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Cancer trials
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Trial details

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

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Trial short name: Geron MDS Imerge

Official title: 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

Principal Investigator:

Cancer type: Blood Related
Cancer location: Myelodysplastic Syndromes
Disease stage: Early Cancer
Trial phase: Phase 2, Phase 3
Intervention: Drug: Imetelstat

Registration #: NCT02598661

Trial description:
The purpose of this study is to look at the effectiveness of a drug called imetelstat in patients with myelodysplastic syndromes (MDS). Patients with MDS who have had treatment and meet a certain criteria may be able to participate. There will be two groups of patients participating in the study; group one will receive a drug called imetelstat while the other group will receive a placebo. Patients participating will not know which treatment they are receiving and will be randomly allocated to one group or the other.

Inclusion Criteria: • 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 Exclusion Criteria: • 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 • 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)