Using PEG-rhG-CSF to help recover neutrophils after stem cell transplant in lymphoma and multiple myeloma patients

Medical Professor,CHONGQING UNIVERSITY CANCER HOSPITAL

This study is testing if an injection called PEG-rhG-CSF can help lymphoma and multiple myeloma patients recover their white blood cells faster after a stem cell transplant.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 7 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Chongqing University Cancer Hospital (other)
• Locations: 1 site (Chongqing, Chongqing)
• Trial ID: NCT06060080 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of PEG-rhG-CSF injection for neutrophil cell reconstruction following autologous hematopoietic stem cell transplantation in patients with lymphoma or multiple myeloma. It is a single-center, open-label trial enrolling approximately 40 patients who meet specific eligibility criteria. Participants will receive a fixed dose of PEG-rhG-CSF on the second day after stem cell infusion, and the primary outcome will measure the median time for neutrophil recovery. Secondary outcomes will assess safety, duration of neutropenia, and other related health indicators.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with lymphoma or multiple myeloma undergoing their first autologous hematopoietic stem cell transplantation.

Not a fit: Patients with splenomegaly or severe comorbidities that conflict with the study protocol may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly improve neutrophil recovery times and overall patient outcomes after stem cell transplantation.

How similar studies have performed: Other studies have shown promising results with similar approaches using granulocyte-colony stimulating factors, indicating potential for success in this trial.

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.

Where this trial is running

Chongqing, Chongqing

• Chongqing University Cancer Hospital — Chongqing, Chongqing, China (RECRUITING)

Conditions: Lymphoma, Multiple Myeloma, PEG-rhG-CSF, Autologous Hematopoietic Stem Cell, Transplantation, Effectiveness, Safety