The Value of Peripheral Blood CD34+ Cell Dynamics Monitoring in Autologous Hematopoietic Stem Cell Transplant Mobilization

Zhongnan Hospital

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Granulocyte Colony-Stimulating Factor

Treatments: Drug: G-CSF; Drug: PEG-rhG-CSF

Study type: Interventional

Funder types: Other

Identifiers

NCT05970185

07

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

PEG-rhG-CSF

Experimental group

Description:

Subcutaneous injection of polyethylene glycolized recombinant human granulocyte-stimulating factor injection 6mg bid in the experimental group the day after the end of chemotherapy

Treatment:

Drug: PEG-rhG-CSF

G-CSF

Active Comparator group

Description:

G-CSF 5ug/kg/d from day 5 after the end of chemotherapy until the end of collection

Treatment:

Drug: G-CSF