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A prospective nested case-control research for the prevalence of pure red cell aplasia after myeloablative-based hematopoietic transplantation using major ABO-incompatible unmanipulated peripheral blood stem cells

A prospective nested case-control research for the prevalence of pure red cell aplasia after myeloablative-based hematopoietic transplantation using major ABO-incompatible unmanipulated peripheral blood stem cells

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000041412
Enrollment
Unknown
Registered
2020-12-25
Start date
2014-08-01
Completion date
Unknown
Last updated
2021-03-15

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

Conditions

Hematologic malignacy

Interventions

presence of PRCA:Nil
absence of PRCA:Nil

Sponsors

The First Affiliated Hospital of Medical College of Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 67 Years

Inclusion criteria

Inclusion criteria: 1. The subjects or their legal representatives signed the informed consent before the clinical study. 2. Women of childbearing age were negative in pregnancy test within 14 days before the administration of the test drug. 3. Subjects aged 15-67 years. 4. Patients with malignant hematological diseases received allogeneic peripheral blood stem cell transplantation with major ABO incompatible blood groups. 5. Subjects with ECoG score of 0-2. 6. Subjects without major organ dysfunction.

Exclusion criteria

Exclusion criteria: 1. Patients with severe liver and kidney function (alanine aminotransferase > 2.5 times of the upper normal limit, serum creatinine > 1.5 times of the upper normal limit), cardiopulmonary dysfunction (cardiac function NYHA III / IV, cardiac ejection fraction 2; 5. Patients with secondary tumor; 6. Patients who cannot independently choose to enter or exit clinical trials due to serious central nervous system disease or mental disease.

Design outcomes

Primary

MeasureTime frame
cumulative incidence of PRCA;

Secondary

MeasureTime frame
overall survival;leukemia-free survival;cumulative replase rate;nonreplase mortality;the incidence of acute GVHD and chronic GVHD;

Countries

China

Contacts

Public ContactHuang he

The First Affiliated Hospital of Medical College of Zhejiang University

hehuangyu@126.com+86 13605714822

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 13, 2026