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NCT Number: NCT06955858

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Tianjin, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. total CD34+ cell count

    Time frame: two weeks

    Median total number of CD34+ cells collected

Secondary outcomes

  1. the proportion of patients collecting more than or equal to 2*10^6 CD34+ cells/kg

    Time frame: two weeks

  2. the proportion of patients collecting more than or equal to 5*10^6 CD34+ cells/kg

    Time frame: two weeks

  3. total mononuclear cell count

    Time frame: two weeks

    Median total number of mononuclear cells collected

  4. time of platelet engraftment

    Time frame: eight weeks

    defined as platelet count >20×109 platelets/L for seven consecutive days without platelet transfusion

  5. time of neutrophil engraftment

    Time frame: four weeks

    defined as the absolute value of neutrophils >0.5×109 cells/L for three consecutive days

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 2, 2025
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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