- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00435955
Comparison of High-Dose Chemotherapy + Rituximab and CHOP + Rituximab in High-Risk Follicular Lymphoma
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
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Torino, Italy, 10154
- Divisione di Ematologia Universitaria
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Follicular Lymphoma at diagnosis
- Stage >I
- age-adjusted I.P.I. score 2 or 3 or three or more adverse factors of the I.L.I. score
Exclusion Criteria:
- Serum positivity for HIV, HCV. HBsAg-positive only if active viral replication, assessed by HBV-DNA was present.
- Major alterations of heart, lung, kidneys, liver, except for those directly disease-related;
- Evidence of second tumors;
- Previous chemotherapy( except patients who received limited radiotherapy);
- Cerebral or CNS involvement.
- Drug addiction or severe psychiatric disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Event free survival at three years
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Secondary Outcome Measures
Outcome Measure |
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Overall survival
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Progression free survival
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CR rate
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Disease free survival I
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Incidence of secondary myelodisplasia and solid cancer
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Rate of molecular remission
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Predictive value of molecular remission
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Corrado Tarella, MD, Università di Torino, Azienda Ospedaliera San Giovanni Battista
- Principal Investigator: Marco Ladetto, MD, Università di Torino Azienda Ospedaliera San Giovanni Battista
- Principal Investigator: Alessandro Pileri, MD, Università di Torino Azienda Ospedaliera San Giovanni Battista (Now retired)
- Principal Investigator: Mario Boccadoro, Università di Torino/Azienda Ospedaliera San Giovanni Battista B
- Principal Investigator: Alessandro Gianni, Istituto Tumori di Milano, Milano Italy
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, Follicular
- Physiological Effects of Drugs
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Rituximab
Other Study ID Numbers
- 3320
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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