Clinical trial · Interventional
PEG-rhG-CSF in Lymphoma Patients After Autologous Hematopoietic Stem Cell Transplantation
A Single Center Randomized Controlled Trial of the Efficacy and Safety of PEG-rhG-CSF After Autologous Hematopoietic Stem Cell Transplantation for Lymphoma Patients
NCT02905942CI-TRIAL-00023925unknownPhase 4ClinicalTrials.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 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 control group received rhG-CSF day +1 after transplantation.
- interventionNames
- Drug: rhG-CSF
Primary outcomes (1)
- measure
- Time to neutrophil engraftment
- timeFrame
- 30days
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. Lymphoma patients with the requirement for autologous hematopoietic stem cell transplantation.
3. The collected CD34+ cells≥1×10E6/kg.
4. ECOG score ≤2.
5. Heart and lung is normal.
6. Blood creatinine ≤1.5×ULN.
7. ALT, AST, TBIL ≤2 ×ULN
8. Not in pregnancy.
9. Written informed consent are acquired.
Exclusion Criteria:
1. Had received autologous hematopoietic stem cell transplantation or allogeneic transplantation.
2. Severe or uncontrolled infectious diseases: HIV, HCV, syphilis, ALT, chronic hepatitis B.
3. Serious complications, such as severe infection, heart, lung, liver and kidney dysfunction.
4. LVEF \<55%.
5. Allergic to the product or other biological products from genetically engineered Escherichia coli strains.
6. Refused to take contraceptive measures during the study period and the subsequent 1 years.
7. Severe mental or neurological disorders.
8. Serious heart, lung, central nervous system disorders.
9. Sickle cell anemia, hemolytic anemia and other hematologic diseases.
10. Participate in other drugs clinical trials 30 days before the screening.
11. Other situation that investigators consider as contra-indication for this study.
\-References
Publications (0)
Data not yet available
No reference posted for this study.