States	Ochsner Clinic Foundation-New Orleans /ID# 214583	New Orleans	Louisiana
United States	Tulane Medical Center - New Orleans /ID# 218166	New Orleans	Louisiana
United States	Weill Cornell Medical College /ID# 214847	New York	New York
United States	Fox Chase Cancer Center /ID# 239372	Philadelphia	Pennsylvania
United States	UPMC Hillman Cancer Ctr /ID# 214051	Pittsburgh	Pennsylvania
United States	Providence Portland Medical Ct /ID# 216231	Portland	Oregon
United States	Saint Louis University Cancer Center /ID# 218164	Saint Louis	Missouri
United States	Gibbs Cancer Center & Research /ID# 216192	Spartanburg	South Carolina
United States	Oncology Hematology Associates (OHA) - Springfield /ID# 216351	Springfield	Missouri
United States	UMass Chan Medical School /ID# 218163	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
AbbVie	Roche-Genentech

Countries where clinical trial is conducted

United States,  Australia,  Canada,  China,  Czechia,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Puerto Rico,  Russian Federation,  Spain,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Dose-Limiting Toxicities (DLTs) (Part 1)	DLTs are any of the hematologic, nonhematologic toxicities, adverse events (AEs) occurring following administration of venetoclax as described in the protocol and evaluated by the Investigator and the sponsor.	Time from treatment of first participant to 20th participant reaching end of cycle 1, approximately 7 Months
Primary	Number of Participants With Dose-Limiting Toxicities (DLTs) of Venetoclax in Combination with Azacitidine (CC-486) (Part 3 Dose Finding Portion)	DLTs are hematologic, nonhematologic toxicities, adverse events (AEs) occurring following administration of venetoclax in combination with CC-486 as described in the protocol and evaluated by the Investigator and the sponsor.	Time from treatment of first participant to the 14th patient in Safety Expansion reaching the end of Cycle 1, approximately 16 months.

External Links

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