Prospective Collection of Data in Patients With Peripheral T-Cell Lymphoma

Recruiting

• Source

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  Public Title	Prospective Collection of Data in Patients With Peripheral T-Cell Lymphoma
  Acronym	T-Cell Project
  Source of Record URL	http://clinicaltrials.gov/show/NCT01142674

• Trial

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  Health Condition(s) or Problem	Lymphoma, T-Cell, Peripheral
  Lay Summary	The designed study follows up the retrospective previous one by the International T-cell Non-Hodgkin's Lymphoma Study Group. It is designed as a prospective collection of information potentially useful to predict the prognosis of newly diagnosed patients with the more frequent subtypes of Peripheral T-cell lymphoma (Peripheral T-cell lymphoma unspecified and Angioimmunoblastic T-cell lymphoma) and to better define clinical characteristics and outcome of the more uncommon subtypes (from ClinicalTrials.gov)
  Who can enter the trial	Inclusion Criteria: 1. Previously-untreated patients with de novo diagnosis of peripheral T-cell or NK/T-cell lymphoma: - Peripheral T-cell lymphoma unspecified; - Peripheral T-cell lymphoma, lymphoepithelioid variant; - Peripheral T-cell lymphoma, T-zone variant ; - Peripheral T-cell lymphoma, parafollicular variant ; - Angioimmunoblastic T-cell lymphoma; - Nasal NK/T-cell lymphoma; - NK/T-cell lymphoma, nasal time; - Anaplastic large-cell lymphoma, T/null cell, ALK+, primary systemic type - Anaplastic large-cell lymphoma, T/null cell, ALK-, primary systemic type - Anaplastic large cell lymphoma, small cell variant, ALK+ - Anaplastic large cell lymphoma, lymphohistiocytic variant, ALK+ - Enteropathy- type T-cell lymphoma; - Hepatosplenic T-cell lymphoma; - Peripheral gamma-delta T-cell lymphoma; - Subcutaneous panniculitis-like T-cell lymphoma; - Unclassifiable peripheral T-cell Lymphoma - Unclassifiable NK-cell lymphoma 2. Age over 18 3. Tissue biopsies adequate for diagnosis and classification and available for centralized review 4. Clinical data including baseline information on disease localization and laboratory parameters at staging, features of treatment adopted and assurance of follow-up updating for at least 5 years are requested 5. Written informed consent Exclusion Criteria: 1. Age < 18 2. Diagnosis of T-cell or NK-cell leukemia or proliferation and other than mature types including: - Adult T-cell leukemia/lymphoma; - Blastic NK-cell leukemia/lymphoma; - Aggressive NK-cell leukemia - T-cell large granular lymphocytic leukemia - T-cell large granular lymphocytic proliferation - NK-cell large granular lymphocytic proliferation - T-cell prolymphocytic leukemia - Precursor T-cell lymphoblastic leukemia/lymphoma - Mycosis fungoides; - Sézary syndrome; - Primary cutaneous ALCL
  Who cannot enter the trial	Inclusion Criteria: 1. Previously-untreated patients with de novo diagnosis of peripheral T-cell or NK/T-cell lymphoma: - Peripheral T-cell lymphoma unspecified; - Peripheral T-cell lymphoma, lymphoepithelioid variant; - Peripheral T-cell lymphoma, T-zone variant ; - Peripheral T-cell lymphoma, parafollicular variant ; - Angioimmunoblastic T-cell lymphoma; - Nasal NK/T-cell lymphoma; - NK/T-cell lymphoma, nasal time; - Anaplastic large-cell lymphoma, T/null cell, ALK+, primary systemic type - Anaplastic large-cell lymphoma, T/null cell, ALK-, primary systemic type - Anaplastic large cell lymphoma, small cell variant, ALK+ - Anaplastic large cell lymphoma, lymphohistiocytic variant, ALK+ - Enteropathy- type T-cell lymphoma; - Hepatosplenic T-cell lymphoma; - Peripheral gamma-delta T-cell lymphoma; - Subcutaneous panniculitis-like T-cell lymphoma; - Unclassifiable peripheral T-cell Lymphoma - Unclassifiable NK-cell lymphoma 2. Age over 18 3. Tissue biopsies adequate for diagnosis and classification and available for centralized review 4. Clinical data including baseline information on disease localization and laboratory parameters at staging, features of treatment adopted and assurance of follow-up updating for at least 5 years are requested 5. Written informed consent Exclusion Criteria: 1. Age < 18 2. Diagnosis of T-cell or NK-cell leukemia or proliferation and other than mature types including: - Adult T-cell leukemia/lymphoma; - Blastic NK-cell leukemia/lymphoma; - Aggressive NK-cell leukemia - T-cell large granular lymphocytic leukemia - T-cell large granular lymphocytic proliferation - NK-cell large granular lymphocytic proliferation - T-cell prolymphocytic leukemia - Precursor T-cell lymphoblastic leukemia/lymphoma - Mycosis fungoides; - Sézary syndrome; - Primary cutaneous ALCL
  What will happen	Sorry, not currently available
  Primary aim	Overall Survival (OS)
  Secondary Aim	Event Free Survival (EFS); 5 years; No; Remission rate with initial therapy; End of front-line therapy; No; Progression Free Survival (PFS); 5-years; No
  Participant Information Sheet	Sorry, not currently available
  Website	Sorry, not currently available
  Recruitment Status	Recruiting
  Nation	England
  Location	Birmingham, London, Manchester, Southampton, Wolverhampton

• Contact

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  Contact for Public Queries

  Monica Bellei, MSc, PhD +39 059 422 4020 monica.bellei@unimore.it Massimo Federico, MD; Julie M. Vose, MD; Raymond Liang, MD; Emanuele Zucca, MD; Joseph M Connors, MD; Steven M. Horwitz, MD; Francine M. Foss, MD; Pier Luigi Zinzani, MD; Silvia Montoto, MD; Aaron Polliack, MD; Stefano A. Pileri, MD; Dennis D. Weisenburger, MD; Thomas Ruediger, MD; Young H. Ko, MD Study Chair; Study Chair; Study Chair; Study Chair; Study Chair; Study Chair; Study Chair; Study Chair; Study Chair; Study Chair; Study Chair; Study Chair; Study Chair; Study Chair Dip. Oncologia ed Ematologia - Università di Modena e Reggio Emilia, , Modena, IT; Nebraska Medical Center, Omaha, NE, USA; Queen Mary Hospital - University of Hong Kong, Hong Kong, HK; IOSI/Oncology Institute of Southern Switzerland, Ospedale S. Giovanni - Bellinzona, CH; British Columbia Cancer Agency, Vancouver, CA; Memorial Sloan-Kettering Cancer Center; Yale Cancer Center, New Haven, CT, USA; Istituto di Ematologia e Oncologia Medica "L. e A. Seragnoli", Policlinico Sant'Orsola, Bologna, IT; St. Bartholomew Hospital, London, UK; Sourasky Medical Center, Tel Aviv, IL; Istituto di Ematologia e Oncologia Medica "L. e A. Seragnoli", Policlinico Sant'Orsola, Bologna, IT; Nebraska Medical Center, Omaha, NE, USA; Universitat Wurzburg, Wurzburg, DE; Samsung Medical Center, Seoul, KR

  Contact for Scientific Queries

  Rajana Advani, MD; Principal Investigator; Julie M Vose, MD; Principal Investigator; Steven Horwitz, MD; Principal Investigator; Barbara Pro, MD; Principal Investigator; Jorge Milone, MD; Principal Investigator; Lucia Zoppegno, MD; Principal Investigator; Astrid Pavlovsky, MD; Principal Investigator; Carmino de Souza, MD; Principal Investigator; Carlos Chiattone, MD, PhD; Principal Investigator; Maria E. Cabrera, MD; Principal Investigator; Raymond Liang, MD; Principal Investigator; Arnon Nagler, MD; Principal Investigator; Giuseppe Rossi, PD; Principal Investigator; Francesco Di Raimondo, MD; Principal Investigator; Renato Cantaffa, MD; Principal Investigator; Nicola Cascavilla, MD; Principal Investigator; Nicola Di Renzo, MD; Principal Investigator; Riccardo Centurioni, MD; Principal Investigator; Maura Brugiatelli, MD; Principal Investigator; Enrica Morra, MD; Principal Investigator; Giovanni Martinelli, MD; Principal Investigator; Armando Santoro, MD; Principal Investigator; Andres Ferreri, MD; Principal Investigator; Massimo Federico, MD; Principal Investigator; Alberto Fragasso, MD; Principal Investigator; Maurizio Musso, MD; Principal Investigator; Savina Aversa, MD; Principal Investigator; Michele Spina, MD; Principal Investigator; Francesco Nobile, MD; Principal Investigator; Francesco Merli, MD; Principal Investigator; Alfonso M. D'Arco, MD; Principal Investigator; Umberto Vitolo, MD; Principal Investigator; Michele Baccarani, MD; Principal Investigator; Sergio Cortelazzo, MD; Principal Investigator; Giovanni Quarta, MD; Principal Investigator; Maria G Cabras, MD; Principal Investigator; Stefano Molica, MD; Principal Investigator; Luigi Rigacci, MD; Principal Investigator; Annunziata Manna, MD; Principal Investigator; Luca Baldini, MD; Principal Investigator; Fabrizio Pane, MD; Principal Investigator; Gianluca Gaidano, MD; Principal Investigator; Francesco Angrilli, MD; Principal Investigator; Francesco Caracciolo, MD; Principal Investigator; Maurizio Martelli, MD; Principal Investigator; Giuseppe Mineo, MD; Principal Investigator; Patrizio Mazza, MD; Principal Investigator; Teodoro Chisesi, MD; Principal Investigator; Won S Kim, MD PhD; Principal Investigator; Veronika Ballova, MD; Principal Investigator; Armando Lopez Guillermo, MD; Principal Investigator; Emanuele Zucca, PD; Principal Investigator; Silvia Montoto, MD; Principal Investigator; John Radford, MD; Principal Investigator; Peter Johnson, MD; Principal Investigator; Raul Gabus, MD; Principal Investigator