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Spots Global Cancer Trial Database for Pralatrexate vs Observation Following CHOP-based Chemotherapy in Undiagnosed Peripheral T-cell Lymphoma Patients

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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