Using PEG-rhG-CSF to help collect stem cells for lymphoma treatment
Clinical Study on the Effectiveness and Safety of PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells for Lymphoma and Multiple Myeloma
This study is testing if a new drug called PEG-rhG-CSF can help collect stem cells more effectively for people with lymphoma and multiple myeloma compared to a standard treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 174 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Chongqing University Cancer Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Chongqing, Chongqing) |
| Trial ID | NCT06026995 on ClinicalTrials.gov |
What this trial studies
This clinical study evaluates the effectiveness and safety of PEG-rhG-CSF in mobilizing autologous hematopoietic stem cells in patients with lymphoma and multiple myeloma. Participants are randomly assigned to receive either PEG-rhG-CSF at a fixed dose or rhG-CSF with a daily mobilization regimen until stem cell collection is complete. The study aims to determine which method is more effective for stem cell mobilization while ensuring patient safety. It is a multi-center, randomized controlled trial involving patients who meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with lymphoma or multiple myeloma requiring autologous stem cell transplantation.
Not a fit: Patients who have previously undergone stem cell transplantation or have severe organ dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the efficiency of stem cell collection for patients undergoing treatment for lymphoma and multiple myeloma.
How similar studies have performed: Other studies have shown promising results with similar approaches in stem cell mobilization, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 18-65 years old, regardless of sex; 2. Patients with lymphoma and multiple myeloma who need autologous hematopoietic stem cell transplantation; 3. KPS score ≥70; 4. creatinine clearance rate ≥ 50mL/min, total bilirubin level \< 1.5mg/dL, ALT and AST \< 2 times the upper limit of normal value; 5. Absolute neutrophil count (ANC)≥1.5×109/L, platelet count ≥80×109/L, Hb≥ 75g/L, WBC ≥ 3.0× 109/L; 6. Patients can tolerate chemotherapy; 7. No active infection before chemotherapy; 8. The patient voluntarily participated in this trial and signed the informed consent form; 9. The researcher thinks that the subjects can benefit. Exclusion Criteria: 1. Those who have previously received allogeneic or autologous hematopoietic stem cell transplantation; 2. Serious or uncontrolled virus infection: HIV, syphilis positive; 3. Severe dysfunction of internal organs; 4. severe mental or nervous system diseases; 5. allergic to PEG-rhG-CSF, rhG-CSF and other preparations or proteins expressed in Escherichia coli; 6. pregnant or lactating female patients; Women of childbearing age refuse to accept contraceptive measures; Those who plan to become pregnant during the study period; 7. The researcher judges other subjects who are not suitable to participate.
Where this trial is running
Chongqing, Chongqing
- Chongqing University Cancer Hospital — Chongqing, Chongqing, China (Recruiting)
Study contacts
- Study coordinator: Yao Liu, doctor
- Email: 64823926@qq.com
- Phone: 132 2868 4685
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.