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Spots Global Cancer Trial Database for Trial for Patients With Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma

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Trial Identification

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

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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