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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01144364
First received: June 11, 2010
Last updated: July 6, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention Phase
Non-Hodgkin's Lymphoma Drug: rituximab [Mabthera/Rituxan] Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label Study of MabThera Maintenance Therapy Compared With no Further Therapy After a Brief Induction With Chemotherapy Plus MabThera on Failure-free Survival in Treatment-naïve Elderly Patients With Advanced Follicular Lymphoma

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants With Disease Progression or Death [ Time Frame: 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. 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.

  • PFS Randomization- Percentage of Participants Estimated to be Free of Progression at 12, 24, and 34 Months [ Time Frame: 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.


Secondary Outcome Measures:
  • Percentage of Participants Estimated to be Free of Progression at 12, 24, and 36 Months [ Time Frame: 12, 24, and 36 months ]
    PFS from enrollment was measured from the date of enrollment to the date of 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. Estimates of PFS function were made with the Kaplan-Meier product-limit method.

  • Disease-Free Survival (DFS) From Randomization - Percentage of Participants Disease Free at 12, 24, and 36 Months [ Time Frame: 12, 24, and 36 months ]
    DFS was defined for all participants who achieved a complete response (CR) or unconfirmed CR (CRu) at Month 3 or later, after the completion of induction phase and was measured from the time of randomization to the date of relapse or death as a result of lymphoma or acute toxicity of treatment. Participants without relapse were censored at their last assessment date. Estimates of DFS were made using Kaplan-Meier product-limit method.

  • Overall Survival (OS) From Randomization - Percentage of Participants Estimated to be Alive at 12, 24, and 34 Months [ Time Frame: 12, 24, and 34 months ]
    OS from randomization was defined as the date of randomization to the date of death from any cause. Participants still alive at the time of the final analysis were censored at the date of the last contact. Estimates of the OS function were made by the Kaplan-Meier product-limit method.

  • Overall Survival (OS) From Randomization - Percentage of Participants With Death [ Time Frame: 12, 24, and 34 months ]
    OS from randomization was defined as the date of randomization to the date of death from any cause. Participants still alive at the time of the final analysis were censored at the date of the last contact. Estimates of the OS function were made by the Kaplan-Meier product-limit method.

  • OS From Enrollment - Percentage of Participants Estimated to be Alive at 12, 24, and 36 Months [ Time Frame: 12, 24, and 36 months ]
    OS from enrollment was defined as the date of enrollment to the date of death from any cause. Participants still alive at the time of the final analysis were censored at the date of the last contact. Estimates of the OS function were made by the Kaplan-Meier product-limit method.

  • Percentage of Participants With a Response During the Induction Phase [ Time Frame: Months 1 to 8 ]
    Participants without a response assessment (due to any reasons) were considered as non-responders.

  • Percentage of Participants With a Molecular Response in the Induction Phase [ Time Frame: Months 5 and 8 ]
    Molecular responders were defined as the proportion of CR/CRu participants with a positive bcl-2/IgH (non-Hodgkin's Lymphoma [NHL] marker) at baseline, whose laboratory values were undetectable after treatment.

  • Duration of Response Using a Traditional Approach - Percentage of Participants Estimated to Have a Sustained Response at 12, 24, and 34 Months [ Time Frame: Months 12, 24, and 34 ]
    Duration of response (DOR) was defined for all participants who achieved a response (CR, CRu, and PR) at Month 3 or later, after the completion of induction phase and was measured from the date of randomization until the date of progression, relapse, or death as a result of follicular lymphoma (FL). Participants without relapse, progression, or death for causes other than FL were censored at their last assessment date. Analyses on this endpoint were performed with two different approaches. For the traditional approach, duration of response was estimated as the proportion of participants alive without progression or relapse of disease with the Kaplan-Meier method.

  • Duration of Response Using the Competing Risk Approach - Cumulative Percentage of Participants With Progression, Relapse or Death as a Result of FL at 12, 24, and 34 Months [ Time Frame: Months 12, 24, and 34 ]
    DOR was defined for all participants who achieved a response (CR, CRu, and PR) at Month 3 or later, after the completion of induction phase and was measured from the date of randomization until the date of progression, relapse, or death as a result of FL. Participants without relapse, progression, or death for causes other than FL were censored at their last assessment date. Analyses on this endpoint were performed with two different approaches. For the competing risk approach, deaths for causes other than FL were considered as competing events. DOR was estimated with the cumulative incidence of progression, relapse, or death as a result of FL.


Enrollment: 234
Actual Study Start Date: January 19, 2004
Study Completion Date: July 21, 2011
Primary Completion Date: July 21, 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: rituximab [Mabthera/Rituxan]
Intravenous repeating dose

  Eligibility

Ages Eligible for Study:   60 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  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: NCT01144364

Locations
Italy
Ospedale Civile Dello Spirito Santo; Divisione Di Ematologia
Pescara, Abruzzo, Italy, 65100
Ospedale Riuniti; Divisione Di Ematologia
Reggio Calabria, Calabria, Italy, 89100
Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica
Napoli, Campania, Italy, 80131
Nuovo Policlinico, Ii Facolta; Divisione Di Ematologia
Napoli, Campania, Italy, 80131
Ospedale Cardarelli; Divisione Di Ematologia
Napoli, Campania, Italy, 80131
Presidio Ospedaliero Umberto I; U.O. Di Medicina Interna Ed Oncoematologia
Nocera Inferiore, Campania, Italy, 84014
A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
Bologna, Emilia-Romagna, Italy, 40138
A.O. Universitaria Policlinico Di Modena; Ematologia
Modena, Emilia-Romagna, Italy, 41100
A.O. Universitaria Policlinico Di Modena; Radiologia
Modena, Emilia-Romagna, Italy, 41100
Az. Osp. Ospedale Civile; U.O. Di Oncologia Medica Ed Ematologia
Piacenza, Emilia-Romagna, Italy, 29100
Az. Osp. S. Maria Delle Croci; U.O. Di Ematologia
Ravenna, Emilia-Romagna, Italy, 48100
Az. Osp. Arcispedale S. Maria Nuova; U.O. Di Ematologia
Reggio Emilia, Emilia-Romagna, Italy, 42100
Policlinico Universitario; Clinica Oncologia - Padiglione Pennato
Udine, Friuli-Venezia Giulia, Italy, 33100
Ospedale S. Eugenio; Divisione Di Ematologia
Roma, Lazio, Italy, 00144
Universita' Degli Studi La Sapienza-Ist.Di Ematologia;Dip. Biotecnologie Cel CELLULARI ED EMATOLOGIA
Roma, Lazio, Italy, 00161
Uni Cattolica; Divisione Di Ematologia
Roma, Lazio, Italy, 00168
ASST PAPA GIOVANNI XXIII; Ematologia
Bergamo, Lombardia, Italy, 24127
A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia
Brescia, Lombardia, Italy, 25123
ASST DI CREMONA; U.O.S. di Ematologia
Cremona, Lombardia, Italy, 26100
Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora
Milano, Lombardia, Italy, 20122
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
Milano, Lombardia, Italy, 20133
Ist. Nazionale Per Lo Studio E Cura Dei Tumori; Div. Ematologia Trapianto Midollo Osseo Allogenico
Milano, Lombardia, Italy, 20133
Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
Milano, Lombardia, Italy, 20162
ASST DI MONZA; Ematologia
Monza, Lombardia, Italy, 20052
Ospedale Regionale Di Torrette; Clinica Di Ematologia
Ancona, Marche, Italy, 60020
Ospedale Civile; S.C. Ematologia
Pesaro, Marche, Italy, 61100
Ospedale Civile SS. Antonio E Biagio DI Alessandria; Ematologia
Alessandria, Piemonte, Italy, 15121
Az. Osp. Di Biella; Divisione Di Ematologia
Biella, Piemonte, Italy, 13051
Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico
Candiolo, Piemonte, Italy, 10060
Az. Osp. S. Croce Ospedale Generale; Sezione Di Ematologia
Cuneo, Piemonte, Italy, 12100
Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico
Orbassano, Piemonte, Italy, 10043
A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Ematologia 1
Torino, Piemonte, Italy, 10126
A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette;S.C. Ematologia
Torino, Piemonte, Italy, 10126
Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica
Bari, Puglia, Italy, 70124
IRCCS Ospedale Casa Sollievo Della Sofferenza; Ematologia E Trapianto Di Midollo Osseo
San Giovanni Rotondo, Puglia, Italy, 71013
Ospedale Oncologico A Businco-Cagliari; Ematologia Sez.
Cagliari, Sardegna, Italy, 09121
Az. Osp. Papardo; Struttura Complessa Di Ematologia
Messina, Sicilia, Italy, 98165
Ospedale V. Cervello; U.O. Ematologia E Trapianti
Palermo, Sicilia, Italy, 90146
Ospedale Ferrarotto; Divisione Di Ematologia
Via S. Sofia 78, Sicilia, Italy, 95123
Az. Osp. Di Careggi; Divisione Di Ematologia
Firenze, Toscana, Italy, 50135
Ospedale Santa Chiara; Unita Operativa Di Ematologia
Pisa, Toscana, Italy, 56100
Azienda Sanitaria Di Bolzano; Ematologia E Centro Trapianto Mid.Osseo
Bolzano, Trentino-Alto Adige, Italy, 39100
Dept. Medicina Clinica E Sperimentale; Sez. Medicina Interna E Scienze Oncologiche - Pol. Monteluce
Perugia, Umbria, Italy, 06126
Ospedale Civile Ss. Giovanni E Paolo; Ematologia
Venezia, Veneto, Italy, 30122
Uni Di Verona Policlinico G.B. Rossi; Divisione E Cattedra Di Ematologia
Verona, Veneto, Italy, 37130
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Chair: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01144364     History of Changes
Other Study ID Numbers: ML17638
Study First Received: June 11, 2010
Results First Received: September 12, 2014
Last Updated: July 6, 2017

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 21, 2017