Dose Dense Chemotherapy + Rituximab +/-Intensified High Dose Chemoimmunotherapy With Support of Peripheral Autologous Stem Cell in Diffuse Large B-Cell Lymphoma
NCT ID: NCT00499018
Last Updated: 2011-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
399 participants
INTERVENTIONAL
2006-01-31
2013-09-30
Brief Summary
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Arm 1: R-MegaCHOP14x4 + R-MAD + MAD + BEAM + ASCT; Arm 1BIS: R-CHOP14x4 + R-MAD + MAD + BEAM + ASCT; Arm 2: R-MegaCHOP14x4 + R-MegaCHOP14x2; Arm 2BIS: R-CHOP14x4 + R-CHOP14x4; Which are different in dose dense chemotherapy + Rituximab with or without intensified high dose chemoimmunotherapy and support of peripheral autologous stem cells.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
R-MegaCHOP14 x 4 Restaging + R-MAD + MAD + BEAM + ASCT
Rituximab
375 mg/m2 day 1
Ciclofosfamide
1200 mg/m2 day 1
Doxorubicina
70 mg/m2 day 1
Vincristina
1,4 mg/m2 (max 2 mg) day 1
Prednisone
100 mg day g 1-5
Pegfilgrastim
6 mg day +1
Mitoxantrone
8 mg/m2/days 1-3
ARA-C
2000 mg/m2/12h day 1 - 3
Lenograstim
5 μg/Kg/days +2
BCNU
300 mg/m2 day -7
ARA-C
200 mg/m2/12 days -6,-5,-4,-3
VP-16
100 mg/m2/12h days -6,-5,-4,-3
ASCT
PBSC Reinfusion
1 BIS
R-CHOP14 x 4 Restaging + R-MAD + MAD + BEAM + ASCT
Rituximab
375 mg/m2 day 1
Vincristina
1,4 mg/m2 (max 2 mg) day 1
Prednisone
100 mg day g 1-5
Pegfilgrastim
6 mg day +1
Lenograstim
5 μg/Kg/days +2
BCNU
300 mg/m2 day -7
ARA-C
200 mg/m2/12 days -6,-5,-4,-3
VP-16
100 mg/m2/12h days -6,-5,-4,-3
ASCT
PBSC Reinfusion
Ciclofosfamide
750 mg/m2 day 1
Doxorubicina
50 mg/m2 day 1
Vincristina
1,4 mg/m2 (max 2 mg) day 1
2
R-MegaCHOP14 x 4 Restaging + R-MegaCHOP x 2
Rituximab
375 mg/m2 day 1
Ciclofosfamide
1200 mg/m2 day 1
Doxorubicina
70 mg/m2 day 1
Vincristina
1,4 mg/m2 (max 2 mg) day 1
Prednisone
100 mg day g 1-5
Pegfilgrastim
6 mg day +1
Mitoxantrone
8 mg/m2/days 1-3
ARA-C
2000 mg/m2/12h day 1 - 3
2 BIS
R-CHOP14 x 4 Restaging + R-CHOP14 x 4
Rituximab
375 mg/m2 day 1
Vincristina
1,4 mg/m2 (max 2 mg) day 1
Prednisone
100 mg day g 1-5
Ciclofosfamide
750 mg/m2 day 1
Doxorubicina
50 mg/m2 day 1
Vincristina
1,4 mg/m2 (max 2 mg) day 1
Interventions
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Rituximab
375 mg/m2 day 1
Ciclofosfamide
1200 mg/m2 day 1
Doxorubicina
70 mg/m2 day 1
Vincristina
1,4 mg/m2 (max 2 mg) day 1
Prednisone
100 mg day g 1-5
Pegfilgrastim
6 mg day +1
Mitoxantrone
8 mg/m2/days 1-3
ARA-C
2000 mg/m2/12h day 1 - 3
Lenograstim
5 μg/Kg/days +2
BCNU
300 mg/m2 day -7
ARA-C
200 mg/m2/12 days -6,-5,-4,-3
VP-16
100 mg/m2/12h days -6,-5,-4,-3
ASCT
PBSC Reinfusion
Ciclofosfamide
750 mg/m2 day 1
Doxorubicina
50 mg/m2 day 1
Vincristina
1,4 mg/m2 (max 2 mg) day 1
Eligibility Criteria
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Inclusion Criteria
2. Histological confirmed diagnosis of Diffuse Large B-Cell Lymphoma CD20+ (newly diagnosis or shifted from low grade NHL and not previously treated) or of Follicular Lymphoma grade III according to REAL/WHO Classification.
3. Advanced stage II, stage III and stage IV with at least two aa-IPI risk factors.
4. Age-adjusted IPI 2-3.
5. ECOG performance status 0-2.
6. LVEF\>45%, measured with echocardiography.
7. Normal hepatic, renal and pulmonary functions.
8. HIV, HCV and HBV negativity.
9. HCV+ admitted only in histologically confirmed absence of replication marks.
10. Positive serology for HBV (occult carriers: AntiHBcAg+, HbsAg-, AntiHBsAg+/-) admitted only upon negativity of weakly positive HBV-DNA test.
11. Life expectancy \> 3 months.
12. Negative pregnancy test.
13. Written Informed Consent.
Exclusion Criteria
* Lymphoblastic NHL
* Burkitt's Lymphoma
* CD 20 negative B-cell Lymphoma
* grade I-IIIa Follicular Lymphoma
* Mantle Cell Lymphoma
* Primary mediastinal NHL with exclusively intrathoracic localization.
2. Age \> 60
3. Stage I disease
4. Age-adjusted IPI 0-1
5. ECOG-PS\>3, if not related to Lymphoma
6. Renal impairment (creatinine\>1,2 mg/dl or creatinine clearance \< 60ml/min)
7. Hepatic impairment (AST/ALT or bilirubin \> 2,5 times normal limit, unless due to Lymphoma)
8. HIV positive patients and/or with HBV or HCV active infection(documented by HBV-DNA and HCV-RNA positive tests)
9. Clinically significant secondary cardiovascular disease e.g. uncontrolled hypertension (resting diastolic blood pressure \> 115 mmHG), uncontrolled multifocal cardiac arrhythmias, symptomatic angina pectoris or congestive cardiac failure NYHA class III-IV
10. LFEV\<45%
11. Severe diabetes mellitus difficult to control with adequate insulin therapy
12. Severe chronic obstructive pulmonary disease with hypoxemia
13. Active bacterial, viral of fungal infection requiring systemic therapy
14. Concurrent thrombohemolytic disease
15. HIV positivity
16. HBV positivity
17. Positive serology for HBV (occult carriers: AntiHBc+, HbsAg-, AntiHbs+/-) with positive HBV-DNA test
18. HCV positivity in presence of replication marks (HCV+, CRP+, AST 1,5-2 times normal ranges)
19. CNS localization of disease
20. Prior (during last 3 years) or concurrent malignancy except adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix or early stage prostate cancer not requiring systemic therapy, or early breast cancer treated with surgery alone. Any other co.existing medical condition that would preclude study therapy administration
21. Pregnancy or breast-feeding women
22. Inability of the patient to give her/his informed consent
23. Known hypersensitivity or anaphylactic reaction to murine antibodies or proteins
18 Years
60 Years
ALL
No
Sponsors
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Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
OTHER
Fondazione Italiana Linfomi - ETS
OTHER
Responsible Party
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A.O. San Giovanni Battista - Molinette Torino
Principal Investigators
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Umberto Vitolo, MD
Role: PRINCIPAL_INVESTIGATOR
S.C. Ematologia II - OSP.S. GIOV.BATTISTA MOLINETTE - TORINO (TO) -
Locations
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Ospedale Umberto I - DH Oncoematologico
Nocera Inferiore, Salerno, Italy
Ospedale Civile Umberto I
Mestre, Venezia, Italy
Osp. Calvi, Noale
Mirano, Venezia, Italy
Az. Osp. SS. Antonio e Biagio e Cesare Arrigo
Alessandria, , Italy
Ospedale Cardinal Massaia
Asti, , Italy
Centro di Riferimento Oncologico
Aviano - PN, , Italy
Azienda Ospedale Policlinico Consorziale
Bari, , Italy
IRCC Istituto tumori Ematologia
Bari, , Italy
Osp. Degli Infermi
Biella, , Italy
Ospedale Policlinico S. Orsola Malpighi
Bologna, , Italy
Spedali Civili
Brescia, , Italy
UTMO Ematologia Università Spedali Civili
Brescia, , Italy
Stabilimento "Perrino"
Brindisi, , Italy
Ospedale di Circolo
Busto Arsizio - VA, , Italy
Ospedale Armando Businco
Cagliari, , Italy
Università Cattolica del Sacro Cuore
Campobasso, , Italy
IRCC
Candiolo (TO), , Italy
Ospedale Pugliese
Catanzaro, , Italy
Ospedale Bufalini
Cesena - FC, , Italy
Stabilimento Ospedaliero
Ciriè - to, , Italy
Ospedale Generale di Zona
Civitanova Marche (MC), , Italy
Presidio Ospedaliero Annunziata
Cosenza, , Italy
Istituti Ospitalieri
Cremona, , Italy
Az. Ospedaliero Universitaria Careggi
Florence, , Italy
Stabilimento Forlì
Forlì, , Italy
Azienda Universitaria San Martino
Genova, , Italy
A.S.L. 9
Ivrea, , Italy
Ospedale Felettino
La Spezia, , Italy
Istituto Vito Fazzi
Lecce, , Italy
Azienda Ospedaliera Papardo
Messina, , Italy
Azienda Ospedaliero Universitaria Policlinico Gaetano Martino
Messina, , Italy
Istituto Europeo di Oncologia
Milan, , Italy
Osp. San Carlo Borromeo
Milan, , Italy
Ospedale Cà Grande - Niguarda
Milan, , Italy
Ospedale Fatebenefratelli
Milan, , Italy
Presidio Osp. Maggiore Policlinico
Milan, , Italy
Azienda Ospedaliera Policlinico
Modena, , Italy
Ospedale S. Gerardo
Monza, , Italy
Università degli Studi Federico II
Napoli, , Italy
Osp. Maggiore Della Carità
Novara, , Italy
Ospedale S. Francesco
Nuoro, , Italy
Ospedale San Luigi
Orbassano (TO), , Italy
Azienda Ospedaliera
Padua, , Italy
Università degli Studi
Parma, , Italy
Fond. Maugeri - Centro medico
Pavia, , Italy
Ospedale Policlinico San Matteo
Pavia, , Italy
Ospedale di Piacenza
Piacenza, , Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, , Italy
Azienda Ospedaliera Ospedale San Carlo
Potenza, , Italy
Ospedale Santa Maria delle Croci
Ravenna, , Italy
Ospedale Bianchi Melacrino Morelli
Reggio Calabria, , Italy
Ospedale Santa Maria Nuova
Reggio Emilia, , Italy
Ospedale Oncologico Regionale
Rionero in Vulture (PZ), , Italy
Istituto Regina Elena
Roma, , Italy
Ospedale S. Eugenio
Roma, , Italy
Policlinico Universitario A. Gemelli
Roma, , Italy
Policlinico Universitario Campus Biomedico
Roma, , Italy
Università degli Studi di Roma "La Sapienza"
Roma, , Italy
Università degli Studi di Roma 'Tor Vergata'
Roma, , Italy
Ospedale di Ronciglione
Ronciglione (VT), , Italy
Istituto Clinico Humanitas
Rozzano - MI, , Italy
Casa Sollievo della Sofferenza
San Giovanni Rotondo (FG), , Italy
Ospedale SS.Annunziata
Sassari, , Italy
Spedali Riuniti
Siena, , Italy
Ospedale Morelli
Sondalo, , Italy
Stabilimento SS. Annunziata
Taranto, , Italy
Azienda Ospedaliera di Perugia
Terni, , Italy
Osp. S. Giovanni Battista "Molinette"
Torino, , Italy
Ospedale Ca Focello
Treviso, , Italy
Presidio Ospedaliero di Vittorio Veneto
Treviso, , Italy
Ospedale Generale Prov. Cardinale G. Panico
Tricase (LE), , Italy
Policlinico Universitario
Udine, , Italy
Osp. di Circolo e Fondazione Macchi
Varese, , Italy
Stabilimento Ospedaliero
Verbania, , Italy
Osp. Sant'Andrea Divisioen di Onco-Ematologia
Vercelli, , Italy
Countries
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References
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Derenzini E, Mazzara S, Melle F, Motta G, Fabbri M, Bruna R, Agostinelli C, Cesano A, Corsini CA, Chen N, Righi S, Sabattini E, Chiappella A, Calleri A, Fiori S, Tabanelli V, Cabras A, Pruneri G, Vitolo U, Gianni AM, Rambaldi A, Corradini P, Zinzani PL, Tarella C, Pileri S. A three-gene signature based on MYC, BCL-2 and NFKBIA improves risk stratification in diffuse large B-cell lymphoma. Haematologica. 2021 Sep 1;106(9):2405-2416. doi: 10.3324/haematol.2019.236455.
Chiappella A, Martelli M, Angelucci E, Brusamolino E, Evangelista A, Carella AM, Stelitano C, Rossi G, Balzarotti M, Merli F, Gaidano G, Pavone V, Rigacci L, Zaja F, D'Arco A, Cascavilla N, Russo E, Castellino A, Gotti M, Congiu AG, Cabras MG, Tucci A, Agostinelli C, Ciccone G, Pileri SA, Vitolo U. Rituximab-dose-dense chemotherapy with or without high-dose chemotherapy plus autologous stem-cell transplantation in high-risk diffuse large B-cell lymphoma (DLCL04): final results of a multicentre, open-label, randomised, controlled, phase 3 study. Lancet Oncol. 2017 Aug;18(8):1076-1088. doi: 10.1016/S1470-2045(17)30444-8. Epub 2017 Jun 28.
Other Identifiers
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EudraCT number 2007-000275-42
Identifier Type: -
Identifier Source: secondary_id
IIL-DLCL04
Identifier Type: -
Identifier Source: org_study_id
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