search
Back to results

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

Primary Purpose

Non-Hodgkin's Lymphoma

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
rituximab [Mabthera/Rituxan]
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma

Eligibility Criteria

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

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.

Sites / Locations

  • Ospedale Civile Dello Spirito Santo; Divisione Di Ematologia
  • Ospedale Riuniti; Divisione Di Ematologia
  • Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica
  • Nuovo Policlinico, Ii Facolta; Divisione Di Ematologia
  • Ospedale Cardarelli; Divisione Di Ematologia
  • Presidio Ospedaliero Umberto I; U.O. Di Medicina Interna Ed Oncoematologia
  • A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
  • A.O. Universitaria Policlinico Di Modena; Ematologia
  • A.O. Universitaria Policlinico Di Modena; Radiologia
  • Az. Osp. Ospedale Civile; U.O. Di Oncologia Medica Ed Ematologia
  • Az. Osp. S. Maria Delle Croci; U.O. Di Ematologia
  • Az. Osp. Arcispedale S. Maria Nuova; U.O. Di Ematologia
  • Policlinico Universitario; Clinica Oncologia - Padiglione Pennato
  • Ospedale S. Eugenio; Divisione Di Ematologia
  • Universita' Degli Studi La Sapienza-Ist.Di Ematologia;Dip. Biotecnologie Cel CELLULARI ED EMATOLOGIA
  • Uni Cattolica; Divisione Di Ematologia
  • ASST PAPA GIOVANNI XXIII; Ematologia
  • A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia
  • ASST DI CREMONA; U.O.S. di Ematologia
  • Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora
  • Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
  • Ist. Nazionale Per Lo Studio E Cura Dei Tumori; Div. Ematologia Trapianto Midollo Osseo Allogenico
  • Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
  • ASST DI MONZA; Ematologia
  • Ospedale Regionale Di Torrette; Clinica Di Ematologia
  • Ospedale Civile; S.C. Ematologia
  • Ospedale Civile SS. Antonio E Biagio DI Alessandria; Ematologia
  • Az. Osp. Di Biella; Divisione Di Ematologia
  • Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico
  • Az. Osp. S. Croce Ospedale Generale; Sezione Di Ematologia
  • Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico
  • A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Ematologia 1
  • A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette;S.C. Ematologia
  • Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica
  • IRCCS Ospedale Casa Sollievo Della Sofferenza; Ematologia E Trapianto Di Midollo Osseo
  • Ospedale Oncologico A Businco-Cagliari; Ematologia Sez.
  • Az. Osp. Papardo; Struttura Complessa Di Ematologia
  • Ospedale V. Cervello; U.O. Ematologia E Trapianti
  • Ospedale Ferrarotto; Divisione Di Ematologia
  • Az. Osp. Di Careggi; Divisione Di Ematologia
  • Ospedale Santa Chiara; Unita Operativa Di Ematologia
  • Azienda Sanitaria Di Bolzano; Ematologia E Centro Trapianto Mid.Osseo
  • Dept. Medicina Clinica E Sperimentale; Sez. Medicina Interna E Scienze Oncologiche - Pol. Monteluce
  • Ospedale Civile Ss. Giovanni E Paolo; Ematologia
  • Uni Di Verona Policlinico G.B. Rossi; Divisione E Cattedra Di Ematologia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
June 11, 2010
Last Updated
July 6, 2017
Sponsor
Hoffmann-La Roche
search

1. Study Identification

Unique Protocol Identification Number
NCT01144364
Brief Title
A Study of MabThera (Rituximab) in Elderly Patients With Untreated Follicular Non-Hodgkin's Lymphoma (NHL)
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
January 19, 2004 (Actual)
Primary Completion Date
July 21, 2011 (Actual)
Study Completion Date
July 21, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
234 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
rituximab [Mabthera/Rituxan]
Intervention Description
Intravenous repeating dose
Primary Outcome Measure Information:
Title
Percentage of Participants With Disease Progression or Death
Description
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.
Time Frame
12, 24, and 34 months
Title
PFS Randomization- Percentage of Participants Estimated to be Free of Progression at 12, 24, and 34 Months
Description
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.
Time Frame
12, 24, and 34 months
Secondary Outcome Measure Information:
Title
Percentage of Participants Estimated to be Free of Progression at 12, 24, and 36 Months
Description
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.
Time Frame
12, 24, and 36 months
Title
Disease-Free Survival (DFS) From Randomization - Percentage of Participants Disease Free at 12, 24, and 36 Months
Description
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.
Time Frame
12, 24, and 36 months
Title
Overall Survival (OS) From Randomization - Percentage of Participants Estimated to be Alive at 12, 24, and 34 Months
Description
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.
Time Frame
12, 24, and 34 months
Title
Overall Survival (OS) From Randomization - Percentage of Participants With Death
Description
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.
Time Frame
12, 24, and 34 months
Title
OS From Enrollment - Percentage of Participants Estimated to be Alive at 12, 24, and 36 Months
Description
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.
Time Frame
12, 24, and 36 months
Title
Percentage of Participants With a Response During the Induction Phase
Description
Participants without a response assessment (due to any reasons) were considered as non-responders.
Time Frame
Months 1 to 8
Title
Percentage of Participants With a Molecular Response in the Induction Phase
Description
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.
Time Frame
Months 5 and 8
Title
Duration of Response Using a Traditional Approach - Percentage of Participants Estimated to Have a Sustained Response at 12, 24, and 34 Months
Description
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.
Time Frame
Months 12, 24, and 34
Title
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
Description
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.
Time Frame
Months 12, 24, and 34

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Chair
Facility Information:
Facility Name
Ospedale Civile Dello Spirito Santo; Divisione Di Ematologia
City
Pescara
State/Province
Abruzzo
ZIP/Postal Code
65100
Country
Italy
Facility Name
Ospedale Riuniti; Divisione Di Ematologia
City
Reggio Calabria
State/Province
Calabria
ZIP/Postal Code
89100
Country
Italy
Facility Name
Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Nuovo Policlinico, Ii Facolta; Divisione Di Ematologia
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Ospedale Cardarelli; Divisione Di Ematologia
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Presidio Ospedaliero Umberto I; U.O. Di Medicina Interna Ed Oncoematologia
City
Nocera Inferiore
State/Province
Campania
ZIP/Postal Code
84014
Country
Italy
Facility Name
A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
Facility Name
A.O. Universitaria Policlinico Di Modena; Ematologia
City
Modena
State/Province
Emilia-Romagna
ZIP/Postal Code
41100
Country
Italy
Facility Name
A.O. Universitaria Policlinico Di Modena; Radiologia
City
Modena
State/Province
Emilia-Romagna
ZIP/Postal Code
41100
Country
Italy
Facility Name
Az. Osp. Ospedale Civile; U.O. Di Oncologia Medica Ed Ematologia
City
Piacenza
State/Province
Emilia-Romagna
ZIP/Postal Code
29100
Country
Italy
Facility Name
Az. Osp. S. Maria Delle Croci; U.O. Di Ematologia
City
Ravenna
State/Province
Emilia-Romagna
ZIP/Postal Code
48100
Country
Italy
Facility Name
Az. Osp. Arcispedale S. Maria Nuova; U.O. Di Ematologia
City
Reggio Emilia
State/Province
Emilia-Romagna
ZIP/Postal Code
42100
Country
Italy
Facility Name
Policlinico Universitario; Clinica Oncologia - Padiglione Pennato
City
Udine
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
33100
Country
Italy
Facility Name
Ospedale S. Eugenio; Divisione Di Ematologia
City
Roma
State/Province
Lazio
ZIP/Postal Code
00144
Country
Italy
Facility Name
Universita' Degli Studi La Sapienza-Ist.Di Ematologia;Dip. Biotecnologie Cel CELLULARI ED EMATOLOGIA
City
Roma
State/Province
Lazio
ZIP/Postal Code
00161
Country
Italy
Facility Name
Uni Cattolica; Divisione Di Ematologia
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
ASST PAPA GIOVANNI XXIII; Ematologia
City
Bergamo
State/Province
Lombardia
ZIP/Postal Code
24127
Country
Italy
Facility Name
A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25123
Country
Italy
Facility Name
ASST DI CREMONA; U.O.S. di Ematologia
City
Cremona
State/Province
Lombardia
ZIP/Postal Code
26100
Country
Italy
Facility Name
Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20122
Country
Italy
Facility Name
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Facility Name
Ist. Nazionale Per Lo Studio E Cura Dei Tumori; Div. Ematologia Trapianto Midollo Osseo Allogenico
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Facility Name
Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20162
Country
Italy
Facility Name
ASST DI MONZA; Ematologia
City
Monza
State/Province
Lombardia
ZIP/Postal Code
20052
Country
Italy
Facility Name
Ospedale Regionale Di Torrette; Clinica Di Ematologia
City
Ancona
State/Province
Marche
ZIP/Postal Code
60020
Country
Italy
Facility Name
Ospedale Civile; S.C. Ematologia
City
Pesaro
State/Province
Marche
ZIP/Postal Code
61100
Country
Italy
Facility Name
Ospedale Civile SS. Antonio E Biagio DI Alessandria; Ematologia
City
Alessandria
State/Province
Piemonte
ZIP/Postal Code
15121
Country
Italy
Facility Name
Az. Osp. Di Biella; Divisione Di Ematologia
City
Biella
State/Province
Piemonte
ZIP/Postal Code
13051
Country
Italy
Facility Name
Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico
City
Candiolo
State/Province
Piemonte
ZIP/Postal Code
10060
Country
Italy
Facility Name
Az. Osp. S. Croce Ospedale Generale; Sezione Di Ematologia
City
Cuneo
State/Province
Piemonte
ZIP/Postal Code
12100
Country
Italy
Facility Name
Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico
City
Orbassano
State/Province
Piemonte
ZIP/Postal Code
10043
Country
Italy
Facility Name
A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Ematologia 1
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy
Facility Name
A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette;S.C. Ematologia
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy
Facility Name
Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica
City
Bari
State/Province
Puglia
ZIP/Postal Code
70124
Country
Italy
Facility Name
IRCCS Ospedale Casa Sollievo Della Sofferenza; Ematologia E Trapianto Di Midollo Osseo
City
San Giovanni Rotondo
State/Province
Puglia
ZIP/Postal Code
71013
Country
Italy
Facility Name
Ospedale Oncologico A Businco-Cagliari; Ematologia Sez.
City
Cagliari
State/Province
Sardegna
ZIP/Postal Code
09121
Country
Italy
Facility Name
Az. Osp. Papardo; Struttura Complessa Di Ematologia
City
Messina
State/Province
Sicilia
ZIP/Postal Code
98165
Country
Italy
Facility Name
Ospedale V. Cervello; U.O. Ematologia E Trapianti
City
Palermo
State/Province
Sicilia
ZIP/Postal Code
90146
Country
Italy
Facility Name
Ospedale Ferrarotto; Divisione Di Ematologia
City
Via S. Sofia 78
State/Province
Sicilia
ZIP/Postal Code
95123
Country
Italy
Facility Name
Az. Osp. Di Careggi; Divisione Di Ematologia
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50135
Country
Italy
Facility Name
Ospedale Santa Chiara; Unita Operativa Di Ematologia
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56100
Country
Italy
Facility Name
Azienda Sanitaria Di Bolzano; Ematologia E Centro Trapianto Mid.Osseo
City
Bolzano
State/Province
Trentino-Alto Adige
ZIP/Postal Code
39100
Country
Italy
Facility Name
Dept. Medicina Clinica E Sperimentale; Sez. Medicina Interna E Scienze Oncologiche - Pol. Monteluce
City
Perugia
State/Province
Umbria
ZIP/Postal Code
06126
Country
Italy
Facility Name
Ospedale Civile Ss. Giovanni E Paolo; Ematologia
City
Venezia
State/Province
Veneto
ZIP/Postal Code
30122
Country
Italy
Facility Name
Uni Di Verona Policlinico G.B. Rossi; Divisione E Cattedra Di Ematologia
City
Verona
State/Province
Veneto
ZIP/Postal Code
37130
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
24085766
Citation
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.
Results Reference
derived
PubMed Identifier
23960180
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs