The Value of Peripheral Blood CD34+ Cell Dynamics Monitoring in Autologous Hematopoietic Stem Cel… (NCT05970185) | Clinical Trial Compass
UnknownEarly Phase 1
The Value of Peripheral Blood CD34+ Cell Dynamics Monitoring in Autologous Hematopoietic Stem Cell Transplant Mobilization
China40 participantsStarted 2024-02-01
Plain-language summary
The aim of this study was to evaluate the difference in the accuracy of CD34+ cell detection by immunomagnetic bead method and flow cytometry in patients with hematologic malignancies pre-treated with stem cell transplantation after mobilization, and the results were compared simultaneously in the groups applying different mobilization protocols.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. Patients evaluated for disease in complete or partial remission.
✓. Normal bone marrow hematopoietic function; no significant cardiac or pulmonary dysfunction.
✓. Liver function and biochemical tests need to meet the following criteria. ALT and AST ≤ 1.5×ULN. TBIL≤1.5×ULN. Blood creatinine ≤ 1.5 × ULN.
✓. PS score of 0-2.
✓. Age ≥ 18.
✓. Women of childbearing potential must have had a pregnancy test (serum or urine) within 7 days prior to enrollment with a negative result and be willing to use an appropriate method of contraception for the duration of the trial.
Exclusion criteria
✕. Pregnant or lactating women.
✕. having other hematological disorders affecting the hematopoietic function of the bone marrow
✕. those with acute or active infections who have received systemic anti-infective therapy within 72h
✕. who are allergic to the study drug or other G-CSF products, or to biological agents expressed by E. coli
✕. Those who, in the judgment of the investigator, have a serious concomitant disease that jeopardizes patient safety or interferes with the patient's ability to complete the study
What they're measuring
1
Total CD34+ cell yield (106/kg)
Timeframe: through study completion, an average of 1 year