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Assess the therapeutic activity and safety of the combination of Chlorambucil and Rituximab in MALT lymphomas and determine whether the addition of Rituximab to Chlorambucil will improve the outcome of MALT lymphoma in comparison to treatment with Chlorambucil alone.
In April 2006, a third arm of treatment was added to compare the antitumor activity and safety of rituximab alone vs chlorambucil alone
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM A | Active Comparator | chlorambucil 6 mg/m2 daily during the first 6 weeks of treatment; two weeks rest; chlorambucil 6 mg/m2 daily during the first two of a four weeks cycles (total of 4 cycles) |
|
| ARM B | Experimental | rituximab 375 mg/m2 iv, d1, d8, d15, d22 chlorambucil 6 mg/m2 os, daily during the first 6 weeks of treatment two weeks rest chlorambucil 6 mg/m2 os daily during the first two of a four weeks cycles (total of 4 cycles) rituximab 375 mg/m2 iv at day 1 of each cycle |
|
| ARM C (Since April 2006) | Experimental | rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chlorambucil (drug) | Drug | chlorambucil 6 mg/m2 daily during the first 6 weeks of treatment, two weeks rest, chlorambucil 6 mg/m2 daily during the first two of a four weeks cycles (total of 4 cycles) |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free-survival (EFS) | Percentage of patients without events (failure of treatment or Death from any cause) after 5 years from trial registration | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Complete and Partial Remission Rate - Percentage of Patients With Complete and Partial Response at the End of Treatment | Response criteria were defined according to the NCI standardized response criteria for non-Hodgkin's lymphoma. Complete response. Disappearance of all detectable clinical and radiographic evidence of disease, disappearance of all disease-related symptoms, if present before therapy, and normalization of those biochemical abnormalities definitely assignable to NHL. Regression of all lymph nodes and nodal masses to normal (≤ 1.5 cm in their greatest transverse diameter for nodes > 1.5 cm before therapy and to ≤ 1 cm for nodes that were 1.1-1.5 cm. Regression by more than 75% in the sum of the products of the greatest diameters). Partial response. Decrease by at least 50% in SPD of the six largest measurable lesions. It is not necessary for all lesions to have regressed to qualify for partial response, but no lesion should have progressed and no new lesion should appear. For primary gastric sites, response was based on GELA histologic grading system. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emanuele Zucca, MD | International Extranodal Lymphoma Study Group/Oncology Institute of Southern Switzerland. Bellinzona | Study Chair |
| Emilio Montserrat, MD | Clinic Hospital Universitari, Hematology. Barcelona | Study Chair |
| Catherine Thieblemont, MD | Centre Hospitalier Lyon Sud, Hematology. Lyon | Study Chair |
| Giovanni Martinelli, MD | Hemato-oncology. European Oncology Institute. Milan | Study Chair |
| Peter Johnson, MD | Oncology Unit. Southampton General Hospital. Southampton | Study Chair |
| Maurizio Martelli, MD | Hematology. Università La Sapienza. Roma | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ACZA Campus Stuivenberg | Antwerp | Belgium | ||||
| AZ StJan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37801707 | Derived | Bommier C, Zucca E, Chevret S, Conconi A, Nowakowski G, Maurer MJ, Cerhan JR, Thieblemont C, Lambert J. Early complete response as a validated surrogate marker in extranodal marginal zone lymphoma systemic therapy. Blood. 2024 Feb 1;143(5):422-428. doi: 10.1182/blood.2023020984. | |
| 23295789 | Derived | Zucca E, Conconi A, Laszlo D, Lopez-Guillermo A, Bouabdallah R, Coiffier B, Sebban C, Jardin F, Vitolo U, Morschhauser F, Pileri SA, Copie-Bergman C, Campo E, Jack A, Floriani I, Johnson P, Martelli M, Cavalli F, Martinelli G, Thieblemont C. Addition of rituximab to chlorambucil produces superior event-free survival in the treatment of patients with extranodal marginal-zone B-cell lymphoma: 5-year analysis of the IELSG-19 Randomized Study. J Clin Oncol. 2013 Feb 10;31(5):565-72. doi: 10.1200/JCO.2011.40.6272. Epub 2013 Jan 7. |
| Label | URL |
|---|---|
| Click here for more information about this study | View source |
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Subjects were enrolled from 10 January 2003 to 07 July 2010
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| ID | Title | Description |
|---|---|---|
| FG000 | ARM A - Chlorambucil | Chlorambucil 6 mg/m2 daily during the first 6 weeks of treatment; two weeks rest; chlorambucil 6 mg/m2 daily during the first two of a four weeks cycles (total of 4 cycles) |
| FG001 | ARM B - Rituximab + Chlorambucil |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| rituximab+chlorambucil | Drug | rituximab 375 mg/m2 iv, d1, 8, 15, 22, chlorambucil 6 mg/m2 os, daily during the first 6 weeks of treatment, ; two weeks rest; chlorambucil 6 mg/m2 os, daily during the first two of a four weeks cycles (total of 4 cycles) rituximab 375 mg/m2 iv at day 1 of each cycle |
|
| rituximab | Drug | rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140 |
|
| End of treatment (after 24 weeks of therapy) |
| Response Duration (Time to Relapse or Progression) - Percentage of Patients in Continuous Remission at Five Years From Trial Registration | Response criteria were defined according to the NCI standardized response criteria for non-Hodgkin's lymphoma. Complete response (CR). Disappearance of all detectable clinical and radiographic evidence of disease, disappearance of all disease-related symptoms, if present before therapy, and normalization of those biochemical abnormalities definitely assignable to NHL. Regression of all lymph nodes and nodal masses to normal (≤ 1.5 cm in their greatest transverse diameter for nodes > 1.5 cm before therapy and to ≤ 1 cm for nodes that were 1.1-1.5 cm. Regression by more than 75% in the sum of the products of the greatest diameters). | 5 years |
| Progression-free-survival (PFS) | Percentage of patients without disease progression after 5 years from trial registration | 5 years |
| Overall Survival | Percentage of patients alive after 5 years from trial registration | 5 years |
| Bruges |
| Belgium |
| St Luc | Brussels | Belgium |
| ULB Hopital Erasme | Brussels | Belgium |
| CHNDRF | Charleroi | Belgium |
| Hospital St Joseph | Gilly | Belgium |
| UCL de Mont Godinne | Yvoir | Belgium |
| Centre Hospitalier de Blois | Blois | France |
| Hopital Avicenne | Bobigny | France |
| CHU | Dijon | France |
| Centre Hospitalier | Lens | France |
| CHRU Lille | Lille | France |
| Centre Hospitalier Lyon Sud | Lyon | France |
| Centre Leon Berard | Lyon | France |
| Institut Paoli Calmettes | Marseille | France |
| Hopital Arnold Villeneuve | Monpellier | France |
| CHU | Nancy | France |
| CHU Hotel Dieu | Nantes | France |
| Centre R. Gauducheau | Nantes-St. Herblain | France |
| Hopital Henri-Mondor | Paris | France |
| Hopital St Louis | Paris | France |
| Necker | Paris | France |
| Centre Henri Becquerel | Rouen | France |
| Spedali Civili | Brescia | Italy |
| Azienda ULSS 15 Alta Padovana | Cittadella | Italy |
| IST | Genova | Italy |
| Humanitas | Milan | Italy |
| San Raffaele Hospital | Milan | Italy |
| IEO | Milan | Italy |
| INT | Milan | Italy |
| Policlinico | Modena | Italy |
| Ospedale Civile | Piacenza | Italy |
| A.O. Bianchi-Melacrino-Morelli, Divisione di Ematologia | Reggio Calabria | Italy |
| Arcispedale S. Maria Nuova | Reggio Emilia | Italy |
| S. Eugenio | Rome | Italy |
| Università Cattolica Sacro Cuore | Rome | Italy |
| Università La Sapienza | Rome | Italy |
| Sassuolo GISL | Sassuolo | Italy |
| AOU Senese | Siena | Italy |
| A.O.U. San Giovanni Battista-Molinette, S.C. Ematologia 2 | Torino | 10134 | Italy |
| Trani GISL | Trani | Italy |
| Ospedale di Circolo Fondazione Macchi | Varese | Italy |
| Policlinico GB Rossi | Verona | Italy |
| Clinic Hospital Universitari | Barcelona | Spain |
| Hopital Mataro' | Barcelona | Spain |
| Hopital Santa Creu i Sant Pau | Barcelona | Spain |
| University Hospital | Salamanca | Spain |
| Joan XXIII | Tarragona | Spain |
| IOSI | Bellinzona | 6500 | Switzerland |
| Aberdeen Royal Infirmary | Aberdeen | United Kingdom |
| Heartlands | Birmingham | United Kingdom |
| Victoria Hospital | Blackpool | United Kingdom |
| Royal Cornwall Hospital | Cornwall | United Kingdom |
| Darent Valley Hospital | Dartford | United Kingdom |
| Royal Devon &Exeter Healtcare NHS Trust | Devon | United Kingdom |
| Russels Hall Hospital | Dudley | United Kingdom |
| Western General Hospital | Edinburgh | United Kingdom |
| Medway Hospital | Gillingham | United Kingdom |
| Raigmore Hospital | Inverness | United Kingdom |
| Liverpool Royal Hospital | Liverpool | United Kingdom |
| University Hospital Aintree | Liverpool | United Kingdom |
| Barts & the London NHS Trust | London | United Kingdom |
| Royal Marsden NHS Foundation Trust | London | United Kingdom |
| St Georges | London | United Kingdom |
| Christie Hospital | Manchester | United Kingdom |
| Mount Vernon Hospital | Middlesex | United Kingdom |
| James Paget Hospital | Norfolk | United Kingdom |
| Queen Elisabeth | Norfolk | United Kingdom |
| Nottingham City Hospital | Nottingham | United Kingdom |
| John Radcliffe | Oxford | United Kingdom |
| Conquest Hospital | Saint Leonard on Sea | United Kingdom |
| Weston Park | Sheffield | United Kingdom |
| Southampton General Hospital | Southampton | United Kingdom |
| Sandwell General Hospital | West Bromwich | United Kingdom |
| Worchestershire Acute Hospital NHS Trust | Worcester | United Kingdom |
rituximab 375 mg/m2 iv, d1, d8, d15, d22 chlorambucil 6 mg/m2 os, daily during the first 6 weeks of treatment two weeks rest chlorambucil 6 mg/m2 os daily during the first two of a four weeks cycles (total of 4 cycles) rituximab 375 mg/m2 iv at day 1 of each cycle |
| FG002 | ARM C (Since April 2006) - Rituximab | Rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140 |
| COMPLETED |
|
| NOT COMPLETED |
|
Evaluable patients
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| ID | Title | Description |
|---|---|---|
| BG000 | ARM A - Chlorambucil | Chlorambucil 6 mg/m2 daily during the first 6 weeks of treatment; two weeks rest; chlorambucil 6 mg/m2 daily during the first two of a four weeks cycles (total of 4 cycles) |
| BG001 | ARM B - Rituximab + Chlorambucil | Rituximab 375 mg/m2 iv, d1, d8, d15, d22 Chlorambucil 6 mg/m2 os, daily during the first 6 weeks of treatment two weeks rest chlorambucil 6 mg/m2 os daily during the first two of a four weeks cycles (total of 4 cycles) rituximab 375 mg/m2 iv at day 1 of each cycle |
| BG002 | ARM C (Since April 2006) - Rituximab | Rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Ann Arbor stage | Stage I: Involvement of 1 LN region or localized involvement of a 1 extra-lymphatic organ/site Stage II: Involvement of 2 or more LN regions on the same side of the diaphragm or localized of 1 associated extra-lymphatic organ/site and its regional nodes Stage III: Involvement of LN regions on both sides of the diaphragm accompanied by localized involvement of an extra-lymphatic organ/site, by involvement of spleen or both. Stage IV: Disseminated involvement of 1 or more extra-lymphatic organs | Count of Participants | Participants |
| |||||||||||||||
| B-symptoms | B-symptoms refer to systemic symptoms of fever, night sweats, and weight loss which can be associated with both Hodgkin's lymphoma and non-Hodgkin's lymphoma | Count of Participants | Participants |
| |||||||||||||||
| International Prognostic Index (IPI) risk | Model for predicting outcomes in patients with aggressive non-Hodgkin's lymphoma on the basis of the patients' clinical characteristics before treatment. Prognostic factors are: Age (< 60 years vs. > 60 years) Serum LDH level (< normal vs > normal) Performance status (0,1 vs. 2-4) Tumor stage (I/II vs. III/IV) Extranodal involvement (< 1 site vs. > 1 site) Risk Groups are: Risk Factors 0 + 1 - IPI Low; Risk Factors 2 - IPI Low Intermediate; Risk Factors 3 - IPI High Intermediate; Risk Factors 4 + 5 - IPI High. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Event-free-survival (EFS) | Percentage of patients without events (failure of treatment or Death from any cause) after 5 years from trial registration | Evaluable patients | Posted | Number | 95% Confidence Interval | percentage of patients | 5 years |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Complete and Partial Remission Rate - Percentage of Patients With Complete and Partial Response at the End of Treatment | Response criteria were defined according to the NCI standardized response criteria for non-Hodgkin's lymphoma. Complete response. Disappearance of all detectable clinical and radiographic evidence of disease, disappearance of all disease-related symptoms, if present before therapy, and normalization of those biochemical abnormalities definitely assignable to NHL. Regression of all lymph nodes and nodal masses to normal (≤ 1.5 cm in their greatest transverse diameter for nodes > 1.5 cm before therapy and to ≤ 1 cm for nodes that were 1.1-1.5 cm. Regression by more than 75% in the sum of the products of the greatest diameters). Partial response. Decrease by at least 50% in SPD of the six largest measurable lesions. It is not necessary for all lesions to have regressed to qualify for partial response, but no lesion should have progressed and no new lesion should appear. For primary gastric sites, response was based on GELA histologic grading system. | Evaluable patients | Posted | Number | 95% Confidence Interval | percentage of patients | End of treatment (after 24 weeks of therapy) |
| |||||||||||||||||||||||||||||||||
| Secondary | Response Duration (Time to Relapse or Progression) - Percentage of Patients in Continuous Remission at Five Years From Trial Registration | Response criteria were defined according to the NCI standardized response criteria for non-Hodgkin's lymphoma. Complete response (CR). Disappearance of all detectable clinical and radiographic evidence of disease, disappearance of all disease-related symptoms, if present before therapy, and normalization of those biochemical abnormalities definitely assignable to NHL. Regression of all lymph nodes and nodal masses to normal (≤ 1.5 cm in their greatest transverse diameter for nodes > 1.5 cm before therapy and to ≤ 1 cm for nodes that were 1.1-1.5 cm. Regression by more than 75% in the sum of the products of the greatest diameters). | Evaluable patients | Posted | Number | 95% Confidence Interval | percentage of patients | 5 years |
| |||||||||||||||||||||||||||||||||
| Secondary | Progression-free-survival (PFS) | Percentage of patients without disease progression after 5 years from trial registration | Evaluable Patients | Posted | Number | 95% Confidence Interval | percentage of patients | 5 years |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Percentage of patients alive after 5 years from trial registration | Evaluable Patients | Posted | Number | 95% Confidence Interval | percentage of patients | 5 years |
|
Seven years and eight months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ARM A | chlorambucil 6 mg/m2 daily during the first 6 weeks of treatment; two weeks rest; chlorambucil 6 mg/m2 daily during the first two of a four weeks cycles (total of 4 cycles) chlorambucil (drug): chlorambucil 6 mg/m2 daily during the first 6 weeks of treatment, two weeks rest, chlorambucil 6 mg/m2 daily during the first two of a four weeks cycles (total of 4 cycles) | 20 | 131 | 4 | 131 | 42 | 131 |
| EG001 | ARM B | rituximab 375 mg/m2 iv, d1, d8, d15, d22 chlorambucil 6 mg/m2 os, daily during the first 6 weeks of treatment two weeks rest chlorambucil 6 mg/m2 os daily during the first two of a four weeks cycles (total of 4 cycles) rituximab 375 mg/m2 iv at day 1 of each cycle rituximab+chlorambucil: rituximab 375 mg/m2 iv, d1, 8, 15, 22, chlorambucil 6 mg/m2 os, daily during the first 6 weeks of treatment, ; two weeks rest; chlorambucil 6 mg/m2 os, daily during the first two of a four weeks cycles (total of 4 cycles) rituximab 375 mg/m2 iv at day 1 of each cycle | 25 | 132 | 20 | 132 | 77 | 132 |
| EG002 | ARM C (Since April 2006) | rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140 rituximab: rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140 | 13 | 138 | 13 | 138 | 59 | 138 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Transaminases increased | Investigations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Peptic ulcer | Gastrointestinal disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
| ||
| Death NOS | General disorders | Systematic Assessment |
| ||
| Accident at home | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Femur fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Pharyngeal Cancer stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vision blurred | Eye disorders | Systematic Assessment |
| ||
| Acute myeloid leukemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Injection site thrombosis | General disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Urosepsis | Infections and infestations | Systematic Assessment |
| ||
| Stent removal | Surgical and medical procedures | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| metrorrhagia | Reproductive system and breast disorders | Systematic Assessment |
| ||
| gastrointestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
| ||
| Chest wall pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Allergic reactions | Immune system disorders | Systematic Assessment |
| ||
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Sepsis NOS | Infections and infestations | Systematic Assessment |
| ||
| Infection NOS | Infections and infestations | Systematic Assessment |
| ||
| Oesophageal candidiasis | Infections and infestations | Systematic Assessment |
| ||
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Disease prpgression NOS | General disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Infection | Infections and infestations | Systematic Assessment |
| ||
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
| ||
| Infusion related reactions | General disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Emanuele Zucca MD, Scientific and Medical Director | International Extranodal Lymphoma Study Group (IELSG) | +41 91 811 9040 | ielsg@eoc.ch |
| ID | Term |
|---|---|
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002699 | Chlorambucil |
| D004364 | Pharmaceutical Preparations |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
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| Male |
|
| Italy |
|
| United Kingdom |
|
| France |
|
| Switzerland |
|
| Spain |
|
| Ann arbor stage ≤ 2 |
|
| Absence of B symptoms |
|
| Low-intermediate |
|
| Intermediate-high |
|
| High |
|
| NA |
|
Rituximab 375 mg/m2 iv, d1, d8, d15, d22 Chlorambucil 6 mg/m2 os, daily during the first 6 weeks of treatment two weeks rest chlorambucil 6 mg/m2 os daily during the first two of a four weeks cycles (total of 4 cycles) rituximab 375 mg/m2 iv at day 1 of each cycle
| OG002 | ARM C (Since April 2006) - Rituximab | Rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140 |
|
|
| OG002 | ARM C (Since April 2006) - Rituximab | Rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140 |
|
|
| Participants |
|
|
|
|