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Completed

NCT Number: NCT00556127

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

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

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Key information

Conditions

Diffuse Large B-cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type POOR PROGNOSIS

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rituximab

Drug

375 mg/m2 on day 1

Epirubicin

Drug

110 mg/m2 on day 3

Cyclophosphamide

Drug

1200 mg/m2 on day 3

Vincristine

Drug

1.4 mg/m2 (maximum 2 mg) on day 3

Prednisone

Drug

40 mg/m2 from day 1 to 5

Granulocyte-Colony-Stimulating Factor

Drug

(G-CSF 5 μg/Kg/day) from day 5 to day 11

Mitoxantrone

Drug

8 mg/m2 for 3-day

Cytarabine ARA-C

Drug

2 g/m2/12 hours for six doses in 3-hour infusion

Dexamethasone

Drug

4 mg/m2/12 hours before ARA-C administration

Carmustine BCNU

Drug

300 mg/m2 on day -7

etoposide

Drug

100 mg/m2/12 hours

melphalan

Drug

140 mg/m2 on day -2

Radiotherapy

Radiation

Involved Field Radiotherapy (IF-RT)

PBSC reinfusion

Procedure

ASCT

Primary outcomes

  1. Failure-free survival

    Time frame: Three years

Sponsors and collaborators

Lead sponsor

Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie

Other

Registry information

Official study title

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

Acronym: DLBCL

Important dates

Study start
2002
Study completion
2006
First posted
Nov 9, 2007
Registry last updated
Nov 9, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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