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

Follicular Lymphoma Clinical Trial

Official title:

MULTICENTER RANDOMIZED PROGRAM COMPARING HIGH-DOSE CHEMOTHERAPY + RITUXIMAB AND PERIPHERAL BLOOD PROGENITOR CELL (PBPC) AUTOGRAFT vs. CHOP + RITUXIMAB AS FIRST-LINE TREATMENT FOR PATIENTS WITH HIGH-RISK FOLLICULAR LYMPHOMA

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00435955
• Other study ID #: 3320
• Status: Active, not recruiting
• Phase: Phase 3
• First received: February 15, 2007
• Last updated: February 15, 2007
• Start date: March 2000

Study information

• Verified date: February 2007
• Source: Azienda Ospedaliera San Giovanni Battista
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Follicular Lymphoma
• Lymphoma
• Lymphoma, Follicular

Intervention

Procedure:
• High dose chemotherapy with autologous transplantation

Drug:
• Rituximab

Locations

Country	Name	City	State
Italy	Divisione di Ematologia Universitaria	Torino

Sponsors (5)

Lead Sponsor	Collaborator
Azienda Ospedaliera San Giovanni Battista	Gruppo Italiano Studio Linfomi, Gruppo Italiano Trapianto di Midollo Osseo, Hoffmann-La Roche, University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event free survival at three years
Secondary	Overall survival
Secondary	CR rate
Secondary	Progression free survival
Secondary	Disease free survival I
Secondary	Incidence of secondary myelodisplasia and solid cancer
Secondary	Rate of molecular remission
Secondary	Predictive value of molecular remission