Trial record 1 of 1 for:    CYC682 – 12
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A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (SEAMLESS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Cyclacel Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
Cyclacel Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01303796
First received: February 21, 2011
Last updated: September 8, 2014
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Acute Myeloid Leukemia
Drug: Sapacitabine and decitabine
Drug: Decitabine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Randomized Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia

Resource links provided by NLM:


Further study details as provided by Cyclacel Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Overall survival [ Time Frame: up to 43 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Complete remission with duration [ Time Frame: Up to 43 months ] [ Designated as safety issue: Yes ]
  • Complete remission with incomplete platelet count recovery and duration [ Time Frame: up to 43 months ] [ Designated as safety issue: Yes ]
  • Partial remission with duration [ Time Frame: up to 43 months ] [ Designated as safety issue: Yes ]
  • Hematological improvement with duration [ Time Frame: up to 43 months ] [ Designated as safety issue: Yes ]
  • Stable disease with duration [ Time Frame: up to 43 months ] [ Designated as safety issue: Yes ]
  • Number of units of blood product transfused [ Time Frame: up to 43 months ] [ Designated as safety issue: No ]
  • Hospitalized days [ Time Frame: up to 43 months ] [ Designated as safety issue: Yes ]
  • 1-year survival [ Time Frame: up to 43 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 485
Study Start Date: January 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
Sapacitabine and decitabine
Drug: Sapacitabine and decitabine
Sapacitabine administered in alternating cycles with decitabine
Active Comparator: Arm C
Decitabine
Drug: Decitabine
Decitabine alone

Detailed Description:

This is a multicenter, randomized, Phase 3 study 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

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed AML based on WHO 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 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 the preceding MDS or MPD
  • Known or suspected central nervous system (CNS) involvement by leukemia
  • Uncontrolled intercurrent illness
  • Known hypersensitivity to decitabine
  • Known to be HIV-positive
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01303796

Contacts
Contact: Judy H Chiao, MD 908-517-7330 jchiao@cyclacel.com

  Hide Study Locations
Locations
United States, Alabama
University of Alabama Comprehensive Cancer Center Terminated
Birmingham, Alabama, United States, 35294
United States, California
Scripps Cancer Center Recruiting
La Jolla, California, United States, 92037
Contact: Alain Perez    858-554-9379      
Principal Investigator: James Mason, M.D.         
UCLA Ronald Reagan Medical Center Recruiting
Los Angeles, California, United States, 90095
Contact: Rose Malone, RN    310-794-0242      
Principal Investigator: Gary Schiller, M.D.         
United States, Connecticut
Norwalk Hospital Recruiting
Norwalk, Connecticut, United States, 06850
Contact: Jennifer Long    203-852-2996      
Principal Investigator: Richard Frank, M.D.         
Cancer Center of Central Connecticut Withdrawn
Southington, Connecticut, United States, 06489
United States, Florida
Shands Cancer Hospital at University of Florida Recruiting
Gainesville, Florida, United States, 32608
Contact: Leslie Pettiford    352-273-6839      
Principal Investigator: Maxim Norkin, M.D.         
Cleveland Clinic Florida Recruiting
Weston, Florida, United States, 33331
Contact: Jessica Woodring    954-659-5538      
Principal Investigator: James Hoffman, M.D.         
United States, Georgia
Blood and Marrow Transplant Group of Georgia Recruiting
Atlanta, Georgia, United States, 30342
Contact: Stacy Brown    404-851-8238      
Principal Investigator: Scott Solomon, M.D.         
Winship Cancer Institute, Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Wilena Session    404-778-5319      
Principal Investigator: Martha Arellano, M.D.         
Georgia Health Sciences University Withdrawn
Augusta, Georgia, United States, 30912
United States, Illinois
The University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Margaret Green, RN    773-702-0267      
Principal Investigator: Wendy Stock, MD         
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Sara Duffey    312-695-1102      
Principal Investigator: Jessica Altman, M.D.         
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Kimberly Koetter, RN    312-942-1346      
Principal Investigator: Parameswaran Venugopal, M.D.         
United States, Indiana
St. Francis Medical Group Oncology and Hematology Specialists Recruiting
Indianapolis, Indiana, United States, 46237
Contact: Reba Baker, RN    317-528-4481      
Principal Investigator: Stephen E. Rubenstein, M.D.         
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Karen Parrott    319-353-6347      
Principal Investigator: Thomas Carter, M.D.         
United States, Maryland
University of Maryland Greenbaum Cancer Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Isabella v d Merwe, RN    410-328-8370      
Principal Investigator: Maria Baer, M.D.         
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Jennifer Paolini    617-667-9923      
Principal Investigator: James Levine, MD         
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Nicole Adams    313-916-8862      
Principal Investigator: Philip Kuriakose, M.D.         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office    507-538-7623      
Principal Investigator: Kebede H. Begna, M.D.         
United States, Missouri
Saint Luke's Cancer Institute Recruiting
Kansas City, Missouri, United States, 64111
Contact: Teresa Maag    816-932-1601      
Principal Investigator: Rakesh Gaur, M.D.         
St. Louis University Cancer Center Recruiting
St. Louis, Missouri, United States, 63110
Contact: Brenda Haliburton    314-268-7058      
Principal Investigator: Mark Fesler, M.D.         
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Rose Hoyt, RN    402-559-4810      
Principal Investigator: Lori Maness, M.D.         
United States, New Hampshire
Dartmouth - Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Clinical Research Nurse    800-639-6918      
Principal Investigator: Marc Gautier, M.D.         
United States, New Jersey
John Theurer Cancer Center at the Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Sora Limor    201-336-8598      
Principal Investigator: Stuart Goldberg, MD         
United States, New York
Westchester Hematology Oncology Group, PC Recruiting
Hawthorne, New York, United States, 10532
Contact: Nasir Ahmed    914-594-4400 ext 108      
Principal Investigator: Karen Seiter, MD         
Beth Israel Medical Center Recruiting
New York, New York, United States, 10003
Contact: Tiffany Xing    212-367-0190      
Principal Investigator: Sanford Kempin, M.D.         
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Ellin Berman, M.D.    212-639-7762      
Principal Investigator: Ellin Berman, M.D.         
Stony Brook University Medical Center Recruiting
Stony Brook, New York, United States, 11794
Contact: Jennifer Sadler    631-444-3464      
Principal Investigator: Michael Schuster, M.D.         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Donna Adams    919-681-4769      
Principal Investigator: David Rizzieri, M.D.         
United States, Ohio
Gabrail Cancer Center Research Recruiting
Canton, Ohio, United States, 44718
Contact: Carrie Smith    330-492-3345 ext 208      
Principal Investigator: Nashat Y. Gabrail, M.D.         
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Ruth Steele    513-584-2951      
Principal Investigator: Stephen Medlin, MD         
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Bethany Foster    216-444-0372      
Principal Investigator: Mikkael Sekeres, M.D.         
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Christine Capper    717-531-0003 ext 285453      
Principal Investigator: David F. Claxton, M.D.         
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Anita Reilly    215-615-3384      
Principal Investigator: Selina Luger, MD         
United States, South Carolina
Saint Francis Hospital Recruiting
Greenville, South Carolina, United States, 29601
Contact: Kristina Stoeppler-Biege, RN    864-255-1517      
Principal Investigator: Fahd Quddus, M.D.         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Violeta Vartic    615-343-1467      
Principal Investigator: Stephen A. Strickland, M.D.         
United States, Texas
Baylor University Medical Center Recruiting
Dallas, Texas, United States, 75246
Contact: Clinical Oncology Research Coordination    214-818-8472      
Principal Investigator: Edward Agura, M.D.         
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030-3387
Contact: Alexandra Thackrey, RN    713-792-7026      
Principal Investigator: Hagop Kantarjian, MD         
Joe Arrington Cancer Research and Treatment Center Recruiting
Lubbock, Texas, United States, 79410
Contact: Sonia Salas    806-725-8068      
Principal Investigator: Donald Quick, M.D.         
United States, Utah
Huntsman Cancer Institute at the University of Utah Terminated
Salt Lake City, Utah, United States, 84112
United States, Wisconsin
The Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Luis Hernandez    414-805-8753      
Principal Investigator: Ehab Atallah, M.D.         
Austria
Studienambulanz Haematologie - Medizinische Universitaetsklinik Recruiting
Innsbruck, Austria
Elisabethinen Krankenhaus Recruiting
Linz, Austria
Onkologische Tagesklinik - Univ. Klinik fur Innere Medizin III - LKH Recruiting
Salzburg, Austria
Klinikum Wels-Grieskirchen GmbH Recruiting
Wels, Austria
AKH Wien / MedUni Wien Recruiting
Wien, Austria
Hanusch Krankenhaus Recruiting
Wien, Austria
Belgium
Ziekenhuis Netwerk Antwerpen Recruiting
Antwerpen, Belgium
AZ Sint-Jan Brugge - Oostende AV Recruiting
Brugge, Belgium
Universite Catholique de Louvain Recruiting
Brussels, Belgium
Centre Hospitalier De Jolimont-Lobbes Recruiting
La Louviere, Belgium
Cliniques Universitaires Ucl De Mont-Godinne Recruiting
Yvoir, Belgium
France
CHU d'Amiens - Hopital Sud Recruiting
Amiens Cedex, France
Centre Hospitalier De La Cote Basque Recruiting
Bayonne, France
CHU de Lyon - Hopital Edouard Herriot Recruiting
Lyon, France
Centre Regional De Lutte Contre Le Cancer - Institut Paoli Calmettes Recruiting
Marseille, France
CHRU De Montpellier - Hospital St. Eloi Recruiting
Montpellier, France
Centre Hospitalier De Mulhouse Recruiting
Mulhouse, France
St Louis/Universite Paris 7 Recruiting
Paris, France
Centre Hospitalier de Perigueux Recruiting
Perigueux, France
Ch Annecy (Chra) Recruiting
Pringy Cedex, France
Centre Hospitalier De Saint-Brieuc Yves Ie Foll Recruiting
St Brieuc, France
CHU de Strasbourg - Hopital Civil Recruiting
Strasbourg, France
Strasbourg Oncologie Liberale Recruiting
Strasbourg, France
CHU de Tour - Hospital Bretonneau Recruiting
Tours, France
Germany
Universitaetsklinik Charite Berlin, Campus Benjamin Franklin Recruiting
Berlin, Germany
Universitaetsklinikum Carl-Gustav-Carus Dresden Recruiting
Dresden, Germany
St. Johannes Hospital Recruiting
Duisburg, Germany
Klinikum Frankfurt Hoechst GmbH Recruiting
Frankfurt, Germany
Asklepios Klinik Altona Recruiting
Hamburg, Germany
Medizinische Hochschule Hannover Recruiting
Hannover, Germany
Slk-Kliniken Heilbronn Recruiting
Heilbronn, Germany
Klinikum St. Georg Ggmbh Leipzig Recruiting
Leipzig, Germany
Johannes Wesling Klinikum Minden Recruiting
Minden, Germany
Universitätsklinikum Münster Recruiting
Munster, Germany
Hungary
University Of Debrecen Recruiting
Debrecen, Hungary
Petz Aladar Megyei Oktato Korhaz Recruiting
Gyor, Hungary
Kaposi Mor Oktato Korhaz Recruiting
Kaposvar, Hungary
Italy
A.O. Ospedali Riuniti Di Bergamo Recruiting
Bergamo, Italy
Istituto Di Ematologia E Oncologia Medica Seragnoli Recruiting
Bologna, Italy
Azienda Ospedaliera Spedali Civili Di Brescia Recruiting
Brescia, Italy
AOU Maggiore della Carità di Novara Recruiting
Novara, Italy
Poland
Akademickie Centrum Kliniczne - Szpital Akademii Medycznej W Gdansku Recruiting
Gdansk, Poland
Wojewódzki Szpital Specjalistyczny w Legnicy, Oddzia¿ Hematologiczny Recruiting
Legnica, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 We Wroclawiu Recruiting
Wroclaw, Poland
Spain
Hematología clínica ICO Badalona Recruiting
Badalona, Spain
Hospital de la Santa Creui Sant pau Recruiting
Barcelona, Spain
Hospital Clinic De Barcelona Recruiting
Barcelona, Spain
Hospital Universitario De Canarias Recruiting
La Laguna, Spain
Hospital Universitario Ramon Y Cajal Recruiting
Madrid, Spain
MD Anderson Cancer Center Recruiting
Madrid, Spain
Hospital Son Llatzer Recruiting
Palma de Mallorca, Spain
Hospital Universitari Son Espases Recruiting
Palma de Mallorca, Spain
Clínica Universidad De Navarra Recruiting
Pamplona/Iruna, Spain
Hospital de Navarra Recruiting
Pamplona/Iruna, Spain
Hospital Clinico Universitario De Salamanca Recruiting
Salamanca, Spain
Hospital Virgen Del Rocío Recruiting
Sevilla, Spain
Hospital Universitario La Fe De Va Recruiting
Valencia, Spain
Sweden
Sunderby Hospital Recruiting
Lulea, Sweden
Skånes Universitets sjukhus Recruiting
Lund, Sweden
United Kingdom
Kings College Hospital and Guys and St Thomas' Hospital Recruiting
London, United Kingdom
Sponsors and Collaborators
Cyclacel Pharmaceuticals, Inc.
Investigators
Study Chair: Hagop Kantarjian, M.D. M.D. Anderson Cancer Center
  More Information

No publications provided

Responsible Party: Cyclacel Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01303796     History of Changes
Other Study ID Numbers: CYC682-12
Study First Received: February 21, 2011
Last Updated: September 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Cyclacel Pharmaceuticals, Inc.:
AML

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Neoplasms by Histologic Type
Neoplasms
Decitabine
Azacitidine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014