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.

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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.

View Eligibility Criteria

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

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 3

Estimated Enrollment:

482

Study ID:

NCT01303796

Recruitment Status:

Completed

Sponsor:

Cyclacel Pharmaceuticals, Inc.

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There are 39 Locations for this study

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University of Alabama Comprehensive Cancer Center
Birmingham Alabama, 35294, United States
Scripps Cancer Center
La Jolla California, 92037, United States
UCLA Ronald Reagan Medical Center
Los Angeles California, 90095, United States
Norwalk Hospital
Norwalk Connecticut, 06850, United States
Shands Cancer Hospital at University of Florida
Gainesville Florida, 32608, United States
Cleveland Clinic Florida
Weston Florida, 33331, United States
Winship Cancer Institute, Emory University
Atlanta Georgia, 30322, United States
Blood and Marrow Transplant Group of Georgia
Atlanta Georgia, 30342, United States
Northwestern Memorial Hospital
Chicago Illinois, 60611, United States
Rush University Medical Center
Chicago Illinois, 60612, United States
The University of Chicago Medical Center
Chicago Illinois, 60637, United States
St. Francis Medical Group Oncology and Hematology Specialists
Indianapolis Indiana, 46237, United States
University of Iowa Hospitals and Clinics
Iowa City Iowa, 52242, United States
University of Maryland Greenbaum Cancer Center
Baltimore Maryland, 21201, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Henry Ford Health System
Detroit Michigan, 48202, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Saint Luke's Cancer Institute
Kansas City Missouri, 64111, United States
St. Louis University Cancer Center
Saint Louis Missouri, 63110, United States
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
Dartmouth - Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States
John Theurer Cancer Center at the Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Westchester Hematology Oncology Group, PC
Hawthorne New York, 10532, United States
Beth Israel Medical Center
New York New York, 10003, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Stony Brook University Medical Center
Stony Brook New York, 11794, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Gabrail Cancer Center Research
Canton Ohio, 44718, United States
University of Cincinnati
Cincinnati Ohio, 45267, United States
Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States
Penn State Milton S. Hershey Medical Center
Hershey Pennsylvania, 17033, United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Saint Francis Hospital
Greenville South Carolina, 29601, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
Baylor University Medical Center
Dallas Texas, 75246, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock Texas, 79410, United States
Huntsman Cancer Institute at the University of Utah
Salt Lake City Utah, 84112, United States
The Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Medizinische Universitaetsklinik
Innsbruck , , Austria
Elisabethinen Krankenhaus
Linz , , Austria
Krankenhaus der Barmherzigen Schwestern
Linz , , Austria
Univ. Klinik fur Innere Medizin III LKH
Salzburg , , Austria
Klinikum Wels-Grieskirchen GmbH
Wels , , Austria
AKH Wien
Wien , , Austria
Hanusch Krankenhaus
Wien , , Austria
Ziekenhuis Netwerk Antwerpen Stuivenberg
Antwerpen , , Belgium
AZ Sint-Jan Brugge-Oostende
Brugge , , Belgium
Universite Catholique de Louvain
Brussels , , Belgium
Centre Hospitalier De Jolimont-Lobbes
La Louviere , , Belgium
Cliniques Universitaires UCL de Mont-Godinne
Yvoir , , Belgium
CHU d'Amiens Hopital Sud
Amiens , , France
Centre Hospitalier de la Cote Basque
Bayonne , , France
CHU de Lyon - Hopital Edouard Herriot
Lyon , , France
Institut Paoli Calmettes
Marseille , , France
CHRU De Montpellier Hopital St. Eloi
Montpellier , , France
Centre Hospitalier De Mulhouse
Mulhouse , , France
Hopital St Louis Universite Paris 7
Paris , , France
Centre Hospitalier de Perigueux
Perigueux , , France
Centre Hospitalier d'Annecy
Pringy , , France
Centre Hospitalier de Saint-Brieuc Yves Ie Foll
St Brieuc , , France
CHU de Strasbourg - Hopital Civil
Strasbourg , , France
Strasbourg Oncologie Liberale
Strasbourg , , France
CHU de Tours Hopital Bretonneau
Tours , , France
Universitaetsklinikum Charite Berlin, Campus Benjamin Franklin
Berlin , , Germany
Universitaetsklinikum Carl-Gustav-Carus Dresden
Dresden , , Germany
St. Johannes Hospital
Duisburg , , Germany
Klinikum Frankfurt Hoechst
Frankfurt , , Germany
Asklepios Klinik Altona
Hamburg , , Germany
Medizinische Hochschule Hannover
Hannover , , Germany
SLK Kliniken Heilbronn
Heilbronn , , Germany
Klinikum St. Georg
Leipzig , , Germany
Johannes Wesling Klinikum
Minden , , Germany
TU Muenchen
Muenchen , , Germany
Universitaetsklinikum Muenster
Muenster , , Germany
University of Debrecen
Debrecen , , Hungary
Petz Aladar Megyei Oktato Korhaz
Győr , , Hungary
Kaposi Mor Oktato Korhaz
Kaposvár , , Hungary
AOU Ospedali Riuniti Umberto I
Ancona , , Italy
AO Ospedali Riuniti di Bergamo
Bergamo , , Italy
Universita di Bologna Ist Ematologia Oncologia Medica Seragnoli
Bologna , , Italy
AO Spedali Civili di Brescia
Brescia , , Italy
Universita Cattolica del Sacro Cuore
Campobasso , , Italy
AOU Careggi
Firenze , , Italy
AOU San Martino IST
Genova , , Italy
PO Vito Fazzi
Lecce , , Italy
Ospedale San Raffaele
Milano , , Italy
AORN Antonio Cardarelli
Napoli , , Italy
Uni. Napoli Ospedale Federico lI
Napoli , , Italy
AOU Maggiore della Carità di Novara
Novara , , Italy
AOOR Villa Sofia Cervello di Palermo
Palermo , , Italy
Policlinico San Matteo Di Pavia
Pavia , , Italy
AOU San Luigi Gonzaga
Torino , , Italy
Akademickie Centrum Kliniczne Szpital Akademii Medycznej w Gdansku
Gdansk , , Poland
Wojewodzki Szpital Specjalistyczny
Legnica , , Poland
Wojewódzki Szpital Specjalistyczny w Legnicy
Legnica , , Poland
University of Lodz N. Copernicus Memorial Hospital
Lodz , , Poland
IHT Instytut Hematologii I Transfuzjologii w Warszawie
Warsaw , , Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 w Wroclawiu
Wroclaw , , Poland
Hospital Universitari Germans Trias i Pujol ICO Badalona
Badalona , , Spain
Hospital Clinic de Barcelona
Barcelona , , Spain
Hospital De La Santa Creu Sant Pau
Barcelona , , Spain
Hospital Universitario Vall d'Hebron
Barcelona , , Spain
Hospital Universitario de Canarias
La Laguna , , Spain
Hospital Universitario Ramon y Cajal
Madrid , , Spain
MD Anderson Cancer Center
Madrid , , Spain
Hospital Son Llatzer
Palma de Mallorca , , Spain
Hospital Universitari Son Espases
Palma de Mallorca , , Spain
Clínica Universidad de Navarra
Pamplona , , Spain
Complejo Hospitalario de Navarra
Pamplona , , Spain
Hospital Clinico Universitario de Salamanca
Salamanca , , Spain
Hospital Clinico Universitario
Santiago de Compostela , , Spain
Hospital Universitario Virgen del Rocio
Sevilla , , Spain
Hospital Universitari "La Fe"
Valencia , , Spain
Sunderby Hospital
Luleå , , Sweden
Skåne Universitetssjukhus Univ Hospital Lund
Lund , , Sweden
Inselspital Bern
Bern , , Switzerland
Kings College Hospital and Guys and St Thomas' Hospital
London , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 3

Estimated Enrollment:

482

Study ID:

NCT01303796

Recruitment Status:

Completed

Sponsor:


Cyclacel Pharmaceuticals, Inc.

How clear is this clinincal trial information?

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