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

Recombinant Human Thrombopoietin for Autologous Hematopoietic Stem Cell Mobilization in Acute Leukemia: A Single-Arm Prospective Study

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

Study Overview

• Status: Not yet recruiting
• Conditions: Hematopoietic Stem Cell Mobilization
• Intervention / Treatment: Drug: Recombinant Human Thrombopoietin（rhTPO）

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Tianjin, China
    • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The group of rhTPO	Drug: Recombinant Human Thrombopoietin（rhTPO）; G-CSF will be administered at a dose of 10 μg/kg/day subcutaneously for 7-10 days post-chemotherapy. rhTPO is started on the same day as G-CSF at 300 U/kg/d and injected subcutaneously until the stem cell collection was completed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total CD34+ cell count	Median total number of CD34+ cells collected	two weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Median total number of mononuclear cells collected	two weeks
time of platelet engraftment	defined as platelet count >20×109 platelets/L for seven consecutive days without platelet transfusion	eight weeks
time of neutrophil engraftment	defined as the absolute value of neutrophils >0.5×109 cells/L for three consecutive days	four weeks

Collaborators and Investigators

• Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Study record dates

Study Major Dates

• Study Start (Estimated): May 30, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: March 26, 2025
• First Submitted That Met QC Criteria: April 30, 2025
• First Posted (Actual): May 2, 2025

Study Record Updates

• Last Update Posted (Actual): May 2, 2025
• Last Update Submitted That Met QC Criteria: April 30, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Recombinant Human Thrombopoietin
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Leukemia
• Other Study ID Numbers: IIT2025002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No