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

NCT ID: NCT05970185

Last Updated: 2024-01-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2024-04-30

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.

Conditions

Granulocyte Colony-Stimulating Factor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

PEG-rhG-CSF

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

Group Type: EXPERIMENTAL

PEG-rhG-CSF

Intervention Type: DRUG

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

G-CSF

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

Group Type: ACTIVE_COMPARATOR

G-CSF

Intervention Type: DRUG

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

Interventions

PEG-rhG-CSF

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

Intervention Type: DRUG

G-CSF

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhongnan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Fuling Zhou

Head, Division of Hematology; Professor of Hematology; Doctoral advisor, Zhongnan Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fuling Zhou

Role: STUDY_DIRECTOR

Wuhan University

Locations

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Countries

China

Central Contacts

Fuling Zhou

Role: CONTACT

zhoufuling@whu.edu.cn

+862767813137

Other Identifiers

07

Identifier Type: -

Identifier Source: org_study_id