KURZPROTOKOLL STORM Öffentlicher Titel Phase II Studie zur Behandlung mit Temsirolimus in Kombination zu Rituximab und DHAP in Patienten mit DLBCL Wissenschaftl. Titel A phase II trial to evaluate the safety, feasibility and efficacy of a salvage therapy consisting of the mTOR inhibitor Temsirolimus (Torisel™) added to the standard therapy of Rituximab and DHAP for the treatment of patients with relapsed or refractory diffuse large cell B-Cell lymphoma – the STORM trial Kurztitel STORM Studienart multizentrisch, prospektiv, Therapiestudie, offen/unverblindet, einarmig, Investigator Initiated Trial (IIT) Studienphase Phase II Erkrankung HAEMA: NHL, hoch-maligne: Rezidiviert/refraktär Einschlusskriterien - Patients with histologically proven diagnosis of diffuse large cell B-cell lymphoma (DLBCL) according to the World Health Organization classification. - Documented relapse or progression following at least one treatment but a maximum of 2 prior treatments. Prior treatment must have included at least 3 cycles of anthracycline containing chemotherapy (e.g. CHOP-like) - Any of the following: at least 1 measurable tumor mass (>1.5 cm x >1.0 cm), involvement of any organ or bone marrow infiltration - Subjects 18 years or older - Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study - Adequate bone marrow reserve: Platelets of at least 75000/l, absolute neutrophil count at least 1500/l, Hemoglobin of at least 10 g/dl - Alanine aminotransferase (ALT) < 2.5 x upper limit of normal (ULN); Aspartate aminotransferase (AST) < 2.5 x ULN - Total bilirubin < 1.5 x ULN except chronic hepatic conditions leading to bilirubin increase but not interfering therapy, e. g. Gilbert´s Syndrom - Calculated creatinine clearance (MDRD) > 70 mL/min - Eastern Cooperative Oncology Group [ECOG] performance Status < 3 - Female subject must be postmenopausal (for at least 6 months), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, doublebarrier method, contraceptive patch, male partner sterilization) before entry and throughout the study. Practicing an effective method of birth control as described above has to be continued for at least 12 month after end of treatment. Female subjects of childbearing age must have a negative serum ß-hCG pregnancy test at screening - Male subject, if sexual active and with a sexual partner of childbearing age must be practicing an effective method of contraception throughout the study (e.g. surgical sterilization or double-barrier method. Prescription oral contraceptives, contraceptive injections, intrauterine device, surgically sterilization or contraceptive patch in female sexual partners). Practicing an effective method of birth control as described above has to be continued for at least 12 month after end of treatment - Pregnancy or breast feeding women - Lymphoma other than DLBCL - Severe concomitant disease (e.g. uncontrolled arterial hypertension, heart failure (NYHA III-IV), uncontrolled diabetes mellitus, pulmonary fibrosis, uncontrolled hyperlipoproteinemia) - Active uncontrolled infections including HIV-positivity, active Hep B or C Ausschlusskriterien © Universitäres Centrum für Tumorerkrankungen (UCT) am Universitätsklinikum Frankfurt Ohne Gewähr für Richtigkeit oder Vollständigkeit, www.uct-frankfurt.de Stand: 21.11.2016; Seite 1 von 2 KURZPROTOKOLL STORM - Mental status precluding patient’s compliance - Prior treatment with Temsirolimus - Known CD20 negativity - Patients refractory to DHAP in a prior treatment line - Prior autologous or allogeneic stem cell or bone marrow transplantation - Peripheral neuropathy or neuropathic pain of Grade 2 or worse - Diagnosed or treated for a malignancy other than NHL except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, DCIS of the breast, or other solid tumors curatively treated with no evidence of disease for >5 years - Concurrent treatment with another investigational agent during the conduct of the trial. Concurrent participation in non-treatment studies is not excluded - Known intolerance to Dexamethasone, Sirolimus or derivates, Cytarabine, Cisplatine or Rituximab Known intolerance to any other ingredients contained in trial therapy. Known intolerance to pre-treatment or premedication in this trial (e. g. Prednisolone, Allopurinol, H1-Blocker, Paracetamole) - Known impairment of hearing capacity Alter 18 Jahre und älter Status Rekrutierung beendet Beginn der Rekrutierung 05.02.2014 Prüfzentren Universitätsklinikum Frankfurt Medizinische Klinik II, Hämatologie/Onkologie Theodor-Stern-Kai 7 60590 Frankfurt am Main Christa Richter Tel: 069 6301-6663 Fax: 069 6301-7463 [email protected] Weitere Ansprechpartner Leiter der klinischen Prüfung Universitätsklinikum Heidelberg PD Dr. med. Mathias Witzens-Harig Im Neuenheimer Feld 672 69120 Heidelberg Tel: 06221 / 5631341 Fax: 06221 / 5633610 [email protected] Sponsoren Universitätsklinikum Freiburg Förderer Universitätsklinik Heidelberg Registrierung in anderen Studienregistern EUDRACT 2011-001491-20 Links Studiendokumente zum Download © Universitäres Centrum für Tumorerkrankungen (UCT) am Universitätsklinikum Frankfurt Ohne Gewähr für Richtigkeit oder Vollständigkeit, www.uct-frankfurt.de Stand: 21.11.2016; Seite 2 von 2
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