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MAXIMA Study: A Study of Maintenance Therapy With MabThera (Rituximab) in Patients With Non-Hodgkin's Lymphoma.

Primary Purpose

Non-Hodgkin's Lymphoma

Status
Completed
Phase
Phase 4
Locations
International
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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • histologically confirmed grade 1, 2 or 3a follicular non-Hodgkin's lymphoma;
  • patients who have received adequate (>=8 cycles) induction therapy with MabThera as first line treatment, or treatment for relapsed disease;
  • demonstrated partial or complete response to induction therapy.

Exclusion Criteria:

  • stable or progressive disease after most recent induction therapy;
  • transformation to high grade lymphoma;
  • patients with prior or concomitant malignancies, except non-melanoma skin cancer or adequately treated in situ cancer of the cervix.

Sites / Locations

  • University "Mother Theresa" Hospital Center; Oncology Department
  • Instituo Lavalle de Oncologia; Hematology
  • Academia Nacional de Medicina; Inst. de Cardiologia
  • Fundaleu; Haematology
  • Hospital Churruca Visca; Haematology
  • Hospital Jr Vidal; Jefe de Servicio de Clinica Medica/Hematologia
  • Sanatorio Allende; Haematology
  • HOSPITAL PRIVADO - CENTRO MEDICO DE CÓRDOBA; Dpto Oncología
  • Hospital General San Martin; Haematology
  • Liverpool Hospital; Haematology
  • Wollongong Hospital; Cancer Services
  • Royal Brisbane Hospital; Oncology Department
  • Haematology & Oncology Clinics of Australia, Mater Medical Centre
  • Mount Medical Center
  • University Clinical Center of the Republic of Srpska, Clinic for Internal Disease, Hematology Dept
  • Inst. of Hematology
  • Uni Hospital Mostar
  • Clinic of Oncology, University Clinical Center Sarajevo
  • Nucleo de Oncologia da Bahia - NOB
  • CEHON
  • ONCOMED
  • Centro de Tratamento Oncologico - Oncoclinica
  • Hospital das Clinicas - UFRGS; Medicina Interna
  • Hospital Mae de Deus
  • Hospital Sao Lucas - PUCRS
  • Centro de Pesquisas Oncologicas - CEPON
  • Hospital das Clinicas - UNICAMP; Hemoterapia
  • Clinica Oncologica De Piracicaba Sc
  • Hospital Alemao Oswaldo Cruz; Oncologia
  • Hospital Estadual do Servidor Publico; Hematologia
  • Hospital das Clinicas - FMUSP, Oncologia
  • UMHAT Dr Georgi Stranski; Hematology
  • Umhat S. George; Hematology
  • UMHAT Alexandrovska EAD; Hematology
  • National Center of Hematology & Transfusiology; Clinical Unit, Clinic of Hematology
  • Mhat Sveta Marina; Dept. of Haematology
  • Centro Médico Carlos Ardila Lule
  • Hospital Pablo Tobon Uribe
  • Clinical Hospital Centre Split; Dept Of Hematology
  • Clinical Hospital Centre Dubrava; Hematology Department
  • University Hospital Center Zagreb; Haematology Department
  • Hospital José Carrasco; Oncology Service
  • Hospital Carlos Andrade Marin; Servicio de Oncología
  • Oncology & Radiotherapy Centre; Oncology
  • Kanta-Hämeen Keskussairaala; Dept of Internal Medicine, Hematology
  • Kymenlaakson keskussairaala
  • Päijät-Hämeen Keskussairaala; Dept of Internal Medicine, Hematology
  • Satakunnan Keskussairaala; Sisaetauti Osasto
  • Internist; Praxis Für Haemotologie & Onkologie
  • Dres.Christian Sperling und Claudia Schelenz
  • Onkologische Schwerpunktpraxis Kurfürstendamm
  • Universitätsklinikum Bonn; Medizinische Klinik und Poliklinik I; Allgemeine Innere Medizin
  • Dres. Matthias Adler Oliver Marschal und Andreas Pies
  • Gemeinschaftspraxis
  • Internistische Praxis Dr. Plingen
  • Internistische Schwerpunktpraxis Erlangen
  • Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
  • Onkologische Gemeinschaftspraxis, Prof. Dr. Gropp, Dr. Depenbusch und Dr. Rösel
  • Überörtliche Gemeinschaftspraxis Schwerpunkt Hämatologie, internistische Onkologie & Palliativmed.
  • Onkologische Schwerpunktpraxis; Herrn Dr. Med. Bertram
  • Dres.Andreas Karcher und Stefan Fuxius
  • Uniklinik Heidelberg, Medizinische Klinik & Poliklinik V
  • Onkologische Schwerpunktpraxis (Eps-Gmbh)
  • Märkische Kliniken GmbH, Klinikum Lüdenscheid; Hämatologie / Onkologie
  • Stauferklinikum Schwäb.Gmünd
  • Gemeinschaftspraxis Dres. Schröder, Sieg
  • Onko. Gemeinschaftspraxis Dres. Tigges/ Böning/ Abenhardt/ Bosse
  • Dres.Ulrich Hutzschenreuter und Uwe Sauer
  • Onkologische Praxis Oldenburg; Dres. Otremba, Reschke, Zirpel, Kühn und Ruff
  • Praxis für Onkologie und Hämatologie
  • Diakonie-Klinikum Klinik für Innere Medizin III Abt.Hämatologie, intern. Onkologie und Palliativmedi
  • Internistische Gemeinschaftspraxis Dres. Hoering/Von Ehr/Responde
  • Haematologisch-Onkologische Praxis; Dr. med. Christoph Maintz und Matthias Groschek
  • Laiko General Hospital - Uni of Athens; 1St Dept. of Internal Medicine
  • Attiko Hospital; Haematology Clinic
  • Theagenio Anticancer Hospital; Dept. of Haematology
  • Rambam Medical Center; Heamatology & Bone Marrow Transplantation
  • Wolfson Mc; Haematology
  • Hadassah Ein Karem Hospital; Haematology
  • Chaim Sheba Medical Center; Hematology BMT & CBB
  • Ichilov Sourasky Medical Center; Heamatology
  • Ospedale Civile Dello Spirito Santo; Divisione Di Ematologia
  • Az. Osp. Pugliese; Dh Oncologico
  • Ospedale S. Gennaro; Divisione Di Ematologia
  • Ospedale Cardarelli; Divisione Di Ematologia
  • A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
  • Arcispedale S. Anna; Sezione Di Ematologia
  • A.O. Universitaria Policlinico Di Modena; Ematologia
  • A.O.U. Policlinico di Modena-Dipartimento di Medicina Diagnostica, Clinica e di Sanità pubblica
  • Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
  • Az. Osp. Uni Ria Policlinico Tor Vergata; Unita Di Ematologia
  • Ospedale S. Eugenio; Divisione Di Ematologia
  • Univ. Cattolica La Sapienza; Cattedra Di Ematologia
  • Uni Cattolica; Divisione Di Ematologia
  • A.O. Universitaria S. Martino Di Genova; Ematologia 1
  • A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia
  • Istituto S. Raffaele Monte Tabor; Divisione Ematologia E Utmo
  • 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
  • Irccs Policlinico San Matteo; Divisione Di Ematologia
  • Ospedale Civile; S.C. Ematologia
  • A.O. Univ.Ospedali Riuniti Umerto I -G.M.Lancisi G.Salesi; U.O. Clinica Di Ematologia
  • Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico
  • Az. Osp. S. Croce Ospedale Generale; Sezione Di Ematologia
  • Univ. Piemonte Est Amedeo Avogadro; Div.Ematologia- Dip.Clinica Med.Sperim.& Ircad
  • 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
  • Ospedale Vito Fazzi; Div. Oncoematologia
  • Az. Osp. C. Panico; Rep. Ematologia E Trapianto
  • Ospedale Oncologico A Businco-Cagliari; Ematologia Sez.
  • 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
  • A.O. Universitaria Senese; Ematologia
  • Azienda Ospedaliera S. Maria della Misericordia; Ematologia
  • Uni Degli Studi; Dip.Med.Clinica E Sperim. Ematologia
  • Ospedale Di Vicenza; Nefrologia, Ematologia
  • Issste; Haematology
  • Hospital Cima (Centro Internacional de Medicina) ; Haematology
  • Hospital Central de Pemex Norte Azcapotzalco
  • Hospital Español de Mexico
  • Hospital Regional Issste; Oncologia
  • Clinca San Jose; Haematology
  • Issstep Puebla, ; Haematology
  • Spitalul Clinic Judetean de Urgenta Brasov,Clinica de Hematologie
  • Fundeni Clinical Inst. ; Hematology Dept
  • Spitalul Clinic Coltea; Clinica de Hematologie
  • Oncology Inst. Cluj-Napoca; Cancer Dept
  • Spitalul Clinic Judetean de Urgenta Sf. Spiridon Iasi, Clinica de Hematologie
  • Spitalul Clinic Judetean de Urgenta Targu-Mures; compartiment Hematologie
  • Regional Clinical Hospital; Hematology
  • Clinical Oncology Dispensary of Ministry of Health of Tatarstan
  • Blokhin Cancer Research Center; Clinical Oncology
  • City Clinical Hospital After Botkin; Hematology
  • Vladimirskiy Regional Scientific Research Inst. ; Hematology
  • Regional Clinical Hospital N.A. Semashko; Hematology
  • City Hematological Center of Clinical Hospital #2; Hematology
  • Rostov State Medical Uni ; Hematology
  • Research Inst. of Hematology & Blood Transfusion ; Hematology
  • Pavlov State Medical Uni ; Bone Marrow Transplantation Clinic
  • Leningrad Regional Clinical Hospital; Hematology #1
  • Stavropol Clinical Oncology Dispansary
  • Bashkirian Republican Clinical Oncology Dispensary
  • Ulyanovsk Regional Oncology Dispensary; Chemotherapy
  • Regional Oncology Center; Chemotherapy
  • Regional Clinical Hospital; Hematology
  • Fakultna Nemocnica Roosevelta; Dept. of Haematology
  • National Oncology Inst. ; Dept. of Haematology
  • Uni Hospital; Clinic of Haematology
  • Uni Hospital ; Dept. of Haematol. & Transfusion Medicine
  • Institute of Oncology Ljubljana
  • Complejo Asistencial Universitario De Burgos; Servicio de Oncologia
  • Hospital General de Castellon; Servicio de Hematologia
  • Hospital Generla de Ciudad Real; Servicio de Oncologia
  • Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
  • Hospital El Bierzo; Servicio de Oncologia
  • Hospital Costa del Sol; Servicio de Hematologia
  • Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia
  • Hospital Universitario Virgen Macarena; Servicio de Hematologia
  • Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
  • Laenssjukhuset; Medicinkliniken/Hematologsektionen
  • Sunderby Sjukhus; Medicinkliniken
  • Skånes Universitetssjukhus; Kliniska Forskningsenheten Onkologimottagning medicinsk behandling
  • Länssjukhuset Sundsvall-Härnösand, Medicinkliniken
  • Uddevalla Sjukhus; Medicinkliniken
  • Akademiska sjukhuset, Onkologkliniken
  • Andreas Klinik; Onko-Hämatologisches Zentrum Cham Zug
  • Kantonsspital Graubünden;Onkologie und Hämatologie
  • Clinica Santa Chiara; Oncologia / Ematologia
  • UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
  • Ankara Numune Egitim Ve Arastirma Hastanesi; Hematoloji Klinigi
  • Hacettepe Uni Medical Faculty; Hematology
  • Gazi Uni Medical School; Hematology
  • Istanbul Uni Capa Hospital; Hematology
  • Ege Uni Medical School; Hematology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants With an Adverse Event (AE) - Overall Summary
Data presented include percentage of participants with any AE, any infusion-related AE, any serious adverse event (SAE), any infusion-related SAE (counted separately from SAEs), death, and participants with toxicity as the primary cause for treatment discontinuation.

Secondary Outcome Measures

Progression-Free Survival - Percentage of Participants With an Event
PFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression or death by any cause. Participants who experienced none of these events at the time of analysis (clinical cutoff) and participants who were lost to follow-up were censored at their last clinical assessment date.
Progression-Free Survival - Time to Event
PFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression or death by any cause. Participants who experienced none of these events at the time of analysis (clinical cutoff) and participants who were lost to follow-up were censored at their last clinical assessment date.
Event-Free Survival (EFS) - Percentage of Participants With an Event
The percentage of participants who experienced PD or death or required a next or new lymphoma treatment over a study period of 2 years with 1 year of follow-up. EFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression, death by any cause, or the institution of new anti-lymphoma treatment. Participants who experienced none of these events at the end of the study and participants who were lost to follow-up were censored at their last clinical assessment date.
Event-Free Survival (EFS) - Time to Event
EFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression, death by any cause, or the institution of new anti-lymphoma treatment. Participants who experienced none of these events at the end of the study and participants who were lost to follow-up were censored at their last clinical assessment date.
Overall Survival (OS) - Percentage of Participants With an Event
As a measure of overall survival (OS), the percentage of participants who died over the study period of 2 years with 1 year of follow-up. OS was determined from the day of first rituximab maintenance infusion until the date of death irrespective of cause. Participants who had not died at the time of end of the whole study and participants who were lost to follow up were censored at the date of the last contact.
Overall Survival (OS) - Time to Event
OS was determined from the day of first rituximab maintenance infusion until the date of death irrespective of cause. Participants who had not died at the time of end of the whole study and participants who were lost to follow up were censored at the date of the last contact.
Time to Next Lymphoma Treatment (NLT) - Percentage of Participants With an Event
As a measure of time to NLT (TNLT), the percentage of participants with new lymphoma treatment over a study period of 2 years with 1 year of follow-up. TNLT was measured from the date of first rituximab maintenance infusion to the date of first documented intake of any new anti-lymphoma treatment (chemotherapy, radiotherapy, immunotherapy, etc). Participants who did not have documentation that an NLT had started and participants who were lost to follow up were censored at their last visit where the assessment for start of any new lymphoma medication was actually made.
Time to NLT - Time to Event
TNLT was measured from the date of first rituximab maintenance infusion to the date of first documented intake of any new anti-lymphoma treatment (chemotherapy, radiotherapy, immunotherapy, etc). Participants who did not have documentation that an NLT had started and participants who were lost to follow up were censored at their last visit where the assessment for start of any new lymphoma medication was actually made.
Percentage of Participants With Response by Best Response to Study Treatment
Percentage of participants with complete response (CR), unconfirmed CR (CRu), no change, or progressive disease (PD). For each participant, the last response to induction therapy immediately prior to study entry was compared to the best response observed during rituximab maintenance therapy. Where possible, assessment of response was based on the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma (NHL).
Percentage of Participants With PR Who Converted to CRu
Percentage of participants with PR or CR(u) conversion while on rituximab maintenance therapy over a study period of 2 years with 1 year of follow-up. For each participant, the last response to induction therapy immediately prior to study entry was compared to the best response observed during rituximab maintenance therapy. Assessment and definition of response was based on the International Workshop to Standardize Response Criteria for NHL.

Full Information

First Posted
January 31, 2007
Last Updated
July 5, 2017
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00430352
Brief Title
MAXIMA Study: A Study of Maintenance Therapy With MabThera (Rituximab) in Patients With Non-Hodgkin's Lymphoma.
Official Title
A Study to Evaluate the Safety of MabThera (Rituximab) Maintenance Therapy in Patients With Follicular Non-Hodgkin's Lymphoma Who Have Responded to Induction Therapy.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
September 4, 2006 (Actual)
Primary Completion Date
May 26, 2011 (Actual)
Study Completion Date
May 26, 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 single arm study will evaluate the safety and efficacy of MabThera maintenance therapy following a MabThera-containing induction regimen in first line or relapsed patients with follicular non-Hodgkin's lymphoma. All patients will receive MabThera 375mg/m2 body surface area, as an intravenous infusion, every 8 weeks. The anticipated time on study treatment is 1-2 years, and the target sample size is 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 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
545 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
rituximab [MabThera/Rituxan]
Intervention Description
375mg/m2 iv every 8 weeks
Primary Outcome Measure Information:
Title
Percentage of Participants With an Adverse Event (AE) - Overall Summary
Description
Data presented include percentage of participants with any AE, any infusion-related AE, any serious adverse event (SAE), any infusion-related SAE (counted separately from SAEs), death, and participants with toxicity as the primary cause for treatment discontinuation.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Progression-Free Survival - Percentage of Participants With an Event
Description
PFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression or death by any cause. Participants who experienced none of these events at the time of analysis (clinical cutoff) and participants who were lost to follow-up were censored at their last clinical assessment date.
Time Frame
Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Title
Progression-Free Survival - Time to Event
Description
PFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression or death by any cause. Participants who experienced none of these events at the time of analysis (clinical cutoff) and participants who were lost to follow-up were censored at their last clinical assessment date.
Time Frame
Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Title
Event-Free Survival (EFS) - Percentage of Participants With an Event
Description
The percentage of participants who experienced PD or death or required a next or new lymphoma treatment over a study period of 2 years with 1 year of follow-up. EFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression, death by any cause, or the institution of new anti-lymphoma treatment. Participants who experienced none of these events at the end of the study and participants who were lost to follow-up were censored at their last clinical assessment date.
Time Frame
Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Title
Event-Free Survival (EFS) - Time to Event
Description
EFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression, death by any cause, or the institution of new anti-lymphoma treatment. Participants who experienced none of these events at the end of the study and participants who were lost to follow-up were censored at their last clinical assessment date.
Time Frame
Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Title
Overall Survival (OS) - Percentage of Participants With an Event
Description
As a measure of overall survival (OS), the percentage of participants who died over the study period of 2 years with 1 year of follow-up. OS was determined from the day of first rituximab maintenance infusion until the date of death irrespective of cause. Participants who had not died at the time of end of the whole study and participants who were lost to follow up were censored at the date of the last contact.
Time Frame
Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Title
Overall Survival (OS) - Time to Event
Description
OS was determined from the day of first rituximab maintenance infusion until the date of death irrespective of cause. Participants who had not died at the time of end of the whole study and participants who were lost to follow up were censored at the date of the last contact.
Time Frame
Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Title
Time to Next Lymphoma Treatment (NLT) - Percentage of Participants With an Event
Description
As a measure of time to NLT (TNLT), the percentage of participants with new lymphoma treatment over a study period of 2 years with 1 year of follow-up. TNLT was measured from the date of first rituximab maintenance infusion to the date of first documented intake of any new anti-lymphoma treatment (chemotherapy, radiotherapy, immunotherapy, etc). Participants who did not have documentation that an NLT had started and participants who were lost to follow up were censored at their last visit where the assessment for start of any new lymphoma medication was actually made.
Time Frame
Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Title
Time to NLT - Time to Event
Description
TNLT was measured from the date of first rituximab maintenance infusion to the date of first documented intake of any new anti-lymphoma treatment (chemotherapy, radiotherapy, immunotherapy, etc). Participants who did not have documentation that an NLT had started and participants who were lost to follow up were censored at their last visit where the assessment for start of any new lymphoma medication was actually made.
Time Frame
Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Title
Percentage of Participants With Response by Best Response to Study Treatment
Description
Percentage of participants with complete response (CR), unconfirmed CR (CRu), no change, or progressive disease (PD). For each participant, the last response to induction therapy immediately prior to study entry was compared to the best response observed during rituximab maintenance therapy. Where possible, assessment of response was based on the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma (NHL).
Time Frame
Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Title
Percentage of Participants With PR Who Converted to CRu
Description
Percentage of participants with PR or CR(u) conversion while on rituximab maintenance therapy over a study period of 2 years with 1 year of follow-up. For each participant, the last response to induction therapy immediately prior to study entry was compared to the best response observed during rituximab maintenance therapy. Assessment and definition of response was based on the International Workshop to Standardize Response Criteria for NHL.
Time Frame
Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult patients, >=18 years of age; histologically confirmed grade 1, 2 or 3a follicular non-Hodgkin's lymphoma; patients who have received adequate (>=8 cycles) induction therapy with MabThera as first line treatment, or treatment for relapsed disease; demonstrated partial or complete response to induction therapy. Exclusion Criteria: stable or progressive disease after most recent induction therapy; transformation to high grade lymphoma; patients with prior or concomitant malignancies, except non-melanoma skin cancer or adequately treated in situ cancer of the cervix.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
University "Mother Theresa" Hospital Center; Oncology Department
City
Tirana
ZIP/Postal Code
1000
Country
Albania
Facility Name
Instituo Lavalle de Oncologia; Hematology
City
Bahia Blanca
ZIP/Postal Code
8001
Country
Argentina
Facility Name
Academia Nacional de Medicina; Inst. de Cardiologia
City
Buenos Aires
ZIP/Postal Code
1425
Country
Argentina
Facility Name
Fundaleu; Haematology
City
Buenos Aires
ZIP/Postal Code
C1114AAN
Country
Argentina
Facility Name
Hospital Churruca Visca; Haematology
City
Buenos Aires
ZIP/Postal Code
C1437JCP
Country
Argentina
Facility Name
Hospital Jr Vidal; Jefe de Servicio de Clinica Medica/Hematologia
City
Corrientes
ZIP/Postal Code
3400
Country
Argentina
Facility Name
Sanatorio Allende; Haematology
City
Córdoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
HOSPITAL PRIVADO - CENTRO MEDICO DE CÓRDOBA; Dpto Oncología
City
Córdoba
ZIP/Postal Code
5016
Country
Argentina
Facility Name
Hospital General San Martin; Haematology
City
La Plata
ZIP/Postal Code
B1904CFS
Country
Argentina
Facility Name
Liverpool Hospital; Haematology
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Wollongong Hospital; Cancer Services
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Royal Brisbane Hospital; Oncology Department
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4006
Country
Australia
Facility Name
Haematology & Oncology Clinics of Australia, Mater Medical Centre
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Mount Medical Center
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
University Clinical Center of the Republic of Srpska, Clinic for Internal Disease, Hematology Dept
City
Banja Luka
ZIP/Postal Code
88000
Country
Bosnia and Herzegovina
Facility Name
Inst. of Hematology
City
Kasindo
ZIP/Postal Code
71123
Country
Bosnia and Herzegovina
Facility Name
Uni Hospital Mostar
City
Mostar
ZIP/Postal Code
88000
Country
Bosnia and Herzegovina
Facility Name
Clinic of Oncology, University Clinical Center Sarajevo
City
Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Facility Name
Nucleo de Oncologia da Bahia - NOB
City
Salvador, Bahia
State/Province
BA
ZIP/Postal Code
40170-380
Country
Brazil
Facility Name
CEHON
City
Salvador
State/Province
BA
ZIP/Postal Code
40110-150
Country
Brazil
Facility Name
ONCOMED
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
30140-083
Country
Brazil
Facility Name
Centro de Tratamento Oncologico - Oncoclinica
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
22640-000
Country
Brazil
Facility Name
Hospital das Clinicas - UFRGS; Medicina Interna
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Hospital Mae de Deus
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90470-340
Country
Brazil
Facility Name
Hospital Sao Lucas - PUCRS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Centro de Pesquisas Oncologicas - CEPON
City
Florianopolis
State/Province
SC
ZIP/Postal Code
88034-000
Country
Brazil
Facility Name
Hospital das Clinicas - UNICAMP; Hemoterapia
City
Campinas
State/Province
SP
ZIP/Postal Code
13083-878
Country
Brazil
Facility Name
Clinica Oncologica De Piracicaba Sc
City
Piracicaba
State/Province
SP
ZIP/Postal Code
13419-155
Country
Brazil
Facility Name
Hospital Alemao Oswaldo Cruz; Oncologia
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01323-020
Country
Brazil
Facility Name
Hospital Estadual do Servidor Publico; Hematologia
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04029-000
Country
Brazil
Facility Name
Hospital das Clinicas - FMUSP, Oncologia
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
UMHAT Dr Georgi Stranski; Hematology
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Umhat S. George; Hematology
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
UMHAT Alexandrovska EAD; Hematology
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
National Center of Hematology & Transfusiology; Clinical Unit, Clinic of Hematology
City
Sofia
ZIP/Postal Code
1757
Country
Bulgaria
Facility Name
Mhat Sveta Marina; Dept. of Haematology
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Centro Médico Carlos Ardila Lule
City
Bucaramanga
Country
Colombia
Facility Name
Hospital Pablo Tobon Uribe
City
Medellin-Antioquia
Country
Colombia
Facility Name
Clinical Hospital Centre Split; Dept Of Hematology
City
Split
ZIP/Postal Code
21000
Country
Croatia
Facility Name
Clinical Hospital Centre Dubrava; Hematology Department
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
University Hospital Center Zagreb; Haematology Department
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Hospital José Carrasco; Oncology Service
City
Cuenca
Country
Ecuador
Facility Name
Hospital Carlos Andrade Marin; Servicio de Oncología
City
Quito
ZIP/Postal Code
2569
Country
Ecuador
Facility Name
Oncology & Radiotherapy Centre; Oncology
City
Cairo
ZIP/Postal Code
11737
Country
Egypt
Facility Name
Kanta-Hämeen Keskussairaala; Dept of Internal Medicine, Hematology
City
Haemeenlinna
ZIP/Postal Code
13530
Country
Finland
Facility Name
Kymenlaakson keskussairaala
City
Kotka
ZIP/Postal Code
48210
Country
Finland
Facility Name
Päijät-Hämeen Keskussairaala; Dept of Internal Medicine, Hematology
City
Lahti
ZIP/Postal Code
15850
Country
Finland
Facility Name
Satakunnan Keskussairaala; Sisaetauti Osasto
City
Pori
ZIP/Postal Code
28500
Country
Finland
Facility Name
Internist; Praxis Für Haemotologie & Onkologie
City
Bad Soden
ZIP/Postal Code
65812
Country
Germany
Facility Name
Dres.Christian Sperling und Claudia Schelenz
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis Kurfürstendamm
City
Berlin
ZIP/Postal Code
10707
Country
Germany
Facility Name
Universitätsklinikum Bonn; Medizinische Klinik und Poliklinik I; Allgemeine Innere Medizin
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Dres. Matthias Adler Oliver Marschal und Andreas Pies
City
Braunschweig
ZIP/Postal Code
38100
Country
Germany
Facility Name
Gemeinschaftspraxis
City
Duisburg
ZIP/Postal Code
47051
Country
Germany
Facility Name
Internistische Praxis Dr. Plingen
City
Düsseldorf
ZIP/Postal Code
40211
Country
Germany
Facility Name
Internistische Schwerpunktpraxis Erlangen
City
Erlangen
ZIP/Postal Code
91052
Country
Germany
Facility Name
Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
City
Freiburg
ZIP/Postal Code
79110
Country
Germany
Facility Name
Onkologische Gemeinschaftspraxis, Prof. Dr. Gropp, Dr. Depenbusch und Dr. Rösel
City
Gütersloh
ZIP/Postal Code
33332
Country
Germany
Facility Name
Überörtliche Gemeinschaftspraxis Schwerpunkt Hämatologie, internistische Onkologie & Palliativmed.
City
Hamburg
ZIP/Postal Code
20259
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis; Herrn Dr. Med. Bertram
City
Hamburg
ZIP/Postal Code
22457
Country
Germany
Facility Name
Dres.Andreas Karcher und Stefan Fuxius
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
Facility Name
Uniklinik Heidelberg, Medizinische Klinik & Poliklinik V
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis (Eps-Gmbh)
City
Jena
ZIP/Postal Code
07743
Country
Germany
Facility Name
Märkische Kliniken GmbH, Klinikum Lüdenscheid; Hämatologie / Onkologie
City
Lüdenscheid
ZIP/Postal Code
58515
Country
Germany
Facility Name
Stauferklinikum Schwäb.Gmünd
City
Mutlangen
ZIP/Postal Code
73557
Country
Germany
Facility Name
Gemeinschaftspraxis Dres. Schröder, Sieg
City
Mülheim
ZIP/Postal Code
45468
Country
Germany
Facility Name
Onko. Gemeinschaftspraxis Dres. Tigges/ Böning/ Abenhardt/ Bosse
City
München
ZIP/Postal Code
80335
Country
Germany
Facility Name
Dres.Ulrich Hutzschenreuter und Uwe Sauer
City
Nordhorn
ZIP/Postal Code
48527
Country
Germany
Facility Name
Onkologische Praxis Oldenburg; Dres. Otremba, Reschke, Zirpel, Kühn und Ruff
City
Oldenburg
ZIP/Postal Code
26121
Country
Germany
Facility Name
Praxis für Onkologie und Hämatologie
City
Recklinghausen
ZIP/Postal Code
45657
Country
Germany
Facility Name
Diakonie-Klinikum Klinik für Innere Medizin III Abt.Hämatologie, intern. Onkologie und Palliativmedi
City
Schwäbisch-Hall
ZIP/Postal Code
74523
Country
Germany
Facility Name
Internistische Gemeinschaftspraxis Dres. Hoering/Von Ehr/Responde
City
Stuttgart
ZIP/Postal Code
70176
Country
Germany
Facility Name
Haematologisch-Onkologische Praxis; Dr. med. Christoph Maintz und Matthias Groschek
City
Wuerselen
ZIP/Postal Code
52146
Country
Germany
Facility Name
Laiko General Hospital - Uni of Athens; 1St Dept. of Internal Medicine
City
Athens
ZIP/Postal Code
11524
Country
Greece
Facility Name
Attiko Hospital; Haematology Clinic
City
Athens
ZIP/Postal Code
124 62
Country
Greece
Facility Name
Theagenio Anticancer Hospital; Dept. of Haematology
City
Thessaloniki
ZIP/Postal Code
54007
Country
Greece
Facility Name
Rambam Medical Center; Heamatology & Bone Marrow Transplantation
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Wolfson Mc; Haematology
City
Holon
ZIP/Postal Code
5810001
Country
Israel
Facility Name
Hadassah Ein Karem Hospital; Haematology
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Chaim Sheba Medical Center; Hematology BMT & CBB
City
Ramat Gan
ZIP/Postal Code
52662
Country
Israel
Facility Name
Ichilov Sourasky Medical Center; Heamatology
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Ospedale Civile Dello Spirito Santo; Divisione Di Ematologia
City
Pescara
State/Province
Abruzzo
ZIP/Postal Code
65100
Country
Italy
Facility Name
Az. Osp. Pugliese; Dh Oncologico
City
Catanzaro
State/Province
Calabria
ZIP/Postal Code
88100
Country
Italy
Facility Name
Ospedale S. Gennaro; Divisione Di Ematologia
City
Napoli
State/Province
Campania
ZIP/Postal Code
80100
Country
Italy
Facility Name
Ospedale Cardarelli; Divisione Di Ematologia
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
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
Arcispedale S. Anna; Sezione Di Ematologia
City
Ferrara
State/Province
Emilia-Romagna
ZIP/Postal Code
44100
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.U. Policlinico di Modena-Dipartimento di Medicina Diagnostica, Clinica e di Sanità pubblica
City
Modena
State/Province
Emilia-Romagna
ZIP/Postal Code
41100
Country
Italy
Facility Name
Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
City
Aviano
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
33081
Country
Italy
Facility Name
Az. Osp. Uni Ria Policlinico Tor Vergata; Unita Di Ematologia
City
Roma
State/Province
Lazio
ZIP/Postal Code
00133
Country
Italy
Facility Name
Ospedale S. Eugenio; Divisione Di Ematologia
City
Roma
State/Province
Lazio
ZIP/Postal Code
00144
Country
Italy
Facility Name
Univ. Cattolica La Sapienza; Cattedra Di 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
A.O. Universitaria S. Martino Di Genova; Ematologia 1
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
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
Istituto S. Raffaele Monte Tabor; Divisione Ematologia E Utmo
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
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
Irccs Policlinico San Matteo; Divisione Di Ematologia
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Ospedale Civile; S.C. Ematologia
City
Pesaro
State/Province
Marche
ZIP/Postal Code
61100
Country
Italy
Facility Name
A.O. Univ.Ospedali Riuniti Umerto I -G.M.Lancisi G.Salesi; U.O. Clinica Di Ematologia
City
Torrette Di Ancona
State/Province
Marche
ZIP/Postal Code
60020
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
Univ. Piemonte Est Amedeo Avogadro; Div.Ematologia- Dip.Clinica Med.Sperim.& Ircad
City
Novara
State/Province
Piemonte
ZIP/Postal Code
28100
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
Ospedale Vito Fazzi; Div. Oncoematologia
City
Lecce
State/Province
Puglia
ZIP/Postal Code
73100
Country
Italy
Facility Name
Az. Osp. C. Panico; Rep. Ematologia E Trapianto
City
Tricase - Le
State/Province
Puglia
ZIP/Postal Code
73039
Country
Italy
Facility Name
Ospedale Oncologico A Businco-Cagliari; Ematologia Sez.
City
Cagliari
State/Province
Sardegna
ZIP/Postal Code
09121
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
A.O. Universitaria Senese; Ematologia
City
Siena
State/Province
Toscana
ZIP/Postal Code
53100
Country
Italy
Facility Name
Azienda Ospedaliera S. Maria della Misericordia; Ematologia
City
Perugia
State/Province
Umbria
ZIP/Postal Code
06100
Country
Italy
Facility Name
Uni Degli Studi; Dip.Med.Clinica E Sperim. Ematologia
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Facility Name
Ospedale Di Vicenza; Nefrologia, Ematologia
City
Vicenza
State/Province
Veneto
ZIP/Postal Code
36100
Country
Italy
Facility Name
Issste; Haematology
City
Chihuahua
ZIP/Postal Code
31100
Country
Mexico
Facility Name
Hospital Cima (Centro Internacional de Medicina) ; Haematology
City
Chihuahua
ZIP/Postal Code
31238
Country
Mexico
Facility Name
Hospital Central de Pemex Norte Azcapotzalco
City
Mexico City
ZIP/Postal Code
02720
Country
Mexico
Facility Name
Hospital Español de Mexico
City
Mexico City
ZIP/Postal Code
11520
Country
Mexico
Facility Name
Hospital Regional Issste; Oncologia
City
Monterrey
ZIP/Postal Code
64380
Country
Mexico
Facility Name
Clinca San Jose; Haematology
City
Obregon
ZIP/Postal Code
85000
Country
Mexico
Facility Name
Issstep Puebla, ; Haematology
City
Puebla
ZIP/Postal Code
72530
Country
Mexico
Facility Name
Spitalul Clinic Judetean de Urgenta Brasov,Clinica de Hematologie
City
Brasov
ZIP/Postal Code
500326
Country
Romania
Facility Name
Fundeni Clinical Inst. ; Hematology Dept
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Spitalul Clinic Coltea; Clinica de Hematologie
City
Bucuresti
ZIP/Postal Code
030171
Country
Romania
Facility Name
Oncology Inst. Cluj-Napoca; Cancer Dept
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Sf. Spiridon Iasi, Clinica de Hematologie
City
Iasi
ZIP/Postal Code
700111
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Targu-Mures; compartiment Hematologie
City
Targu-mures
ZIP/Postal Code
540136
Country
Romania
Facility Name
Regional Clinical Hospital; Hematology
City
Belgorod
ZIP/Postal Code
ND
Country
Russian Federation
Facility Name
Clinical Oncology Dispensary of Ministry of Health of Tatarstan
City
Kazan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Blokhin Cancer Research Center; Clinical Oncology
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
City Clinical Hospital After Botkin; Hematology
City
Moscow
ZIP/Postal Code
125101
Country
Russian Federation
Facility Name
Vladimirskiy Regional Scientific Research Inst. ; Hematology
City
Moscow
ZIP/Postal Code
129110
Country
Russian Federation
Facility Name
Regional Clinical Hospital N.A. Semashko; Hematology
City
Nizhny Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
City Hematological Center of Clinical Hospital #2; Hematology
City
Novosibirsk
ZIP/Postal Code
630051
Country
Russian Federation
Facility Name
Rostov State Medical Uni ; Hematology
City
Rostov-na-donu
ZIP/Postal Code
344022
Country
Russian Federation
Facility Name
Research Inst. of Hematology & Blood Transfusion ; Hematology
City
St Petersburg
ZIP/Postal Code
191024
Country
Russian Federation
Facility Name
Pavlov State Medical Uni ; Bone Marrow Transplantation Clinic
City
St Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Leningrad Regional Clinical Hospital; Hematology #1
City
St Petersburg
Country
Russian Federation
Facility Name
Stavropol Clinical Oncology Dispansary
City
Stavropol
ZIP/Postal Code
ND
Country
Russian Federation
Facility Name
Bashkirian Republican Clinical Oncology Dispensary
City
UFA
ZIP/Postal Code
450054
Country
Russian Federation
Facility Name
Ulyanovsk Regional Oncology Dispensary; Chemotherapy
City
Ulyanovsk
ZIP/Postal Code
ND
Country
Russian Federation
Facility Name
Regional Oncology Center; Chemotherapy
City
Volgograd
ZIP/Postal Code
400138
Country
Russian Federation
Facility Name
Regional Clinical Hospital; Hematology
City
Yaroslavl
ZIP/Postal Code
150062
Country
Russian Federation
Facility Name
Fakultna Nemocnica Roosevelta; Dept. of Haematology
City
Banska Bystrica
ZIP/Postal Code
975 17
Country
Slovakia
Facility Name
National Oncology Inst. ; Dept. of Haematology
City
Bratislava
ZIP/Postal Code
833 10
Country
Slovakia
Facility Name
Uni Hospital; Clinic of Haematology
City
Kosice
ZIP/Postal Code
040 66
Country
Slovakia
Facility Name
Uni Hospital ; Dept. of Haematol. & Transfusion Medicine
City
Martin
ZIP/Postal Code
036 59
Country
Slovakia
Facility Name
Institute of Oncology Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Facility Name
Complejo Asistencial Universitario De Burgos; Servicio de Oncologia
City
Burgos
ZIP/Postal Code
09006
Country
Spain
Facility Name
Hospital General de Castellon; Servicio de Hematologia
City
Castellon
ZIP/Postal Code
12004
Country
Spain
Facility Name
Hospital Generla de Ciudad Real; Servicio de Oncologia
City
Ciudad Real
ZIP/Postal Code
13005
Country
Spain
Facility Name
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
City
Jaen
ZIP/Postal Code
23007
Country
Spain
Facility Name
Hospital El Bierzo; Servicio de Oncologia
City
Leon
ZIP/Postal Code
24411
Country
Spain
Facility Name
Hospital Costa del Sol; Servicio de Hematologia
City
Malaga
ZIP/Postal Code
29600
Country
Spain
Facility Name
Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena; Servicio de Hematologia
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Laenssjukhuset; Medicinkliniken/Hematologsektionen
City
Halmstad
ZIP/Postal Code
30185
Country
Sweden
Facility Name
Sunderby Sjukhus; Medicinkliniken
City
Luleå
ZIP/Postal Code
S-971 80
Country
Sweden
Facility Name
Skånes Universitetssjukhus; Kliniska Forskningsenheten Onkologimottagning medicinsk behandling
City
Malmö
ZIP/Postal Code
205 02
Country
Sweden
Facility Name
Länssjukhuset Sundsvall-Härnösand, Medicinkliniken
City
Sundsvall
ZIP/Postal Code
85186
Country
Sweden
Facility Name
Uddevalla Sjukhus; Medicinkliniken
City
Uddevalla
ZIP/Postal Code
45180
Country
Sweden
Facility Name
Akademiska sjukhuset, Onkologkliniken
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Facility Name
Andreas Klinik; Onko-Hämatologisches Zentrum Cham Zug
City
Cham
ZIP/Postal Code
6330
Country
Switzerland
Facility Name
Kantonsspital Graubünden;Onkologie und Hämatologie
City
Chur
ZIP/Postal Code
7000
Country
Switzerland
Facility Name
Clinica Santa Chiara; Oncologia / Ematologia
City
Locarno
ZIP/Postal Code
6601
Country
Switzerland
Facility Name
UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Ankara Numune Egitim Ve Arastirma Hastanesi; Hematoloji Klinigi
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Hacettepe Uni Medical Faculty; Hematology
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Gazi Uni Medical School; Hematology
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Facility Name
Istanbul Uni Capa Hospital; Hematology
City
Istanbul
ZIP/Postal Code
34390
Country
Turkey
Facility Name
Ege Uni Medical School; Hematology
City
Izmir
ZIP/Postal Code
35100
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
24824768
Citation
Witzens-Harig M, Foa R, Di Rocco A, van Hazel G, Chamone DF, Rowe JM, Arcaini L, Poddubnaya I, Ho AD, Ivanova V, Vranovsky A, Thurley D, Oertel S. Maintenance with rituximab is safe and not associated with severe or uncommon infections in patients with follicular lymphoma: results from the phase IIIb MAXIMA study. Ann Hematol. 2014 Oct;93(10):1717-24. doi: 10.1007/s00277-014-2103-3. Epub 2014 May 14. Erratum In: Ann Hematol. 2014 Oct;93(10):1807.
Results Reference
derived

Learn more about this trial

MAXIMA Study: A Study of Maintenance Therapy With MabThera (Rituximab) in Patients With Non-Hodgkin's Lymphoma.

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