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

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ClinicalTrials.gov Identifier: NCT00435955
Recruitment Status : Unknown
Verified February 2007 by Azienda Ospedaliera San Giovanni Battista.
Recruitment status was:  Active, not recruiting
First Posted : February 16, 2007
Last Update Posted : February 16, 2007
Sponsor:
Collaborators:
University of Turin, Italy
Gruppo Italiano Trapianto di Midollo Osseo
Gruppo Italiano Studio Linfomi
Hoffmann-La Roche
Information provided by:
Azienda Ospedaliera San Giovanni Battista

Study Description
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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.

Condition or disease Intervention/treatment Phase
Follicular Lymphoma Procedure: High dose chemotherapy with autologous transplantation Drug: Rituximab Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Event free survival at three years

Secondary Outcome Measures :
  1. Overall survival
  2. CR rate
  3. Progression free survival
  4. Disease free survival I
  5. Incidence of secondary myelodisplasia and solid cancer
  6. Rate of molecular remission
  7. Predictive value of molecular remission

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00435955


Locations
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Italy
Divisione di Ematologia Universitaria
Torino, Italy, 10154
Sponsors and Collaborators
Azienda Ospedaliera San Giovanni Battista
University of Turin, Italy
Gruppo Italiano Trapianto di Midollo Osseo
Gruppo Italiano Studio Linfomi
Hoffmann-La Roche
Investigators
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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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00435955    
Other Study ID Numbers: 3320
First Posted: February 16, 2007    Key Record Dates
Last Update Posted: February 16, 2007
Last Verified: February 2007
Keywords provided by Azienda Ospedaliera San Giovanni Battista:
Follicular lymphoma
age adjusted IPI >1
IIL score > 2
 Molecular remission
High dose chemotherapy and autologous transplantation
Rituximab
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents