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

Not Applicable

Not yet recruiting

• Conditions: Hematopoietic Stem Cell Mobilization
• Interventions: Drug: Recombinant Human Thrombopoietin（rhTPO）

• Registration Number: NCT06955858
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-26
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-30
• Last Update Submitted: 2025-04-30
• Study First Posted: 2025-05-02
• Last Update Posted: 2025-05-02
• Study Start: 2025-05-30
• Primary Completion: 2026-07-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
The group of rhTPO	Recombinant Human Thrombopoietin（rhTPO）	-

Primary Outcome Measures

Name	Time	Method
total CD34+ cell count	two weeks	Median total number of CD34+ cells collected

Secondary Outcome Measures

Name	Time	Method
the proportion of patients collecting more than or equal to 2*10^6 CD34+ cells/kg	two weeks
the proportion of patients collecting more than or equal to 5*10^6 CD34+ cells/kg	two weeks
total mononuclear cell count	two weeks	Median total number of mononuclear cells collected
time of platelet engraftment	eight weeks	defined as platelet count \>20×109 platelets/L for seven consecutive days without platelet transfusion
time of neutrophil engraftment	four weeks	defined as the absolute value of neutrophils \>0.5×109 cells/L for three consecutive days

Trial Locations

Locations (1)

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Tianjin, China