Clinical trial · Interventional
Efficacy Study of Outpatient Therapy for Lymphoma
A Multicentre Phase II Study of Risk-adjusted Outpatient-based Salvage Therapy for Patients With Relapsed and Refractory Lymphoma
NCT00163761CI-TRIAL-00020463completedPhase 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)
This is a Phase II trial evaluating the efficacy (overall response rate) of a risk-adjusted outpatient based approach to lymphoma salvage therapy with vinorelbine, gemcitabine and pegfilgrastim and/or gemcitabine, ifosfamide, vinorelbine and pegfilgrastim.
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 |
|---|---|---|---|
| Hodgkin's Disease | Hodgkin Lymphoma | ALIAS | 0.90 |
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine, vinorelbine, filgastrim | Drug | — | UNRESOLVED |
| gemcitabine, vinorelbine, ifosfamide, filgastrim | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Commence VGF treatment
- description
- Drug. Vinorelbine, gemcitabine and filgrastim 21 day cycle
- interventionNames
- Drug: gemcitabine, vinorelbine, filgastrim
- type
- ACTIVE_COMPARATOR
- label
- Commence F-GIV treatment
- description
- Drug. Gemcitabine, ifosfamide, Vinorelbine and filgrastim 21 day cycle
- interventionNames
- Drug: gemcitabine, vinorelbine, ifosfamide, filgastrim
Primary outcomes (1)
- measure
- To evaluate the efficacy (overall response rate) of a risk-adjusted outpatient-based approach to lymphoma salvage therapy with VGF (vinorelbine, gemcitabine and pegfilgrastim) and/or F-GIV (gemcitabine, Ifosfamide, vinorelbine and pegfilgrastim).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * age \> 18 years * relapsed or primary refractory non-Hodgkin's lymphoma (NHL) or Hodgkin's Disease (HD) * ECOG 0 - 2 * written informed consent Exclusion criteria: * Intention to proceed with any form of transplant therapy following fewer than 2 cycles of protocol salvage therapy * bilirubin \> 50μmol/litre unless secondary to lymphoma * creatinine \> 2 x upper limit of normal unless secondary to lymphoma, absolute neutrophil count \<0.5 x 109/litre and / or platelets \< 50 x 109/litre unless secondary to lymphoma * relapse within 6 months of a prior transplant procedure (autologous or allogeneic) * known sensitivity to E coli derived preparations
References
Publications (0)
Data not yet available
No reference posted for this study.