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A multicenter prospective research for the risk of HBV reaction in HBsAg negativity hematological malignancy patients who accepting allogeneic hematopoietic stem cell transplantation

A multicenter prospective research for the risk of HBV reaction in HBsAg negativity hematological malignancy patients who accepting allogeneic hematopoietic stem cell transplantation

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800018462
Enrollment
Unknown
Registered
2018-09-20
Start date
2018-09-19
Completion date
Unknown
Last updated
2018-09-24

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

Conditions

hematologic malignacy

Interventions

Group 1:anti-HBc(-)anti-HBs(-)
Group 2:anti-HBc(-)anti-HBs(+)
Group 3:anti-HBc(+)anti-HBs(-)
Group 4:anti-HBc(+)anti-HBs(+)

Sponsors

the First Affiliated Hospital of Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 60 Years

Inclusion criteria

Inclusion criteria: 1. The informed consent is signed by the subjects or their legal representatives before the start of clinical research; 2. Male and female patients,and the female patients with negative pregnancy test; 3. aged younger than 60 years old; 4. Hematological malignancy patients with HBsAg negativity and can't detect HBV-DNA in peripheral blood who undergo allogeneic hematopoietic stem cell transplantation; 5. ECOG physical status score 0~2 score; 6. No major organ dysfunction.

Exclusion criteria

Exclusion criteria: 1. Patients with severe liver and renal function and heart and lung dysfunction; 2. An uncontrolled or severe infection; 3. Hematological malignancy patients with HBsAg postive or detecting HBV-DNA in peripheral blood bofore allogeneic hematopoietic stem cell transplantation,or the hematopoietic stem cell donor with HBsAg postive or detecting HBV-DNA in peripheral blood; 4. ECOG performance status >2; 5. second tumour; 6. severe neurologic and psychiatric disorder interfering with the ability to consent on the trial.

Design outcomes

Primary

MeasureTime frame
Cumulative incidence of HBV reaction;overall survival;disease-free survival;cumulative replase rate;

Secondary

MeasureTime frame
nonreplase mortality;the incidence of acute GVHD and chronic GVHD;

Countries

China

Contacts

Public ContactHuang He

the First Affiliated Hospital of Zhejiang University School of Medicine

hehuangyu@126.com+86 13605714822

Outcome results

None listed

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