Acute Myeloid Leukemia Clinical Trial
— SEAMLESSOfficial title:
A Phase III Randomized Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia
Verified date | May 2022 |
Source | Cyclacel Pharmaceuticals, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 482 |
Est. completion date | July 31, 2017 |
Est. primary completion date | December 15, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 70 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Austria | 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 | |
Belgium | 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 | |
France | 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 | |
Germany | 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 | |
Hungary | University of Debrecen | Debrecen | |
Hungary | Petz Aladar Megyei Oktato Korhaz | Gyor | |
Hungary | Kaposi Mor Oktato Korhaz | Kaposvár | |
Italy | 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 | |
Poland | 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 | |
Spain | 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 | |
Sweden | Sunderby Hospital | Luleå | |
Sweden | Skåne Universitetssjukhus Univ Hospital Lund | Lund | |
Switzerland | Inselspital Bern | Bern | |
United Kingdom | Kings College Hospital and Guys and St Thomas' Hospital | London | |
United States | Blood and Marrow Transplant Group of Georgia | Atlanta | Georgia |
United States | Winship Cancer Institute, Emory University | Atlanta | Georgia |
United States | University of Maryland Greenbaum Cancer Center | Baltimore | Maryland |
United States | University of Alabama Comprehensive Cancer Center | Birmingham | Alabama |
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Gabrail Cancer Center Research | Canton | Ohio |
United States | Northwestern Memorial Hospital | Chicago | Illinois |
United States | Rush University Medical Center | Chicago | Illinois |
United States | The University of Chicago Medical Center | Chicago | Illinois |
United States | University of Cincinnati | Cincinnati | Ohio |
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
United States | Baylor University Medical Center | Dallas | Texas |
United States | Henry Ford Health System | Detroit | Michigan |
United States | Duke University Medical Center | Durham | North Carolina |
United States | Shands Cancer Hospital at University of Florida | Gainesville | Florida |
United States | Saint Francis Hospital | Greenville | South Carolina |
United States | John Theurer Cancer Center at the Hackensack University Medical Center | Hackensack | New Jersey |
United States | Westchester Hematology Oncology Group, PC | Hawthorne | New York |
United States | Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania |
United States | MD Anderson Cancer Center | Houston | Texas |
United States | St. Francis Medical Group Oncology and Hematology Specialists | Indianapolis | Indiana |
United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
United States | Saint Luke's Cancer Institute | Kansas City | Missouri |
United States | Scripps Cancer Center | La Jolla | California |
United States | Dartmouth - Hitchcock Medical Center | Lebanon | New Hampshire |
United States | UCLA Ronald Reagan Medical Center | Los Angeles | California |
United States | Joe Arrington Cancer Research and Treatment Center | Lubbock | Texas |
United States | The Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | Beth Israel Medical Center | New York | New York |
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
United States | Norwalk Hospital | Norwalk | Connecticut |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Mayo Clinic | Rochester | Minnesota |
United States | St. Louis University Cancer Center | Saint Louis | Missouri |
United States | Huntsman Cancer Institute at the University of Utah | Salt Lake City | Utah |
United States | Stony Brook University Medical Center | Stony Brook | New York |
United States | Cleveland Clinic Florida | Weston | Florida |
Lead Sponsor | Collaborator |
---|---|
Cyclacel Pharmaceuticals, Inc. |
United States, Austria, Belgium, France, Germany, Hungary, Italy, Poland, Spain, Sweden, Switzerland, United Kingdom,
Kantarjian HM, Begna KH, Altman JK, Goldberg SL, Sekeres MA, Strickland SA, Arellano ML, Claxton DF, Baer MR, Gautier M, Berman E, Seiter K, Solomon SR, Schiller GJ, Luger SM, Butrym A, Gaidano G, Thomas XG, Montesinos P, Rizzieri DA, Quick DP, Venugopal — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Survival | The distribution of overall survival was estimated by the method of Kaplan and Meier. A log-rank analysis stratified by randomization stratification factors was used to compare overall survival between Arm A (decitabine/sapacitabine) versus Arm C (decitabine). Cox proportional hazards models were used to identify predictive factors for overall survival. | up to 43 months | |
Secondary | Complete Remission (CR) | Normalization of peripheral neutrophils to >=1000 /microliter, platelet to >=100,000/microliter within 2 weeks of bone marrow biopsy/aspirate, and bone marrow to <=5 % blasts; independent of transfusions*; and no extramedullary leukemia. * independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response |
up to 43 months | |
Secondary | Complete Remission With Incomplete Platelet Count Recovery (CRp) | Normalization of bone marrow to <=5% blasts; peripheral neutrophils >=1000 /microliter, platelet <=100,000 /microliter within 2 weeks of bone marrow biopsy/aspirate; independent of transfusions*; and no extramedullary leukemia. *independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response |
up to 43 months | |
Secondary | Partial Remission (PR) | Normalization of peripheral neutrophils to >=1000 /microliter, platelet to >=100,000/microliter within 2 weeks of bone marrow biopsy/aspirate, >=50% decrease in bone marrow blasts over pre-treatment but still >5%; independent of transfusions* *independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response |
up to 43 months | |
Secondary | Hematological Improvement | HI with duration (HI) Erythroid response (HI-E) for patients with pre-treatment hemoglobin < 11 g/dL; Major response: >2 g/dL increase in hemoglobin; for RBC, transfusion independence* Minor response: 1 to 2 g/dL increase in hemoglobin; for RBC, a 50% decrease in transfusion requirements Platelet response (HI-P) for pre-treatment platelet count <100,000/mm3; Major response: an absolute increase of platelet count by >=30,000/mm3; stabilization of platelet counts and platelet transfusion independence* Minor response: >=50% increase in platelet count with a net increase > 10,000/mm3 but <30,000/mm3 Neutrophil response (HI-N) for absolute neutrophil count (ANC) < 1,500/mm3 before therapy; Major response: >=100% increase, or an absolute increase of >500/mm3, whichever is greater Minor response: >=100% increase, but absolute increase < 500/mm3 independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response |
up to 43 months | |
Secondary | Stable Disease (SD) | Failure to achieve at least hematologic improvement (HI), but no evidence of clinically significant progression for > 16 weeks. | up to 43 months | |
Secondary | Blood Products Transfused | Number of units of packed red blood cells (PRBC) and/or platelet transfusions administered per 8-week period prior to the first dose of study drug and through the date of treatment discontinuation. | up to 43 months | |
Secondary | Hospitalized Days | In-patient days in hospital. | up to 12 months | |
Secondary | 1-year Survival | One-year survival is the percentage of patients who are alive at 1-year measured from the date of randomization. | Percentage of patients alive at 1 year after randomization (participants were assessed up to 43 months for overall survival curve estimation but this measure presents the 1 year survival rate percentage). | |
Secondary | Duration of Complete Remission (dCR) | Durations of normalization of peripheral neutrophils to >=1000 /microliter, platelet to >=100,000/microliter within 2 weeks of bone marrow biopsy/aspirate, and bone marrow to <=5 % blasts; independent of transfusions*; and no extramedullary leukemia. * independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response |
up to 43 months | |
Secondary | Duration of Complete Remission With Incomplete Platelet Count Recovery (dCRp) | Duration of normalization of bone marrow to <=5% blasts; peripheral neutrophils >=1000 /microliter, platelet <=100,000 /microliter within 2 weeks of bone marrow biopsy/aspirate; independent of transfusions*; and no extramedullary leukemia. *independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response |
up to 43 months | |
Secondary | Duration of Partial Remission (dPR) | Duration of normalization of peripheral neutrophils to >=1000 /microliter, platelet to >=100,000/microliter within 2 weeks of bone marrow biopsy/aspirate, >=50% decrease in bone marrow blasts over pre-treatment but still >5%; independent of transfusions* *independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response |
up to 43 months | |
Secondary | Duration of Hematological Improvement (dHI) | Duration of HI Erythroid response (HI-E) for patients with pre-treatment hemoglobin < 11 g/dL; Major response: >2 g/dL increase in hemoglobin; for RBC, transfusion independence* Minor response: 1 to 2 g/dL increase in hemoglobin; for RBC, a 50% decrease in transfusion requirements Platelet response (HI-P) for pre-treatment platelet count <100,000/mm3; Major response: an absolute increase of platelet count by >=30,000/mm3; stabilization of platelet counts and platelet transfusion independence* Minor response: >=50% increase in platelet count with a net increase > 10,000/mm3 but <30,000/mm3 Neutrophil response (HI-N) for absolute neutrophil count (ANC) < 1,500/mm3 before therapy; Major response: >=100% increase, or an absolute increase of >500/mm3, whichever is greater Minor response: >=100% increase, but absolute increase < 500/mm3 independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response |
up to 43 months | |
Secondary | Duration of Stable Disease (dSD) | Failure to achieve at least hematologic improvement (HI), but no evidence of clinically significant progression for > 16 weeks. | up to 43 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
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