Skip to content

A prospective, open, single-arm multicenter clinical study for FluCy-pATG conditioning regimen combined with matched sibling hematopoietic stem cell transplantation for patients with aplastic anemia

A prospective, open, single-arm multicenter clinical study for FluCy-pATG conditioning regimen combined with matched sibling hematopoietic stem cell transplantation for patients with aplastic anemia

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900025688
Enrollment
Unknown
Registered
2019-09-05
Start date
2019-09-16
Completion date
Unknown
Last updated
2019-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acquired severe aplastic anaemia

Interventions

Case series:FluCy-pATG conditioning

Sponsors

Hematolgy Department of Wuhan Union Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged <= 60 years; 2. Male and female patient; 3. Severe aplastic anemia or transplansion dependant aplastic anemia by Camitta criteria; 4. Suitable fully matched sibling donor available (10/10 or 9/10 match for human leukocyte antigen); 5. The score of ECOG in this study was less than 2; 6. Patient and/or legal guardian must sign informed consent for HSCT.

Exclusion criteria

Exclusion criteria: 1. Uncontrolled viral, bacterial, and fungal infections (progression of disease during antifungal therapy); 2. Antilymphocytic immunoglobulin severe allergy (anaphylactic shock or laryngeal edema); 3. Combined with serious heart, lung, liver or kidney disease: Left ventricular ejection fraction (LVEF) 2.0 x the upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 2.0 x ULN; Estimated creatinine clearance 130umol/L. 4. Heart, liver, pancreas with severe iron deposition or serum ferritin> 3000 ug/ L 5. Pregnant and lactating women; 6. Men and women who do not agree to contraception during the trial period; 7. HIV seropositive; 8. Malignant tumor; 9. Prior allogeneic stem cell transplant or prior solid organ transplant.

Design outcomes

Primary

MeasureTime frame
incidences of acute graft-vs-host-disease (aGVHD);incidence of chronic GVHD;immune reconstitution;

Secondary

MeasureTime frame
Sustained engraftment;TRM;Incidence of fungal infection;Incidence of CMV infection;Incidence of EBV infection;over survival;

Countries

China

Contacts

Public ContactLinghui Xia

hematology department of Wuhan Union Hospital

xlh64@medmail.com.cn+86 18627733999

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026