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

NCT ID: NCT06955858

Last Updated: 2025-05-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-30
• Study Completion Date: 2026-12-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

The group of rhTPO

Group Type: EXPERIMENTAL

Recombinant Human Thrombopoietin（rhTPO）

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Tianjin, , China

Countries

China

Other Identifiers

IIT2025002

Identifier Type: -

Identifier Source: org_study_id