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Non-Hodgkin's LymphomaPhase 3NCT01144364

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

A Phase 3 study testing rituximab [Mabthera/Rituxan] in people with Non-Hodgkin's Lymphoma, run by Hoffmann-La Roche at 45 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 60 to 75 years
Conditions the study is for
Non-Hodgkin's Lymphoma
What is being tested?
rituximab [Mabthera/Rituxan]
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
234 participants
Where
45 sitesItaly
Study dates
19 Jan 2004to 21 Jul 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

45 sites in 1 country.

45 sites in 1 country

Italy45 sites

  • Ospedale Civile SS. Antonio E Biagio DI Alessandria; Ematologia

    Alessandria, Piedmont, 15121

  • Ospedale Regionale Di Torrette; Clinica Di Ematologia

    Ancona, The Marches, 60020

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

    Bari, Apulia, 70124

  • ASST PAPA GIOVANNI XXIII; Ematologia

    Bergamo, Lombardy, 24127

  • Az. Osp. Di Biella; Divisione Di Ematologia

    Biella, Piedmont, 13051

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

    Bologna, Emilia-Romagna, 40138

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

    Bolzano, Trentino-Alto Adige, 39100

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

    Brescia, Lombardy, 25123

  • Ospedale Oncologico A Businco-Cagliari; Ematologia Sez.

    Cagliari, Sardinia, 09121

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

    Candiolo, Piedmont, 10060

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

    Cremona, Lombardy, 26100

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

    Cuneo, Piedmont, 12100

  • Az. Osp. Di Careggi; Divisione Di Ematologia

    Florence, Tuscany, 50135

  • Az. Osp. Papardo; Struttura Complessa Di Ematologia

    Messina, Sicily, 98165

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

    Milan, Lombardy, 20122

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

    Milan, Lombardy, 20133

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

    Milan, Lombardy, 20133

  • Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia

    Milan, Lombardy, 20162

  • A.O. Universitaria Policlinico Di Modena; Ematologia

    Modena, Emilia-Romagna, 41100

  • A.O. Universitaria Policlinico Di Modena; Radiologia

    Modena, Emilia-Romagna, 41100

  • ASST DI MONZA; Ematologia

    Monza, Lombardy, 20052

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

    Naples, Campania, 80131

  • Nuovo Policlinico, Ii Facolta; Divisione Di Ematologia

    Naples, Campania, 80131

  • Ospedale Cardarelli; Divisione Di Ematologia

    Naples, Campania, 80131

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

    Nocera Inferiore, Campania, 84014

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

    Orbassano, Piedmont, 10043

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

    Palermo, Sicily, 90146

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

    Perugia, Umbria, 06126

  • Ospedale Civile; S.C. Ematologia

    Pesaro, The Marches, 61100

  • Ospedale Civile Dello Spirito Santo; Divisione Di Ematologia

    Pescara, Abruzzo, 65100

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

    Piacenza, Emilia-Romagna, 29100

  • Ospedale Santa Chiara; Unita Operativa Di Ematologia

    Pisa, Tuscany, 56100

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

    Ravenna, Emilia-Romagna, 48100

  • Ospedale Riuniti; Divisione Di Ematologia

    Reggio Calabria, Calabria, 89100

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

    Reggio Emilia, Emilia-Romagna, 42100

  • Ospedale S. Eugenio; Divisione Di Ematologia

    Rome, Lazio, 00144

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

    Rome, Lazio, 00161

  • Uni Cattolica; Divisione Di Ematologia

    Rome, Lazio, 00168

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

    San Giovanni Rotondo, Apulia, 71013

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

    Turin, Piedmont, 10126

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

    Turin, Piedmont, 10126

  • Policlinico Universitario; Clinica Oncologia - Padiglione Pennato

    Udine, Friuli Venezia Giulia, 33100

  • Ospedale Civile Ss. Giovanni E Paolo; Ematologia

    Venezia, Veneto, 30122

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

    Verona, Veneto, 37130

  • Ospedale Ferrarotto; Divisione Di Ematologia

    Via S. Sofia 78, Sicily, 95123

Other trials in Italy

About this study

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

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.

Being tested
rituximab [Mabthera/Rituxan]
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rituximab [Mabthera/Rituxan]Drug

    Intravenous repeating dose

Study groups in NCT01144364
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: rituximab [Mabthera/Rituxan]

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12, 24, and 34 months

  2. 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.

    Measured: 12, 24, and 34 months

Secondary outcomes (9)

  1. Percentage of Participants Estimated to be Free of Progression at 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.

    Measured: 12, 24, and 36 months

  2. Disease-Free Survival (DFS) From Randomization - Percentage of Participants Disease Free at 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.

    Measured: 12, 24, and 36 months

  3. Overall Survival (OS) From Randomization - Percentage of Participants Estimated to be Alive at 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.

    Measured: 12, 24, and 34 months

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

    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.

    Measured: 12, 24, and 34 months

  5. OS From Enrollment - Percentage of Participants Estimated to be Alive at 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.

    Measured: 12, 24, and 36 months

  6. Percentage of Participants With a Response During the Induction Phase

    Participants without a response assessment (due to any reasons) were considered as non-responders.

    Measured: Months 1 to 8

  7. Percentage of Participants With a Molecular Response in the Induction Phase

    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.

    Measured: Months 5 and 8

  8. Duration of Response Using a Traditional Approach - Percentage of Participants Estimated to Have a Sustained Response at 12, 24, and 34 Months

    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.

    Measured: Months 12, 24, and 34

  9. 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

    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.

    Measured: Months 12, 24, and 34

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2010 (estimated)
  2. Study start19 Jan 2004
  3. Primary completion21 Jul 2011
  4. Study completion21 Jul 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
234 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01144364
Sponsor's protocol ID
ML17638
Status last verified
Jun 2017
First submitted
11 Jun 2010
Last updated
15 Aug 2017

Publications

  • 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.

    PubMed 24085766

  • 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.

    PubMed 23960180

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rituximab [Mabthera/Rituxan] in people with Non-Hodgkin's Lymphoma, run by Hoffmann-La Roche at 45 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Disease Progression or Death (time frame: 12, 24, and 34 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01144364, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2017.

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