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Multi center clinical study of the risk classification and stratified intervention on pre-engraftment syndrome after umbilical cord blood transplantation

Multi center clinical study of the risk classification and stratified intervention on pre-engraftment syndrome after umbilical cord blood transplantation

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONC-16009013
Enrollment
Unknown
Registered
2016-08-12
Start date
2016-09-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

hematologic malignancies patients with PES after umbilical cord blood transplantation

Interventions

Patients without PES:No
PES without risk factors:MP 0.5mg/kg/d
PES with 1 score:MP 1mg/kg/d
PES with 2 scores:MP 2mg/kg/d

Sponsors

Anhui Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Diagnosed with hematologic malignancies, any age, any gender, any race; 2. No HLA matched sibling donor or unwilling to choose HLA matched sibling donor transplantation; 3. No severe organ failure and active infection; 4. Patients and their families voluntarily carried out UCBT and signed informed consent; 5. If PES occures, patients and their families voluntarily carry out different doses of MP stratified intervention treatment and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Serious viscera dysfunction or disease, such as serious diseases and function disorder in heart, liver, kidney and pancreas; 2. Patients with pregnancy; 3. Participants and/or authorized family members refused to accept UCBT; 4. Researchers believe that can damage the unnecessary risks to safety, make the results of the study subjects any life-threatening illness, condition or organ system dysfunction; drug dependence; uncontrolled mental disease; cognitive impairment; 5. Participate in other similar clinical researches in 3 months; 6. Researchers think that the patient doesn't fit into the group (e.g., patients are expected to be discontinue because of funding problems).

Design outcomes

Primary

MeasureTime frame
180d transplant related mortality (TRM);

Secondary

MeasureTime frame
Cumulative incidence of acute GVHD;relapse rate;one year overall survival;one year leukemia free survival;Cumulative rate of neutrophil engraftment;Cumulative rate of platelet engraftment;neutrophil engraftment time;platelet engraftment time;

Countries

China

Contacts

Public ContactZimin Sun

Anhui Provincial Hospital

zmsun_vip@163.com+86 13605518126

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 22, 2026