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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by Azienda Ospedaliera San Giovanni Battista.
Recruitment status was  Active, not recruiting
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
ClinicalTrials.gov Identifier:
NCT00435955
First received: February 15, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted
  Purpose

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 Intervention Phase
Follicular Lymphoma
Procedure: High dose chemotherapy with autologous transplantation
Drug: Rituximab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliera San Giovanni Battista:

Primary Outcome Measures:
  • Event free survival at three years

Secondary Outcome Measures:
  • Overall survival
  • CR rate
  • Progression free survival
  • Disease free survival I
  • Incidence of secondary myelodisplasia and solid cancer
  • Rate of molecular remission
  • Predictive value of molecular remission

Estimated Enrollment: 240
Study Start Date: March 2000
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00435955

Locations
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
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

No publications provided by Azienda Ospedaliera San Giovanni Battista

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00435955     History of Changes
Other Study ID Numbers: 3320
Study First Received: February 15, 2007
Last Updated: February 15, 2007
Health Authority: Italy: Ministry of Health

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:
Lymphoma, Follicular
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 16, 2014