Study of Pralatrexate Versus Observation Following CHOP-based Chemotherapy in Previously Undiagnosed Peripheral T-cell Lymphoma Patients

Recruiting

• Source

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  Public Title	Study of Pralatrexate Versus Observation Following CHOP-based Chemotherapy in Previously Undiagnosed Peripheral T-cell Lymphoma Patients
  Acronym	Sorry, not currently available
  Source of Record URL	http://clinicaltrials.gov/show/NCT01420679

• Trial

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  Health Condition(s) or Problem	Peripheral T-cell Lymphoma
  Lay 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. (from ClinicalTrials.gov)
  Who can enter the trial	Inclusion Criteria: - Patient has one of the following peripheral T-cell lymphoma (PTCL) subtypes confirmed by an independent central pathology reviewer, using the Revised European American Lymphoma World Health Organization disease classification: - T/natural killer (NK)-cell leukemia/lymphoma - Adult T-cell lymphoma (TCL)/leukemia (human T-cell leukemia virus 1+) - Angioimmunoblastic TCL - Anaplastic large cell lymphoma (ALCL), primary systemic type, excluding anaplastic lymphoma kinase positive (ALK+) with International Prognostic Index (IPI) score less than 2 at initial diagnosis and complete response (CR) after CHOP-based therapy - PTCL-unspecified - Enteropathy-type intestinal lymphoma - Hepatosplenic TCL - Subcutaneous panniculitis TCL - Transformed mycosis fungoides (tMF) - Extranodal T/NK-cell lymphoma nasal or nasal type - Primary cutaneous gamma-delta TCL - Primary cutaneous CD8+ aggressive epidermic cytotoxic TCL - Documented completion of at least 6 cycles of CHOP-based therapy: - CHOP 21 - CHOP 14 - CHOP + etoposide - Other CHOP variants: substitution allowed for 1 component with a drug of the same mechanism of action. Additional components, except alemtuzumab, are allowed. Rituximab may be added if not given within 3 cycles of randomization. - Patient has achieved CR or partial response (PR) per per investigator's assessment following completion of CHOP-based therapy and has had radiological assessment within 21 days prior to randomization. - Eastern Cooperative Oncology Group performance status less than or equal to 2. - Adequate blood, liver, and kidney function as defined by laboratory tests. - Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to randomization and agree to practice a medically acceptable contraceptive regimen from study treatment initiation until at least 30 days after the last administration of pralatrexate. - Men who are sexually active, including those with a pregnant partner, must agree to practice a medically acceptable barrier method contraceptive regimen (eg, condoms) while receiving pralatrexate and for 90 days after the last administration of pralatrexate. - Has given written informed consent. Exclusion Criteria: - Patient has: - Precursor T/NK neoplasms - ALCL (ALK+) with IPI score less than 2 at initial diagnosis and CR after CHOP-based therapy - T cell prolymphocytic leukemia - T cell large granular lymphocytic leukemia - Mycosis fungoides, except tMF - Sézary syndrome - Primary cutaneous CD30+ disorders: ALCL and lymphomatoid papulosis - If there is a history of prior malignancies other than those below, must be disease free for at least 5 years. Patients with malignancies listed below less than 5 years before study entry may be enrolled if they have received treatment resulting in complete resolution of the cancer and have no clinical, radiologic, or laboratory evidence of active/recurrent disease. - non-melanoma skin cancer - carcinoma in situ of the cervix - localized prostate cancer - localized thyroid cancer - Receipt of prior chemotherapy (CT)
  Who cannot enter the trial	Inclusion Criteria: - Patient has one of the following peripheral T-cell lymphoma (PTCL) subtypes confirmed by an independent central pathology reviewer, using the Revised European American Lymphoma World Health Organization disease classification: - T/natural killer (NK)-cell leukemia/lymphoma - Adult T-cell lymphoma (TCL)/leukemia (human T-cell leukemia virus 1+) - Angioimmunoblastic TCL - Anaplastic large cell lymphoma (ALCL), primary systemic type, excluding anaplastic lymphoma kinase positive (ALK+) with International Prognostic Index (IPI) score less than 2 at initial diagnosis and complete response (CR) after CHOP-based therapy - PTCL-unspecified - Enteropathy-type intestinal lymphoma - Hepatosplenic TCL - Subcutaneous panniculitis TCL - Transformed mycosis fungoides (tMF) - Extranodal T/NK-cell lymphoma nasal or nasal type - Primary cutaneous gamma-delta TCL - Primary cutaneous CD8+ aggressive epidermic cytotoxic TCL - Documented completion of at least 6 cycles of CHOP-based therapy: - CHOP 21 - CHOP 14 - CHOP + etoposide - Other CHOP variants: substitution allowed for 1 component with a drug of the same mechanism of action. Additional components, except alemtuzumab, are allowed. Rituximab may be added if not given within 3 cycles of randomization. - Patient has achieved CR or partial response (PR) per per investigator's assessment following completion of CHOP-based therapy and has had radiological assessment within 21 days prior to randomization. - Eastern Cooperative Oncology Group performance status less than or equal to 2. - Adequate blood, liver, and kidney function as defined by laboratory tests. - Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to randomization and agree to practice a medically acceptable contraceptive regimen from study treatment initiation until at least 30 days after the last administration of pralatrexate. - Men who are sexually active, including those with a pregnant partner, must agree to practice a medically acceptable barrier method contraceptive regimen (eg, condoms) while receiving pralatrexate and for 90 days after the last administration of pralatrexate. - Has given written informed consent. Exclusion Criteria: - Patient has: - Precursor T/NK neoplasms - ALCL (ALK+) with IPI score less than 2 at initial diagnosis and CR after CHOP-based therapy - T cell prolymphocytic leukemia - T cell large granular lymphocytic leukemia - Mycosis fungoides, except tMF - Sézary syndrome - Primary cutaneous CD30+ disorders: ALCL and lymphomatoid papulosis - If there is a history of prior malignancies other than those below, must be disease free for at least 5 years. Patients with malignancies listed below less than 5 years before study entry may be enrolled if they have received treatment resulting in complete resolution of the cancer and have no clinical, radiologic, or laboratory evidence of active/recurrent disease. - non-melanoma skin cancer - carcinoma in situ of the cervix - localized prostate cancer - localized thyroid cancer - Receipt of prior chemotherapy (CT)
  What will happen	Drug; Pralatrexate Injection; Intravenous (IV) push administration over 30 seconds to 5 minutes via a patent IV line containing normal saline (0.9% sodium chloride). Initial dose: 30 mg/m2 Administered weekly for 3 weeks of a 4-week cycle until criteria for discontinuation per the protocol are met.; Pralatrexate; FOLOTYN; PDX; Pralatrexate; (RS)-10-propargyl-10-deazaaminopterin
  Primary aim	Progression-free Survival (PFS); Overall Survival (OS)
  Secondary Aim	Objective Response to Pralatrexate versus Observation; Assessed at 8 weeks (+/-1 wk) then every 12 weeks (+/-1 wk) through 3 years, then every 24 weeks (+/-4 wks) until progression of disease (PD) or up to 7 years post-randomization; No
  Participant Information Sheet	Sorry, not currently available
  Website	Sorry, not currently available
  Recruitment Status	Recruiting
  Nation	England, Scotland, Northern Ireland, Wales
  Location	Plymouth, West Bromwich, Glasgow, Belfast, Cardiff, Eastbourne, Edinburgh, Harrow, Liverpool, Northwood, Warwick

• Contact

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  Contact for Public Queries

  Lacey Chance 1-888-255-6702 lchance@allos.com Michael Saunders, MD Study Director Allos Therapeutics

  Contact for Scientific Queries

  Farrukh Awan, MD; Principal Investigator; Craig Gordon, MD; Principal Investigator; Steven Horwitz, MD; Principal Investigator; Jia Ruan, MD; Principal Investigator; Seema Naik, MD; Principal Investigator; Simon Durrant, MD; Principal Investigator; Ian Lewis; Principal Investigator; Bryone Kuss, MD; Principal Investigator; Anna Johnston, MD; Principal Investigator; Stephen Opat, MD; Principal Investigator; Constantine Tam, MD; Principal Investigator; John Catalano, MD; Principal Investigator; H. Miles Prince; Principal Investigator; Michael Leahy, MD; Principal Investigator; Paul Cannell, MD; Principal Investigator; Werner Linkesch, MD; Principal Investigator; Achiel Van Hoof, MD; Principal Investigator; Delphine Pranger, MD; Principal Investigator; Fritz Offner, MD; Principal Investigator; Anne Sonet, MD; Principal Investigator; Maura Romeo, MD; Principal Investigator; Adriana Scheliga, MD; Principal Investigator; Laura Fogliatto, MD; Principal Investigator; Fabio Andre Franke, MD; Principal Investigator; Nelson Castro, MD; Principal Investigator; Bernardo Garicochea, MD; Principal Investigator; Tadeu Paiva Júnior, Jr., MD; Principal Investigator; José Salvador, MD; Principal Investigator; Eduardo Johnson Buargue, MD; Principal Investigator; Sergio Lunardon Padilha, MD; Principal Investigator; Paulo Mora, MD; Principal Investigator; Juliana Pereira, MD; Principal Investigator; Rodrigo Silva Santucci, MD; Principal Investigator; Nikolay Tzvetkov, MD; Principal Investigator; Dontcho Peytchev, MD; Principal Investigator; Liana Gercheva, MD; Principal Investigator; Morel Rubinger, MD; Principal Investigator; Matthew Cheung, MD; Principal Investigator; Inès Chamakhi, MD; Principal Investigator; Karina Peña Negrete, MD; Principal Investigator; Kenny Mauricio Galvez, MD; Principal Investigator; Jiri Mayer, MD; Principal Investigator; David Belada, MD; Principal Investigator; Jan Novak, MD; Principal Investigator; Marek Trneny, MD; Principal Investigator; Adrian Tempescul, MD; Principal Investigator; Krimo Bouabdallah, MD; Principal Investigator; Bertrand Coiffier, MD; Principal Investigator; Andreas Hüttmann, MD; Principal Investigator; Paul La Rosée, PD; Principal Investigator; Johannes Atta, MD; Principal Investigator; Kwong Yok Lam, MD; Principal Investigator; Zoltan Gasztonyi, MD; Principal Investigator; Zsolt Nagy, MD; Principal Investigator; Lidia Sreter, MD; Principal Investigator; Elisabeth Vandenberghe, MD; Principal Investigator; Rosa Ruchlemer, MD; Principal Investigator; Dina Ben Yehuda, MD; Principal Investigator; Ofer Shpilberg, MD; Principal Investigator; Ilya Kirgner, MD; Principal Investigator; Arnon Nagler, MD; Principal Investigator; Pier Paolo Fattori, MD; Principal Investigator; Pier Luigi Zinzani, Prof; Principal Investigator; Giuseppe Rossi, MD; Principal Investigator; Massimo Federico, MD; Principal Investigator; Alfonso Zaccaria, MD; Principal Investigator; Giuseppe Leone, MD; Principal Investigator; Maurizio Martelli, MD; Principal Investigator; Alberto Fabbri, MD; Principal Investigator; Joo Seop Chung; Principal Investigator; Hyeon Seok Eom, MD; Principal Investigator; Jong-Seok Lee, MD; Principal Investigator; Je-Jung Lee, MD; Principal Investigator; June-Won Cheong, MD; Principal Investigator; Sung-Soo Yoon, MD; Principal Investigator; Won Seog Kim, MD; Principal Investigator; Byung Soo Kim, MD; Principal Investigator; Jung Hee Lee, MD; Principal Investigator; Cheol Won Suh, MD; Principal Investigator; Benjamin Rubio-Jurado, MD; Principal Investigator; David Gomez Almaguer, MD; Principal Investigator; Valentin Lozano Zavaleta, MD; Principal Investigator; Leanne Berkahn, MD; Principal Investigator; Andrew Butler, MD; Principal Investigator; David Simpson, MD; Principal Investigator; Samma Issa, MD; Principal Investigator; Mirna Chumbes Sipan, MD; Principal Investigator; Willy Quiñones, MD; Principal Investigator; Jorge Fernando Salas Sánchez; Principal Investigator; Jan Walewski, MD; Principal Investigat