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A prospective, single center, single arm, exploratory clinical study of HLA mismatched allogeneic hematopoietic stem cell transplantation in the treatment of high-risk hematologic malignancies

A prospective, single center, single arm, exploratory clinical study of HLA mismatched allogeneic hematopoietic stem cell transplantation in the treatment of high-risk hematologic malignancies

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038000
Enrollment
Unknown
Registered
2020-09-08
Start date
2020-09-01
Completion date
Unknown
Last updated
2020-11-16

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

Conditions

Hematological malignancy

Interventions

experimental group:HLA mismatched allo-HSCT

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. Adult patients with high-risk hematological malignancies (18-55 years old) had allo HSCT indications; 2. Unrelated HLA identical sibling donors; 3. There are no unrelated donors with HLA matching >= 8 / 10, or it is difficult to find non blood donors because of the emergency condition; 4. There is no suitable donor for HLA matching; 5. There is no suitable umbilical cord blood donor; 6. Suitable donors with mismatched HLA matching (within three generations and HLA high resolution matching < 5 / 10); 7. Subjects or their legal representatives sign informed consent before the start of clinical study.

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), and patients with cardiopulmonary insufficiency (NYHA III / IV, cardiac ejection fraction = 2; 4. Patients with secondary tumor; 5. Patients with severe central nervous system disease or mental illness can not choose to enter or withdraw from clinical trials; 6. Patients with other contraindications of allo HSCT.

Design outcomes

Primary

MeasureTime frame
neutrophil engraftment;platelet engraftment;incidence of GVHD;

Secondary

MeasureTime frame
Immune reconstitution;incidence of infection;overall survival;disease-free survival;cumulative replase rate;nonreplase mortality;

Countries

China

Contacts

Public ContactHe Huang

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 4, 2026