Acute Myeloid Leukemia Clinical Trial
A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia
Summary
This Phase 3 study assesses two drug regimens as the initial treatment of patients who are at least 70 years of age and have newly diagnosed acute myeloid leukemia (AML) for whom the doctor does not recommend the use of standard intensive treatment or the patient has decided not to receive standard intensive treatment after being fully informed about its benefits and risks by his/her doctor. The two drug regimens are sapacitabine administered in alternating cycles with decitabine or decitabine alone. The purpose of the study is to learn which drug regimen is more likely to keep AML in check as long as possible.
Full Description
This is a multicenter, randomized, Phase 3 study ("SEAMLESS") comparing two drug regimens (arms) as the front-line treatment of elderly patients aged 70 years or older with newly diagnosed acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy. In Arm A, sapacitabine is administered in alternating cycles with decitabine, and in Arm C decitabine is administered alone. The primary efficacy endpoint is overall survival. The study is designed to demonstrate an improvement in overall survival of Arm A versus Arm C.
Eligibility Criteria
Inclusion Criteria:
Newly diagnosed AML based on WHO (World Health Organization) classification
Age 70 years or older for whom the treatment of choice is low-intensity therapy by investigator assessment or who has refused intensive induction therapy recommended by investigator
ECOG (Eastern Cooperative Oncology Group) performance status 0-2
Adequate renal function
Adequate liver function
Able to swallow capsules
Agree to practice effective contraception
Ability to understand and willingness to sign the informed consent form
Exclusion Criteria:
AML is of the sub-type of acute promyelocytic leukemia or extramedullary myeloid tumor without bone marrow involvement
Having received any systemic anti-cancer therapy for AML or received treatment with hypomethylating agents or cytotoxic chemotherapy for preceding myelodysplastic syndrome (MDS) or myeloproliferative disease (MPD)
Known or suspected central nervous system (CNS) involvement by leukemia
Uncontrolled intercurrent illness
Known hypersensitivity to decitabine
Known to be HIV-positive
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There are 39 Locations for this study
Birmingham Alabama, 35294, United States
La Jolla California, 92037, United States
Los Angeles California, 90095, United States
Norwalk Connecticut, 06850, United States
Gainesville Florida, 32608, United States
Weston Florida, 33331, United States
Atlanta Georgia, 30322, United States
Atlanta Georgia, 30342, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60637, United States
Indianapolis Indiana, 46237, United States
Iowa City Iowa, 52242, United States
Baltimore Maryland, 21201, United States
Boston Massachusetts, 02215, United States
Detroit Michigan, 48202, United States
Rochester Minnesota, 55905, United States
Kansas City Missouri, 64111, United States
Saint Louis Missouri, 63110, United States
Omaha Nebraska, 68198, United States
Lebanon New Hampshire, 03756, United States
Hackensack New Jersey, 07601, United States
Hawthorne New York, 10532, United States
New York New York, 10003, United States
New York New York, 10065, United States
Stony Brook New York, 11794, United States
Durham North Carolina, 27710, United States
Canton Ohio, 44718, United States
Cincinnati Ohio, 45267, United States
Cleveland Ohio, 44195, United States
Hershey Pennsylvania, 17033, United States
Philadelphia Pennsylvania, 19104, United States
Greenville South Carolina, 29601, United States
Nashville Tennessee, 37232, United States
Dallas Texas, 75246, United States
Houston Texas, 77030, United States
Lubbock Texas, 79410, United States
Salt Lake City Utah, 84112, United States
Milwaukee Wisconsin, 53226, United States
Innsbruck , , Austria
Linz , , Austria
Linz , , Austria
Salzburg , , Austria
Wels , , Austria
Wien , , Austria
Wien , , Austria
Antwerpen , , Belgium
Brugge , , Belgium
Brussels , , Belgium
La Louviere , , Belgium
Yvoir , , Belgium
Amiens , , France
Bayonne , , France
Lyon , , France
Marseille , , France
Montpellier , , France
Mulhouse , , France
Paris , , France
Perigueux , , France
Pringy , , France
St Brieuc , , France
Strasbourg , , France
Strasbourg , , France
Tours , , France
Berlin , , Germany
Dresden , , Germany
Duisburg , , Germany
Frankfurt , , Germany
Hamburg , , Germany
Hannover , , Germany
Heilbronn , , Germany
Leipzig , , Germany
Minden , , Germany
Muenchen , , Germany
Muenster , , Germany
Debrecen , , Hungary
Győr , , Hungary
Kaposvár , , Hungary
Ancona , , Italy
Bergamo , , Italy
Bologna , , Italy
Brescia , , Italy
Campobasso , , Italy
Firenze , , Italy
Genova , , Italy
Lecce , , Italy
Milano , , Italy
Napoli , , Italy
Napoli , , Italy
Novara , , Italy
Palermo , , Italy
Pavia , , Italy
Torino , , Italy
Gdansk , , Poland
Legnica , , Poland
Legnica , , Poland
Lodz , , Poland
Warsaw , , Poland
Wroclaw , , Poland
Badalona , , Spain
Barcelona , , Spain
Barcelona , , Spain
Barcelona , , Spain
La Laguna , , Spain
Madrid , , Spain
Madrid , , Spain
Palma de Mallorca , , Spain
Palma de Mallorca , , Spain
Pamplona , , Spain
Pamplona , , Spain
Salamanca , , Spain
Santiago de Compostela , , Spain
Sevilla , , Spain
Valencia , , Spain
Luleå , , Sweden
Lund , , Sweden
Bern , , Switzerland
London , , United Kingdom
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