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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: The group of rhTPOExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

total CD34+ cell count

Median total number of CD34+ cells collected

Time frame
two weeks

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

Median total number of mononuclear cells collected

Time frame
two weeks
4

time of platelet engraftment

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

Time frame
eight weeks

Other outcomes

Sponsors and contacts

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