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

Phase 2

Completed

• Conditions: Diffuse Large B-Cell Lymphoma; POOR PROGNOSIS
• Interventions: 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

• Registration Number: NCT00556127
• Lead Sponsor: Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2002-06
• Study Completion: 2006-09
• Status Verified: 2007-11
• Study First Submitted: 2007-11-08
• Study First Submitted QC: 2007-11-08
• Last Update Submitted: 2007-11-08
• Study First Posted: 2007-11-09
• Last Update Posted: 2007-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Epirubicin	-
1	Cyclophosphamide	-
1	Vincristine	-
1	Granulocyte-colony-stimulating factor	-
1	Mitoxantrone	-
1	Cytarabine ARA-C	-
1	Carmustine BCNU	-
1	Radiotherapy	-
1	PBSC reinfusion	-
1	Rituximab	-
1	Prednisone	-
1	Dexamethasone	-
1	Etoposide	-
1	Melphalan	-

Primary Outcome Measures

Name	Time	Method
Failure-free survival	Three years

Trial Locations

Locations (14)

Centro Trapianti Midollo Osseo, P.O. Businco; 🇮🇹 Cagliari, Italy

Ospedale S. Gerardo; 🇮🇹 Monza, Italy

Osp. maggiore della Carità; 🇮🇹 Novara, Italy

Divisione di Medicina, Ospedale Generale E. Agnelli, Pinerolo; 🇮🇹 Torino, Italy

Spedali Civili; 🇮🇹 Brescia, Italy

Università degli Studi Policlinico Monteluce; 🇮🇹 Perugia, Italy

Istituto per la Ricerca e la Cura del Cancro, Candiolo; 🇮🇹 Torino, Italy

Osp. S. Giovanni Battista "Molinette"; 🇮🇹 Torino, Italy

Az. Ospedaliera SS. Antonio e Biagio e Cesare Arrigo; 🇮🇹 Alessandria, Italy

Ospedale Regionale, Divisione di Oncologia,; 🇮🇹 Aosta, Italy

Azienda Ospedaliera Ospedale Policlinico Consorziale; 🇮🇹 Bari, Italy

Osp. degli Infermi; 🇮🇹 Biella, Italy

Stabilimento Ospedaliero Ciriè -; 🇮🇹 Torino, Italy

Ospedale di Chivasso e Ivrea; 🇮🇹 Torino, Italy