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

Fuling Zhou, Head, Division of Hematology; Professor of Hematology; Doctoral Advisor, Zhongnan Hospital

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Granulocyte Colony-Stimulating Factor
• Intervention / Treatment: Drug: PEG-rhG-CSF; Drug: G-CSF

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Fuling Zhou; Phone Number: +862767813137; Email: zhoufuling@whu.edu.cn

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430071
      • Zhongnan Hospital of Wuhan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: 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
Active Comparator: G-CSF; G-CSF 5ug/kg/d from day 5 after the end of chemotherapy until the end of collection	Drug: G-CSF; G-CSF 5ug/kg/d from day 5 after the end of chemotherapy until the end of collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total CD34+ cell yield (106/kg)	Total CD34+ cell yield (106/kg)	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy differences between immunomagnetic bead assays and flow cytometry assays	Differences in the accuracy of immunomagnetic bead assay and flow cytometry in the detection of CD34+ cells after mobilization in lymphoma patients prepped for stem cell transplantation	through study completion, an average of 1 year
Height	height in meters	One day before chemotherapy
Weight	Weight in kg	One day before chemotherapy
Vital signs and physical examination	Exclude unrelated organic disease by imaging studies	One day before chemotherapy
ECOG score (d1 pre-chemotherapy)	The ECOG scoring standard (Eastern Cooperative Oncology Group) is an index to understand the patient's general health status and tolerance to treatment from the patient's physical strength. The patient's activity status is divided into 6 grades from 0 to 5, with higher scores indicating worse outcomes.	One day before chemotherapy
Blood routine	Blood routine: Blood routine was tested daily, and peripheral blood CD34+ cell percentage was monitored from the time leukocytes started to rise after the nadir by immunomagnetic bead assay and flow cytometry, and collection was initiated if CD34+ percentage was >0.1% and peripheral blood leukocytes were >3.5×109/L.	Blood routine was tested daily, an average of 1 year
Adverse event record	Adverse event record: record any adverse events that occurred during the drug administration.	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Zhongnan Hospital
• Investigators: Study Director: Fuling Zhou, Wuhan University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: July 12, 2023
• First Submitted That Met QC Criteria: July 31, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No