Status:
NOT_YET_RECRUITING
The Value of Peripheral Blood CD34+ Cell Dynamics Monitoring in Autologous Hematopoietic Stem Cell Transplant Mobilization
Lead Sponsor:
Zhongnan Hospital
Conditions:
Granulocyte Colony-Stimulating Factor
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- Other conditions that, in the judgment of the investigator, are not suitable for inclusion in this study.
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05970185
Start Date
February 1 2024
End Date
April 30 2024
Last Update
January 18 2024
Active Locations (1)
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1
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430071