Acute Myeloid Leukemia Clinical Trial
— VALOROfficial title:
A Phase 3, Randomized, Controlled, Double-Blind, Multinational Clinical Study of the Efficacy and Safety of Vosaroxin and Cytarabine Versus Placebo and Cytarabine in Patients With First Relapsed or Refractory Acute Myeloid Leukemia (VALOR)
Verified date | March 2017 |
Source | Sunesis Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study compared treatment groups of patients treated with vosaroxin and cytarabine versus patients treated with placebo and cytarabine.
Status | Completed |
Enrollment | 711 |
Est. completion date | March 1, 2017 |
Est. primary completion date | September 26, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Provided signed, written informed consent - At least 18 years of age - Had a diagnosis of AML according to World Health Organization (WHO) classification - First relapsed or refractory AML (refractory to initial induction therapy) with at least 5% blasts by bone marrow or aspirate or 1% blasts in peripheral blood with additional requirements for relapsed or refractory - Had an ECOG score of 0-2 - Had adequate liver and renal function as indicated by certain laboratory values - Had adequate cardiac function (left ventricular ejection fraction at least 40% by multiple gated acquisition scan or ECG) - Nonfertile or agreed to use an adequate method of contraception until 30 days after the last treatment - Had any clinically significant nonhematologic toxicity after prior chemotherapy recovered to Grade 1 per NCI-CTCAE Exclusion Criteria: - Had acute promyelocytic leukemia - Had more than 2 cycles of induction therapy for AML - Had completed a single cycle of treatment containing a total dose of 5 g/m2 or more of cytarabine within 90 days before randomization - Refractory to or relapsed within the previous 3 months after therapy with an IDAC- or HIDAC-containing regimen - Had received a hematopoietic stem cell transplant (HSCT) within the previous 90 days - Had received active immunosuppressive therapy for graft-versus-host disease (GVHD) within 2 weeks before study start - Had any other severe concurrent disease, or have a history of serious disease involving the heart, kidney, liver, or other organ system - Had evidence of central nervous system involvement of active AML - Had other active malignancies (including other hematologic malignancies) or been diagnosed with other malignancies within the last 12 months, except nonmelanoma skin cancer or cervical intraepithelial neoplasia - Had an active, uncontrolled infection - Had received any other investigational therapy within 14 days or not recovered from acute affects of the other investigational therapy - Had received prior or current hydroxyurea or medications to reduce blast count within 24 hours before randomization - Had received previous treatment with vosaroxin - Pregnant or lactating - Had any other medical, psychological, or social condition that may interfere with consent, study participation, or follow-up - Had known HIV seropositivity |
Country | Name | City | State |
---|---|---|---|
Australia | Haematology and Bone Marrow Transplant Unit, Royal Adelaide Hospital | Adelaide | South Australia |
Australia | Flinders Medical Centre | Bedford Park | South Australia |
Australia | Royal Brisbane and Women's Hospital | Brisbane | Queensland |
Australia | Concord Repatriation General Hospital | Concord | New South Wales |
Australia | The Canberra Hospital | Garran | Australian Capital Territory |
Australia | Andrew Love Cancer Center, Geelong Hospital, Barwon Health | Geelong | Victoria |
Australia | Haematology Department, Gosford Hospital | Gosford | New South Wales |
Australia | The Alfred Hospital | Melbourne | Victoria |
Australia | Department of Clinical Haematology and BMT Service, Royal Melbourne Hospital | Parkville | Victoria |
Australia | Royal Perth Hospital | Perth | Western Australia |
Australia | Westmead Hospital | Westmead | New South Wales |
Austria | Universitatsklinik Graz, Universitatsklinik fur Innere Medizin, Abteilung fur Hamatologie | Graz | |
Austria | University Hospital for Internal Medicine V, Innsbruck Medical University | Innsbruck | |
Austria | Landeskrankenhaus Salzburg, Universitaetsklinik fur innere Medizin lll, Universitaetsklinikum der PMU | Salzburg | |
Austria | AKH Wien / MedUniWien Universtatsklinik fur Innere Medizin 1 | Wien | |
Belgium | ZNA Middleheim Lindendreef 1 | Antwerpen | |
Belgium | ZNA Stuivenberg, Lange Beeldekensstraat 267 | Antwerpen | |
Belgium | AZ St.-Jan Brugge-Oostende AV | Brugge | |
Belgium | Cliniques Universitaires Saint Luc | Brussels | |
Belgium | UZ Leuven, campus Gasthuisberg, Department of Haematology | Leuven | |
Belgium | H.-Hartziekenhuis Roeselare - Menen vzw | Roeselare | |
Canada | Charles LeMoyne Hospital | Greenfield Park | Quebec |
Canada | Queen Elizabeth II Health Sciences Centre | Halifax | Nova Scotia |
Canada | Saint John Regional Hospital | Saint John | New Brunswick |
Canada | University Health Network, Princess Margaret Hospital | Toronto | Ontario |
Canada | Division of Hematology, Vancouver General Hospital | Vancouver | British Columbia |
Czechia | Fakultni nemocnice Brno, Interni hematoonkologicka klinika | Brno | |
Czechia | Fakultni nemocnice Hradec Kralove, 2. Interni klinika-oddeleni klinicke hematologie | Hradec Kralove | |
Czechia | Fakultni nemocnice Kralovske Vinohrady, Oddeleni klinicke hematologie | Praha | Srobarova |
France | CHU Angers, Service des maladies du sang | Angers Cedex 01 | |
France | Hopital Avicenne- Departement Onco-hematologie | Bobigny | |
France | Hopital Mignot | Le Chesnay | |
France | CHU Lille, Service des maladies du sang, Hopital Huriez | Lille | Lille Cedex |
France | Institut Paoli Calmettes | Marseille | |
France | CHU Nantes Hotel Dieu, Service d'hematologie clinique | Nantes | |
France | CHU de Bordeaux- Hopital Haut-Leveque, Centre Francois Magendle | Pessac | |
France | Centre Hospitalier Lyon Sud - Service d'Hematologie - Pavillon Marcel Berard - Bat. 1G - 1er etage, 165 Chemin du grand Revoyet | Pierre Benite | |
France | Service d'hematologie- Hopital Purpan- CHU de Toulouse | Toulouse | |
Germany | St. Johannes-Hospital | Duisburg | |
Germany | Klinikum Frankfurt am Main-Hochst, Department of Hematology and Oncology, Klinikum Frankfurt Academic Hospital of the University of Frankfurt | Frankfurt | |
Germany | Universitatsklinikum Hamburg-Eppendorf; ll. Medizinische Klinik und Poliklinik; Onkologie, Hamatologie und Knochenmarktransplantation | Hamburg | |
Germany | Medizinische Hochschule Hannover, Abteilung Hamatologie | Hannover | |
Germany | SLK-Kliniken Heilbronn GmbH, Medizinische Klinik | Heilbronn | |
Germany | Staedtisches Krankenhaus Kiel GmbH, Infektionsambulanz der 2. Medizinischen Klinik | Kiel | |
Germany | Klinikum St. Georg gGmbH; Klinik fur Internistische Onkologie/Hamatologie | Leipzig | |
Germany | University Hospital of Muenster | Muenster | |
Germany | Klinikum rechts der Isar der Technischen Universitat Munchen lll, Medizinische Klinik | Munich | |
Hungary | University of Debrecen Medical and Health Sciences Center | Debrecen | |
Hungary | Petz Aladar County Hospital | Gyor | |
Hungary | kaposi Mor Oktato Korhaz Belgyogyaszati Osztaly | Kaposvar | |
Hungary | Szegedi Tudomanyegyetem, 11. Belgyogyaszati Klinika | Szeged | |
Italy | Ospedale "A. Perrino", U.O. Compessa di Ematologia | Brindisi | |
Italy | Azienda Ospedaliero-Universitaria Sant'Anna, Sezione di Ematologia, Dipartmento di Science Biomediche e Terapie Avanzate | Ferrara | |
Italy | Ospedaliera Universitaria San Martino di Genova | Genova | |
Italy | Ospedale "Vito Fazzi", U.O Ematologia | Lecce | |
Italy | AORN "A. Cardarelli", U.O.S.C. Ematologia con TMO | Napoli | |
Italy | Azienda Ospedaliero-Universitaria Maggiore Della Carita, Struttura Complessa Direzione Universitaria Ematologia | Novara | |
Italy | Fondazione IRCCS, Policlinico S. Matteo - Dipartimento di Ematologia | Pavia | |
Korea, Republic of | Dept. of Hematology, Asan Medical Center | Seoul | |
Korea, Republic of | Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine | Seoul | |
Korea, Republic of | Seoul National University Hospital | Seoul | |
Korea, Republic of | Seoul St. Mary's Hospital | Seoul | |
New Zealand | Canterbury Health Laboratories | Christchurch | |
New Zealand | Haematology Research, Auckland District Health Board, Auckland City Hospital | Grafton | Auckland |
New Zealand | Department of Haematology, Waikato Hospital | Hamilton | |
New Zealand | Regional Cancer Treatment Service, Palmerston North Hospital | Palmerston North | |
Poland | Uniwersyteckle Centrum Kliniczne | Gdansk | |
Poland | Klinika Hematologii i Chorob Rozrostowych Ukladu Krwiotworczego, Szpital Kliniczny Przemiemienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu | Poznan | |
Poland | Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu | Wroclaw | |
Spain | Hospital de la Santa Creu i Sant Pau | Barcelona | |
Spain | Hospital del Mar | Barcelona | |
Spain | Hospital Universitari Germans Trias i Pujol | Barcelona | |
Spain | Hospital Universitario Vall d'Hebron | Barcelona | |
Spain | Centro Oncologico MD Anderson International Espana | Madrid | |
Spain | Hospital Universitario La Paz | Madrid | |
Spain | Hospital Sont Llatzer | Palma de Mallorca | |
Spain | Hospital Universitario de Salamanca | Salamanca | |
Spain | Hospital Universitari Politecnic la Fe Hematology Department | Valencia | |
United Kingdom | Blackpool Victoria Hospital, Blackpool Teaching Hospitals NHS Foundation Trust | Blackpool | |
United Kingdom | Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital | Cambridge | |
United Kingdom | Department of Haematology, University Hospital of Wales | Cardiff | |
United Kingdom | Queen's Centre for Oncology and Hematology, Castle Hill Hospital | Cottingham | |
United Kingdom | Leicester Royal Infirmary, University Hospitals of Leicester, NHS Trust | Leicester | |
United Kingdom | Department of Haematology, Royal Liverpool University Hospital | Liverpool | |
United Kingdom | Department of Haematology, Guy's Hospital | London | |
United Kingdom | Central Manchester University Hospitals NHS Trust, Manchester Royal Infirmary | Manchester | |
United States | University of Michigan | Ann Arbor | Michigan |
United States | Georgia Health Sciences University | Augusta | Georgia |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Mecklenburg Medical Group | Charlotte | North Carolina |
United States | Rush University Medical Center, Division of Hematology/Oncology | Chicago | Illinois |
United States | University of Chicago | Chicago | Illinois |
United States | University Hospitals fo Cleveland | Cleveland | Ohio |
United States | Ellis Fischel Cancer Center, University of Missouri Health Care | Columbia | Missouri |
United States | UT Southwestern Medical Center at Dallas | Dallas | Texas |
United States | HCA HealthONE - Rocky Mountain Blood and Marrow Transplant Program | Denver | Colorado |
United States | Henry Ford Health System | Detroit | Michigan |
United States | Duke University Medical Center | Durham | North Carolina |
United States | Holy Cross Hospital | Fort Lauderdale | Florida |
United States | John Theurer Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey |
United States | The University of Texas, M.D. Anderson Cancer Center, Department of Leukemia | Houston | Texas |
United States | Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana |
United States | St. Francis Medical Group Oncology and Hematology Specialists | Indianapolis | Indiana |
United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
United States | Baptist Cancer Institute | Jacksonville | Florida |
United States | Moores UCSD Cancer Center | La Jolla | California |
United States | North Shore Long Island Jewish Health System | Lake Success | New York |
United States | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
United States | UCLA Division of Hematology/Oncology | Los Angeles | California |
United States | Family Cancer Center | Memphis | Tennessee |
United States | Department of Medicine Section of Hematology/Oncology, West Virginia University Hospitals, Mary Babb Randolph Cancer Center, West Virginia University | Morgantown | West Virginia |
United States | Henry-Joyce Cancer Clinic | Nashville | Tennessee |
United States | Tennessee Oncology, PLLC | Nashville | Tennessee |
United States | Ochsner Clinic Foundation | New Orleans | Louisiana |
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
United States | Weill Cornell Medical College | New York | New York |
United States | Cancer Care Centers of South Texas | San Antonio | Texas |
United States | Sharp Clinical Oncology Research | San Diego | California |
United States | University of California San Francisco | San Francisco | California |
United States | Stony Brook University Medical Center | Stony Brook | New York |
United States | H. Lee Moffitt Cancer Center & Research Institute | Tampa | Florida |
United States | New York Medical College, Division of Oncology/Hematology | Valhalla | New York |
United States | George Washington University-Medical Faculty Associates | Washington | District of Columbia |
United States | Wake Forest University Health Sciences | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Sunesis Pharmaceuticals |
United States, Australia, Austria, Belgium, Canada, Czechia, France, Germany, Hungary, Italy, Korea, Republic of, New Zealand, Poland, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Overall Remission (OR) Rate Based on the IWG Response Criteria | Group A patient OR compared to Group B patient OR Overall Remission includes Complete Remission (CR), Complete Remission with incomplete platelet recovery (CRp), Complete Remission with incomplete blood count recovery (CRi), and Partial Remission (PR). Complete remission means bone marrow blast count of less than 5% with adequate recovery of peripheral blood counts as typically defined by the IWG. Both CRi and CRp refer complete remission but with incomplete blood count and platelet recovery, respectively. PR, or partial remission, refers to remission in which bone marrow contains blast counts between 5 and 25 percent. |
Up to 5 years or the duration of the study | |
Other | Event Free Survival (EFS) | Up to 5 years or duration of study | ||
Other | Leukemia-Free Survival (LFS) | Durability of remission (CR) assessed by LFS | Up to 5 years or the duration of the study | |
Primary | Overall Survival | Vosaroxin + cytarabine patient survival versus placebo + cytarabine patient survival | Up to 5 years or duration of study | |
Secondary | Complete Remission (CR) Rate Based on Modified International Working Group (IWG) Criteria. | Group A (Vosaroxin + cytarabine) patient CR as compared to Group B (placebo + cytarabine) patient CR. Complete remission (CR) is typically defined using IWG criteria as bone marrow blast count of less than 5% with adequate recovery of peripheral blood counts. | Up to 5 years or duration of study | |
Secondary | All Cause Mortality | Vosaroxin + cytarabine mortality versus placebo + cytarabine mortality | 30 Days | |
Secondary | All Cause Mortality | Vosaroxin + cytarabine mortality versus placebo + cytarabine mortality | 60 Days |
Status | Clinical Trial | Phase | |
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