Deutsches Leukämie-Studienregister
Studie: 63935937MDS3001

Kurzübersicht
Öffentlicher Titel Phase II/III Studie zu Imetelstat bei myelodysplastischen Syndromen mit niedrigem oder mittlerem IPSS-Risiko
Wissenschaftl. Titel A Study to Evaluate Imetelstat (GRN163L) in Transfusion-Dependent Subjects with IPSS Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) that is Relapsed/Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment
Kurztitel 63935937MDS3001
Studiennummer KN/ELN LN_NN_2020_697
Studiengruppe NN
Studienart randomisiert, prospektiv, doppelblind
Studienphase Phase II/III
Erkrankung Myelodysplastisches Syndrom (MDS) - Niedrigrisko und Intermediär I
Einschlusskriterien
  • Man or woman greater than or equal to (>=) 18 years of age
  • In Part 1, diagnosis of myelodysplastic syndrome (MDS) according to World Health Organization (WHO) criteria
  • International Prognostic Scoring System (IPSS) low Risk or intermediate-1 risk MDS
  • Red blood cell (RBC) transfusion dependent, defined as requiring at least 4 RBC units transfused over an 8-week period during the 16 weeks prior to Study Entry; pre-transfusion hemoglobin (Hb) should be less than or equal to 9.0 gram per deciliter (g/dL) to count towards the 4 units total
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
Ausschlusskriterien
  • Participant has known allergies, hypersensitivity, or intolerance to imetelstat or its excipients
  • Participant has received an investigational drug or used an invasive investigational medical device within 30 days prior to Study Entry or is currently enrolled in an investigational study
  • Prior treatment with imetelstat
  • Have received corticosteroids greater than (>) 30 milligram per day (mg/day) prednisone or equivalent, or growth factor treatment within 4 weeks prior to study entry
  • a) Prior treatment with a hypomethylating agent (example [eg], azacitidine, decitabine); b) Prior treatment with lenalidomide; c) Has received an erythropoiesis-stimulating agent (ESA) or any chemotherapy, immunomodulatory, or immunosuppressive therapy within 4 weeks prior to study entry (8 weeks for long-acting ESAs)
Alter >= 18 Jahre
Status Aktiv
Beginn der Rekrutierung 10.03.2020
Kurzprotokoll Kurzprotokoll
Sponsoren Geron Corporation
Registrierung in anderen Studienregistern ClinicalTrials.gov NCT02598661
European Clinical Trials Database - EUDRACT 2015‐002874‐19
erstellt 19.11.2020 Zenawit Krüger
geändert 23.12.2020 Student Studienregister
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