Status:
NOT_YET_RECRUITING
Clinical Study of rhTPO in Hematopoietic Stem Cell Mobilization for Autologous Transplantation in Acute Leukemia
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
Hematopoietic Stem Cell Mobilization
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Evaluation of the efficacy and safety of recombinant human thrombopoietin (rhTPO) at 300 U/kg/day for hematopoietic stem cell mobilization in autologous transplantation among acute leukemia patients
Eligibility Criteria
Inclusion
- Age 18～65 years, regardless of gender.
- Histopathologically confirmed acute leukemia with immunohistochemical validation
- Sustained complete hematologic remission with documented minimal residual disease (MRD) negativity.
- Eastern Cooperative Oncology Group (ECOG) performance status smaller than 2 and a life expectancy of more than 6 months
- No active infectious disease; no severe organ failure.
- Willingness to participate with written informed consent for study enrollment.
Exclusion
- Liver dysfunction (alanine aminotransferase or bilirubin greater than two times the normal upper limit).
- Renal dysfunction (creatinine or urea higher than 1.5 times the normal upper limit).
- Any disease that could put patients at high risk, including but not limited to unstable cardiac disease, uncontrolled atrial fibrillation or hypertension, severe diabetic retinopathy
- rhTPO aller- gies.
- Severe prior thrombosis-event.
- History of other malignancy, unless cured for more than 3 years
- Pregnant or lactating women
- Severe infectious disease (uncured tuberculosis, pulmonary aspergillosis)
- Epilepsia, dementia or any mental disease requiring treatment.
- Other conditions deemed inappropriate for study participation by the investigator.
Key Trial Info
Start Date :
May 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06955858
Start Date
May 30 2025
End Date
December 30 2026
Last Update
May 2 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, China