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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-011433-27 |
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This multicenter, open-label study will assess the efficacy and safety of MabThera (rituximab) added to standard chemotherapy in participants with untreated Mantle Cell Lymphoma not eligible for autologous stem cell transplantation. Participants will receive MabThera (372 mg/m^2 intravenously) on Day 1 of each 28-day treatment cycle in addition to standard chemotherapy for 6 cycles. In participants experiencing complete or partial response, MabThera will be continued as consolidation therapy for 2 more cycles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rituximab | Experimental | Rituximab, 375 milligram per meter square (mg/m^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclophosphamide | Drug | as prescribed, 6 cycles |
| |
| Fludarabine |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | Overall Response Rate (ORR) was determined by tumor response according to International Workshop Group to Standardize Response Criteria for mantle cell lymphoma (MCL) criteria from confirmed evaluations of both target, radiographically evaluated, and non-target lesions. A responder is defined as a subject experiencing either a complete (CR)/ unconfirmed complete (Cru), or partial response (PR) by these criteria. As per criteria; CR = disappearance of all evidence of disease; CRu = the sum of the product of the diameters (SPD) of multiple nodes decreased by at least 75%; PR = regression of measurable disease and no new sites. | Up to 50 months (approximately) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall survival is defined as time from date of enrollment to the date of death, regardless of the cause of death. | From the time of enrollment until death due to any cause (up to 50 months [approximately]) |
| Progression-free Survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brasov | 500326 | Romania | ||||
A total 8 participants were enrolled from Romania.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rituximab | Rituximab, 375 milligram per meter square (mg/m^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles). Cyclophosphamide: as prescribed, 6 cycles Fludarabine: as prescribed, 6 cycles Mitoxantrone: as prescribed, 6 cycles Rituximab [Mabthera/Rituxan]: 375 mg/m^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
as prescribed, 6 cycles |
|
| Mitoxantrone | Drug | as prescribed, 6 cycles |
|
| Rituximab | Drug | 375 mg/m^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles |
|
|
PFS is defined as the interval between the day of enrollment and the first documentation of progressive disease or death. Progression of disease is defined as at least a 20 percent (%) increase in the sum of longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. |
| From the time of enrollment until death due to any cause (up to 50 months [approximately]) |
| Number of Participant With Adverse Event (AE) | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with study treatment. | Up to 50 months (approximately) |
| Bucharest |
| 005098 |
| Romania |
| Bucharest | 022328 | Romania |
| Bucharest | 030171 | Romania |
| Cluj-Napoca | 400015 | Romania |
| Iași | 700111 | Romania |
| Târgu Mureş | 540136 | Romania |
| Timișoara | 300079 | Romania |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Rituximab | Rituximab, 375 milligram per meter square (mg/m^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with regularly prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles). Cyclophosphamide: as prescribed, 6 cycles Fludarabine: as prescribed, 6 cycles Mitoxantrone: as prescribed, 6 cycles Rituximab [Mabthera/Rituxan]: 375 mg/m^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | 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 | Overall Response Rate (ORR) | Overall Response Rate (ORR) was determined by tumor response according to International Workshop Group to Standardize Response Criteria for mantle cell lymphoma (MCL) criteria from confirmed evaluations of both target, radiographically evaluated, and non-target lesions. A responder is defined as a subject experiencing either a complete (CR)/ unconfirmed complete (Cru), or partial response (PR) by these criteria. As per criteria; CR = disappearance of all evidence of disease; CRu = the sum of the product of the diameters (SPD) of multiple nodes decreased by at least 75%; PR = regression of measurable disease and no new sites. | Efficacy population included all the participants who had received at least one dose of study treatment. | Posted | Number | percentage of participants | Up to 50 months (approximately) |
|
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Overall survival is defined as time from date of enrollment to the date of death, regardless of the cause of death. | Efficacy population included all the participants who had received at least one dose of study treatment. | Posted | Median | 95% Confidence Interval | days | From the time of enrollment until death due to any cause (up to 50 months [approximately]) |
|
| ||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) | PFS is defined as the interval between the day of enrollment and the first documentation of progressive disease or death. Progression of disease is defined as at least a 20 percent (%) increase in the sum of longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. | Efficacy population included all the participants who had received at least one dose of study treatment. | Posted | Median | 95% Confidence Interval | days | From the time of enrollment until death due to any cause (up to 50 months [approximately]) |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participant With Adverse Event (AE) | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with study treatment. | Safety population included all the participants who had received at least one dose of study treatment. | Posted | Number | participants | Up to 50 months (approximately) |
|
|
Up to approximately 50 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 | Rituximab, 375 milligram per meter square (mg/m^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles). Cyclophosphamide: as prescribed, 6 cycles Fludarabine: as prescribed, 6 cycles Mitoxantrone: as prescribed, 6 cycles Rituximab [Mabthera/Rituxan]: 375 mg/m^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles | 3 | 8 | 8 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Neutropenia | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Toxicity | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Leucopenia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Gastric Pain | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Ascending Aorta Dilatation | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Drug Eruption | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Dermatitis Eczematous | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Tracheitis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hepatitis Ag HBS+ | Hepatobiliary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Herpes | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Vertiginous syndrome | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Supraventricular arrhythmia | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Respiratory Virosis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Oral Candidiasis | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| ß2-microglobuline ↗ | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| C- reactive protein | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
|
The study was prematurely terminated with 8 participants enrolled, all of them are included into the statistical analyses.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| 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 |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| D008942 | Mitoxantrone |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D000880 | Anthraquinones |
| D000095322 | Anthrones |
| D000873 | Anthracenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011809 | Quinones |
| D011083 | Polycyclic Compounds |
| 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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