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This study will evaluate the efficacy, safety, and tolerability of long-term maintenance therapy with rituximab in participants with advanced follicular lymphoma who have had a positive response to first-line treatment with a rituximab-containing regimen. The anticipated time on study treatment is 2 years, and the target sample size is 124 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rituximab | Experimental | Participants will receive rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months or until progression, relapse, death, or institution of a new anti-lymphoma treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | Rituximab will be administered at 375 mg/m^2 every 8 weeks for 24 months or until progression, relapse, death, or institution of a new anti-lymphoma treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Event-free Survival | Event-free survival (EFS) was defined as the time from baseline (Week 0) to the time to progression, relapse, death from any cause, or institution of a new treatment, whichever occurs first. Mean EFS was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval. ITT population (patients who received at least one maintenance MabThera infusion) was used for this analysis. | From randomization to the time to progression, relapse, death from any cause, or institution of a new treatment, whichever occurs first, assessed up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | An adverse event (AE) was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. A serious adverse event (SAE) was defined as any untoward medical occurrence that is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect, requires intervention to prevent permanent impairment or damage, or results in death |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Budapest | 1071 | Hungary | ||||
A total number of 124 patients were recruited. Of these, 83 patients completed the maintenance therapy with rituximab (MabThera) and entered the 3-year follow-up phase. Of these, 69 patients completed the follow-up phase.
This study was conducted between 08 July 2005 to 12 Aug 2013 at 15 sites in Hungary.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rituximab | Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Up to 27 months |
| Overall Survival (OS) | Overall survival, defined as the time between baseline (Week 0) and the date of death irrespective of the cause of death. Mean OS was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval. ITT population was used for this analysis. | From randomization until death, assessed up to 5 years |
| Time to Progression (TTP) | Time to progression (TTP) defined as time from baseline to disease progression or relapse, death from the follicular lymphoma or institution of a new regimen because of the follicular lymphoma. Mean TTP was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval. ITT population was used for this analysis. | From baseline (Week 0) to disease progression, relapse, death from the follicular lymphoma or institution of a new regimen, whichever occurs first, assessed up to 5 years |
| Time to Next Anti-lymphoma Treatment (TTNLT) | Time to next anti-lymphoma treatment (TTNLT) defined as time from baseline to institution of a new antilymphoma regimen (including chemo-, radio- or immunotherapies). Mean TTNLT was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval. | From baseline (Week 0) to institution of a new antilymphoma regimen, assessed up to 5 years |
| Duration of Response (DR) | Duration of Response (DR) defined as time from first documented response to induction treatment to relapse or progression or death from the follicular lymphoma. Mean DR was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval. | From first documented response to induction treatment to relapse or progression or death, assessed up to 5 years |
| Disease-free Survival (DFS) | Disease free survival (DFS) being defined as time from first documented complete response to induction treatment to relapse or progression or death from the follicular lymphoma. Mean DFS was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval. | From first documented complete response to induction treatment to relapse or progression or death, whichever occurs first, assessed up to 5 years |
| Budapest |
| 1083 |
| Hungary |
| Budapest | 1085 | Hungary |
| Budapest | 1088 | Hungary |
| Budapest | 1122 | Hungary |
| Budapest | 1135 | Hungary |
| Debrecen | 4032 | Hungary |
| Győr | 9024 | Hungary |
| Gyula | 5700 | Hungary |
| Kaposvár | 7400 | Hungary |
| Miskolc | 3529 | Hungary |
| NyÃregyháza | 4400 | Hungary |
| Pécs | 7624 | Hungary |
| Szeged | 6720 | Hungary |
| Szekszárd | 7100 | Hungary |
| Székesfehérvár | 8000 | Hungary |
| Szolnok | 5004 | Hungary |
| Szombathely | 9700 | Hungary |
| Tatabánya | 2800 | Hungary |
| Veszprém | 8200 | Hungary |
| Zalaegerszeg | 8900 | Hungary |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Rituximab | Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Event-free survival (EFS) was defined as the time from baseline (Week 0) to the time to progression, relapse, death from any cause, or institution of a new treatment, whichever occurs first. Mean EFS was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval. ITT population (patients who received at least one maintenance MabThera infusion) was used for this analysis. | ITT population: All participants who received at least one maintenance rituximab infusion were included in the analysis. | Posted | Mean | 95% Confidence Interval | months | From randomization to the time to progression, relapse, death from any cause, or institution of a new treatment, whichever occurs first, assessed up to 5 years |
|
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| |||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs) | An adverse event (AE) was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. A serious adverse event (SAE) was defined as any untoward medical occurrence that is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect, requires intervention to prevent permanent impairment or damage, or results in death | Safety population: All participants who received at least one dose of study medication and had safety data after the first dose of study drug. | Posted | Number | participants | Up to 27 months |
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| Secondary | Overall Survival (OS) | Overall survival, defined as the time between baseline (Week 0) and the date of death irrespective of the cause of death. Mean OS was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval. ITT population was used for this analysis. | ITT population: All participants who received at least one maintenance rituximab infusion were included in the analysis. | Posted | Mean | 95% Confidence Interval | months | From randomization until death, assessed up to 5 years |
|
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| Secondary | Time to Progression (TTP) | Time to progression (TTP) defined as time from baseline to disease progression or relapse, death from the follicular lymphoma or institution of a new regimen because of the follicular lymphoma. Mean TTP was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval. ITT population was used for this analysis. | ITT population: All participants who received at least one maintenance rituximab infusion were included in the analysis. | Posted | Mean | 95% Confidence Interval | months | From baseline (Week 0) to disease progression, relapse, death from the follicular lymphoma or institution of a new regimen, whichever occurs first, assessed up to 5 years |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Next Anti-lymphoma Treatment (TTNLT) | Time to next anti-lymphoma treatment (TTNLT) defined as time from baseline to institution of a new antilymphoma regimen (including chemo-, radio- or immunotherapies). Mean TTNLT was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval. | ITT population: All participants who received at least one maintenance rituximab infusion were included in the analysis. | Posted | Mean | 95% Confidence Interval | months | From baseline (Week 0) to institution of a new antilymphoma regimen, assessed up to 5 years |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Response (DR) | Duration of Response (DR) defined as time from first documented response to induction treatment to relapse or progression or death from the follicular lymphoma. Mean DR was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval. | ITT population: All participants who received at least one maintenance rituximab infusion were included in the analysis. Subset of the ITT population was used since not the entire ITT population provided appropriate data for analysis | Posted | Mean | 95% Confidence Interval | months | From first documented response to induction treatment to relapse or progression or death, assessed up to 5 years |
|
| ||||||||||||||||||||||||||
| Secondary | Disease-free Survival (DFS) | Disease free survival (DFS) being defined as time from first documented complete response to induction treatment to relapse or progression or death from the follicular lymphoma. Mean DFS was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval. | ITT population: All participants who received at least one maintenance rituximab infusion were included in the analysis. Subset of the ITT population was used since not the entire ITT population provided appropriate data for analysis. | Posted | Mean | 95% Confidence Interval | months | From first documented complete response to induction treatment to relapse or progression or death, whichever occurs first, assessed up to 5 years |
|
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Up to 27 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 | Rituximab | Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months | 14 | 124 | 3 | 124 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agranulocytosis | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Gastric ulcer | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Oral disorder | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Oedema | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Acute hepatitis B | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Erysipelas | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Hepatitis B | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Strongyloidiasis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Carcinoid tumour of the gastrointestinal tract | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
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| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
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| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
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| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
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| Pleural neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
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| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
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| Vascular encephalopathy | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetes mellitus | Endocrine disorders | MedDRA 18.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| F. Hoffmann-La Roche AG | Roche Trial Information Hotline | +41 61 6878333 | global.trial_information@roche.com |
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| 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 |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| 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 |
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