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NCT06424639

PHASE4

Luspatercept Plus CsA vs CsA for the Treatment of Newly Diagnosed Non-Transfusion-Dependent NSAA

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

Summary

In a randomized, controlled clinical trial, the efficacy and safety of rodsipil combined with cyclosporine versus cyclosporine alone in the treatment of newly diagnosed non-transfusion-dependent NSAA were compared.

Official title: A Randomized, Controlled Trial Comparing the Safety and Efficacy of Luspatercept Plus Cyclosporine Versus Cyclosporine Alone for the Treatment of Newly Diagnosed Non-transfusion-dependent Non-severe Aplastic Anemia (NSAA)

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-05

Completion Date

2025-12

Last Updated

2024-05-22

Healthy Volunteers

Conditions

Aplastic Anemia

Interventions

DRUG

Luspatercept

Luspatercept (dose of 1.0 mg/kg, subcutaneous injection every 3 weeks) Cyclosporine (3-5mg/kg/day)

DRUG

cyclosporine

Cyclosporine (3-5mg/kg/day)

Inclusion Criteria: 1. Age ≥ 18 years 2. Hemoglobin level of 6-10 g/dL 3. Definition of NSAA: Patients with AA diagnosis but not SAA or VSAA diagnosis (at least two of the following conditions can be diagnosed as AA: (i) Hemoglobin \< 100 g/L; (ii) Platelet count \< 50×10\^9/L; (iii) Neutrophil count \< 1.5×10\^9/L. SAA diagnosis criteria include less than 25% (or 25-50%, but residual hematopoietic cells \< 30%) of bone marrow cells, plus at least two of the following conditions: (i) Neutrophil count \< 0.5×10\^9/L; (ii) Platelet count \< 20×10\^9/L; (iii) Retroperitoneal lymph node count \< 20×10\^9/L. VSAA meets the criteria for SAA, but with neutrophil count \< 0.2×10\^9/L. (British guidelines, 2015)) 4. No active infection 5. No other concurrent neoplasms (except in situ carcinoma) 6. Baseline liver and renal function within 1.5 times of normal value 7. No pregnancy or breastfeeding 8. Agree to sign informed consent form 9. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Exclusion Criteria: 1. Congenital aplastic anemia 2. Presence of chromosomal aberrations 3. Cytogenetic evidence of clonal hematological myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML) 4. PNH clone ≥50% 5. Previous use of alemtuzumab, any ATG, or any dose of cyclosporine for immunosuppressive treatment 6. Previous hematopoietic stem cell transplant (HSCT) 7. Uncontrolled infection or bleeding under standard treatment 8. Allergy to rituximab, cyclosporine, or excipients 9. History of allergy to polyethylene glycol (PEG) 80 10. Active infection or cirrhosis of the liver or portal hypertension due to HIV, HCV, or HBV 11. Screening QTcF (Fridericia QT corrected formula) less than 450 milliseconds or less than 480 milliseconds of bundle branch block determined by three ECG averages, and assessed on-site; unstable angina; uncontrolled hypertension (\>180/100 mmHg); pulmonary hypertension 12. Any malignant tumor within 5 years, except local basal cell carcinoma; previous thromboembolic event, history of myocardial infarction or stroke (including antiphospholipid syndrome); currently using anticoagulants 13. Pregnant or lactating women 14. Participated in another clinical trial within 3 months

Locations (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China