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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

Tracking Information
First Submitted Date  ICMJE February 15, 2007
First Posted Date  ICMJE February 16, 2007
Last Update Posted Date February 16, 2007
Study Start Date  ICMJE March 2000
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2007)
Event free survival at three years
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2007)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of High-Dose Chemotherapy + Rituximab and CHOP + Rituximab in High-Risk Follicular Lymphoma
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Follicular Lymphoma
Intervention  ICMJE
  • Procedure: High dose chemotherapy with autologous transplantation
  • Drug: Rituximab
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: February 15, 2007)
240
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00435955
Other Study ID Numbers  ICMJE 3320
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Azienda Ospedaliera San Giovanni Battista
Collaborators  ICMJE
  • University of Turin, Italy
  • Gruppo Italiano Trapianto di Midollo Osseo
  • Gruppo Italiano Studio Linfomi
  • Hoffmann-La Roche
Investigators  ICMJE
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
PRS Account Azienda Ospedaliera San Giovanni Battista
Verification Date February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP