Clinical trial · Interventional
Efficacy , Safety of Treatment R NIMP for Relapsed Aggressive Lymphomas
Phase II Study of Treatment of Relapsed Agressive Lymphomas
NCT00842595CI-TRIAL-00011461completedPhase 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)
The primary objective of the protocol is to estimate the complete response rate of three courses of the association of rituximab, navelbine, ifosfamide, mitoxantrone, and prednisone in relapsed aggressive non hodgkin's B-cell 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 |
|---|---|---|---|
| Diffuse Large B-Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ifosfamide | Drug | Ifosfamide | ALIAS |
| Mitoxantrone | Drug | Mitoxantrone | ALIAS |
| Prednisone | Drug | Prednisone | ALIAS |
| rituximab | Drug | Rituximab | ALIAS |
| vinorelbine | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- R NIMP
- description
- (Mabthera®) Rituximab IV 375 mg/m²day 1 (Navelbine ®)Vinorelbine IV 25mg/m² day 1 and day 5 (Novantrone®)Mitoxantrone IV 10 mg/m² day 1 (Holoxan®)Ifostamide IV 1000 mg/m²day 1 to day 5 (Cortancyl®)prednisone oral day 1 to day 5
- interventionNames
- Drug: rituximab
- Drug: vinorelbine
- Drug: ifosfamide
- Drug: Mitoxantrone
- Drug: Prednisone
Primary outcomes (1)
- measure
- Complete remission rate
- timeFrame
- CR AFTER 3 R NIMP COURSES
Secondary outcomes (3)
- measure
- overall remission rate
- timeFrame
- OS after 3 R NIMP COURSES
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Both genders, between 18 and 75 years old * CD 20+ large cell lymphoma * In first relapse * No previous autologous stem cell transplantation or relapsing more than 12 months after an autologous stem cell transplantation * Ann Arbor stage I, II, III ou IV * ECOG 0,1 or 2 * Signed informed consent Exclusion Criteria: * age: before 18 and more than 75 years old * other type of lymphoma * Informed consent not signed
References
Publications (0)
Data not yet available
No reference posted for this study.