Acute Myeloid Leukemia Clinical Trial
Volasertib in Combination With Low-dose Cytarabine in Patients Aged 65 Years and Above With Previously Untreated Acute Myeloid Leukaemia, Who Are Ineligible for Intensive Remission Induction Therapy (POLO-AML-2)
Summary
To investigate the efficacy, safety, and pharmacokinetics of intravenous volasertib + subcutaneous low dose cytarabine in patients >= 65 years of age with previously untreated acute myeloid leukaemia, ineligible for intensive remission induction therapy
Eligibility Criteria
Inclusion criteria:
Age >= 65years.
Cytologically/histologically confirmed acute myeloid leukaemia (AML) according to WHO classification; (except for acute promyelocytic leukaemia (APL).
Previously untreated AML (except for hydroxyurea and/or corticosteroid therapy for no more than 28 days (cumulative)). Previous therapy for Myelodysplastic Syndrome (MDS) is allowed.
Investigator considers patient ineligible for intensive remission induction therapy based on documented medical reasons (e.g. disease characteristics like AML genetics, type of AML (de novo or secondary), and patient characteristics like performance score, concomitant diagnoses, organ dysfunctions).
Patient is eligible for Low-Dose Cytarabine (LDAC) treatment.
Eastern co-operative oncology group (ECOG) performance score <= 2 at screening.
Signed and dated written informed consent by start date of Screening visit in accordance with Good Clinical Practice (GCP) and local legislation.
Exclusion criteria:
Prior or concomitant chemotherapy for AML (with the exception of hydroxyurea and/or corticosteroid therapy for no more than 28 days (cumulative)). Please note that any prior therapy for MDS is allowed.
Treatment with any investigational drug within 2 weeks before first administration of present trial drug.
Acute promyelocytic leukaemia (French-American-British (FAB) classification subtype M3).
Current clinical central nervous system (CNS) symptoms deemed by the investigator to be related to leukaemic CNS involvement (no lumbar puncture required, clinical assessment per investigator´s judgement is sufficient).
Hypersensitivity to one of the trial drugs or the excipients.
Severe illness or organ dysfunction involving the heart, kidney, liver or other organ system (e.g. active infection, clinically relevant impairment of cardiac function, severe heart failure/cardiac insufficiency, unstable angina pectoris or history of recent myocardial infarction), which in the opinion of the investigator precludes treatment with LDAC.
Corrected QT interval according to Fridericia (QTcF) prolongation > 470 ms or QT prolongation deemed clinically relevant by the investigator (e.g., congenital long QT syndrome).The QTcF will be calculated as the mean of the 3 Electrocardiogram (ECGs) taken at screening.
Total bilirubin > 3 x upper limit of normal (ULN).
Creatinine clearance (CLcr) < 30 ml/min (estimated creatinine clearance by the Cockcroft-Gault (C-G) equation) .
Active hepatitis B or hepatitis C, or laboratory evidence for a chronic infection.
HIV infection.
Second malignancy currently requiring active therapy (except for hormonal/anti-hormonal treatment e.g. in prostate or breast cancer).
Any significant concurrent psychiatric disorder or social situation that according to the investigator´s judgement would compromise patient´s safety or compliance, interfere with consent, study participation, or interpretation of study results.
Known or suspected active alcohol or drug abuse.
Patient unable to comply with the protocol, in the opinion of the investigator.
Male patients with partners of childbearing potential who are unwilling to use condoms in combination with a second medically acceptable method of contraception during the trial and for a minimum of 6 months after study treatment.
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There are 122 Locations for this study
Los Angeles California, 90095, United States
Duluth Minnesota, 55805, United States
Nashville Tennessee, 37232, United States
Houston Texas, 77030, United States
Mendoza , M5500, Argentina
San Miguel de Tucumán , T4000, Argentina
Graz , 8036, Austria
Leoben , 8700, Austria
Wien , 1130, Austria
Brugge , 8000, Belgium
Bruxelles , 1200, Belgium
Haine-Saint-Paul , 7100, Belgium
Hasselt , 3500, Belgium
Leuven , 3000, Belgium
Liège , 4000, Belgium
Roeselare , 8800, Belgium
Yvoir , 5530, Belgium
Jau , 17210, Brazil
Porto Alegre , 90470, Brazil
Ribeirao Preto , 14048, Brazil
Edmonton Alberta, T6G 2, Canada
Vancouver British Columbia, V5Z 1, Canada
Montreal Migration Data, H1T 2, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H3G 1, Canada
Hradec Kralove , 500 0, Czechia
Plzen - Lochotin , 304 6, Czechia
Praha 10 , 100 3, Czechia
Helsinki , 00290, Finland
Turku , 20521, Finland
Amiens , 80054, France
Caen , 14000, France
La Tronche , 38700, France
Le Chesnay , 78157, France
Limoges Cedex 1 , 87042, France
Marseille , 13273, France
Nantes , 44000, France
Paris Cedex 12 , 75012, France
Pessac , 33604, France
Pierre Bénite , 69495, France
Rennes Cedex 9 , 35033, France
Toulouse , 31059, France
Augsburg , 86156, Germany
Berlin , 13353, Germany
Braunschweig , 38114, Germany
Erlangen , 91054, Germany
Essen , 45147, Germany
Frankfurt/Main , 60590, Germany
Göttingen , 37075, Germany
Halle (Saale) , 06120, Germany
Hamburg , 20246, Germany
Hannover , 30625, Germany
Heidelberg , 69120, Germany
Kiel , 24105, Germany
Mainz , 55131, Germany
Marburg , 35043, Germany
München , 81675, Germany
Münster , 48149, Germany
Regensburg , 93053, Germany
Stuttgart , 70376, Germany
Ulm , 89081, Germany
Villingen-Schwenningen , 78052, Germany
Athens , 115 2, Greece
Athens , 11526, Greece
Ioannina , 45 50, Greece
Patras , 26504, Greece
Thessaloniki , 57010, Greece
Budapest , 1083, Hungary
Gyor , 9024, Hungary
Szeged , 6725, Hungary
Bangalore , 56003, India
Mumbai , 40001, India
Brescia , 25123, Italy
Milano , 20162, Italy
Torino , 10126, Italy
Aichi, Nagoya , 460-0, Japan
Aichi, Nagoya , 466-8, Japan
Akita, Akita , 010-8, Japan
Fukui, Yoshida-gun , 910-1, Japan
Fukuoka, Fukuoka , 812-8, Japan
Hyogo, Kobe , 650-0, Japan
Kanagawa, Isehara , 259-1, Japan
Kanagawa, Yokohama , 232-0, Japan
Miyagi, Sendai , 980-8, Japan
Nagasaki, Nagasaki , 852-8, Japan
Okayama, Kurashiki , 710-8, Japan
Okayama, Okayama , 700-8, Japan
Osaka, Osaka , 545-8, Japan
Tokyo, Chuo-ku , 104-0, Japan
Tokyo, Sinagawa-ku , 141-8, Japan
Hwasun , 519-7, Korea, Republic of
Seoul , 06591, Korea, Republic of
Seoul , 110-7, Korea, Republic of
Seoul , 120-7, Korea, Republic of
Seoul , 135-7, Korea, Republic of
Seoul , 138-7, Korea, Republic of
Monterrey , 64460, Mexico
Amsterdam , 1081 , Netherlands
Bergen , N-502, Norway
Grålum , N-171, Norway
Lodz , 93-51, Poland
Torun , 87-10, Poland
Lisboa , 1649-, Portugal
Porto , 4099-, Portugal
Porto , 4200-, Portugal
Porto , 4202-, Portugal
Irkutsk , 66407, Russian Federation
Moscow , 11547, Russian Federation
Nizhniy Novgorod , 60312, Russian Federation
St. Petersburg , 19429, Russian Federation
Moreleta Park, Pretoria , 0044, South Africa
Badalona , 08916, Spain
Barcelona , 08025, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Madrid , 28041, Spain
Madrid , 28046, Spain
Salamanca , 37007, Spain
Valencia , 46009, Spain
ChangHua , 500, Taiwan
Taipei , 100, Taiwan
Taipei , 112, Taiwan
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