Clinical trial · Interventional
Clinical Study on PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells
Clinical Study on the Effectiveness and Safety of PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells for Lymphoma and Multiple Myeloma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a randomized controlled, open and multi-center clinical study. Patients who meet the selection criteria and do not meet the exclusion criteria are randomly given PEG-rhG-CSF with a fixed dose of 12mg when white blood cells reach the lowest point, or given rhG-CSF with a daily mobilization of 5-10μ g/kg until the collection is completed, so as to evaluate the effectiveness and safety of PEG-rhG-CSF in mobilizing autologous stem cells for lymphoma and multiple myeloma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PEG-rhG-CSF | Drug | — | UNRESOLVED |
| RhG-CSF | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- experimental group
- interventionNames
- Drug: PEG-rhG-CSF
- type
- ACTIVE_COMPARATOR
- label
- control group
- interventionNames
- Drug: RhG-CSF
Primary outcomes (1)
- measure
- The proportion of patients with CD34+ cells ≥2×106/kg
- timeFrame
- 28 days
- description
- The proportion of patients with CD34+ cells ≥2×106/kg
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available