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The prospective randomized controlled clinical study of recombinant human thrombopoietin (rhTPO) on hematopoietic reconstruction after umbilical cord blood transplantation in patients with hematologic malignancies

The prospective randomized controlled clinical study of recombinant human thrombopoietin (rhTPO) on hematopoietic reconstruction after umbilical cord blood transplantation in patients with hematologic malignancies

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-16009357
Enrollment
Unknown
Registered
2016-10-10
Start date
2016-10-10
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 after umbilical cord blood transplantation

Interventions

rhTPO (for the first time + maintenance) treatment group:Patients are treated with rhTPO 300u/kg in 6 hours after UCBT and from +14d~+28d after UCBT
rhTPO maintenance treatment group:patients are treated with rhTPO 300u/kg from +14d~+28d after UCBT
Blank control group:No rhTPO usage

Sponsors

Department of Hematology, Anhui Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients were diagnosed withhematologic malignancies, weight more than 30kg, Any age, any gender, any race; 2. Voluntary acceptance of UCBT; 3. Voluntary acceptance of rhTPO open randomized controlled study; 4. Each participant must sign a consent form (ICF), shows that he/she understand the study purpose and procedures, and are willing to participate in research;Considering from the patient, if the signature is not conducive to patient treatment, it is signed by the legal representative of ICF.

Exclusion criteria

Exclusion criteria: 1. Serious viscera dysfunction or disease, such as serious diseases and function disorder in heart, liver, kidney and pancreas; 2. Can not tolerate rhTPO subcutaneous injection; 3. Participants and/or authorized family members refused to accept UCBT and rhTPO therapy; 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
Platelet implantation time;

Secondary

MeasureTime frame
Platelet transfusion units;Neutrophil implantation time;Platelet recovery rate;Neutrophil recovery rate;Cumulative incidence of II~IV,III~IV acute GVHD rate;180d transplant related mortality;relapse rate;one year overall survival;one year leukemia free survival;

Contacts

Public ContactXiaoyu Zhu

Anhui Provincial Hospital

bayinhexy@126.com+86 15255456091

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 23, 2026