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Multicentric Study, Three Randomized Arms (R-CVP vs R-CHOP vs R-FM),for Patients With Stage II-IV Follicular Lymphoma

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ClinicalTrials.gov Identifier: NCT00774826
Recruitment Status : Unknown
Verified February 2011 by Fondazione Italiana Linfomi ONLUS.
Recruitment status was:  Active, not recruiting
First Posted : October 17, 2008
Last Update Posted : February 15, 2011
Sponsor:
Information provided by:
Fondazione Italiana Linfomi ONLUS

Study Description
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Brief Summary:

The purpose of this study is to define an improvement and theassessment of the Time to Treatment Failure in patients randomized in three different arms:

R-CVP vs R-CHOP vs R-FM.


Condition or disease Intervention/treatment Phase
Follicular Lymphoma Drug: R-CVP Drug: R-CHOP Drug: R-FM Phase 3

Detailed Description:
Assessment of Overall Survival (OS)in patients treated with R-CVP, R-CHOP and R-FM. -Assessment of Progression Free Survival (PFS)in patients treated with R-CVP, R-CHOP - Assessment of Duration of Response (DR)in patients treated with R-CVP, R-CHOP and R-FM. - Assessment of Response Rate(RR) in patients treated with R-CVP, R-CHOP and R-FM. - Assessment of molecular Response Rate in patients treated with R-CVP, R-CHOP and R-FM. - Assessment of toxicity of R-CVP, R-CHOP, R-FM treatments.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 534 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Multicentric IIL Study, Three Randomized Arms (R-CVP vs R-CHOP vs R-FM),for Treatment of Patients With Stage II-IV Follicular Lymphoma
Study Start Date : December 2005
Actual Primary Completion Date : September 2010
Estimated Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
R-CVP x 3; Restaging if> RP then R-CVP x 5
 Drug: R-CVP
Rituximab: 375 mg/mq day 1 Ciclofosfamide: 750 mg/mq day 1, Vincristina: 1,4 mg/mq day 1 Prednisone: 40 mg/mq day 1-5,
Experimental: 2
R-CHOP x 3; Restaging if > RP then R-CHOP x 3 plus 2 Rituximab
 Drug: R-CHOP
Rituximab: 375 mg/mq day 1 Ciclofosfamide: 750 mg/mq day 1 Doxorubicina: 50 mg/mq day 1 Vincristina: 1.4 mg/mq day 1 Prednisone: 100 mg/mq day 1-5
Experimental: 3
R-FM x 3; Restaging if > RP then R-FM x 3 plus 2 Rituximab
 Drug: R-FM
Rituximab: 375 mg/mq day 1, Fludarabina: 25 mg/mq day 1-3, Mitoxantrone: 10 mg/mq day 1,


Outcome Measures
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Primary Outcome Measures :
  1. Assessment of the Time to Treatment Failure (TTF)in patients treated with R-CVP, R-CHOP and R-FM. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Assessment of Overall Survival (OS)in patients treated with R-CVP, R-CHOP and R-FM. - [ Time Frame: 3 years ]
  2. Assessment of Progression Free Survival (PFS)in patients treated with R-CVP, R-CHOP [ Time Frame: 2 years ]
  3. Assessment of Duration of Response (DR)in patients treated with R-CVP, R-CHOP and R-FM. [ Time Frame: 2 years ]
  4. Assessment of Response Rate(RR) in patients treated with R-CVP, R-CHOP and R-FM. [ Time Frame: 2 years ]
  5. Assessment of molecular Response Rate in patients treated with R-CVP, R-CHOP and R-FM. [ Time Frame: 2 years ]
  6. Assessment of toxicity of R-CVP, R-CHOP, R-FM treatments. [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histological DIAGNOSIS of B cell follicular lymphoma
  2. ECOG performance status 0-2
  3. Age range 18-75
  4. Ann Arbor Stage: II-IV
  5. Assessment of pathology with diagnostics biopsy

  6. Presence of one of these criteria:

    • B Sistemic symptoms B
    • Extranodale pathology
    • Cytopenia
    • Splenomegaly
    • Leukemia
    • Serous effusion
    • Ves > 20 mm/h
    • Ldh > normal value
    • Nodale or extranodal mass > 7 cm
    • 3 or more nodal sites > 3 cm
    • Adenopatic syndrome
  7. LVEF > 50%
  8. Normal hepatic (bilirubin < 1.5 mg/dl) and renal functionality (creatinin < 2 mg/dl). If there is a lymphoma it's allow values of bilirubin > 1.5 mg/dl and of creatinin > 2mg/dl
  9. No previous treatment for follicolar lymphoma unless RT-IF
  10. Lifetime > 6 mounth
  11. Absence of HbsAg, HCV e HIV
  12. Negative Coombs Test
  13. Negative pregnant test
  14. Cotracceptive method during the treatment and the follow three months
  15. Formal written consent
  16. Ability to follow the patients after the treatment for follow up

Exclusion Criteria:

  1. Histological Diagnosis of all type of lymphoma unless Follicularlymphoma, CD20 lymphoma, stage IIIb of follicular lymphoma and high degree lymphoma
  2. Stage I of Ann Arbor scale
  3. Central Nervous system involvement
  4. HIV, HBV OR HCV Positivity
  5. Cardiac Pathology
  6. Positive Coombs Test
  7. Previous chemotherapeutic treatment
  8. Hypersensitivity to antibodyes or other murine proteins
  9. Previous cancer pathology unless in situ cervix and epithelial carcinomas
  10. Other type of infections
  11. Pregnant and nursing woman
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): NCT00774826


Locations
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Sponsors and Collaborators
Fondazione Italiana Linfomi ONLUS
Investigators
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Principal Investigator: Massimo Federico, PhD Azienda Ospedaliero-Universitaria di Modena
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: MASSIMO FEDERICO, AZIENDA OSPEDALIERA POLICLINICO - MODENA (MO)
ClinicalTrials.gov Identifier: NCT00774826    
Other Study ID Numbers: IIL-FOLL05
Eudract Number 2005-005406-24
First Posted: October 17, 2008    Key Record Dates
Last Update Posted: February 15, 2011
Last Verified: February 2011
Keywords provided by Fondazione Italiana Linfomi ONLUS:
Follicular lymphoma
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