Comparison of HD Chemotherapy Followed by Auto-Transplant and R-CHOP in High Risk Patients With DLBCL. - Full Text View

Sponsored by:	Gruppo Italiano Terapie Innovative nei Linfomi
Information provided by:	Gruppo Italiano Terapie Innovative nei Linfomi
ClinicalTrials.gov Identifier:	NCT00355199

Purpose

Multicentric randomized phase III study comparing high doses of chemotherapy with Rituximab followed by auto-transplant HPC versus CHOP plus Rituximab as first line therapy in high risk patients with DLBCL Non-Hodgkin's lymphomas.

Condition	Intervention	Phase
Diffuse Large B Cells Non-Hodgkin's Lymphomas	Drug: Rituximab-HDS Drug: Rituximab-CHOP	Phase III

MedlinePlus related topics: Lymphoma

Drug Information available for: Rituximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Multicentric Randomized Phase III Study Comparing High Doses of Chemotherapy With Rituximab Followed by Auto-Transplant HPC Versus CHOP Plus Rituximab as First Line Therapy in High Risk Patients With DLBCL Non-Hodgkin's Lymphomas

Further study details as provided by Gruppo Italiano Terapie Innovative nei Linfomi:

Primary Outcome Measures:

Complete remission and disease free survival
Overall survival and event free survival
Toxicity

Secondary Outcome Measures:

Efficacy of R-HDS conditioning as salvage therapy in patients non-responders after four cycles of R-CHOP 14

Estimated Enrollment:	240
Study Start Date:	May 2005

Arms	Assigned Interventions
1: Experimental rituximab-HDS	Drug: Rituximab-HDS Rituximab-HDS
2: Active Comparator Rituximab-CHOP	Drug: Rituximab-CHOP Rituximab-CHOP

Detailed Description:

Diffuse large B cells Non-Hodgkin's lymphomas represents one of the most frequent form of lymphoma. Its clinical development progresses rapidly and is characterized by a biphasic survival curve with patients in complete remission (which can be considered cured) and patients that relapse. This last group of subjects have only 25%-33% chance of long free disease survival if treated with a second line therapy with high dose chemotherapy plus autologous transplant of PBPC.

Therefore in order to achieve an improvement of the overall survival in patient with DLBCL, it is necessary to increase the number of complete remission after first line therapy.

The aim of R-HDS study, multicentre randomized phase III trial, is to evaluate and compare the efficacy and safety of an intensive conditioning regimen with high intensity chemo-immunotherapy (R-HDS) plus autologous transplantation versus CHOP conditioning regimen plus Rituximab in patients with unfavorable prognosis at diagnosis.

Eligibility

Ages Eligible for Study:	15 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of DLBCL CD20+.
Patients with Ann Arbor classification B-bulk >= II
Patients of age between 18-65 with age-adjusted IPI 2-3 and ECOG performance status 0-3 or patients of age 61-65 with IPI 3, 4, 5 and ECOG performance status 0-2. The disease stage criteria must be documented with instrumental examinations and bone marrow biopsy.
Hematology parameters one week before starting study as follows: Hb >= 9 g/dl, WBC >= 3 x 10exp9/l, neutrophils >= 1.5 x 10exp9/l, PLT >= 100 x 10exp9/l.
Patients with pulmonary DLCO >= 50% and cardiac EF >= 40%.
Voluntary written informed consent must be signed before recruitment, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. Patients must to be informed on the risk of sterility and they must agree to use contraception for the duration of the study. Male subject have to the opportunity of freezing seminal fluid.

Exclusion Criteria:

Diagnosis different from that describe above.
Patients with concomitant, serious and uncontrolled illnesses such as cardiopathies (i.e. congestive cardiopathy, ischemic hearth disease, cardiac arrhythmia not controlled by therapy, IMA in the last six months, hearth disease NYHA class III or IV), hepatopathy not related to the lymphoma (bilirubin >= 2 mg/dl, ALT >= 2.5 times the normal value, alkaline phosphatase >=2.5 times the upper limit), kidneys insufficiency not related to the lymphoma (creatinine >=2 mg/dl).
Patients affected by opportunistic infections or with positive serology for HIV, HCV, HbsAg (cases with normal levels of hepatic enzymes and not showing active viral replication documented with HBV-DNA are not excluded from randomization; patients with HBV+ can be enrolled after receiving prophylaxis with lamivudina one week before starting chemotherapy. These patients should be monitored twice a month for HbsAg, HBCab, HBV-DNA).
Patients which have or have had another type of cancer exception made for skin cancers (melanoma and "in situ" cervical cancer not included).
Patient with a history of anaphylaxes or more generally patients which have had any serious allergic reaction after serum infusion.
Patient with uncontrolled epilepsy, CNS disorders or psychiatric problems which, according to the investigator, is likely to interfere with participation in this clinical study (i.e. the signing of the informed consent, therapy compliance).
Inability to attend follow-up visits.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00355199

Contacts

Contact: Marchioli Roberto, Dr

+39-0872-570204

marchioli@negrisud.it

Locations

Italy
Divisione di Ematologia - Ospedale Centrale di Bolzano	Recruiting
Bolzano, Italy
Principal Investigator: Sergio Cortelazzo, MD
Sub-Investigator: Atto Billio, MD
Sub-Investigator: Carlo Rosanelli, MD
Divisione di Ematologia - Ospedale Ferrarotto	Recruiting
Catania, Italy
Principal Investigator: Francesco Di Raimondo, MD
Sub-Investigator: Giuseppe Palumbo, MD
Sub-Investigator: Paolo Fiumara, MD
Sub-Investigator: Annalisa Chiarenza, MD
Sub-Investigator: Luciana Schinocca, MD
U.O. Ematologia - Ospedali Riuniti di Bergamo	Recruiting
Bergamo, Italy
Principal Investigator: Alessandro Rambaldi, MD
Sub-Investigator: Anna Grassi, MD
Sub-Investigator: Piera Viero, MD
Sub-Investigator: Andrea Rossi, MD
Sub-Investigator: Federica Delaini, BSc
Clinica di Ematologia - Nuovo Ospedale Torrette	Recruiting
Ancona, Italy
Principal Investigator: Pietro Leoni, MD
Sub-Investigator: Mauro Montanari, MD
Sub-Investigator: Guido Gini, MD
Sub-Investigator: Rosanna Re, MD
CTMO - Ematologia - Ospedale "R. Binaghi"	Recruiting
Cagliari, Italy
Principal Investigator: Giorgio La Nasa, MD
Sub-Investigator: Antonella Pizzati, MD
S.C. Ematologia - Azienda Ospedaliera S. Croce e Carle	Recruiting
Cuneo, Italy
Principal Investigator: Andrea Gallamini, MD
Sub-Investigator: Roberta Calvi, MD
U.O. Ematologia - Istituto Nazionale dei Tumori	Recruiting
Milano, Italy
Principal Investigator: Paolo Corradini, MD
Sub-Investigator: Matteo Carrabba, MD
Sub-Investigator: Anna Dodero, MD
Sub-Investigator: Liana Bevilacqua, MD
Oncologia Medica - Istituto Nazionale dei Tumori	Recruiting
Milano, Italy
Principal Investigator: Alessandro Gianni, MD
Sub-Investigator: Massimo Di Nicola, MD
Sub-Investigator: Liliana Devizzi, MD
Sub-Investigator: Michele Magni, MD
Sub-Investigator: Paola Matteucci, MD
Divisione Ematologia - Istituto S. Raffaele	Recruiting
Milano, Italy
Principal Investigator: Fabio Ciceri, MD
Sub-Investigator: Roberto Crocchiolo, MD
Ematologia - Azienda Ospedaliera V. Cervello	Recruiting
Palermo, Italy
Principal Investigator: Caterina Patti, MD
Sub-Investigator: Salvatore Mirto, MD
Sub-Investigator: Monica Leone, MD
Sub-Investigator: Alessandro Costa, MD
Sub-Investigator: Alessandro Mistretta, MD
Ematologia Clinica - Ospedale Civile di Pescara	Recruiting
Pescara, Italy
Principal Investigator: Giuseppe Fioritoni, MD
Sub-Investigator: Francesco Angrilli, MD
Sub-Investigator: Antonio Spadano, MD
Sub-Investigator: Luigi D'Arcangelo, MD
Sub-Investigator: Cecilia Passeri, MD
Ematologia e TMO - Ospedale S. Camillo	Recruiting
Roma, Italy
Principal Investigator: Valerio Zoli, MD
Divisione Universitaria di Ematologia - Azienda Ospedaliera S. Giovanni Battista (Molinette)	Recruiting
Torino, Italy
Principal Investigator: Corrado Tarella, MD
Sub-Investigator: Daniele Caracciolo, MD
Sub-Investigator: Manuela Zanni, MD
Sub-Investigator: Marco Ladetto, MD
Dipartimento di Medicina Clinica e Sperimentale - Università di Verona	Recruiting
Verona, Italy
Principal Investigator: Fabio Benedetti, MD
Sub-Investigator: Marco Sorio, MD
Divisione di Ematologia - Presidio Ospedaliero S. Bortolo	Recruiting
Vicenza, Italy
Principal Investigator: Maurizio Frezzato, MD
Sub-Investigator: Carlo Visco, MD
Divisione di Ematologia - Azienda Ospedaliera	Recruiting
Padova, Italy
Principal Investigator: Gianpietro Semenzato, MD
Sub-Investigator: Renato Zambello, MD
Sub-Investigator: Livio Trentin, MD

Sponsors and Collaborators

Gruppo Italiano Terapie Innovative nei Linfomi

Investigators

Study Chair:

Sergio Cortelazzo, MD

Divisione di Ematologia - Ospedale Centrale di Bolzano - 39100 Bolzano Italy

More Information

Study ID Numbers:	EUDRACT: 2005-00700-14
Study First Received:	July 20, 2006
Last Updated:	November 7, 2007
ClinicalTrials.gov Identifier:	NCT00355199
Health Authority:	Italy: Ministry of Health

Keywords provided by Gruppo Italiano Terapie Innovative nei Linfomi:

DLBCL
R-HDS
R-CHOP14

Study placed in the following topic categories:

Lymphoma, B-Cell
Lymphatic Diseases
Immunoproliferative Disorders
Rituximab
B-cell lymphomas

Lymphoma, small cleaved-cell, diffuse
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Immune System Diseases
Antineoplastic Agents

Therapeutic Uses
Physiological Effects of Drugs
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009