Status:
WITHDRAWN
Efficacy of Romiplostim in Treatment of SAA in Adults Previously Untreated With or Refractory to Immunosuppressive Therapy
Lead Sponsor:
Amgen
Conditions:
Severe Aplastic Anemia (SAA)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Romiplostim has been used in clinical trials for the treatment of severe and very severe aplastic anemia (SAA/vSAA) in Asian participants who are either previously untreated with immunosuppressive the...
Eligibility Criteria
Inclusion
- Age ≥ 18 years at time of enrollment
- Diagnosis of SAA/vSAA confirmed by blood, bone marrow, and cytogenetic studies
- An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1 at screening
- Arm 1 only: participant requires initial treatment for SAA/vSAA, no matched related donor is available for allogenic hematopoietic cell transplantation (HCT) and will begin IST with antithymocyte globulin and CsA
- Arm 2 only: refractory to at least one course of immunosuppressive therapy including horse or rabbit ATG; or ineligible for ATG treatment and refractory to CsA
Exclusion
- Diagnosed as having congenital aplastic anemia (AA) (Fanconi anemia, congenital dyskeratosis, etc)
- History of other malignancy within the past 5 years, with exceptions.
- Aplastic anemia with hemolytic paroxysmal nocturnal hemoglobinuria (PNH) (hemolytic predominant is defined as lactate dehydrogenase (LDH) \> 1.5 x the upper limit of site normal
- Arm 1 only: Previously treated with ATG, CsA, or Alemtuzumab
- Previously treated with PEGylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF), recombinant human thrombopoietin protein (TPO), romiplostim and other TPO-receptor agonist (eltrombopag, etc)
- Patients who are eligible for allogenic HCT and have an available matched related donor
Key Trial Info
Start Date :
August 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 25 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05323617
Start Date
August 31 2023
End Date
February 25 2025
Last Update
September 29 2023
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