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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

Primary Purpose

Follicular Lymphoma

Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
R-CVP
R-CHOP
R-FM
Sponsored by
Fondazione Italiana Linfomi - ETS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Follicular Lymphoma focused on measuring Follicular lymphoma, Rituximab

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ente ecclesiastico Ospedale generale regionale Miulli
  • Az.Ospedaliera SS.Antonio, Biagio e Cesare Arrigo-U.O.A.Ematologia
  • Presidio Ospedaliero C.Massaia di Asti
  • Istituto Nazionale Tumori
  • IRCCS Istituto tumori Giovanni Paolo II
  • Divisione Medicina B Ospedale degli Infermi
  • Policlinico Sant'Orsola - Istituto di Ematologia e Oncologia medica L.e A. Seragnoli
  • Ospedale di Bolzano Divisione di Ematologia e Centro Trapianti di Midollo Osseo
  • A.O.Spedali civili di Brescia
  • Presidio Ospedaliero A.Perrino
  • Ospedale Businco, Divisione di Ematologia
  • Ospedale Civile
  • Istituto per la ricerca e la cura del cancro
  • A.O. dell'Annunziata Unita' Operativa di Ematologia
  • Ospedale Ramazzini Day Hospital Oncologico
  • Ospedale Garibaldi-Nesima
  • Universita' degli studi di Catania
  • A.O. Pugliese A. Ciaccio
  • A.O.Pugliese Ciaccio Diviisone di Ematologia
  • Ospedale civico di Chivasso
  • Ospedale di Ciriè U.O.N.A. Oncologia servizio di Ematologia
  • Ospedale civile Divisione di Ematologia
  • Ospedale San Sebastiano
  • Presidio Ospedaliero Annunziata
  • Azienda istituti ospedalieri di Cremona
  • Policlinico Careggi, cattedra e diviisone di Ematologia
  • E.O.Ospedali Galliera U.O.Ematologia
  • Ospedale San Martino - Divisione di Ematologia
  • Ospedale Felettino reparto di Oncologia
  • Ospedale Vito Fazzi
  • Ospedale A.Manzoni Oncologia medica
  • Ospedale Madonna delle grazie U.O. Ematologia
  • Azienda Ospedaliera Papardo
  • Policlinico universitario U.O. Ematologia
  • Azienda Ospedaliera Fatebenefratelli e Oftalmico
  • IRCCS San Raffaele Unità di Chemioterapia
  • Osp. San Carlo Borromeo Divisione di Oncologia Medica
  • Ospedale Maggiore IRCCS-Dipartimento di Ematologia
  • Ospedale Niguarda CA' Granda
  • Ospedale San Paolo U.O. Oncologia Medica
  • Policlinico di Modena - Università degli studi
  • Ospedale S. Gerardo Divisione di ematologia
  • AORN Cardarelli U.O.Ematologia
  • Ospedale P.F.Calvi dipartimento id Oncologia ed Ematologia
  • Presidio Ospedaliero Umberto I Medicina ed Onco-Ematologia
  • A.O. Maggiore della Carità S.C.D.U. Ematologia
  • A.O. di Padova Divisione di Oncologia Medica
  • Casa di cura La Maddalena Unita' di Ematologia
  • Policlinico P.Giaccone
  • Universita' degli studi di Parma
  • Policlinico San Matteo - Medicina generale
  • Policlinico San Matteo
  • Policlinico Monteluce Divisione di Ematologia
  • Ospedale Santo Spirito Dipartimento di Ematologia
  • Ospedale Santo Spirito-Dipartimento di Oncologia
  • Ospedale Civile, Sezione di Ematologia
  • Ospedale S. Chiara Azienda ospedaliera pisana
  • Presidio Ospedali riuniti "Bianchi, Melacrino, Morelli" Divisione di ematologia
  • Azienda ospedaliera Arcispedale S.Maria Nuova
  • Ospedale Oncologico regionale CROB
  • A.O.S.Andrea Reparto di Ematologia e Immunoematologia
  • Azienda Policlinico Umberto I - La Sapienza
  • Istituto Regina Elena
  • Ospedale San Giacomo U.O. Ematologia
  • Policlinico A. Gemelli Università Cattolica del Sacro Cuore
  • Policlinico Universitario Campus biomedico
  • Policlinico Universitario Tor Vergata
  • Universita' La Sapienza
  • P.O. Roncilgione U.O. Ematologia
  • Istituto clinco Humanitas
  • IRCCS Casa Sollievo della Sofferenza
  • Istituto di Ematologia Università degli studi di Sassari
  • Ospedale civile DH oncologico
  • Ospedale San Paolo
  • A.O. della Valtellina e della Valchiavenna Presidio Ospedaliero di Sondalo
  • Azienda Ospedaliera S. Maria
  • Ospedale S. Maria Clinica Medica Servizio Oncologico
  • A.O.San Giovanni Battista
  • A.O.Cardinale Panico Ematologia e centro trapianti
  • Azienda Ospedaliera Ospedali riuniti di Trieste
  • Ospedale di circolo e Fondazione Macchi
  • O.C.SS. Giovanni e Paolo - U.O. Ematologia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

1

2

3

Arm Description

R-CVP x 3; Restaging if> RP then R-CVP x 5

R-CHOP x 3; Restaging if > RP then R-CHOP x 3 plus 2 Rituximab

R-FM x 3; Restaging if > RP then R-FM x 3 plus 2 Rituximab

Outcomes

Primary Outcome Measures

Assessment of the Time to Treatment Failure (TTF)in patients treated with R-CVP, R-CHOP and R-FM.

Secondary Outcome Measures

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.

Full Information

First Posted
October 14, 2008
Last Updated
February 14, 2011
Sponsor
Fondazione Italiana Linfomi - ETS
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1. Study Identification

Unique Protocol Identification Number
NCT00774826
Brief Title
Multicentric Study, Three Randomized Arms (R-CVP vs R-CHOP vs R-FM),for Patients With Stage II-IV Follicular Lymphoma
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 Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
December 2005 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
March 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Fondazione Italiana Linfomi - ETS

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Follicular Lymphoma
Keywords
Follicular lymphoma, Rituximab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
534 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
R-CVP x 3; Restaging if> RP then R-CVP x 5
Arm Title
2
Arm Type
Experimental
Arm Description
R-CHOP x 3; Restaging if > RP then R-CHOP x 3 plus 2 Rituximab
Arm Title
3
Arm Type
Experimental
Arm Description
R-FM x 3; Restaging if > RP then R-FM x 3 plus 2 Rituximab
Intervention Type
Drug
Intervention Name(s)
R-CVP
Intervention Description
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,
Intervention Type
Drug
Intervention Name(s)
R-CHOP
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
R-FM
Intervention Description
Rituximab: 375 mg/mq day 1, Fludarabina: 25 mg/mq day 1-3, Mitoxantrone: 10 mg/mq day 1,
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Assessment of Overall Survival (OS)in patients treated with R-CVP, R-CHOP and R-FM. -
Time Frame
3 years
Title
Assessment of Progression Free Survival (PFS)in patients treated with R-CVP, R-CHOP
Time Frame
2 years
Title
Assessment of Duration of Response (DR)in patients treated with R-CVP, R-CHOP and R-FM.
Time Frame
2 years
Title
Assessment of Response Rate(RR) in patients treated with R-CVP, R-CHOP and R-FM.
Time Frame
2 years
Title
Assessment of molecular Response Rate in patients treated with R-CVP, R-CHOP and R-FM.
Time Frame
2 years
Title
Assessment of toxicity of R-CVP, R-CHOP, R-FM treatments.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histological DIAGNOSIS of B cell follicular lymphoma ECOG performance status 0-2 Age range 18-75 Ann Arbor Stage: II-IV Assessment of pathology with diagnostics biopsy 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 LVEF > 50% 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 No previous treatment for follicolar lymphoma unless RT-IF Lifetime > 6 mounth Absence of HbsAg, HCV e HIV Negative Coombs Test Negative pregnant test Cotracceptive method during the treatment and the follow three months Formal written consent Ability to follow the patients after the treatment for follow up Exclusion Criteria: Histological Diagnosis of all type of lymphoma unless Follicularlymphoma, CD20 lymphoma, stage IIIb of follicular lymphoma and high degree lymphoma Stage I of Ann Arbor scale Central Nervous system involvement HIV, HBV OR HCV Positivity Cardiac Pathology Positive Coombs Test Previous chemotherapeutic treatment Hypersensitivity to antibodyes or other murine proteins Previous cancer pathology unless in situ cervix and epithelial carcinomas Other type of infections Pregnant and nursing woman
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Massimo Federico, PhD
Organizational Affiliation
Azienda Ospedaliero-Universitaria di Modena
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ente ecclesiastico Ospedale generale regionale Miulli
City
Acquaviva delle fonti (BA)
Country
Italy
Facility Name
Az.Ospedaliera SS.Antonio, Biagio e Cesare Arrigo-U.O.A.Ematologia
City
Alessandria
Country
Italy
Facility Name
Presidio Ospedaliero C.Massaia di Asti
City
Asti
Country
Italy
Facility Name
Istituto Nazionale Tumori
City
Aviano
Country
Italy
Facility Name
IRCCS Istituto tumori Giovanni Paolo II
City
Bari
Country
Italy
Facility Name
Divisione Medicina B Ospedale degli Infermi
City
Biella
Country
Italy
Facility Name
Policlinico Sant'Orsola - Istituto di Ematologia e Oncologia medica L.e A. Seragnoli
City
Bologna
Country
Italy
Facility Name
Ospedale di Bolzano Divisione di Ematologia e Centro Trapianti di Midollo Osseo
City
Bolzano
Country
Italy
Facility Name
A.O.Spedali civili di Brescia
City
Brescia
Country
Italy
Facility Name
Presidio Ospedaliero A.Perrino
City
Brindisi
Country
Italy
Facility Name
Ospedale Businco, Divisione di Ematologia
City
Cagliari
Country
Italy
Facility Name
Ospedale Civile
City
Camposanpiero (PD)
Country
Italy
Facility Name
Istituto per la ricerca e la cura del cancro
City
Candiolo (TO)
Country
Italy
Facility Name
A.O. dell'Annunziata Unita' Operativa di Ematologia
City
Carpi (MO)
Country
Italy
Facility Name
Ospedale Ramazzini Day Hospital Oncologico
City
Carpi (Mo)
Country
Italy
Facility Name
Ospedale Garibaldi-Nesima
City
Catania
Country
Italy
Facility Name
Universita' degli studi di Catania
City
Catania
Country
Italy
Facility Name
A.O. Pugliese A. Ciaccio
City
Catanzaro
Country
Italy
Facility Name
A.O.Pugliese Ciaccio Diviisone di Ematologia
City
Catanzaro
Country
Italy
Facility Name
Ospedale civico di Chivasso
City
Chivasso (TO)
Country
Italy
Facility Name
Ospedale di Ciriè U.O.N.A. Oncologia servizio di Ematologia
City
Ciriè (TO)
Country
Italy
Facility Name
Ospedale civile Divisione di Ematologia
City
Civitanova Marche (MC)
Country
Italy
Facility Name
Ospedale San Sebastiano
City
Correggio (RE)
Country
Italy
Facility Name
Presidio Ospedaliero Annunziata
City
Cosenza
Country
Italy
Facility Name
Azienda istituti ospedalieri di Cremona
City
Cremona
Country
Italy
Facility Name
Policlinico Careggi, cattedra e diviisone di Ematologia
City
Firenze
Country
Italy
Facility Name
E.O.Ospedali Galliera U.O.Ematologia
City
Genova
Country
Italy
Facility Name
Ospedale San Martino - Divisione di Ematologia
City
Genova
Country
Italy
Facility Name
Ospedale Felettino reparto di Oncologia
City
La Spezia
Country
Italy
Facility Name
Ospedale Vito Fazzi
City
Lecce
Country
Italy
Facility Name
Ospedale A.Manzoni Oncologia medica
City
Lecco
Country
Italy
Facility Name
Ospedale Madonna delle grazie U.O. Ematologia
City
Matera
Country
Italy
Facility Name
Azienda Ospedaliera Papardo
City
Messina
Country
Italy
Facility Name
Policlinico universitario U.O. Ematologia
City
Messina
Country
Italy
Facility Name
Azienda Ospedaliera Fatebenefratelli e Oftalmico
City
Milano
Country
Italy
Facility Name
IRCCS San Raffaele Unità di Chemioterapia
City
Milano
Country
Italy
Facility Name
Osp. San Carlo Borromeo Divisione di Oncologia Medica
City
Milano
Country
Italy
Facility Name
Ospedale Maggiore IRCCS-Dipartimento di Ematologia
City
Milano
Country
Italy
Facility Name
Ospedale Niguarda CA' Granda
City
Milano
Country
Italy
Facility Name
Ospedale San Paolo U.O. Oncologia Medica
City
Milano
Country
Italy
Facility Name
Policlinico di Modena - Università degli studi
City
Modena
Country
Italy
Facility Name
Ospedale S. Gerardo Divisione di ematologia
City
Monza (MI)
Country
Italy
Facility Name
AORN Cardarelli U.O.Ematologia
City
Napoli
Country
Italy
Facility Name
Ospedale P.F.Calvi dipartimento id Oncologia ed Ematologia
City
Noale
Country
Italy
Facility Name
Presidio Ospedaliero Umberto I Medicina ed Onco-Ematologia
City
Nocera Inferiore
Country
Italy
Facility Name
A.O. Maggiore della Carità S.C.D.U. Ematologia
City
Novara
Country
Italy
Facility Name
A.O. di Padova Divisione di Oncologia Medica
City
Padova
Country
Italy
Facility Name
Casa di cura La Maddalena Unita' di Ematologia
City
Palermo
Country
Italy
Facility Name
Policlinico P.Giaccone
City
Palermo
Country
Italy
Facility Name
Universita' degli studi di Parma
City
Parma
Country
Italy
Facility Name
Policlinico San Matteo - Medicina generale
City
Pavia
Country
Italy
Facility Name
Policlinico San Matteo
City
Pavia
Country
Italy
Facility Name
Policlinico Monteluce Divisione di Ematologia
City
Perugia
Country
Italy
Facility Name
Ospedale Santo Spirito Dipartimento di Ematologia
City
Pescara
Country
Italy
Facility Name
Ospedale Santo Spirito-Dipartimento di Oncologia
City
Pescara
Country
Italy
Facility Name
Ospedale Civile, Sezione di Ematologia
City
Piacenza
Country
Italy
Facility Name
Ospedale S. Chiara Azienda ospedaliera pisana
City
Pisa
Country
Italy
Facility Name
Presidio Ospedali riuniti "Bianchi, Melacrino, Morelli" Divisione di ematologia
City
Reggio Calabria
Country
Italy
Facility Name
Azienda ospedaliera Arcispedale S.Maria Nuova
City
Reggio Emilia
Country
Italy
Facility Name
Ospedale Oncologico regionale CROB
City
Rionero in Vulture (PZ)
Country
Italy
Facility Name
A.O.S.Andrea Reparto di Ematologia e Immunoematologia
City
Roma
Country
Italy
Facility Name
Azienda Policlinico Umberto I - La Sapienza
City
Roma
Country
Italy
Facility Name
Istituto Regina Elena
City
Roma
Country
Italy
Facility Name
Ospedale San Giacomo U.O. Ematologia
City
Roma
Country
Italy
Facility Name
Policlinico A. Gemelli Università Cattolica del Sacro Cuore
City
Roma
Country
Italy
Facility Name
Policlinico Universitario Campus biomedico
City
Roma
Country
Italy
Facility Name
Policlinico Universitario Tor Vergata
City
Roma
Country
Italy
Facility Name
Universita' La Sapienza
City
Roma
Country
Italy
Facility Name
P.O. Roncilgione U.O. Ematologia
City
Ronciglione (VT)
Country
Italy
Facility Name
Istituto clinco Humanitas
City
Rozzano (MI)
Country
Italy
Facility Name
IRCCS Casa Sollievo della Sofferenza
City
San Giovanni Rotondo (FG)
Country
Italy
Facility Name
Istituto di Ematologia Università degli studi di Sassari
City
Sassari
Country
Italy
Facility Name
Ospedale civile DH oncologico
City
Sassuolo (MO)
Country
Italy
Facility Name
Ospedale San Paolo
City
Savona
Country
Italy
Facility Name
A.O. della Valtellina e della Valchiavenna Presidio Ospedaliero di Sondalo
City
Sondalo
Country
Italy
Facility Name
Azienda Ospedaliera S. Maria
City
Terni
Country
Italy
Facility Name
Ospedale S. Maria Clinica Medica Servizio Oncologico
City
Terni
Country
Italy
Facility Name
A.O.San Giovanni Battista
City
Torino
Country
Italy
Facility Name
A.O.Cardinale Panico Ematologia e centro trapianti
City
Tricase (LE)
Country
Italy
Facility Name
Azienda Ospedaliera Ospedali riuniti di Trieste
City
Trieste
Country
Italy
Facility Name
Ospedale di circolo e Fondazione Macchi
City
Varese
Country
Italy
Facility Name
O.C.SS. Giovanni e Paolo - U.O. Ematologia
City
Venezia
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
29095677
Citation
Luminari S, Ferrari A, Manni M, Dondi A, Chiarenza A, Merli F, Rusconi C, Tarantino V, Tucci A, Vitolo U, Kovalchuk S, Angelucci E, Pulsoni A, Arcaini L, Angrilli F, Gaidano G, Stelitano C, Bertoldero G, Cascavilla N, Salvi F, Ferreri AJM, Vallisa D, Marcheselli L, Federico M. Long-Term Results of the FOLL05 Trial Comparing R-CVP Versus R-CHOP Versus R-FM for the Initial Treatment of Patients With Advanced-Stage Symptomatic Follicular Lymphoma. J Clin Oncol. 2018 Mar 1;36(7):689-696. doi: 10.1200/JCO.2017.74.1652. Epub 2017 Nov 2.
Results Reference
derived
PubMed Identifier
25596266
Citation
Rossi D, Bruscaggin A, La Cava P, Galimberti S, Ciabatti E, Luminari S, Rigacci L, Tucci A, Pulsoni A, Bertoldero G, Vallisa D, Rusconi C, Spina M, Arcaini L, Angrilli F, Stelitano C, Merli F, Gaidano G, Federico M, Palumbo GA. The genotype of MLH1 identifies a subgroup of follicular lymphoma patients who do not benefit from doxorubicin: FIL-FOLL study. Haematologica. 2015 Apr;100(4):517-24. doi: 10.3324/haematol.2014.108183. Epub 2015 Jan 16.
Results Reference
derived

Learn more about this trial

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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