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Clinical Trials in China / NCT06378060
Recruiting Phase 2

Clinical Study on Modified Allogeneic Hematopoietic Stem Cell Transplantation Regimen for Severe Aplastic Anemia

NCT06378060 · tracked via the Priya Life Science China tracker
Sponsor
Hematology department of the 920th hospital
Phase
Phase 2
Started
2024-03-01
Last updated
2024-04-22

Condition(s) studied

Severe Aplastic Anemia

Investigational drug(s) / intervention(s)

Modified transplantation system

Modified transplantation system: Conditioning regimen: fludarabine 30mg/m2×5\~6d,cyclophosphamide 50mg/kg×2d, melphalan 100mg/m2×1d aGVHD prophylaxis: PTCY 25mg/kg×2d, ATG 4.5mg/kg total, MMF 15mg/kg +5d\~+35d, Ruxolitinib 5mg bid -1d\~+50d and 2.5mg bid +51d\~+110d, CSA

Study summary

The aim of this study was to evaluate the safety and efficacy of a modified allogeneic hematopoietic stem cell transplantation regimen for aplastic anemia.

Eligibility

Sex
ALL
Min age
3 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1. Patients with benign or malignant hematological diseases such as leukemia, lymphoma, thalassemia, aplastic anemia, etc. diagnosed by NCCN guidelines, and requiring allogeneic hematopoietic stem cell transplantation as determined by the researchers; 2. Age 3-65 years old; 3. Weight 10Kg-100Kg; 4. Eastern Cooperative Oncology Group (ECOG) score ≤3; 5. No major organ injury (ECG ejection fraction \>45%; bilirubin \< 2 times the upper limit of normal value; AST and ALT \< 3 times the upper limit of normal value; serum creatinine \< 2 times the upper limit of normal value); 6. No severe infection; 7. Subjects voluntarily participated in this clinical trial and signed the informed consent. Exclusion Criteria: 1. patients with nonhematologic diseases who are not eligible for transplantation or who do not wish to receive transplantation; 2. patients with an expected survival of less than 1 month; 3. patients with previous autologous or allogeneic hematopoietic stem cell transplantation; 4. pregnant patients; 5. patients with severe mental or neurological disorders that would affect the ability to provide informed consent and/or to report or observe adverse events; 6. other conditions that the investigator determines to be inappropriate for enrollment.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China Kunming Yunnan Recruiting

More Hematology department of the 920th hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06378060 on ClinicalTrials.gov ↗ ← All trials in China