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

NCT06955858 | Not Yet Recruiting

• 1 other identifier: IIT2025002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Hematopoietic Stem Cell Mobilization

Keywords

Recombinant Human Thrombopoietin

Outcome Measures

Primary Outcomes (1)

• total CD34+ cell count

  Median total number of CD34+ cells collected

  two weeks

Secondary Outcomes (5)

• 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

• time of platelet engraftment

  eight weeks

• time of neutrophil engraftment

  four weeks

Study Arms (1)

The group of rhTPO

EXPERIMENTAL

Drug: Recombinant Human Thrombopoietin（rhTPO）

Interventions

Recombinant Human Thrombopoietin（rhTPO） DRUG

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.

The group of rhTPO

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

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

Tianjin, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: May 2, 2025
• Study Start: May 30, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 2, 2025

Record last verified: 2025-04

Locations

CN (1)