Efficacy and Safety of PEG-rhG-CSF Injection for Neutrophil Reconstitution Following AHSCT in Lymphoma/Multiple Myeloma

September 23, 2023 updated by: Yao Liu

Medical Professor,CHONGQING UNIVERSITY CANCER HOSPITAL

This study evaluates the effectiveness and safety of PEG-rhG-CSF injection for the reconstruction of neutrophil cells after autologous hematopoietic stem cell transplantation in lymphoma/multiple myeloma patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a single-center, open-label clinical trial. Inclusion criteria involve patients with confirmed lymphoma or multiple myeloma receiving autologous hematopoietic stem cell transplantation for the first time. After calculating the sample size, an initial cohort of 40 trial patients is expected to be enrolled. Patients meeting the eligibility criteria will be assigned to receive PEG-rhG-CSF treatment on the second day after hematopoietic stem cell infusion, with a fixed dose of 6 mg. The primary outcome measure of this study is the median time for neutrophil cell reconstruction. Secondary study endpoints include safety indicators of the medication, the duration of neutrophil cell reduction (ANC≤2.0×10^9/L), the number of days patients spend in the laminar flow ward after transplantation, the usage of antibiotics, antifungal, or antiviral drugs, as well as patient expenditures, among other indicators.

Criteria for withdrawal/discontinuation of treatment:

(1) Subjects voluntarily request to withdraw from the trial;(2) Subjects who, although not explicitly requesting withdrawal from the trial, no longer adhere to the trial protocol for treatment and assessments, resulting in loss to follow-up; (3) Subjects with poor compliance who switch treatment regimens midway or use prohibited drugs within the protocol; (4) Subjects who were incorrectly enrolled; (5) Subjects experiencing intolerable allergic reactions or adverse events; (6) Subjects who pass away; (7) Other situations that meet the exclusion criteria arise.

Management of detachment cases:

When patients withdraw from the study due to allergic reactions or adverse events, researchers should take appropriate treatment measures based on the subject's condition. For mid-study withdrawal or loss to follow-up, researchers should actively take measures to complete the final assessment to analyze their efficacy and safety. All dropout cases should be documented in the case report form, and the trial conclusion form should be filled out along with the reasons for the subject dropout.

Study Type

Interventional

Enrollment (Estimated)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400030
        • Recruiting
        • Chongqing University Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18-65, any gender;
  2. Patients with lymphoma/multiple myeloma requiring autologous hematopoietic stem cell transplantation;
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 before transplantation;
  4. Basic normal function of heart, lungs, liver, and kidneys (no severe heart disease, no severe lung disease; transaminases ≤ 3× upper limit of normal, blood bilirubin ≤ 2.0 mg/dl; blood creatinine ≤ 2× upper limit of normal);
  5. Pre-transplant blood counts meet the following criteria: ANC (Absolute Neutrophil Count) ≥ 1.5×10^9/L, HGB (Hemoglobin) ≥ 90g/L, PLT (Platelets) ≥ 100×10^9/L;
  6. No other severe diseases that conflict with this protocol;
  7. Expected survival of ≥ 3 months and willingness to follow-up;
  8. Voluntary participation in this clinical trial and signing of informed consent;
  9. The investigator believes that the subject will benefit from participation.

Exclusion Criteria:

  1. Patients with splenomegaly;
  2. Individuals who have previously undergone allogeneic or autologous hematopoietic stem cell transplantation;
  3. HIV antibody-positive, HbsAg-positive, or HCV antibody-positive;
  4. Impaired liver or kidney function (transaminases >3× ULN or blood bilirubin >2.0 mg/dl; blood creatinine >2× ULN);
  5. Decompensated heart failure, dilated cardiomyopathy, coronary artery disease with ST-segment depression on electrocardiogram, or myocardial infarction within the last Six months;
  6. Clinical symptoms of cognitive impairment or severe mental illness;
  7. Allergic reactions to polyethylene glycol recombinant human granulocyte colony-stimulating factor injection or recombinant human granulocyte colony-stimulating factor injection;
  8. Pregnant or breastfeeding women;
  9. Investigators believe participation in this clinical trial is unsuitable.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clinical Study on PEG-rhG-CSF in the Treatment of Lymphoma/Multiple Myeloma
In this study, lymphoma/multiple myeloma patients who meet the inclusion criteria will be administered PEG-rhG-CSF injection at a fixed dose of 6 mg on the second day after hematopoietic stem cell infusion, and the effectiveness and safety of the treatment will be observed.
Drug: pegylated recombinant human granulocyte-colony stimulating factor
Lymphoma/multiple myeloma patients who meet the inclusion criteria will be administered PEG-rhG-CSF injection at a fixed dose of 6 mg on the second day after hematopoietic stem cell infusion, and the effectiveness and safety of the treatment will be observed.
Other Names:
  • PEG-rhG-CSF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median time to neutrophil cell reconstruction
Time Frame: 0-21 days
day-based
0-21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Tests
Time Frame: 30 days
Counts： red blood cells [male:(4.3-5.8)×10¹²/L ),female:(3.8-5.1)×10¹²/L]; white blood cells (3.5-9.5×10^9/L); neutrophils (1.5~8.0)×10^9/L; lymphocytes (0.8-3.5)X10^9/L; and platelets (100-300)×10^9/L.
30 days
Duration of absolute neutrophil count (ANC)
Time Frame: 30 days
The normal range for neutrophil count is approximately 1.8-6.3 x 10^9/L. If the ANC (Absolute Neutrophil Count) falls to ≤2.0 x 10^9/L, it is considered a possible side effect caused by the experimental drug used in this cancer patient.
30 days
Number of days staying in the laminar flow ward after transplantation
Time Frame: 30 days
A laminar flow ward is used to prevent the risk of infection in patients undergoing their first autologous hematopoietic stem cell transplantation treatment.Typically, after receiving autologous hematopoietic stem cell transplantation treatment, patients reside in the Laminar flow ward for 1-3 months.
30 days
Biochemical examination
Time Frame: 30 days
Alanine aminotransferase (0~40U/L), glutamine aminotransferase(<15U/L), alkaline phosphatase (40-150U/L) et al.
30 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usage of antibiotics, antifungal, or antiviral medications
Time Frame: 100 days
It is primarily used to prevent infections in patients' bodies following autologous hematopoietic stem cell transplantation. Record the type and dosage of medication used.
100 days
Cost
Time Frame: 100 days
The total treatment cost at the time of patient discharge. Usually denominated in RMB
100 days
Incidence of adverse events
Time Frame: 100 days
lack of appetite, allergic reaction
100 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yao Liu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2022

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

September 4, 2023

First Submitted That Met QC Criteria

September 23, 2023

First Posted (Actual)

September 29, 2023

Study Record Updates

Last Update Posted (Actual)

September 29, 2023

Last Update Submitted That Met QC Criteria

September 23, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023Quick review011

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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