Status:
NOT_YET_RECRUITING
Ropustin for Refractory Aplastic Anaemia After Radiotherapy - a Single-centre, Prospective, Open-label, Single-arm Study
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Aplastic Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
To investigate the efficacy and safety of roprostin in the treatment of refractory AA after radiotherapy.
Eligibility Criteria
Inclusion
- Age ≥18 years, male or female.
- Diagnosis consistent with refractory AA after radiotherapy. refractory is defined as patients who have failed to respond to at least an adequate amount of supportive therapy, cyclosporine or povidone TPO-RA for 3 months .
- At least one of the following conditions was met at enrolment: haemoglobin \<90 g/L. Platelets \<30 x 10\^9/L, neutrophils \<1.0 x 10\^9/L.
- Baseline liver and renal function is less than two times the normal value.
- No active infection.
- Agreed to sign the consent form.
- Eastern Cooperative Oncology Group (ECOG) score of 0-2.
Exclusion
- Other causes of whole blood cytopenia, such as myelodysplastic syndromes (MDS).
- Presence of cytogenetic evidence of clonal haematological bone marrow disorders (MDS, AML).
- PNH clones ≥50%.
- Hematopoietic stem cell transplantation (HSCT) prior to enrolment.
- Prior treatment with ATG.
- Infection or bleeding uncontrolled by standard therapy.
- Allergy to roprostin.
- Active HIV, HCV or HBV infection or cirrhosis or portal hypertension.
- Any concomitant malignancy, localised basal cell carcinoma of the skin within 5 years.
- Previous history of thromboembolic events, heart attack or stroke (including antiphospholipid antibody syndrome) and current use of anticoagulants.
- Pregnant or lactating (breastfeeding) women.
- Participation in another clinical trial within 3 months.
Key Trial Info
Start Date :
July 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06516484
Start Date
July 30 2024
End Date
December 31 2025
Last Update
July 24 2024
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730