Clinical trial · Interventional
Rituximab in Addition to Chemotherapy With Autologous Stem Cell Transplantation as Treatment Diffuse Large B-Cell Lymphoma
Programma di Terapia Per Pazienti Affetti da Linfoma Diffuso a Grandi Cellule B CD20 Positive
NCT00556127CI-TRIAL-00000961DLBCLcompletedPhase 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 purpose of this trial was to evaluate efficacy and safety of adding Rituximab to dose-dense and High-Dose Chemotherapy (HDC) with Autologous Stem Cell Transplantation (ASCT) as first line treatment in young patients with DLBCL at Intermediate-High and High risk aaIPI score
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 |
|---|---|---|---|
| Diffuse Large B-Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| POOR PROGNOSIS | — | UNRESOLVED | — |
Interventions
Interventions (14)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carmustine BCNU | Drug | Carmustine | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Cytarabine ARA-C | Drug | Cytarabine | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Epirubicin | Drug | Epirubicin | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Granulocyte-colony-stimulating factor | Drug | — | UNRESOLVED |
| Melphalan | Drug | Melphalan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: Rituximab
- Drug: Epirubicin
- Drug: Cyclophosphamide
- Drug: Vincristine
- Drug: Prednisone
- Drug: Granulocyte-colony-stimulating factor
- Drug: Mitoxantrone
- Drug: Cytarabine ARA-C
- Drug: Dexamethasone
- Drug: Carmustine BCNU
- Drug: Etoposide
- Drug: Melphalan
- Radiation: Radiotherapy
- Procedure: PBSC reinfusion
Primary outcomes (1)
- measure
- Failure-free survival
- timeFrame
- Three years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * previously untreated aggressive B-cell lymphoma (Diffuse Large B-Cell, * Primary Mediastinal, * Follicular grade III b Lymphoma); * age 18 to 60; * III-IV Ann Arbor stage; * 0-2 Eastern Cooperative Oncology Group (ECOG) performance status (PS); * intermediate-high (IH) and high (H) risk score according to age-adjusted International Prognostic Index (IPI). * Patients with Primary Mediastinal Lymphoma were included only if they had advanced stage III or IV disease. Exclusion Criteria: * HIV, * hepatitis B or C virus seropositivity; * CNS involvement at diagnosis; * abnormal renal, pulmonary and hepatic function; * left ventricular ejection fraction less than 45%; * pregnancy.
References
Publications (0)
Data not yet available
No reference posted for this study.