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

NCT ID: NCT06060080

Last Updated: 2023-09-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-22
• Study Completion Date: 2024-04-30

Brief Summary

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.

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.

Conditions

Lymphoma; Multiple Myeloma

Keywords

PEG-rhG-CSF; Autologous Hematopoietic Stem Cell; Transplantation; Effectiveness; Safety

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

pegylated recombinant human granulocyte-colony stimulating factor

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

PEG-rhG-CSF

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yao Liu

OTHER

Sponsor Role: lead

Responsible Party

Yao Liu

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Yao Liu

Role: primary

Other Identifiers

2023Quick review011

Identifier Type: -

Identifier Source: org_study_id