Efficacy/Safety of CPI-613 in Combination With HD Cyt. and Mito. vs HD Cyt. and Mito. in Older Patients With R/R AML

PHASE3TerminatedINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

November 12, 2018

Primary Completion Date

October 25, 2021

Study Completion Date

January 19, 2022

Conditions
Relapsed/Refractory Acute Myeloid Leukemia
Interventions
DRUG

CPI-613 + High Dose Cytarabine and Mitoxantrone

CPI-613 + High Dose Cytarabine and Mitoxantrone CPI-613: 2000mg/m2, 5 doses once a day, days 1-5 Cytarabine 1gm/m2, 5 doses every 12hrs starting day 3 through day 5 Mitoxantrone 6mg/m2, 3 doses, once a day following the first, third and fifth doses of Cytarabine

DRUG

High Dose Cytarabine and Mitoxantrone

Cytarabine 1gm/m2, 5 doses every 12hrs starting day 3 through day 5 Mitoxantrone 6mg/m2, 3 doses, once a day following the first, third and fifth doses of Cytarabine

DRUG

Mitoxantrone, Etoposide and Cytarabine

"Mitoxantrone, Etoposide and Cytarabine~Etoposide 80mg/m over 60 minutes as a central line IV infusion; 6 doses Day 1 though 6 Cytarabine 1000mg/m2 over 3 hours as a central line IV infusion: 6 doses, Day 1 through 6 Mitoxantrone 6 mg/m2 over 30 minutes as a central line IV infusion: 6 dose, Day 1 through 6"

DRUG

Fludarabine, Cytarabine, Filgrastim

"Fludarabine, Cytarabine and Filgrastim~Fludarabine 30mg/m2/day over 30 minutes as a central line IV infusion; 5 doses Day 1 though 5 Cytarabine 2g/m2 over 4 hours as a central line IV infusion: 4 hours after Fludarabine: 5 doses, Day 1 through 5 Filgrastim 5µg/kg/day by SQ or as per institutional guidelines starting from Day 1 through Day 5"

Trial Locations (60)

1140

Hanuschkrankenhaus der WGKK, Vienna

1200

Clinique Universitaire St Luc, Brussels

2250

Gosford Hospital, Gosford

2298

Calvary Mater Newcastle Hospital, Waratah

2640

Border Medical Oncology Research Unit, Albury

5020

Paracelsus Medical University, Salzburg

6000

Royal Perth Hospital, Perth

8000

Algemeen Ziekenhuis Sint-Jan, Bruges

8036

Universitätsklinik für Innere Medizin, Graz

9000

UN Gent, Ghent

9300

Service d'Hématologie Clinique, Hôpital Avicenne-APHP-Université Paris, Bobigny

10065

Memorial Sloan Kettering Cancer Center, New York

11794

Stony Brook University Hospital, Long Island City

13005

CHU la Conecption, Marseille

14033

CHU de Caen, Caen

22908

University of Virginia, Charlottesville

24105

UniversitatsklinikumUKSH Kiel, Kiel

27157

Wake Forest Baptist Health, Winston-Salem

27599

UNC Chapel Hill, Chapel Hill

28033

MD Anderson Cancer Center, Madrid

29010

Hospital Universitario Virgen de la Victoria, Málaga

35033

Universitatsklinikum Marburg, Marburg

37007

Hospital Clínico Universitario de Salamanca, Salamanca

38043

Centre Hospitalier Universitaire Grenoble Hopital Michalon, Grenoble

40207

Norton Cancer Institute, Louisville

40436

University of Kentucky, Lexington

41500

Zespół Szpitali Miejskich w Chorzowie, Chorzów

44195

Cleveland Clinic, Cleveland

45219

University of Cincinnati, Cincinnati

46026

Hospital U. P. La Fe, Valencia

50556

Katedra i Klinika Hematologii, Wroclaw

52242

University of Iowa-Holden Cancer Care Center, Iowa City

60153

Loyola University Medical Center, Maywood

60611

Northwestern Memorial Hospital, Chicago

60637

University of Chicago, Chicago

65929

Klinikum Frankfurt Hoechst, Frankfurt

69495

Centre hospitalier Lyon Sud, Pierre-Bénite

70376

Robert-Bosch- Krankenhaus, Stuttgart

75010

Hopital Saint Louis, Paris

75246

Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas

75390

University of Texas - Southwestern Medical Center, Dallas

76508

Baylor Temple (BSW), Temple

77030

MD Andrson Cancer Center, Houston

78157

Centre Hospitalier de Versailles - Hôpital André Mignot, Le Chesnay

80054

CHU Amiens, Amiens

80211

Uniwersyteckie Centrum Kliniczne Klinika Hematologii i Transplantologii, Gdansk

85258

Honor Health Research Institute, Scottsdale

92868

Chao Family Comprehensive Cancer Center (University of California Irvine), Orange

94115

California Pacific Medical Center, San Francisco

97239

Oregon Health & Science University, Portland

07960

Atlantic Health System, Morristown

08901

Rutgers Cancer Institute of New Jersey, New Brunswick

06202

CHU de Nice, Nice

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

08916

Institut Catala d'Oncologia (ICO) - Hospital Universitari Germans Trias i Pujol, Badalona

08035

Hospital Vall d'Hebron, Barcelona

07120

Hospital Son ESPASES, Palma de Mallorca

Sponsors
All Listed Sponsors
lead

Cornerstone Pharmaceuticals

INDUSTRY

NCT03504410 - Efficacy/Safety of CPI-613 in Combination With HD Cyt. and Mito. vs HD Cyt. and Mito. in Older Patients With R/R AML | Biotech Hunter | Biotech Hunter