Clinical trial · Interventional
Comparison of High-Dose Chemotherapy + Rituximab and CHOP + Rituximab in High-Risk Follicular Lymphoma
MULTICENTER RANDOMIZED PROGRAM COMPARING HIGH-DOSE CHEMOTHERAPY + RITUXIMAB AND PERIPHERAL BLOOD PROGENITOR CELL (PBPC) AUTOGRAFT vs. CHOP + RITUXIMAB AS FIRST-LINE TREATMENT FOR PATIENTS WITH HIGH-RISK FOLLICULAR LYMPHOMA
NCT00435955CI-TRIAL-00000604unknownPhase 3ClinicalTrials.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 this study is to determine whether an intensified treatment plus Rituximab followed by autologous transplantation is superior to a conventional chemotherapy regimen also supplemented with Rituximab.
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 |
|---|---|---|---|
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High dose chemotherapy with autologous transplantation | Procedure | — | UNRESOLVED |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Event free survival at three years
Secondary outcomes (7)
- measure
- Overall survival
- measure
- CR rate
- measure
- Progression free survival
- measure
- Disease free survival I
- measure
- Incidence of secondary myelodisplasia and solid cancer
- measure
- Rate of molecular remission
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. Follicular Lymphoma at diagnosis 2. Stage \>I 3. age-adjusted I.P.I. score 2 or 3 or three or more adverse factors of the I.L.I. score Exclusion Criteria: 1. Serum positivity for HIV, HCV. HBsAg-positive only if active viral replication, assessed by HBV-DNA was present. 2. Major alterations of heart, lung, kidneys, liver, except for those directly disease-related; 3. Evidence of second tumors; 4. Previous chemotherapy( except patients who received limited radiotherapy); 5. Cerebral or CNS involvement. 6. Drug addiction or severe psychiatric disease
References
Publications (1)
- DERIVEDLadetto M, De Marco F, Benedetti F, Vitolo U, Patti C, Rambaldi A, Pulsoni A, Musso M, Liberati AM, Olivieri A, Gallamini A, Pogliani E, Rota Scalabrini D, Callea V, Di Raimondo F, Pavone V, Tucci A, Cortelazzo S, Levis A, Boccadoro M, Majolino I, Pileri A, Gianni AM, Passera R, Corradini P, Tarella C; Gruppo Italiano Trapianto di Midollo Osseo (GITMO); Intergruppo Italiano Linfomi (IIL). Prospective, multicenter randomized GITMO/IIL trial comparing intensive (R-HDS) versus conventional (CHOP-R) chemoimmunotherapy in high-risk follicular lymphoma at diagnosis: the superior disease control of R-HDS does not translate into an overall survival advantage. Blood. 2008 Apr 15;111(8):4004-13. doi: 10.1182/blood-2007-10-116749. Epub 2008 Jan 31. PMID 18239086