Study of Efficacy and Safety of Eltrombopag in Lower-risk MDS Patients With Platelet Transfusion … (NCT04797000) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study of Efficacy and Safety of Eltrombopag in Lower-risk MDS Patients With Platelet Transfusion Dependence
Japan36 participantsStarted 2021-05-25
Plain-language summary
This study is designed to evaluate the efficacy and safety of eltrombopag monotherapy in Japanese adult patients with platelet transfusion-dependent lower-risk Myelodysplastic syndromes (LR-MDS).
Who can participate
Age range20 Years – 100 Years
SexALL
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Inclusion Criteria:
* Patients diagnosed with MDS according to the WHO classification revised 4th edition by investigator assessment with one of the following prognostic risk categories, based on the International
Prognostic Scoring System (IPSS-R):
* very low (0-1.5)
* low (2-3)
* intermediate risks (3.5-4.5) All following criteria for prognostic variables per IPSS-R should be met.
* Bone marrow blast \< 5% (per both investigator's assessment and central review)
* Cytogenetic very good, good or intermediate risk corresponding to IPSS-R
* Platelet transfusion dependence
* Refractory, intolerant to, or ineligible for MDS treatments
* Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0 or 1
Exclusion Criteria:
* Patients with a history of prior administration of eltrombopag, romiplostim, or other TPO-RA
* Therapy-related MDS per WHO classification revised 4th edition
* MDS/myeloproliferative neoplasms including chronic myelomonocytic leukaemia per the WHO classification revised 4th edition
* MDS with excess blasts (EB) per WHO classification revised 4th edition
* Known history of IPSS-R high or very high risk MDS
* Currently receiving treatments for MDS (e.g., HMA, cyclosporine A (CsA) or lenalidomide). Supportive treatment with erythropoiesis-stimulating agents (ESAs) or erythroid mutation agent in anemic patients or granulocyte-colony stimulating factor (G-CSF) in patients with severe neutropenia and recurrent infections is allowed if at stable dos…
What they're measuring
1
Percentage of participants who achieve platelet transfusion independence at Week 24