A Study of MabThera (Rituximab) in Elderly Patients With Untreated Follicular Non-Hodgkin's Lymphoma (NHL)

NCT01144364 | Completed Phase 3 Results

• 1 other identifier: ML17638
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 45

Brief Summary

This study will evaluate the efficacy and safety of brief induction therapy with a chemotherapeutic regimen containing MabThera, followed by either maintenance therapy with MabThera or no further therapy. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Conditions

Non-Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Disease Progression or Death

  PFS from randomization was measured from the date of randomization to the date of documented disease progression, relapse, or death from any cause. PFS function was estimated using Kaplan-Meier product-limit method. Responding participants and participants who were lost to follow up were censored at their last assessment date.

  12, 24, and 34 months

• PFS Randomization- Percentage of Participants Estimated to be Free of Progression at 12, 24, and 34 Months

  PFS from randomization was measured from the date of randomization to the date of documented disease progression, relapse, or death from any cause. Responding participants and participants who were lost to follow-up were censored at their last assessment date. PFS was estimated using Kaplan-Meier methods.

  12, 24, and 34 months

Secondary Outcomes (9)

• Percentage of Participants Estimated to be Free of Progression at 12, 24, and 36 Months

  12, 24, and 36 months

• Disease-Free Survival (DFS) From Randomization - Percentage of Participants Disease Free at 12, 24, and 36 Months

  12, 24, and 36 months

• Overall Survival (OS) From Randomization - Percentage of Participants Estimated to be Alive at 12, 24, and 34 Months

  12, 24, and 34 months

• Overall Survival (OS) From Randomization - Percentage of Participants With Death

  12, 24, and 34 months

• OS From Enrollment - Percentage of Participants Estimated to be Alive at 12, 24, and 36 Months

  12, 24, and 36 months

Study Arms (1)

1

EXPERIMENTAL

Drug: rituximab [Mabthera/Rituxan]

Interventions

rituximab [Mabthera/Rituxan] DRUG

Intravenous repeating dose

1

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients 60-75 years of age;
• B-cell follicular NHL;
• no previous treatment;
• active disease, with rapid progression.

You may not qualify if:

• other cancer within 3 years of study, except carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, or ductal carcinoma in situ of the breast treated with lumpectomy;
• long-term use (\>1 month) of systemic corticosteroids;
• central nervous system involvement;
• history of significant cardiovascular disease;
• positive test result for HIV, or hepatitis B or C.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (45)

Ospedale Civile Dello Spirito Santo; Divisione Di Ematologia

Pescara, Abruzzo, 65100, Italy

Location

Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica

Bari, Apulia, 70124, Italy

Location

IRCCS Ospedale Casa Sollievo Della Sofferenza; Ematologia E Trapianto Di Midollo Osseo

San Giovanni Rotondo, Apulia, 71013, Italy

Location

Ospedale Riuniti; Divisione Di Ematologia

Reggio Calabria, Calabria, 89100, Italy

Location

Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica

Napoli, Campania, 80131, Italy

Location

Nuovo Policlinico, Ii Facolta; Divisione Di Ematologia

Napoli, Campania, 80131, Italy

Location

Ospedale Cardarelli; Divisione Di Ematologia

Napoli, Campania, 80131, Italy

Location

Presidio Ospedaliero Umberto I; U.O. Di Medicina Interna Ed Oncoematologia

Nocera Inferiore, Campania, 84014, Italy

Location

A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna

Bologna, Emilia-Romagna, 40138, Italy

Location

A.O. Universitaria Policlinico Di Modena; Ematologia

Modena, Emilia-Romagna, 41100, Italy

Location

A.O. Universitaria Policlinico Di Modena; Radiologia

Modena, Emilia-Romagna, 41100, Italy

Location

Az. Osp. Ospedale Civile; U.O. Di Oncologia Medica Ed Ematologia

Piacenza, Emilia-Romagna, 29100, Italy

Location

Az. Osp. S. Maria Delle Croci; U.O. Di Ematologia

Ravenna, Emilia-Romagna, 48100, Italy

Location

Az. Osp. Arcispedale S. Maria Nuova; U.O. Di Ematologia

Reggio Emilia, Emilia-Romagna, 42100, Italy

Location

Policlinico Universitario; Clinica Oncologia - Padiglione Pennato

Udine, Friuli Venezia Giulia, 33100, Italy

Location

Ospedale S. Eugenio; Divisione Di Ematologia

Rome, Lazio, 00144, Italy

Location

Universita' Degli Studi La Sapienza-Ist.Di Ematologia;Dip. Biotecnologie Cel CELLULARI ED EMATOLOGIA

Rome, Lazio, 00161, Italy

Location

Uni Cattolica; Divisione Di Ematologia

Rome, Lazio, 00168, Italy

Location

ASST PAPA GIOVANNI XXIII; Ematologia

Bergamo, Lombardy, 24127, Italy

Location

A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia

Brescia, Lombardy, 25123, Italy

Location

ASST DI CREMONA; U.O.S. di Ematologia

Cremona, Lombardy, 26100, Italy

Location

Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora

Milan, Lombardy, 20122, Italy

Location

Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1

Milan, Lombardy, 20133, Italy

Location

Ist. Nazionale Per Lo Studio E Cura Dei Tumori; Div. Ematologia Trapianto Midollo Osseo Allogenico

Milan, Lombardy, 20133, Italy

Location

Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia

Milan, Lombardy, 20162, Italy

Location

ASST DI MONZA; Ematologia

Monza, Lombardy, 20052, Italy

Location

Ospedale Civile SS. Antonio E Biagio DI Alessandria; Ematologia

Alessandria, Piedmont, 15121, Italy

Location

Az. Osp. Di Biella; Divisione Di Ematologia

Biella, Piedmont, 13051, Italy

Location

Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico

Candiolo, Piedmont, 10060, Italy

Location

Az. Osp. S. Croce Ospedale Generale; Sezione Di Ematologia

Cuneo, Piedmont, 12100, Italy

Location

Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico

Orbassano, Piedmont, 10043, Italy

Location

A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Ematologia 1

Turin, Piedmont, 10126, Italy

Location

A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette;S.C. Ematologia

Turin, Piedmont, 10126, Italy

Location

Ospedale Oncologico A Businco-Cagliari; Ematologia Sez.

Cagliari, Sardinia, 09121, Italy

Location

Az. Osp. Papardo; Struttura Complessa Di Ematologia

Messina, Sicily, 98165, Italy

Location

Ospedale V. Cervello; U.O. Ematologia E Trapianti

Palermo, Sicily, 90146, Italy

Location

Ospedale Ferrarotto; Divisione Di Ematologia

Via S. Sofia 78, Sicily, 95123, Italy

Location

Ospedale Regionale Di Torrette; Clinica Di Ematologia

Ancona, The Marches, 60020, Italy

Location

Ospedale Civile; S.C. Ematologia

Pesaro, The Marches, 61100, Italy

Location

Azienda Sanitaria Di Bolzano; Ematologia E Centro Trapianto Mid.Osseo

Bolzano, Trentino-Alto Adige, 39100, Italy

Location

Az. Osp. Di Careggi; Divisione Di Ematologia

Florence, Tuscany, 50135, Italy

Location

Ospedale Santa Chiara; Unita Operativa Di Ematologia

Pisa, Tuscany, 56100, Italy

Location

Dept. Medicina Clinica E Sperimentale; Sez. Medicina Interna E Scienze Oncologiche - Pol. Monteluce

Perugia, Umbria, 06126, Italy

Location

Ospedale Civile Ss. Giovanni E Paolo; Ematologia

Venezia, Veneto, 30122, Italy

Location

Uni Di Verona Policlinico G.B. Rossi; Divisione E Cattedra Di Ematologia

Verona, Veneto, 37130, Italy

Location

Related Publications (2)

• Ladetto M, Lobetti-Bodoni C, Mantoan B, Ceccarelli M, Boccomini C, Genuardi E, Chiappella A, Baldini L, Rossi G, Pulsoni A, Di Raimondo F, Rigacci L, Pinto A, Galimberti S, Bari A, Rota-Scalabrini D, Ferrari A, Zaja F, Gallamini A, Specchia G, Musto P, Rossi FG, Gamba E, Evangelista A, Vitolo U; Fondazione Italiana Linfomi. Persistence of minimal residual disease in bone marrow predicts outcome in follicular lymphomas treated with a rituximab-intensive program. Blood. 2013 Nov 28;122(23):3759-66. doi: 10.1182/blood-2013-06-507319. Epub 2013 Oct 1.

  PMID: 24085766 DERIVED

• Vitolo U, Ladetto M, Boccomini C, Baldini L, De Angelis F, Tucci A, Botto B, Chiappella A, Chiarenza A, Pinto A, De Renzo A, Zaja F, Castellino C, Bari A, Alvarez De Celis I, Evangelista A, Parvis G, Gamba E, Lobetti-Bodoni C, Ciccone G, Rossi G. Rituximab maintenance compared with observation after brief first-line R-FND chemoimmunotherapy with rituximab consolidation in patients age older than 60 years with advanced follicular lymphoma: a phase III randomized study by the Fondazione Italiana Linfomi. J Clin Oncol. 2013 Sep 20;31(27):3351-9. doi: 10.1200/JCO.2012.44.8290. Epub 2013 Aug 19.

  PMID: 23960180 DERIVED

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann- LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2010
• First Posted: June 15, 2010
• Study Start: January 19, 2004
• Primary Completion: July 21, 2011
• Study Completion: July 21, 2011
• Last Updated: August 15, 2017
• Results First Posted: December 4, 2014

Record last verified: 2017-06

Locations

IT (45)