Clinical trial NCT05970185: The Value of Peripheral Blood CD34+ Cell Dynamics Monitoring in Autologous Hematopoietic Stem Cell Transplant Mobilization
Official title: Fuling Zhou, Head, Division of Hematology; Professor of Hematology; Doctoral Advisor, Zhongnan Hospital
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Granulocyte Colony-Stimulating Factor
Lead sponsor: Zhongnan Hospital
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Treatment programs The mobilization protocol is.

1. etoposide 0.1 grams per square meter qd d1-3
2. algocytidine 0.5 grams per square meter q12h d1-3
3. whitening injection (subcutaneous injection of polyethylene glycolized recombinant human granulocyte-stimulating factor injection 6mg bid in the experimental group on the second day after chemotherapy, and G-CSF 5ug/kg/d in the control group from the fifth day after chemotherapy until the end of collection).

In both groups, routine blood tests were performed daily, and the percentage of CD34+ cells in peripheral blood was monitored from the time leukocytes started to rise after the nadir by immunomagnetic bead assay and flow cytometry, and collection was initiated if the percentage of CD34+ was \>0.1% and peripheral blood leukocytes were \>3.5×109/L.

Collection was stopped when the CD34+ cell count was \>5×106/kg, and no more than three attempts were made. Collection was considered a failure when CD34+ cells collected in any of the three attempts did not reach 2×106/kg.

Eligibility criteria: Inclusion Criteria:

1. Malignant lymphoma diagnosed by histology and/or cytology; expected survival \> 3 months.
2. Patients evaluated for disease in complete or partial remission.
3. Normal bone marrow hematopoietic function; no significant cardiac or pulmonary dysfunction.
4. 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.
5. PS score of 0-2.
6. Age ≥ 18.
7. 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.

Subjects voluntarily enrolled in the study, signed an informed consent form, were compliant and cooperated with the follow-up.

Exclusion Criteria:

1. Pregnant or lactating women.
2. having other hematological disorders affecting the hematopoietic function of the bone marrow
3. those with acute or active infections who have received systemic anti-infective therapy within 72h
4. who are allergic to the study drug or other G-CSF products, or to biological agents expressed by E. coli
5. 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
6. Other conditions that, in the judgment of the investigator, are not suitable for inclusion in this study.

Primary outcomes:
measure: Total CD34+ cell yield (106/kg)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Accuracy differences between immunomagnetic bead assays and flow cytometry assays
timeFrame: through study completion, an average of 1 year
measure: Height
timeFrame: One day before chemotherapy
measure: Weight
timeFrame: One day before chemotherapy
measure: Vital signs and physical examination
timeFrame: One day before chemotherapy
measure: ECOG score (d1 pre-chemotherapy)
timeFrame: One day before chemotherapy
measure: Blood routine
timeFrame: Blood routine was tested daily, an average of 1 year
measure: Adverse event record
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
Study officials:
affiliation: Wuhan University
name: Fuling Zhou
role: STUDY_DIRECTOR
References: