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Brief Title: Pralatrexate vs Observation Following CHOP-based Chemotherapy in Undiagnosed Peripheral T-cell Lymphoma Patients
Official Title: A Multi-center, Randomized, Phase 3 Study of Sequential Pralatrexate Versus Observation in Patients Previously Undiagnosed Peripheral T-cell Lymphoma Who Achieved an Objective Response After Initial Treatment With CHOP-based Chemotherapy
Study ID: NCT01420679
Brief Summary: The purpose of this study is to see if pralatrexate extends response and survival following CHOP-based chemotherapy (CHOP: cyclophosphamide, doxorubicin, vincristine, and prednisone) and if pralatrexate improves response in patients with partial response following CHOP-based chemotherapy. Patients will either receive pralatrexate or be under observation. All patients will receive vitamins B12 and folic acid and attend regular clinic visits to evaluate their disease and health.
Detailed Description: This was an international, multi-center, randomized, Phase 3, open-label study of sequential pralatrexate versus observation in patients with previously undiagnosed PTCL who have achieved an objective response following initial treatment with CHOP-based chemotherapy. Upon documentation of completion of an objective response following at least 6 cycles of a designated CHOP-based chemotherapy confirmation of histopathology by independent review, and confirmation that all eligibility criteria were met, patients were randomized in a 2:1 ratio to either pralatrexate or observation, according to a permuted block design with stratification factor of Tumor Response per Investigator at completion of CHOP-based therapy (Complete Response \[CR\] vs Partial Response \[PR\]). All patients who receive at least 1 dose of pralatrexate were followed for safety through 35 (± 5) days after their last dose of pralatrexate or until all treatment-related AEs have resolved or returned to baseline/Grade 1, whichever is longer, or until it was determined that the outcome does not change with further follow-up.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Detroit Clinical Research Center, PC, Novi, Michigan, United States
New York Presbyterian Hospital, New York, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Flinders Medical Center, Bedford Park, South Australia, Australia
Royal Hobart Hospital, Hobart, Tasmania, Australia
Monash Medical Centre, Clayton, Victoria, Australia
Saint Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia
Frankston Hospital, Frankston, Victoria, Australia
Cabrini Health, Malvern, Victoria, Australia
Royal Perth Hospital, Perth, Western Australia, Australia
AZ Sint-Jan, Brugge, , Belgium
Universitair Ziekenhuis Gent, Gent, , Belgium
Sunnybrook Health Science Centre, Toronto, Ontario, Canada
Hôpital du Sacré-Coeur de Montréal, Montreal, Quebec, Canada
Hôpital Morvan, Brest, , France
CHU Haut-Leveque, Pessac, , France
St James Hospital, Dublin 8, , Ireland
Shaare Zedek Medical Center, Jerusalem, , Israel
Hadassah Ein-Kerem Medical Centre, Jerusalem, , Israel
Rabin Medical Center, Petach Tikva, , Israel
Chaim Sheba Medical Center, Tel Hashomer, , Israel
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Forli, Italy
Az. Ospedaliera Universitaria S. Orsola Malpighi, Bologna, , Italy
Spedali Civili di Brescia, Brescia, , Italy
Ospedale S. Maria delle Croci, Ravenna, , Italy
Università Cattolica del Sacro Cuore, Roma, , Italy
Az. Ospedaliera Università Senese, Siena, , Italy
Middlemore Hospital, Otahuhu, Auckland, New Zealand
Auckland City Hospital / Auckland University, Auckland, , New Zealand
Christchurch Hospital, Christchurch, , New Zealand
North Shore Hospital, Milford, , New Zealand
Klinika Nowotworów Ukladu Chlonnego Centrum Onkologii Instytut Marii Sklodowskiej-Curie, Warszawa, Mazowieckie, Poland
Dept of Hematology and Transplantology, Gdansk, , Poland
Małopolskie Centrum Medyczne, Kraków, , Poland
Auxilio Mutuo Cancer Center, San Juan, , Puerto Rico
Clinica Universidad de Navarra, Pamplona, Navarra, Spain
Complejo Hospitalario de Navarra, Servicio de Hematologia, Pamplona, Navarra, Spain
Complejo Hospitalario Universitario A Coruña- Hospital A Coruña, A Coruña, , Spain
Hospital General Vall d'Hebron, Barcelona, , Spain
Hospital Clínic i Provincial de Barcelona, Barcelona, , Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
Hospital de Madrid Norte-Sanchinarro, Madrid, , Spain
Hospital Universitario Puerta de Hierro Majadahonda, Madrid, , Spain
Royal Cornwall Hospital, Truro, Cornwall, United Kingdom
Poole Hospital NHS Foundation Trust, Poole General Hospital, Poole, Dorset, United Kingdom
Derriford Hospital, Plymouth, England, United Kingdom
Sandwell & West Birmingham Hospitals NHS Trust, West Bromwich, England, United Kingdom
Antrim Area Hospital, Antrim, Northern Ireland, United Kingdom
NHS Greater Glasgow and Clyde Western Infirmary, Glasgow, Scotland, United Kingdom
Belfast City Hospital, Belfast, , United Kingdom
Velindre Hospital, Cardiff, , United Kingdom
Royal Liverpool University Hospital, Liverpool, , United Kingdom
Mount Vernon Cancer Centre, Middlesex, , United Kingdom
UHCW (University Hospital Coventry and Warwickshire), Warwick, , United Kingdom