Clinical trial · Interventional
PEG-rhG-CSF Compared With rhG-CSF in Lymphoma Patients After Autologous Hematopoietic Stem Cell Transplantation
A Multicenter Randomized Controlled Trial of the Efficacy and Safety of PEG-rhG-CSF Compared With rhG-CSF After Autologous Hematopoietic Stem Cell Transplantation for Lymphoma Patients
NCT05156554CI-TRIAL-00055505unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of the study is to evaluate the efficacy and safety of PEG-rhG-CSF compared with rhG-CSF on the recovery of hematopoietic function after autologous stem cell transplantation in patients with lymphoma.
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
- PEG-rhG-CSF
- description
- Patients in PEG-rhG-CSF group received PEG-rhG-CSF day+1 after transplantation.
- interventionNames
- Drug: PEG-rhG-CSF
- type
- ACTIVE_COMPARATOR
- label
- rhG-CSF
- description
- Patients in rhG-CSF group received rhG-CSF day+1 after transplantation.
- interventionNames
- Drug: rhG-CSF
Primary outcomes (1)
- measure
- Time to neutrophil engraftment
- timeFrame
- 30 days
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with age between 18 and 65 years; 2. hematopoietic stem cell transplantation for the first time; 3. Lymphoma patients with the requirement for autologous; 4. ECOG score ≤2; 5. Estimated survival time \> 3 months; 6. All acute toxicity caused by previous chemotherapy or treatment has been restored; 7.1) The absolute value of neutrophils (\>1.5×10\^9/L); Hemoglobin (\> 90 g/L); 2)Upper Limit Normal (ULN) or creatinine clearance rate (\>40 mL/min) of serum creatinine (\<1.5 times normal value upper limit) (estimated by Cockcroft-Gault formula); Serum total bilirubin \< 1.5 times ULN; Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) = 2.5 times ULN; 7) Coagulation function: International Normalized Ratio (INR) = 1.5 times ULN; Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) = 1.5 times ULN (unless the subject is receiving anticoagulant therapy and PT and APTT are using anticoagulant therapy at screening time). Within the expected range; Thyrotropin (TSH) or free thyroxine (FT4) or free triiodothyronine (FT3) were all within the normal range (+10%); 8.Not in pregnancy; 9.Written informed consent are acquired. Exclusion Criteria: 1. Had received autologous hematopoietic stem cell transplantation or allogeneic transplantation; 2. bone marrow involvement; 3. Patients with active autoimmune diseases requiring systematic treatment were excluded according to the clinical judgment of the investigators; 4. Patients with active infections requiring systematic treatment were excluded according to the clinical judgment of the investigators; 5. Serious complications, such as severe infection, heart, lung, liver and kidney dysfunction; 6. patients in fever of unknown origin before medication(\>38℃); 7. central nervous system involvement; 8. Patients that received pelvic radiotherapy; 9. patients will received Chemotherapy or radiotherapy under the diaphragm after transplantation ; 10. Participation or consideration of participation in another biomedical study during the follow-up period of the present trial; 11. Pregnant or lactating women; 12. Serious heart, lung, hemorrhagic disease; 13. Past psychiatric history; incapacitated or restricted; 14. patient's condition increase the risk of receiving the drug treatment or confusion about the toxic reaction; 15. Severe intolerance to the growth factor under study, or hypersensitivity to one of their components; 16. the patients did not comply with the study; 17. Other situation that investigators consider as contra-indication for this study.
References
Publications (0)
Data not yet available
No reference posted for this study.