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

NCT05970185 | Unknown Early Phase 1

• 1 other identifier: 07
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Granulocyte Colony-Stimulating Factor

Outcome Measures

Primary Outcomes (1)

• Total CD34+ cell yield (106/kg)

  Total CD34+ cell yield (106/kg)

  through study completion, an average of 1 year

Secondary Outcomes (7)

• Accuracy differences between immunomagnetic bead assays and flow cytometry assays

  through study completion, an average of 1 year

• Height

  One day before chemotherapy

• Weight

  One day before chemotherapy

• Vital signs and physical examination

  One day before chemotherapy

• ECOG score (d1 pre-chemotherapy)

  One day before chemotherapy

Study Arms (2)

PEG-rhG-CSF

EXPERIMENTAL

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

G-CSF

ACTIVE COMPARATOR

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

Drug: G-CSF

Interventions

PEG-rhG-CSF 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

PEG-rhG-CSF

G-CSF DRUG

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

G-CSF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Malignant lymphoma diagnosed by histology and/or cytology; expected survival \> 3 months.
• 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.
• Subjects voluntarily enrolled in the study, signed an informed consent form, were compliant and cooperated with the follow-up.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhongnan Hospital: lead

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

Location

MeSH Terms

Interventions

pegylated granulocyte colony-stimulating factor; Granulocyte Colony-Stimulating Factor

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Fuling Zhou

  Wuhan University

  STUDY DIRECTOR

Central Study Contacts

Fuling Zhou

CONTACT

+862767813137; zhoufuling@whu.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Division of Hematology; Professor of Hematology; Doctoral advisor, Zhongnan Hospital

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: August 1, 2023
• Study Start: February 1, 2024
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)