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

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · Apr 30, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment called recombinant human thrombopoietin (rhTPO) to help mobilize hematopoietic stem cells in patients with acute leukemia who are preparing for an autologous stem cell transplant. Essentially, the study aims to see if giving patients rhTPO can safely and effectively increase the number of stem cells in their blood, which are crucial for their recovery after treatment.

To participate in this trial, patients should be between 18 and 65 years old and have been diagnosed with acute leukemia, with their disease currently under control. They also need to be in good overall health, with no serious infections or organ failures, and should be willing to provide written consent to join the study. If eligible, participants can expect regular health check-ups and monitoring during the trial, which is an important step in finding new treatments for leukemia. It’s important to note that the study is not yet recruiting participants, so those interested will need to wait for the trial to begin.

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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.