Study Of Venetoclax Tablet With Intravenous or Subcutaneous Azacitidine to Assess Change in Disease Activity In Adult Participants With Newly Diagnosed Higher-Risk Myelodysplastic Syndrome

Myelodysplastic Syndrome (MDS) Clinical Trial

— Verona  

Official title:

A Randomized, Double-Blind, Phase 3 Study Evaluating the Safety and Efficacy of Venetoclax in Combination With Azacitidine in Patients Newly Diagnosed With Higher-Risk Myelodysplastic Syndrome (Higher-Risk MDS)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04401748
• Other study ID #: M15-954
• Secondary ID: 2023-507153-16-0
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 10, 2020
• Est. completion date: September 10, 2025

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Myelodysplastic Syndrome (MDS) is a group of disorders that gradually affect the ability of a person's bone marrow (semi-liquid tissue present in many bones like backbones) to produce normal blood cells. Some people with MDS have a risk of the disease progressing to acute myeloid leukemia (AML), and a risk of death from the disease itself. Symptoms of MDS include fatigue, shortness of breath, unusual paleness due to anemia (low red blood cell count), easy or unusual bruising, and red spots just beneath the skin caused by bleeding. The purpose of this study is to see how safe and effective venetoclax and azacitidine (AZA) combination are when compared to AZA and a placebo (contains no medicine), in participants with newly diagnosed higher-risk MDS.

Venetoclax is an investigational drug being developed for the treatment of MDS. The study consists of two treatment arms - In one arm, participants will receive venetoclax and AZA. In another arm, participants will receive AZA and placebo. Adult participants with newly diagnosed higher-risk MDS will be enrolled. Around 500 participants will be enrolled in approximately 220 sites worldwide.

Participants in one arm will receive oral doses of venetoclax tablet and intravenous (infusion in the vein) or subcutaneous (given under the skin) AZA solution. Participants in another arm will receive oral doses of placebo tablet and intravenous or subcutaneous AZA solution.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood and bone marrow tests, checking for side effects, and completing questionnaires.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 531
• Est. completion date: September 10, 2025
• Est. primary completion date: September 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants with a diagnosis of Myelodysplastic Syndrome (MDS) according to the 2016 World Health Organization (WHO) classification wtih presence of < 20% bone marrow blasts per marrow biopsy/aspirate at screening.

• Participants must meet the following disease activity criteria:

• Overall Revised International Prognostic Scoring System (IPSS-R) score > 3 (intermediate, high or very high).

• Eastern Cooperative Oncology Group (ECOG) performance status of <= 2.

• Hematopoietic stem cell transplant (HSCT) eligible with no pre-arranged HSCT at the time of Study Day 1, or HSCT ineligible without plan for HSCT at the time of Study Day 1.

Exclusion Criteria:

• Prior therapy for MDS with any hypomethylating agent, chemotherapy, or allogenic stem cell transplantation.

• Prior diagnosis of therapy-related MDS (t-MDS), MDS evolving from a pre-existing myeloproliferative neoplasm (MPN), MDS/MPN including chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), juvenile myelomonocytic leukemia (JMML) and unclassifiable MDS/MPN.

Related Conditions & MeSH terms

• Myelodysplastic Syndrome (MDS)
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• Venetoclax
Tablet: Oral
• Azacitidine
Subcutaneous (SC) or Intravenous (IV) injection
• Placebo
Tablet; Oral

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital /ID# 221805	Adelaide	South Australia
Australia	Duplicate_Blacktown Hospital /ID# 234079	Blacktown	New South Wales
Australia	St Vincent's Hospital Melbourne /ID# 221809	Fitzroy Melbourne	Victoria
Australia	Austin Health /ID# 221807	Heidelberg	Victoria
Australia	St George Hospital /ID# 221810	Kogarah	New South Wales
Australia	Port Macquarie Base Hospital /ID# 234078	Port Macquarie	New South Wales
Australia	Gold coast University Hospital /ID# 222606	SouthPort	Queensland
Austria	Ordensklinikum Linz GmbH Elisabethinen /ID# 221387	Linz	Oberoesterreich
Austria	Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 221092	Salzburg
Austria	Medizinische Universitaet Wien /ID# 221446	Vienna	Wien
Austria	Klinikum Wels-Grieskirchen GmbH /ID# 221386	Wels	Oberoesterreich
Austria	Hanusch Krankenhaus /ID# 221093	Wien
Belgium	ZNA Middelheim /ID# 218907	Antwerp
Belgium	AZ Sint-Jan Brugge /ID# 218212	Brugge
Belgium	UZ Gent /ID# 218767	Gent	Oost-Vlaanderen
Belgium	Hospital La Louviere Site Jolimont - Helora /ID# 218921	La Louvière	Hainaut
Belgium	Universitair Ziekenhuis Leuven /ID# 218905	Leuven	Vlaams-Brabant
Belgium	Cliniques Universitaires UCL Saint-Luc /ID# 219066	Woluwe-Saint-Lambert	Bruxelles-Capitale
Belgium	Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 219064	Yvoir	Namur
Brazil	Hospital Universitario Walter Cantidio /ID# 223434	Fortaleza	Ceara
Brazil	Hospital Universitário Pedro Ernesto /ID# 223080	Rio de Janeiro
Brazil	Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 221339	Sao Paulo
Brazil	Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein /ID# 221370	São Paulo	Sao Paulo
Canada	CIUSSS du Nord-de-l'ile-de-Montréal_Hopital du Sacré-Coeur de Montréal /ID# 218973	Montreal	Quebec
Canada	McGill University Health Center Research Institute /ID# 222519	Montreal	Quebec
Canada	Ottawa Hospital Research Institute /ID# 219105	Ottawa	Ontario
Canada	CHUQ- Hôpital de l'Enfant-Jesus /ID# 221200	Quebec City	Quebec
Canada	BC Cancer - Surrey /ID# 219098	Surrey	British Columbia
Canada	Sunnybrook Health Sciences Ctr /ID# 219103	Toronto	Ontario
China	Peking University International Hospital /ID# 222987	Beijing
China	West China Hospital, Sichuan University /ID# 221601	Chengdu	Sichuan
China	Guangdong Provincial People's Hospital /ID# 221442	Guangzhou	Guangdong
China	Nanfang Hospital of Southern Medical University /ID# 224566	Guangzhou	Guangdong
China	Zhujiang Hospital of Southern Medical University /ID# 222071	Guangzhou	Guangdong
China	Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 225982	Hangzhou	Zhejiang
China	The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 221494	Hangzhou	Zhejiang
China	Lanzhou University Second Hospital /ID# 225980	Lanzhou	Gansu
China	The First Affiliated Hospital of Nanchang University /ID# 225983	Nanchang	Jiangxi
China	Jiangsu Province Hospital /ID# 221342	Nanjing	Jiangsu
China	Zhongda Hospital Southeast University /ID# 221849	Nanjing	Jiangsu
China	Shanghai Sixth People's Hospital /ID# 221546	Shanghai	Shanghai
China	Shengjing Hospital of China Medical University /ID# 222945	Shenyang	Liaoning
China	The Second Hospital of Hebei Medical University /ID# 222919	Shijiazhuang	Hebei
China	The First Affiliated Hospital of Soochow University /ID# 221640	Suzhou	Jiangsu
China	Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 221567	Tianjin	Tianjin
China	Tianjin Medical University General Hospital /ID# 226810	Tianjin
China	Tongji Hospital Tongji Medical College of HUST /ID# 221474	Wuhan	Hubei
China	Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 221475	Wuhan	Hubei
China	Shaanxi Provincial people's Hospital /ID# 225728	Xi'an	Shaanxi
China	The Fourth Affiliated Hospital Zhejiang University School of Medicine /ID# 225918	Yiwu	Zhejiang
China	Henan Cancer Hospital /ID# 221447	Zhengzhou	Henan
China	People's Hospital of Henan Province /ID# 225790	Zhengzhou	Henan
Czechia	Fakultni nemocnice Brno /ID# 221351	Brno
Czechia	Fakultni nemocnice Hradec Kralove /ID# 221163	Hradec Kralove
Czechia	Fakultni Nemocnice Ostrava /ID# 219143	Ostrava
Czechia	Fakultni nemocnice Plzen /ID# 221162	Plzen
Czechia	Ustav hematologie a krevni transfuze /ID# 221350	Praha
Czechia	Vseobecna fakultni nemocnice v Praze /ID# 221229	Praha
France	CH Henri Duffaut /ID# 225185	Avignon CEDEX 9	Vaucluse
France	CHU Grenoble - Hopital Michallon /ID# 220988	La Tronche	Isere
France	CHRU Lille - Hopital Claude Huriez /ID# 220991	Lille	Nord
France	Hopital de la Conception /ID# 224882	Marseille	Bouches-du-Rhone
France	CHU de Nantes, Hotel Dieu -HME /ID# 222074	Nantes	Pays-de-la-Loire
France	CHU de Nice - Hôpital Archet 1 /ID# 220992	Nice	Alpes-Maritimes
France	AP-HP - Hopital Saint-Louis /ID# 222075	Paris
France	Centre Hospitalier Universitaire de Bordeaux /ID# 220989	Pessac CEDEX	Gironde
France	Centre Henri Becquerel /ID# 220986	Rouen
Germany	Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 221189	Berlin
Germany	Universitaetsklinikum Duesseldorf /ID# 221169	Düsseldorf	Nordrhein-Westfalen
Germany	Medizinische Hochschule Hannover /ID# 221173	Hannover
Germany	Universitaetsklinikum Koeln /ID# 234219	Köln	Nordrhein-Westfalen
Germany	Universitaetsklinikum Leipzig /ID# 221168	Leipzig	Sachsen
Germany	Universitatsklinikum Mannheim /ID# 221172	Mannheim	Baden-Wuerttemberg
Germany	Klinikum rechts der Isar /ID# 221170	Munich
Germany	Stauferklinikum Schwaebisch Gmuend /ID# 224917	Mutlangen	Baden-Wuerttemberg
Hungary	Duplicate_Debreceni Egyetem Klinikai Kozpont /ID# 221702	Debrecen	Hajdu-Bihar
Hungary	Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 221703	Kaposvár	Somogy
Hungary	Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 221704	Nyiregyhaza	Szabolcs-Szatmar-Bereg
Hungary	Szegedi Tudományegyetem /ID# 221705	Szeged
Hungary	Fejér Vármegyei Szent György Egyetemi Oktató Kórház /ID# 222953	Szekesfehervar	Fejer
Israel	Rabin Medical Center /ID# 221184	Haifa
Israel	Rambam Health Care Campus /ID# 221083	Haifa	H_efa
Israel	Hadassah Medical Center-Hebrew University /ID# 222006	Jerusalem	Yerushalayim
Israel	Shaare Zedek Medical Center /ID# 233181	Jerusalem	Yerushalayim
Israel	The Chaim Sheba Medical Center /ID# 221110	Ramat Gan	Tel-Aviv
Israel	Tel Aviv Sourasky Medical Center /ID# 221896	Tel Aviv	Tel-Aviv
Italy	IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 220810	Bologna
Italy	Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 220816	Napoli
Italy	Grande Ospedale Metropolitano Bianchi Melacrino Morelli /ID# 220818	Reggio Calabria
Italy	Azienda Ospedaliero-Universitaria Sant'Andrea /ID# 220819	Rome
Italy	Istituto Clinico Humanitas /ID# 220815	Rozzano	Milano
Japan	University of Fukui University Hospital /ID# 221568	???	Fukui
Japan	Kyushu University Hospital /ID# 223473	Fukuoka-shi	Fukuoka
Japan	Fukushima Medical University Hospital /ID# 222015	Fukushima-shi	Fukushima
Japan	Chugoku Central Hospital /ID# 222955	Fukuyama	Hiroshima
Japan	National Hospital Organization Mito Medical Center /ID# 222278	Higashi Ibaraki-gun	Ibaraki
Japan	Saitama Medical Center /ID# 222016	Kawagoe-shi	Saitama
Japan	Kobe City Medical Center General Hospital /ID# 221977	Kobe-shi	Hyogo
Japan	Nagasaki University Hospital /ID# 222241	Nagasaki-shi	Nagasaki
Japan	Nagoya University Hospital /ID# 221566	Nagoya-shi	Aichi
Japan	Okayama Medical Center /ID# 222310	Okayama-shi	Okayama
Japan	Kindai University Hospital /ID# 222284	Osakasayama-shi	Osaka
Japan	Aiiku Hospital /ID# 222351	Sapporo	Hokkaido
Japan	Sapporo Hokuyu Hospital /ID# 222133	Sapporo-shi	Hokkaido
Japan	Tohoku University Hospital /ID# 221976	Sendai-shi	Miyagi
Japan	NTT Medical Center Tokyo /ID# 222365	Shinagawa-ku	Tokyo
Japan	Yamagata University Hospital /ID# 221574	Yamagata-shi	Yamagata
Korea, Republic of	Pusan National University Hospital /ID# 232353	Busan
Korea, Republic of	Seoul National University Bundang Hospital /ID# 221695	Seongnam-si	Gyeonggido
Korea, Republic of	Asan Medical Center /ID# 221227	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Samsung Medical Center /ID# 221224	Seoul
Korea, Republic of	Seoul National University Hospital /ID# 221226	Seoul
Korea, Republic of	Yonsei University Health System Severance Hospital /ID# 233171	Seoul	Seoul Teugbyeolsi
Netherlands	Maxima Medisch Centrum /ID# 223010	Eindhoven
Netherlands	Medisch Spectrum Twente /ID# 223012	Enschede
Netherlands	Maastricht Universitair Medisch Centrum /ID# 221630	Maastricht
Netherlands	Erasmus Medisch Centrum /ID# 218937	Rotterdam
Netherlands	Isala /ID# 223011	Zwolle
Poland	Szpital Uniwersytecki nr 2 im. dr. Jana Biziela /ID# 233321	Bydgoszcz	Kujawsko-pomorskie
Poland	Uniwersyteckie Centrum Kliniczne /ID# 222069	Gdansk	Pomorskie
Poland	Pratia Onkologia Katowice /ID# 224728	Katowice
Poland	Wojewódzki Szpital Specjalistyczny im. M.Kopernika w Lodzi /ID# 221784	Lodz	Lodzkie
Poland	Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie /ID# 221667	Lublin	Lubelskie
Poland	Lux Med Onkologia - Szpital Szamocka /Id# 222203	Warszawa	Mazowieckie
Poland	MTZ Clinical Research Powered by Pratia /ID# 221354	Warszawa	Mazowieckie
Puerto Rico	Hospital Erasto Gaertner /ID# 221341	Curitiba
Puerto Rico	Pan American Center for Oncology Trials, LLC /ID# 221010	Rio Piedras
Puerto Rico	VA Caribbean Healthcare System /ID# 221012	San Juan
Russian Federation	Kaluga Regional Clinical Hospital /ID# 221211	Kaluga	Kaluzhskaya Oblast
Russian Federation	Hospital n.a. V.V. Veresaev /ID# 225435	Moscow
Russian Federation	MMCC Kommunarka /ID# 221213	Moscow
Russian Federation	Republican hospital named after V.A. Baranov /ID# 221214	Petrozavodsk
Russian Federation	Clinic UZI 4D /ID# 221215	Pyatigorsk	Stavropol Skiy Kray
Russian Federation	Almazov National Medical Research Centre /ID# 221449	Sankt-Peterburg
Spain	Hospital Universitario Germans Trias i Pujol /ID# 221274	Badalona	Barcelona
Spain	Hospital Universitario Vall d'Hebron /ID# 221323	Barcelona
Spain	Hospital Universitario Reina Sofia /ID# 221273	Córdoba	Cordoba
Spain	Hospital General Universitario Gregorio Maranon /ID# 221271	Madrid
Spain	Hospital Universitario 12 de Octubre /ID# 221272	Madrid
Spain	Hospital Universitario Quirón Salud Madrid /ID# 221275	Pozuelo de Alarcón	Madrid
Spain	Hospital Universitario de Salamanca /ID# 221297	Salamanca
Spain	Hospital Universitario Virgen del Rocio /ID# 221276	Sevilla
Spain	Hospital Universitario y Politecnico La Fe /ID# 221270	Valencia
Taiwan	Kaohsiung Chang Gung Memorial Hospital /ID# 223573	Kaohsiung City	Kaohsiung
Taiwan	China Medical University Hospital /ID# 218987	Taichung
Taiwan	Chi-Mei Medical Center /ID# 218991	Tainan
Taiwan	National Cheng Kung University Hospital /ID# 218989	Tainan
Turkey	Ankara City Hospital /ID# 222093	Ankara
Turkey	Hacettepe University Faculty of Medicine /ID# 222094	Ankara
Turkey	Akdeniz Universitesi Tip Fakul /ID# 222095	Antalya
Turkey	Duplicate_Erciyes University Medical Fac /ID# 222090	Melikgazi	Kayseri
Turkey	Ondokuz mayis University Facul /ID# 222091	Samsun
Turkey	Acibadem Maslak Hastanesi /ID# 222072	Tuzla
United Kingdom	NHS Grampian /ID# 222509	Aberdeen
United Kingdom	University Hospitals Birmingham NHS Foundation Trust /ID# 221233	Birmingham
United Kingdom	University Hospitals Bristol /ID# 222510	Bristol	Bristol, City Of
United Kingdom	Cardiff & Vale University Health Board /ID# 221236	Cardiff	Wales
United Kingdom	The Royal Marsden NHS Foundation Trust /ID# 221232	London
United Kingdom	University College London Hospitals NHS Foundation Trust /ID# 221240	London
United Kingdom	Oxford University Hospitals NHS Foundation Trust /ID# 221231	Oxford	Oxfordshire
United Kingdom	Derriford Hospital and the Royal Eye Infirmary /ID# 222514	Plymouth	Devon
United Kingdom	University Hospitals Dorset NHS Foundation Trust /ID# 221237	Poole	Dorset
United States	New York Oncology Hematology - Albany Cancer Center /ID# 223778	Albany	New York
United States	VA Ann Arbor Healthcare System /ID# 221365	Ann Arbor	Michigan
United States	Texas Oncology - Austin Midtown /ID# 223729	Austin	Texas
United States	Hematology/Oncology Clinic /ID# 224257	Baton Rouge	Louisiana
United States	Bend Memorial Clinic /ID# 220999	Bend	Oregon
United States	St. Luke's Mountain State Tumor Institute /ID# 220838	Boise	Idaho
United States	Beth Israel Deaconess Medical Center /ID# 225069	Boston	Massachusetts
United States	Dana-Farber Cancer Institute /ID# 219162	Boston	Massachusetts
United States	Massachusetts General Hospital /ID# 225068	Boston	Massachusetts
United States	Rocky Mountain Cancer Centers - Boulder /ID# 223723	Boulder	Colorado
United States	University at Buffalo /ID# 221206	Buffalo	New York
United States	Novant Health Presbyterian Medical Center /ID# 222561	Charlotte	North Carolina
United States	Tennessee Oncology - Chattanooga / McCallie /ID# 221311	Chattanooga	Tennessee
United States	Duplicate_Rush University Medical Center /ID# 221007	Chicago	Illinois
United States	Northwestern University Feinberg School of Medicine /ID# 220843	Chicago	Illinois
United States	Oncology Hematology Care, Inc. /ID# 223724	Cincinnati	Ohio
United States	Maryland Oncology Hematology /ID# 223776	Columbia	Maryland
United States	Pontchartrain Cancer Center - Covington /ID# 221005	Covington	Louisiana
United States	Texas Oncology - Medical City Dallas /ID# 223725	Dallas	Texas
United States	Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 223727	Dallas	Texas
United States	Titan Health Partners LLC, d/b/a Astera Cancer Care /ID# 221003	East Brunswick	New Jersey
United States	Willamette Valley Cancer Institute and Research Center /ID# 223733	Eugene	Oregon
United States	Florida Cancer Specialists - Fort Myers /ID# 221319	Fort Myers	Florida
United States	Duplicate_Parkview Cancer Institute /ID# 223620	Fort Wayne	Indiana
United States	Texas Oncology - Forth Worth /ID# 223777	Fort Worth	Texas
United States	Duplicate_Providence Medical Foundation /ID# 222633	Fullerton	California
United States	Virginia Cancer Specialists - Gainesville /ID# 223726	Gainesville	Virginia
United States	Cancer & Hematology Centers /ID# 220848	Grand Rapids	Michigan
United States	Ingalls Memorial Hosp /ID# 220844	Harvey	Illinois
United States	Comprehensive Cancer Centers of Nevada - Horizon Ridge /ID# 222635	Henderson	Nevada
United States	Memorial Healthcare System /ID# 222703	Hollywood	Florida
United States	MD Anderson Cancer Center at Texas Medical Center /ID# 219163	Houston	Texas
United States	MidAmerica Division, Inc. /ID# 221895	Kansas City	Missouri
United States	University of California, Los Angeles /ID# 221760	Los Angeles	California
United States	Tennessee Oncology-Nashville Centennial /ID# 220854	Nashville	Tennessee
United States	Yale University School of Medicine /ID# 222764	New Haven	Connecticut
United States	Weill Cornell Medical College /ID# 222898	New York	New York
United States	Helen F. Graham Cancer Center & Research Institute /ID# 223731	Newark	Delaware
United States	The Valley Hospital /ID# 232337	Paramus	New Jersey
United States	Illinois Cancer Care, PC /ID# 220840	Peoria	Illinois
United States	UPMC Hillman Cancer Ctr /ID# 223201	Pittsburgh	Pennsylvania
United States	Virginia Cancer Institute at Reynolds Crossing /ID# 221002	Richmond	Virginia
United States	Virginia Commonwealth University Medical Center Main Hospital /ID# 221590	Richmond	Virginia
United States	Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 221321	Saint Louis Park	Minnesota
United States	Florida Cancer Specialists - North /ID# 221318	Saint Petersburg	Florida
United States	Utah Cancer Specialists Salt Lake Clinic /ID# 219160	Salt Lake City	Utah
United States	Texas Oncology - San Antonio Medical Center /ID# 223728	San Antonio	Texas
United States	VA Puget Sound Health Care System /ID# 221358	Seattle	Washington
United States	Avera Cancer Institute /ID# 243461	Sioux Falls	South Dakota
United States	Stony Brook University Hospital /ID# 224450	Stony Brook	New York
United States	Florida Cancer Specialists - Panhandle /ID# 221315	Tallahassee	Florida
United States	Baylor Scott & White Medical Center- Temple /ID# 221332	Temple	Texas
United States	Torrance Memorial Physician Network Cancer Care /ID# 222702	Torrance	California
United States	Texas Oncology - Northeast Texas /ID# 223734	Tyler	Texas
United States	Florida Cancer Specialists - East /ID# 221317	West Palm Beach	Florida
United States	PIH Health Whittier Hospital /ID# 222647	Whittier	California
United States	Cancer Center of Kansas /ID# 222648	Wichita	Kansas
United States	Novant Health Forsyth Medical Center /ID# 221004	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
AbbVie	Genentech, Inc.

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)	OS is defined as the number of days from the date of randomization to the date of death of any cause, or last known date to be alive.	Up To 5 Years
Secondary	Modified Overall Response (mOR)	mOR [complete remission (CR) + marrow complete remission (mCR) + partial response (PR)] is defined as achieving a CR, mCR, or PR at any time point during the study per the modified International Working Group (IWG) 2006 criteria for myelodysplastic syndrome (MDS).	Up To 5 Years
Secondary	Percentage of Participants Achieving Overall Hematological Improvement (HI)	Overall HI is defined as achieving the response of HI-platelet or HI-neutrophil, or HI-erythroid at any time point during the study prior to post-treatment therapy per the modified IWG 2006 criteria for MDS.	Up to 5 Years
Secondary	Complete Remission (CR)	CR is defined as achieving a complete remission at any time point during the study per the modified International Working Group (IWG) 2006 criteria for myelodysplastic syndrome (MDS).	Up To 36 Months
Secondary	Percentage of Participants Achieving Transfusion Independence (TI) Who are Transfusion Dependent at Baseline	TI is when the participants who were transfusion dependent on red blood cell (RBC) and/or Platelet at baseline achieve transfusion independence post baseline. TI is a period of at least 56 days with no transfusion after the date of the first dose of study drug to the last dose of study drug + 30 days, or 1 day before the date of progressive disease/ relapse from CR or PR per the modified IWG 2006 criteria for MDS, or 1 day before the initiation of post-treatment therapy or 1 day before death, whichever is earliest.	Up To 5 Years
Secondary	Time to Deterioration in Physical Functioning as Measured by Physical Functioning Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scale	Time to deterioration in physical functioning, as measured by the EORTC QLQ-C30 physical functioning score is defined as the time from the date of randomization to the date of death of any cause, or the first time worsening of score from baseline >= a pre-specified threshold. Participants rate items on a 4-point scale, with 1 as "not at all" and 4 as "very much."	Up To 5 Years
Secondary	Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue Short Form (SF) 7a Scale Score	Fatigue will be assessed using the PROMIS Fatigue SF 7a Global Fatigue Score. PROMIS Fatigue SF 7a is a 7-item questionnaire that assesses the impact and experience of fatigue over the past 7 days. Participants rate items on a 5-point scale, with 1 as "never" an 5 as "always".	Up To 5 Years
Secondary	Overall Response (OR)	OR [complete remission (CR) + partial response (PR)] is defined as achieving a CR or PR at any time point during the study per the modified IWG 2006 criteria for MDS.	Up To 5 Years

External Links

•   This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.