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GMIHO Klinische Studien und Register

Pegfilgrastim Studie 2006-003682-14, Publikation, 01.10.2006 – 01.10.2013, Prof. Dr. med. Jochen Casper, Randomisierte Phase II-Studie zum Einsatz von Pegfilgrastim nach autologer Blutstammzelltransplantation

NITRO 2007-001262-32, Publikation, 01.06.2007 – 01.02.2013, Prof. Dr. med. Ulrich Gatzemeier, Randomized double-blind phase II study to compare nitroglycerin plus oral vinorelbine plus cisplatin with oral vinorelbine plus cisplatin alone in patients with stage IIIB/IV non- small cell lung cancer (NSCLC)

OSHO 76 2006-003683-54, Auswertung, 01.10.2007 – 31.12.2013, PD Dr. med. Herbert G. Sayer, Palifermin, Prospektive, offene, randomisierte, multizentrische Studie zur Effektivität von Palifermin in der Prophylaxe der Mukositis nach allogener Stammzelltransplantation mit myeloablativer Ganzkörperbestrahlung

Deutsches MDS-Register Rekrutierung, Prof. Dr. med. Ulrich Germing

LenaMain 2007-003945-33, Rekrutierung, 01.09.2008 – 30.06.2014, PD Dr. med. Guido Kobbe, Lenalidomide (Revlimid®), A randomised comparison of daily 25 mg versus 5 mg lenalidomide as maintenance therapy after high-dose therapy and autologous stem cell transplantation in patients with multiple myeloma

LEOMEX 2008-001405-41, Publikation, 01.01.2009 – 31.12.2013, Dr. med. Stefan Schönland, Lenalidomide (Revlimid®), A prospective single center trial of treatment with Lenalidomide-Melphalan-Dexamethasone in patients with AL amyloidosis

CHAMP 2009-014677-41, Auswertung, 30.06.2009 – 30.06.2014, Prof. Dr. med. Wolfgang Schütte, Panitumumab, An open-label, randomised, multicentre, phase II clinical study of panitumumab plus pemetrexed and cisplatin (Pem-CisP) versus PemCis in the first-line treatment of patients with stage IIIB or IV primary nonsquamous non-small cell lung cancer, with particular regard to the KRAS status

DSMM XIII 2008-004083-39, Rekrutierung, 01.07.2009 – 31.12.2020, Priv.-Doz. Dr. med. Christian Straka, Lenalidomide (Revlimid®), The combination of Lenalidomide and Dexamethasone with or without intensification by high-dose Melphalan in the treatment of multiple myeloma

RV-0279 MM_LEN_DEX_CY 2008-003829-16, Follow-Up, 01.07.2009 – 30.06.2014, PD Dr. med. Martin Kropff, MD, Lenalidomide (Revlimid®), Dexamethasone, Cyclophosphamide, An open, randomized clinical phase I/II trial to investigate maximum tolerated dose, efficacy, and safety of lenalidomide/low-dose dexamethasone in combination with continuous oral cyclophosphamide compared to lenalidomide/low-dose dexamethasone combined with single cyclophosphamidedoses IV in patients with relapsed/refractory multiple myeloma

LE-MON-5 2008-001866-10, Behandlung, 01.09.2009 – 30.06.2016, Prof. Dr. med. Ulrich Germing, Lenalidomide (Revlimid®), A multicenter, single-arm, open-label phase II study of the safety of lenalidomide monotherapy and markers for disease progression in patients with IPSS low- or intermediate-1 risk myelodysplastic syndromes (MDS) associated with an isolated deletion 5q cytogenetic abnormality (del 5q)

PURO 2009-015119-42, Abgeschlossen, 01.09.2009 – 01.10.2013, Prof. Dr. med. Kurt Miller, Panitumumab (GemCisP), An open-label, randomised, multicentre, phase II study to evaluate the efficacy of chemotherapy with gemcitabine and cisplatin in combination with the EGF receptor antibody panitumumab (GemCisP) versus GemCis in the first-line therapy of locally advanced/metastatic urothelial carcinoma in patients with wild-type HRAS

NeoRit 2009-016782-28, Rekrutierung, 01.12.2009 – 31.12.2015, Prof. Dr. med. Ralf-Dieter Hofheinz, Panitumumab (Vectibix®), Panitumumab in combination with radiotherapy in patients with locally advanced KRAS and BRAF wildtype rectal cancer

PASO 2009-018025-73, Follow-Up, 01.01.2010 – 31.03.2015, Dr. med. Friedrich Overkamp, Paclitaxel, Randomisierte Phase II Studie zum Vergleich der Paclitaxel Monotherapie vs. Paclitaxel plus Sorafenib in der Zweit- oder Drittlinienbehandlung von Patientinnen mit metastasiertem Brustkrebs (PASO)

PROVE 2010-018849-59, Rekrutierung, 01.04.2010 – 31.12.2016, Prof. Dr. med. Jalid Sehouli, Panitumumab (Vectibix®), An randomized phase II trial of standard carboplatin and pegylated liposomal doxorubicin with or without panitumumab in platinum-sensitive recurrent ovarian cancer

CRESCENDO 2010-018339-16, Follow-Up, 01.08.2010 – 31.03.2014, Prof. Dr. med. Andreas Hochhaus, Imatinib (Glivec®), A prospective, multicenter, phase IV study to assess the compliance in patients with Philadelphia chromosome-positive (Ph+) and/or BCR-ABL-positive chronic myelogenous leukemia (CML) under long-term imatinib therapy (Compliance: Role Emerges for Success in CML: Evaluation aND Optimisation)

R2-DHAP 2009-010824-25, Rekrutierung, 01.08.2010 – 31.12.2015, Prof. Dr. med. Bertram Glaß, Lenalidomide (Revlimid®), Open-label, Multicenter Phase I/II Study: Salvage Therapy of Progressive and Relapsed Aggressive Non-Hodgkin-Lymphoma by Combination of Lenalidomide (Revlimid®) with Rituximab, Dexamethason, High-dose ARA-C and Cisplatinum

SKIP 2010-019564-37, Abgeschlossen, 01.12.2010 – 31.12.2013, Prof. Dr. med. Hanno Riess, Doxycycline, Panitumumab, A double blind placebo controlled multicenter Phase II Trial of Skin Toxicity Treatment in Subjects with advanced or metastatic colorectal carcinoma receiving Panitumumab

Napoleon-Register Vorbereitung, 31.12.2012 – 30.11.2017, Prof. Dr. med. Uwe Platzbecker, National recommendations for the risk-adapted treatment of acute promyelocytic leukemia (APL) APL-Registry 2013

ROMDS 2012-003436-22, Rekrutierung, 01.03.2013 – 31.12.2018, Prof. Dr. med. Ulrich Germing, Romiplosti, 5-Azacitidine, A Phase I Study of Romidepsin Additional to 5-Azacitidine in Higher-risk MDS after Insufficient Response to 5-Azacitidine Monotherapy

EUROPA 2013-004328-12, Vorbereitung, 30.11.2013 – 31.12.2018, Prof. Dr. med. Uwe Platzbecker, Romiplostim, Prospective validation of a predictive model of response to romiplostim in patients with IPSS low or intermediate-1 risk myelodysplastic syndrome (MDS) and thrombocytopenia - the EUROPEtrial by the GFM and GMDSSG

T-RACE II 2013-002564-69, Vorbereitung, 01.12.2013 – 31.12.2015, Prof. Dr. med. Jalid Sehouli, Romiplostim, Double-blind, placebo-controlled multicenter phase II trial to evaluate the efficacy and safety of romiplostim for the treatment of chemotherapy-induced thrombocytopenia in subjects with relapsed ovarian cancer (2nd and 3rd line)

Diese Forschungsstudien wurden unterstützt durch die pharmazeutische Industrie: Amgen, Bayer Vital, BioVitrum, Celgene, Chugai, Novartis, Pierre Fabre, Teva