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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Fondazione Italiana Linfomi ONLUS.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Fondazione Italiana Linfomi ONLUS
ClinicalTrials.gov Identifier:
NCT00774826
First received: October 14, 2008
Last updated: February 14, 2011
Last verified: February 2011
  Purpose

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 Intervention Phase
Follicular Lymphoma
Drug: R-CVP
Drug: R-CHOP
Drug: R-FM
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Fondazione Italiana Linfomi ONLUS:

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

Secondary Outcome Measures:
  • Assessment of Overall Survival (OS)in patients treated with R−CVP, R−CHOP and R−FM. − [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Assessment of Progression Free Survival (PFS)in patients treated with R-CVP, R-CHOP [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Assessment of Duration of Response (DR)in patients treated with R-CVP, R-CHOP and R-FM. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Assessment of Response Rate(RR) in patients treated with R-CVP, R-CHOP and R-FM. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Assessment of molecular Response Rate in patients treated with R-CVP, R-CHOP and R-FM. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Assessment of toxicity of R-CVP, R-CHOP, R-FM treatments. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 534
Study Start Date: December 2005
Estimated Study Completion Date: March 2014
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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,

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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: NCT00774826

  Show 82 Study Locations
Sponsors and Collaborators
Fondazione Italiana Linfomi ONLUS
Investigators
Principal Investigator: Massimo Federico, PhD Azienda Ospedaliera - Universitaria di Modena
  More Information

No publications provided

Responsible Party: MASSIMO FEDERICO, AZIENDA OSPEDALIERA POLICLINICO - MODENA (MO)
ClinicalTrials.gov Identifier: NCT00774826     History of Changes
Other Study ID Numbers: IIL−FOLL05, Eudract Number 2005−005406−24
Study First Received: October 14, 2008
Last Updated: February 14, 2011
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Fondazione Italiana Linfomi ONLUS:
Follicular lymphoma
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 18, 2014