Rituximab in Addition to Chemotherapy With Autologous Stem Cell Transplantation as Treatment Diffuse Large B-Cell Lymphoma

Study Overview
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Brief Summary
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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

Official Title
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Programma di Terapia Per Pazienti Affetti da Linfoma Diffuso a Grandi Cellule B CD20 Positive

Conditions
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Diffuse Large B-Cell Lymphoma, POOR PROGNOSIS

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Rituximab<br>* 375 mg/m2 on day 1<br>Drug: Epirubicin<br>* 110 mg/m2 on day 3<br>Drug: Cyclophosphamide<br>* 1200 mg/m2 on day 3<br>Drug: Vincristine<br>* 1.4 mg/m2 (maximum 2 mg) on day 3<br>Drug: Prednisone<br>* 40 mg/m2 from day 1 to 5<br>Drug: Granulocyte-colony-stimulating factor<br>* (G-CSF 5 μg/Kg/day) from day 5 to day 11<br>Drug: Mitoxantrone<br>* 8 mg/m2 for 3-day<br>Drug: Cytarabine ARA-C<br>* 2 g/m2/12 hours for six doses in 3-hour infusion<br>Drug: Dexamethasone<br>* 4 mg/m2/12 hours before ARA-C administration<br>Drug: Carmustine BCNU<br>* 300 mg/m2 on day -7<br>Drug: Etoposide<br>* 100 mg/m2/12 hours<br>Drug: Melphalan<br>* 140 mg/m2 on day -2<br>Radiation: Radiotherapy<br>* Involved Field Radiotherapy (IF-RT)<br>Procedure: PBSC reinfusion<br>* ASCT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure-free survival |  | Three years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Large B-cell Lymphoma, Rituximab, ASCT