Clinical Study of rhTPO in Hematopoietic Stem Cell Mobilization for Autologous Transplantation in Acute Leukemia

Institute of Hematology & Blood Diseases Hospital, China

Status: Not yet enrolling

Conditions: Hematopoietic Stem Cell Mobilization

Treatments: Drug: Recombinant Human Thrombopoietin（rhTPO）

Study type: Interventional

Funder types: Other

Identifiers

NCT06955858

IIT2025002

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18～65 years, regardless of gender.
2. Histopathologically confirmed acute leukemia with immunohistochemical validation
3. Sustained complete hematologic remission with documented minimal residual disease (MRD) negativity.
4. Eastern Cooperative Oncology Group (ECOG) performance status smaller than 2 and a life expectancy of more than 6 months
5. No active infectious disease; no severe organ failure.
6. Willingness to participate with written informed consent for study enrollment.

Exclusion criteria

1. Liver dysfunction (alanine aminotransferase or bilirubin greater than two times the normal upper limit).
2. Renal dysfunction (creatinine or urea higher than 1.5 times the normal upper limit).
3. 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
4. rhTPO aller- gies.
5. Severe prior thrombosis-event.
6. History of other malignancy, unless cured for more than 3 years
7. Pregnant or lactating women
8. Severe infectious disease (uncured tuberculosis, pulmonary aspergillosis)
9. Epilepsia, dementia or any mental disease requiring treatment.
10. Other conditions deemed inappropriate for study participation by the investigator.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

The group of rhTPO

Experimental group

Treatment:

Drug: Recombinant Human Thrombopoietin（rhTPO）