Clinical trial · Interventional
Colony-Stimulating Factors to Relieve Neutropenia in Patients With Recurrent Non-Hodgkin's Lymphoma
A Randomized, Multicenter, Open-Label Study of Single Dose Filgrastim-SD/01 Versus Daily Filgrastim Following ESHAP Chemotherapy for Non-Hodgkin's Lymphoma
NCT00004192CI-TRIAL-00072595completedPhase 2ClinicalTrials.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)
RATIONALE: Colony-stimulating factors may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Randomized phase II trial to compare the effectiveness of filgrastim-SD/01 with that of filgrastim to relieve the neutropenia following combination chemotherapy in patients who have non-Hodgkin's lymphoma.
Conditions
Conditions (2)
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 |
| Neutropenia | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| methylprednisolone | Drug | — | UNRESOLVED |
| pegfilgrastim | Biological | Pegfilgrastim | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Single Dose Filgrastim (SD/01)
- description
- Participants receive etoposide IV over 1 hour on days 1-4, cisplatin IV continuously on days 1-4, methylprednisolone IV over 15 minutes on days 1-5, and cytarabine IV over 2 hours on day 5. Treatment is repeated every 21 days for up to 4 courses. Arm I: Participants receive filgrastim-SD/01 subcutaneously (SQ) on day 6.
- interventionNames
- Biological: filgrastim
- Drug: cisplatin
- Drug: cytarabine
- Drug: etoposide
- Drug: methylprednisolone
- type
- EXPERIMENTAL
- label
- Daily Filgrastim (G-CSF)
- description
- Participants receive etoposide IV over 1 hour on days 1-4, cisplatin IV continuously on days 1-4, methylprednisolone IV over 15 minutes on days 1-5, and cytarabine IV over 2 hours on day 5. Treatment is repeated every 21 days for up to 4 courses. Arm II: Participants receive filgrastim (G-CSF) SQ daily beginning on day 6 and continuing for 12 days or until blood counts recover.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of non-Hodgkin's lymphoma (NHL) o Relapsed disease or Refractory to first line cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy * Age 18 and over * ECOG 0-2Absolute neutrophil count at least 1,500/mm3Platelet count at least 150,000/mm3 * Creatinine not greater than 1.5 mg/dL or Creatinine clearance greater than 60 mL/min * Fertile patients must use effective barrier contraception * At least 4 weeks since prior radiotherapy * At least 72 hours since prior antimicrobials * At least 30 days since other prior investigational drug Exclusion Criteria: * No myelodysplastic syndrome or chronic myeloid leukemia * Not pregnant or nursing/Negative pregnancy test * No other prior malignancy except * Curatively treated basal cell or squamous cell carcinoma * Carcinoma in situ of the cervix * Surgically cured malignancy * No hypersensitivity to E. coli derived products (e.g., filgrastim (G-CSF), insulin, asparaginase) * No prior bone marrow or peripheral blood stem cell (PBSC) transplantation for NHL * No prior filgrastim-SD/01 * No other concurrent myelopoietic growth factors * No concurrent WBC transfusions * No concurrent PBSC collection * No more than 2 prior courses of chemotherapy for any malignancy * No concurrent corticosteroids except topical steroids or as pre-medications or associated with chemotherapy * No other concurrent investigational drug * No concurrent prophylactic antibiotics during course 1
References
Publications (0)
Data not yet available
No reference posted for this study.