| 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 