docKompetenznetz "Akute und chronische Leukämien"
download 
Plainte Transcription
Kompetenznetz "Akute und chronische Leukämien"
Kompetenznetz "Akute und chronische Leukämien" KURZPROTOKOLL MDS Lenalidomide III Öffentlicher Titel This is a study of oral lenalidomide administered in adult subjects with Myelodysplastic syndromes (MDS) Kurztitel MDS Lenalidomide III Studiennummer KN/ELN LN_GFMGRO_2006_221 Studiengruppe GFM group Studienart multizentrisch Studienphase Phase II Erkrankung Myelodysplastisches Syndrom (MDS) - Intermediär II und Hochrisiko Leukämiestadium . Haupt- und Nebenzielkriterien - Evaluate response to lenalidomide (according to IWG criteria) in adult MDS with deletion (del) 5q[31] cytogenetic abnormality and intermediate-2 or high-risk (International Prognostic Scoring System [IPSS]) MDS (Hauptzielkriterium) - Evaluate duration of response, progression to AML, survival and safety of lenalidomide in subjects with intermediate-2-risk or high risk MDS associated with a del 5q [31] - Age 18 years at the time of signing the informed consent form - Must understand and voluntarily sign an informed consent form - Must be able to adhere to the study visit schedule and other protocol requirements - Concurrent corticosteroids used for medical conditions other than MDS allowed provided subject is on a stable or decreasing dose for 1 week prior to study entry - Prior thalidomide allowed - Documented diagnosis of MDS (RA, RARS, RAEB, RAEB-T and CMML with WBC less than 13,000/mm3 according to FAB classification) that meets IPSS criteria for intermediate-2 or high-risk disease and has an associated Del 5q [31] (the deleted chromosomal region must include 5q [31]), with or without additional cytogenetic abnormalities - Women of childbearing potential (WCBP?) must have a negative serum or urine pregnancy test 10 – 14 days and again within 24 hours prior to starting study drug. In addition, sexually active WCBP must agree to continued abstinence from heterosexual intercourse or use 2 adequate contraceptive methods, started at least one month prior to onset of treatment, and continued during the whole study until the first menstruations that follow treatment discontinuation (See appendix for acceptable methods). WCBP must agree to have pregnancy tests weekly for the first 4 weeks, then every 4 weeks if menstruation is regular or every 2 weeks if menstruation is irregular,while on study drug. Negativity of the test should be checked before restarting treatment - Platelet count greater than 25,000u/L - Absolute Neutrophil count greater than 500u/L - (A woman of child-bearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e., who has had menses at any time in the preceding 24 consecutive months) - Pregnant or lactating females - Prior therapy with lenalidomide - Proliferative (WBC 13,000/mL) chronic myelomonocytic leukemia (CMML) - Prior grade-2 NCI CTCAE (v 3.0) allergic reaction to thalidomide - Prior desquamating (blistering) rash while taking thalidomide Einschlusskriterien Ausschlusskriterien © Informationszentrum im Kompetenznetz Leukämien | Deutsches Leukämie Studienregister Ohne Gewähr für Richtigkeit oder Vollständigkeit, www.kompetenznetz-leukaemie.de | www.studienregister-online.de Stand: 13.01.2017; Seite 1 von 4 Kompetenznetz "Akute und chronische Leukämien" KURZPROTOKOLL MDS Lenalidomide III - Prior history of malignancy other than MDS (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been free of disease for 3 years - Use of cytotoxic chemotherapeutic agents or experimental agents (agents that are not commercially available) for the treatment of MDS within 28 days - Less than 6 months since prior allogeneic bone marrow transplantation - Less than 3 months since prior autologous bone marrow or stem cell transplantation - Recombinant human erythropoietin (rHuEPO) therapy received within 28 days - Use of androgens other than for treating hypogonadism - Known HIV-1 positivity - Any serious medical condition or psychiatric illness that will prevent the subject from signing the informed consent form or will place the subject at unacceptable risk if he or she participates in the study - Any of the following laboratory abnormalities: - Serum creatinine > 2.0 mg/dL (177 mmol/L) - Serum aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase - (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase (SGPT) > 3.0 x upper limit of normal (ULN) - Serum total bilirubin > 1.5 mg/dL - Subjects with grade-2 neuropathy - Clinically significant anemia due to iron, B12, or folate deficiencies, or autoimmune or hereditary hemolysis or gastrointestinal bleeding (the subject must have a marrow aspirate that is evaluable for storage iron) Alter >= 18 Jahre Status Geschlossen Beginn der Rekrutierung 17.11.2006 Rekrutierende Länder Frankreich Belgien Studienleiter/in Fenaux, Dr. med., Pierre Hopital Avicenne Sercice d'Hematologie Tel: +33 (0)148 957050 E-Mail: [email protected] Kontaktperson f. wissenschaftl. Anfragen (WHO) Ades, Dr. med., Lionel Hopital Avicenne Service d’Hematologie 125 rue de Stalingrad 93009 Bobigny Tel: +33 (0)1 48 95 70 55 Fax: +33 (0)1 48 70 58/59 E-Mail: [email protected] Ansprechpartner Studienleiter Dombret, Prof. Dr. med., Hervé Tel: +33 (0)1 53722102 E-Mail: [email protected] Studienleiter Fenaux, Dr. med., Pierre Tel: +33 (0)148 957050 E-Mail: [email protected] © Informationszentrum im Kompetenznetz Leukämien | Deutsches Leukämie Studienregister Ohne Gewähr für Richtigkeit oder Vollständigkeit, www.kompetenznetz-leukaemie.de | www.studienregister-online.de Stand: 13.01.2017; Seite 2 von 4 Kompetenznetz "Akute und chronische Leukämien" KURZPROTOKOLL MDS Lenalidomide III Studienleiter Stamatoullas, Dr. med., Aspasia Tel: +33 (0)2 32082288 E-Mail: [email protected] Studienleiter Quesnel, Dr. med., Bruno Tel: +33 (0)329 446640 E-Mail: [email protected] Studienleiter Hunault-Berger, Dr. med., Mathilde Tel: +33 (0)241 354475 E-Mail: [email protected] Studienleiter Guerci-Bresler, Dr. med., Agnès Tel: +33 (0)383 153281 E-Mail: [email protected] Studienleiter Beyne-Rauzy, Dr. med., Odile Tel: +33 (0)561 779679 E-Mail: [email protected] Studienleiter Legros, Dr. med., Laurence Tel: +33 (0)4920 35844 E-Mail: [email protected] Studienleiter Dreyfus, Dr. med., Francois E-Mail: [email protected] Studienleiter Guilhot, Dr. med., Francois Tel: +33 (0)549 444201 E-Mail: [email protected] Studienleiter Vey, Dr. med., Nobert Tel: +33 (0)431 223695 E-Mail: [email protected] Studienleiter Delaunay, Dr. med., Jacques Tel: +33 (0)2 40083271 E-Mail: [email protected] Studienleiter Lamy, Dr. med., Thierry Tel: +33 (0)299 284291 E-Mail: [email protected] Studienleiter Bordessoule, Dr. med., Dominique Tel: +33 (0)5 55056642 E-Mail: [email protected] Studienleiter Ravoet, Dr. med., Christophe Tel: +32 (0)64 233984 E-Mail: [email protected] Sponsoren Celgene © Informationszentrum im Kompetenznetz Leukämien | Deutsches Leukämie Studienregister Ohne Gewähr für Richtigkeit oder Vollständigkeit, www.kompetenznetz-leukaemie.de | www.studienregister-online.de Stand: 13.01.2017; Seite 3 von 4 Kompetenznetz "Akute und chronische Leukämien" KURZPROTOKOLL MDS Lenalidomide III Groupe Francophone des Myélodysplasie Registrierung in anderen Studienregistern ClinicalTrials.govNCT00424229 (primäres Register) © Informationszentrum im Kompetenznetz Leukämien | Deutsches Leukämie Studienregister Ohne Gewähr für Richtigkeit oder Vollständigkeit, www.kompetenznetz-leukaemie.de | www.studienregister-online.de Stand: 13.01.2017; Seite 4 von 4
