Clinical trial · Interventional
A Phase II Study of Paclitaxel and Topotecan With Filgrastim-SD/01 Support For Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma
A Phase II Study of Paclitaxel and Topotecan With Filgrastim-SD/01 Support For Patients With Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma
NCT00038545CI-TRIAL-00035523completedPhase 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)
For patients with relapsed and refractory aggressive non-Hodgkin's 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 |
|---|---|---|---|
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Filgrastim SD/01 | Drug | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Topotecan | Drug | Topotecan | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
INCLUSION: * Bidimensionally measurable current/refractory aggressive NHL (Diffuse lg cell, diffuse mixed cell, follicular lg non-cleaved, immunoblastic, Ki-1+ALCL, peripheral T-cell lymphoma, mantle cell lymphoma \& transformed lymphoma.) * No more than 3 prior treatment regimens. No anti-lymphoma therapy within the past 3 weeks. * Not be eligible for treatment of a higher priority. * Performance status \<2 Zubrod, \> 60 Karnofsky. * Good marrow reserve: ANC\>1.5 x 10(9)/L, platelets \> 100 x 10(9)/L. * Bilirubin \<1.5mg/dL, SGOT, SGPT \< 2 x normal values. * Serum creatinine \< 1.8 mg/dL. * Age \> 18 yrs. * Signed informed consent. * Life expectancy of \> 12 weeks. * No prior Taxane (paclitaxel or docetaxel), topotecan, or CPT-11. * No prior stem cell or bone marrow transplantation. * No prior second malignancies except for basal cell carcinoma of the skin. EXCLUSION: * Active or prior history of CNS lymphoma. * Serious intercurrent medical illnesses requiring hospitalization. * History of primary/secondary immunodeficiency (other than related to the malignant lymphoma because treatment is dependent on a functional immune system) or patients taking immunosuppressive drugs (systemic corticosteroids). * Prior exposure to Filgrastim-SD/01. * Women who are pregnant or lactating. * Participation in another clinical trial. * Positive HIV antibody. * History of prior sensitivity to E. coli derived products (such as filgrastim/neupogen).
References
Publications (0)
Data not yet available
No reference posted for this study.