Comparison of High-Dose Chemotherapy + Rituximab and CHOP + Rituximab in High-Risk Follicular Lymphoma

NCT ID: NCT00435955

Last Updated: 2007-02-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-03-31

Brief Summary

The purpose of this study is to determine whether an intensified treatment plus Rituximab followed by autologous transplantation is superior to a conventional chemotherapy regimen also supplemented with Rituximab.

Detailed Description

The place of intensified regimens with autologous stem cell transplantation (ASCT) is poorly defined in FL at diagnosis . Most data arise from studies performed in the pre-Rituximab age. According to these studies, ASCT improved overall survival versus standard salvage approaches in relapsed patients with a high proportion of patients achieving a durable molecular remission. Data at diagnosis are less clear. Three studies have been so far published with contradictory results. Two of these studies showed that intensive therapy ensures a better disease control although in one study a significant extra-mortality from secondary tumors was observed in the intensified arm. A third study found no advantage for patients treated intensively. These results led to the widespread notion that ASCT is not superior to conventional chemotherapy in unselected FL patients. Our previous non-randomized experience employing high dose sequential chemotherapy with a final TBI-free ASCT added some clues to these considerations. Our study employs an autografting procedure which is associated to fewer secondary tumors as it does not include total body irradiation. Moreover we have observed that the our regimen (named HDS) is particularly effective in high-risk patients, suggesting that this specific subgroup is the most appropriate setting for intensified regimens

The present multicenter open label randomized trial took advantage of these observations. In addition we have included Rituximab in both arms as the inclusion of this novel agent is expected to significantly modify the performance of available treatments. We have thus compared a Rituximab-supplemented version of HDS (R-HDS) regimen with six CHOP courses supplemented by an identical number of Rituximab courses. Aim of the study was verify if an intensified approach could be beneficial as first line treatment of high-risk FL patients in the Rituximab age.

Conditions

Follicular Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

High dose chemotherapy with autologous transplantation

Intervention Type: PROCEDURE

Rituximab

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Follicular Lymphoma at diagnosis

2. Stage >I

3. age-adjusted I.P.I. score 2 or 3 or three or more adverse factors of the I.L.I. score

Exclusion Criteria

1. Serum positivity for HIV, HCV. HBsAg-positive only if active viral replication, assessed by HBV-DNA was present.

2. Major alterations of heart, lung, kidneys, liver, except for those directly disease-related;

3. Evidence of second tumors;

4. Previous chemotherapy( except patients who received limited radiotherapy);

5. Cerebral or CNS involvement.

6. Drug addiction or severe psychiatric disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Turin, Italy

OTHER

Sponsor Role: collaborator

Gruppo Italiano Trapianto di Midollo Osseo

OTHER

Sponsor Role: collaborator

Gruppo Italiano Studio Linfomi

OTHER

Sponsor Role: collaborator

Hoffmann-La Roche

INDUSTRY

Sponsor Role: collaborator

Azienda Ospedaliera San Giovanni Battista

OTHER

Sponsor Role: lead

Principal Investigators

Corrado Tarella, MD

Role: PRINCIPAL_INVESTIGATOR

Università di Torino, Azienda Ospedaliera San Giovanni Battista

Marco Ladetto, MD

Role: PRINCIPAL_INVESTIGATOR

Università di Torino Azienda Ospedaliera San Giovanni Battista

Alessandro Pileri, MD

Role: PRINCIPAL_INVESTIGATOR

Università di Torino Azienda Ospedaliera San Giovanni Battista (Now retired)

Mario Boccadoro

Role: PRINCIPAL_INVESTIGATOR

Università di Torino/Azienda Ospedaliera San Giovanni Battista B

Alessandro Gianni

Role: PRINCIPAL_INVESTIGATOR

Istituto Tumori di Milano, Milano Italy

Locations

Divisione di Ematologia Universitaria

Torino, , Italy

Countries

Italy

References

Ladetto M, De Marco F, Benedetti F, Vitolo U, Patti C, Rambaldi A, Pulsoni A, Musso M, Liberati AM, Olivieri A, Gallamini A, Pogliani E, Rota Scalabrini D, Callea V, Di Raimondo F, Pavone V, Tucci A, Cortelazzo S, Levis A, Boccadoro M, Majolino I, Pileri A, Gianni AM, Passera R, Corradini P, Tarella C; Gruppo Italiano Trapianto di Midollo Osseo (GITMO); Intergruppo Italiano Linfomi (IIL). Prospective, multicenter randomized GITMO/IIL trial comparing intensive (R-HDS) versus conventional (CHOP-R) chemoimmunotherapy in high-risk follicular lymphoma at diagnosis: the superior disease control of R-HDS does not translate into an overall survival advantage. Blood. 2008 Apr 15;111(8):4004-13. doi: 10.1182/blood-2007-10-116749. Epub 2008 Jan 31.

Reference Type: DERIVED

PMID: 18239086 (View on PubMed)

Other Identifiers

3320

Identifier Type: -

Identifier Source: org_study_id