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Brief Title: Trial for Patients With Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma
Official Title: Randomized Phase II Trial On Primary Chemotherapy With High-Dose Methotrexate And High-Dose Cytarabine With Or Without Thiotepa, And With Or Without Rituximab, Followed By Brain Irradiation Vs. High-Dose Chemotherapy Supported By Autologous Stem Cells Transplantation For Immunocompetent Patients With Newly Diagnosed Primary CNS Lymphoma
Study ID: NCT01011920
Brief Summary: This is a multicenter open label randomized phase II trial. Enrolled Primary Central Nervous System Lymphoma (PCNSL) patients will be stratified according to the IELSG score and randomized to receive one of the follows as primary chemotherapy: * Arm A: Methotrexate (MTX) + Cytarabine (Ara-C) * Arm B: MTX + Ara-C + rituximab * Arm C: MTX + Ara-C + rituximab + thiotepa. Chemotherapy will be administered every three weeks. The maximum number of chemotherapy induction courses will be 4. Patients in Stable Disease (SD) or better after two courses will receive two more courses of the same primary chemotherapy regimen. Stem-cells harvest will be performed in the three arms after the second course. After 4 courses response assessment will be performed. Patients who will not achieve SD or better after the 4th course, as well as those who will experience Progressive Disease (PD) at any time and those who will not achieve a sufficient stem cell harvest, will receive Whole Brain Radiation Therapy (WBRT) 36-40 Gy +/- tumor bed boost of 9 Gy. Patients who will achieve SD or better after the 4th course will be stratified according to objective response to primary chemotherapy and to primary chemotherapy regimen and randomly allocated to receive as consolidation therapy one of the follows: * Arm D: WBRT 36 Gy +/- boost 9 Gy * Arm E: Carmustine (BCNU) + Thiotepa + Autologous Peripheral Blood Stem Cell Transplant (APBSCT) Patients in Complete Response (CR) after WBRT or APBSCT will remain in follow-up. Patients who will not achieve a CR after WBRT will be managed according to physician's preferences. Patients who will not achieve a CR after APBSCT will be referred to WBRT.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University Hospital, Aachen, , Germany
Universitätsklinikum Erlangen, Erlangen, , Germany
"Klinik fßr Hämatologie Universitätsklinikum Essen", Essen, , Germany
Uniklinik Freiburg, Freiburg, , Germany
Universitätskrankenhaus Hamburg-Eppendorf, Hamburg, , Germany
Friedrich Schiller Universitaet Jena, Jena, , Germany
Johannes Gutenberg Universität Mainz, Mainz, , Germany
Technische Universität in Mßnchen, Mßnchen, , Germany
Universitätsklinikum Ulm, Ulm, , Germany
A.O. SS. Antonio e Biagio e Cesare Arrigo, Alessandria, , Italy
Spedali Civili, Brescia, , Italy
San Raffaele H Scientific Institute, Milan, , Italy
Ospedale Umberto I, Nocera Inferiore, , Italy
Ospedale Civile S.Spirito, Pescara, , Italy
Arcispedale Santa Maria Nuova, Reggio Emilia, , Italy
Istituto Nazionale dei Tumori Regina Elena, Roma, , Italy
UniversitĂ degli Studi La Sapienza, Roma, , Italy
Humanitas, Rozzano, , Italy
Ospedale Maggiore S. Giovanni Battista, Torino, , Italy
Policlinico G.B. Rossi, Verona, , Italy
IOSI - Oncology Institute of Southern Switzerland, Bellinzona, , Switzerland
Nottingham City Hospital, Nottingham, , United Kingdom
Queen's Hospital, Romford, , United Kingdom
Name: AndrĂŠs JM Ferreri, MD
Affiliation: San Raffaele H Scientific Institute, Milan, Italy
Role: STUDY_CHAIR
Name: Gerald Illerhaus, MD
Affiliation: University Medical Center, Freiburg, Germany
Role: STUDY_CHAIR
Name: Emanuele Zucca, MD
Affiliation: IOSI, Bellinzona, Switzerland
Role: PRINCIPAL_INVESTIGATOR