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This French national, multicenter, prospective, longitudinal, observational study will describe the treatment modalities of a cohort of patients with relapsed or refractory follicular non-Hodgkin's lymphoma, with evaluation of the cohort overall and according to the presence or not of MabThera® (rituximab) maintenance therapy. Actively participating physicians will enroll patients and collect therapeutic management data in a real-life setting up to 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Participants | Participants with histologically confirmed, refractory/relapsed cluster of differentiation-20 (CD20) positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. All participants received at least one cycle of rituximab (MabThera) during maintenance therapy or observation period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Modalities of the Therapeutic Decision Before First Study Induction Treatment Phase | At study inclusion, the therapeutic management of participants was decided by either "pluri-disciplinary consultation meeting," "Only the physician in charge of the participant," "Discussion between physicians," or "Punctual consultation of an external physician." Percentage of participants with each of these modalities of therapeutic decision was reported. | Baseline |
| Percentage of Participants With Treatments Prescribed Over the First Study Induction Phase | Over the first treatment induction period, participants received following therapies for the treatment of refractory/relapsed follicular non-Hodgkin's lymphoma: chemotherapy combined with MabThera, chemotherapy alone, MabThera monotherapy, and stem cell transplantation, radio-immunotherapy, or radiation therapy combined with any other treatment. Study induction treatment phase consists total of three visits (one before the first cycle, one halfway through therapy and one after the last cycle to evaluate response). Induction treatment duration ranged between <3 months to >6 months. Each participants may received more than one therapy. | Induction Phase: 18.7 months |
| Percentage of Participants With Chemotherapies Prescribed Over the First Study Induction Phase | Over the first study induction phase, participants received the following chemotherapy: regimen including fludarabine; regimen including aracytine - platinum salts; cyclophosphamide/hydroxydaunorubicin/oncovin/prednisone (CHOP-like); cyclophosphamide/vincristine/prednisone (CVP); regimen including ifosfamide - etoposide; and other chemotherapy. One participant could receive more than one type of chemotherapy over the first treatment induction period. | Induction Phase: 18.7 months |
| Percentage of Participants With MabThera as Maintenance Therapy | During the maintenance period participants received four weekly infusion of MabThera. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Last Induction Treatment Response | Last Induction treatment response: the last response assessment over the first study induction treatment (complete response [CR]: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CR unconfirmed: CR along with regression in lymph node mass by more than [>]75% in the sum of the products of greatest diameters [SPD]; Partial Response [PR]: greater than or equal to [>=] 50% decrease in SPD of 6 largest dominant nodes or nodal masses; Progression was 1 of the following: 1) lymphadenopathy; 2) a >=50% increase in previously noted or new appearance of hepato/splenomegaly; 3) >=50% increase in blood lymphocyte count with at least 5000 B lymphocytes/μL; 4) transformation to Richter's syndrome; or 5) occurrence of cytopenia; Stable disease [SD]: absence of necessary criteria to achieve CR or PR, but no advancement to progression) was described at the end of first study induction. |
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Inclusion Criteria:
Exclusion Criteria:
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Recruitment of approximately 90 physicians who treat patients with follicular non-Hodgkin's lymphoma to actively participate in this observational study. Patients with relapsed or refractory follicular non-Hodgkin's lymphoma (World Health Organization grade 1-3) and requiring treatment are to be enrolled prospectively. Subgroup of interest: patients receiving MabThera® (rituximab) maintenance therapy.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuilly-sur-Seine | 92521 | France |
Of 260 participants, 5 were excluded as no data available and duplicate cases (N=255; safety population) and 14 were excluded as other selection criteria not met (N=241; overall population).
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Participants with histologically confirmed, refractory/relapsed cluster of differentiation-20 (CD20) positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants with histologically confirmed, refractory/relapsed CD2 0-positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Participants With Modalities of the Therapeutic Decision Before First Study Induction Treatment Phase | At study inclusion, the therapeutic management of participants was decided by either "pluri-disciplinary consultation meeting," "Only the physician in charge of the participant," "Discussion between physicians," or "Punctual consultation of an external physician." Percentage of participants with each of these modalities of therapeutic decision was reported. | Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed = participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Baseline |
|
Up to 6 years
Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).
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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 | All Participants | Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lung infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-LaRoche | 800-821-8590 | genentech@druginfo.com |
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| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Maintenance/observation Phase: 67.8 months |
| Percentage of Participants With MabThera Maintenance Therapy and at Least One Observation Phase | After study induction period (three visits) participants entered into either of two periods: 1. period of maintenance with MabThera followed by observation or 2. period of observation/maintenance without MabThera, followed by maintenance with MabThera. | Maintenance/observation Phase: 67.8 months |
| Duration of MabThera Maintenance Therapy When Associated With Observation | Duration of MabThera maintenance therapy was calculated from the end of induction period to the day before the first disease progression over the study (or to the date of last participant information if no disease progression until the end of the participant follow-up). Disease progression was based on the followings: Eastern Cooperative Oncology Group performance status; presence of B symptoms (fever 38°C in absence of infection for more than 8 days, night sweats, weight loss exceeding 10% in 6 months); evaluation of tumor mass (Groupe d'Etudes des Lymphomes Folliculaires criteria); number of nodal sites; number and location of extranodal sites; Ann-Arbor stage (I to IV); any histological documentation: type of biopsy (nodal, extranodal, bone marrow); histological type (progression of follicular non-Hodgkin's lymphomas or transformation); latest available hemoglobin, neutrophils, normal or leukemic lymphocytes, platelets, lactate dehydrogenase, and total gamma globulins level. | Maintenance/observation Phase: 67.8 months |
| Percentage of Participants With Prescription of Injection Prophylaxis | Participants was prescribed with either of the following infection prophylaxis treatment: anti-pneumocystosis agents, antiviral agents, or immunoglobulins. | Maintenance/observation Phase: 67.8 months |
| Percentage of Participants With Injection Prophylaxis Treatment | Participants received anti-pneumocystosis agents, antiviral agents, or immunoglobulins as infection prophylaxis. One participant could receive more than one infection prophylaxis treatment. | Maintenance/observation Phase: 67.8 months |
| Percentage of Participants With Modalities of the Therapeutic Decision at First Study Disease Progression | The therapeutic management of participants was decided by either "pluri-disciplinary consultation meeting," "Only the physician in charge of the participant," "Discussion between physicians," or "Punctual consultation of an external physician." Percentage of participants with each of these modalities of therapeutic decision was reported. | Up to 6 years |
| Number of Participants With Therapeutic Management After the First Study Disease Progression | After the first disease progression the participants received chemotherapy, immunotherapy, radio immunotherapy, stem cell transplantation, or radiation therapy for therapeutic management of the refractory/relapsed follicular non-Hodgkin's lymphoma. One participant could receive more than one type of treatment after the first study disease progression. | Up to 6 years |
| Induction Phase: 18.7 months |
| Percentage of Participants With Number of Disease Progressions | Participants with at least one disease progression after the first study induction period were reported. | Up to 6 years |
| Percentage of Participants With Disease Characteristics at First Study Disease Progression | Disease characteristics included (tumor burden, measured from whole body computed tomography (CT) scan. Groupe d'Etudes des Lymphomes Folliculaires (GELF) criteria defined as parameters to initiate treatment in participants with untreated follicular lymphoma, grade 1,2,or 3A; having just one of the criteria justified treatment: 1. involvement of >=3 nodal sites, each with diameter of >=3 centimeter(cm); 2. any nodal/extranodal tumor mass with diameter of >=7cm; 3. B symptoms (temperature >=38 degrees celsius or night sweats or weight loss >10% over past 6 months); 4. splenomegaly; 5. pleural effusion/peritoneal ascites; 6. cytopenia (leukocytes <1×10^9 and/or platelets <100×10^9/L. One participant could present with more than 1 GELF criterion. Ann Arbor staging was used as staging system for lymphomas (Stage I to IV); stage depended upon the place where malignant tissue was located (through biopsy, CT scan, or positron emission tomography) and on systemic symptoms due to lymphoma). | Up to 6 years |
| Progression Free Survival (PFS) | The PFS was defined as the time from the date of first induction treatment over the study (first treatment administration of first cycle) to the date of first disease progression or participants death or date of lymphoma transformation diagnosis. | Up to 6 years |
| Time to Next Treatment | Time to next treatment was calculated from the date of the end of first induction treatment administration over the study to the date of the start of next treatment after disease progression. | Up to 6 years |
| Overall Survival (OS) | The overall survival was defined as the time from the date of first induction treatment administration over the study to the date of participants' death or early study withdrawal. OS was calculated using Kaplan-Meier method. | Up to 6 years |
| Number of Participants Who Used MabThera | Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months) |
| MabThera Regimen: Dose of MabThera | All participants who received MabThera treatment before the first disease progression were reported. | Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months) |
| MabThera Regimen: Infusion Duration | Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months) |
| MabThera Regimen: Number of Cycles of MabThera | Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months) |
| MabThera Regimen: Time Between Cycles | Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months) |
| Percentage of Participants With Discontinuations and Modifications of MabThera During Maintenance Phase | Maintenance phase : 67.8 months |
| Function Assessment of Chronic Illness Therapy-General (FACT-G) With Lymphoma-Specific Additional Concerns Subscale (Lym) Total Score | The FACT-G with Lymphoma-Specific Additional Concerns Subscale (Lym) total score was calculated by adding the score obtained on the FACT-G (physical well-being, scored 0-28; social well-being, scored 0-28; functional well-being, scored 0-28; emotional well-being, scored 0-24), to the score obtained on the LYM subscale (15 items; responses to each item range from 0, "Not at all" to 4, "Very much"). Total score ranges from 0 to 168. Higher scores indicated a better participant-reported outcome/quality of life over the past week when responding to the items. | Up to 6 years (assessed at start, mid and end of induction [induction: 18.7 months], at each infusion during maintenance [maintenance phase: 67.8 months], and at disease progression [maximum up to 6 years]) |
| Number and Type of Hospitalization Associated With MabThera Perfusion | Number and type of hospitalization (a day hospitalization, short-lasting hospitalization, and short-stay hospitalization) was reported. | Up to 6 years |
| Participant moved/changed medical team |
|
| No data and duplicate cases |
|
| Did not met selection criteria |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Percentage of Participants With Last Induction Treatment Response | Last Induction treatment response: the last response assessment over the first study induction treatment (complete response [CR]: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CR unconfirmed: CR along with regression in lymph node mass by more than [>]75% in the sum of the products of greatest diameters [SPD]; Partial Response [PR]: greater than or equal to [>=] 50% decrease in SPD of 6 largest dominant nodes or nodal masses; Progression was 1 of the following: 1) lymphadenopathy; 2) a >=50% increase in previously noted or new appearance of hepato/splenomegaly; 3) >=50% increase in blood lymphocyte count with at least 5000 B lymphocytes/μL; 4) transformation to Richter's syndrome; or 5) occurrence of cytopenia; Stable disease [SD]: absence of necessary criteria to achieve CR or PR, but no advancement to progression) was described at the end of first study induction. | Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed (N)=number of participants evaluable for this outcome measure. | Posted | Number | percentage of participants | Induction Phase: 18.7 months |
|
|
|
| Secondary | Percentage of Participants With Number of Disease Progressions | Participants with at least one disease progression after the first study induction period were reported. | Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= those participants who entered in maintenance/observation after the first induction and before the first disease progression over the study. | Posted | Number | percentage of participants | Up to 6 years |
|
|
|
| Secondary | Percentage of Participants With Disease Characteristics at First Study Disease Progression | Disease characteristics included (tumor burden, measured from whole body computed tomography (CT) scan. Groupe d'Etudes des Lymphomes Folliculaires (GELF) criteria defined as parameters to initiate treatment in participants with untreated follicular lymphoma, grade 1,2,or 3A; having just one of the criteria justified treatment: 1. involvement of >=3 nodal sites, each with diameter of >=3 centimeter(cm); 2. any nodal/extranodal tumor mass with diameter of >=7cm; 3. B symptoms (temperature >=38 degrees celsius or night sweats or weight loss >10% over past 6 months); 4. splenomegaly; 5. pleural effusion/peritoneal ascites; 6. cytopenia (leukocytes <1×10^9 and/or platelets <100×10^9/L. One participant could present with more than 1 GELF criterion. Ann Arbor staging was used as staging system for lymphomas (Stage I to IV); stage depended upon the place where malignant tissue was located (through biopsy, CT scan, or positron emission tomography) and on systemic symptoms due to lymphoma). | Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants with at least one disease progression over the study period. n=number of evaluable participant for each disease characteristics. | Posted | Number | percentage of participants | Up to 6 years |
|
|
|
| Secondary | Progression Free Survival (PFS) | The PFS was defined as the time from the date of first induction treatment over the study (first treatment administration of first cycle) to the date of first disease progression or participants death or date of lymphoma transformation diagnosis. | Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. | Posted | Median | 95% Confidence Interval | months | Up to 6 years |
|
|
|
| Secondary | Time to Next Treatment | Time to next treatment was calculated from the date of the end of first induction treatment administration over the study to the date of the start of next treatment after disease progression. | Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. | Posted | Median | 95% Confidence Interval | months | Up to 6 years |
|
|
|
| Secondary | Overall Survival (OS) | The overall survival was defined as the time from the date of first induction treatment administration over the study to the date of participants' death or early study withdrawal. OS was calculated using Kaplan-Meier method. | Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. | Posted | Median | 95% Confidence Interval | months | Up to 6 years |
|
|
|
| Secondary | Number of Participants Who Used MabThera | All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. | Posted | Number | participants | Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months) |
|
|
|
| Primary | Percentage of Participants With Treatments Prescribed Over the First Study Induction Phase | Over the first treatment induction period, participants received following therapies for the treatment of refractory/relapsed follicular non-Hodgkin's lymphoma: chemotherapy combined with MabThera, chemotherapy alone, MabThera monotherapy, and stem cell transplantation, radio-immunotherapy, or radiation therapy combined with any other treatment. Study induction treatment phase consists total of three visits (one before the first cycle, one halfway through therapy and one after the last cycle to evaluate response). Induction treatment duration ranged between <3 months to >6 months. Each participants may received more than one therapy. | Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. | Posted | Number | percentage of participants | Induction Phase: 18.7 months |
|
|
|
| Primary | Percentage of Participants With Chemotherapies Prescribed Over the First Study Induction Phase | Over the first study induction phase, participants received the following chemotherapy: regimen including fludarabine; regimen including aracytine - platinum salts; cyclophosphamide/hydroxydaunorubicin/oncovin/prednisone (CHOP-like); cyclophosphamide/vincristine/prednisone (CVP); regimen including ifosfamide - etoposide; and other chemotherapy. One participant could receive more than one type of chemotherapy over the first treatment induction period. | Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. | Posted | Number | percentage of participants | Induction Phase: 18.7 months |
|
|
|
| Primary | Percentage of Participants With MabThera as Maintenance Therapy | During the maintenance period participants received four weekly infusion of MabThera. | Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= those who entered in maintenance/observation after the first induction and before the first disease progression over the study. | Posted | Number | 95% Confidence Interval | percentage of participants | Maintenance/observation Phase: 67.8 months |
|
|
|
| Primary | Percentage of Participants With MabThera Maintenance Therapy and at Least One Observation Phase | After study induction period (three visits) participants entered into either of two periods: 1. period of maintenance with MabThera followed by observation or 2. period of observation/maintenance without MabThera, followed by maintenance with MabThera. | Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed = those who received at least one MabThera infusion over the maintenance therapy period. | Posted | Number | percentage of participants | Maintenance/observation Phase: 67.8 months |
|
|
|
| Primary | Duration of MabThera Maintenance Therapy When Associated With Observation | Duration of MabThera maintenance therapy was calculated from the end of induction period to the day before the first disease progression over the study (or to the date of last participant information if no disease progression until the end of the participant follow-up). Disease progression was based on the followings: Eastern Cooperative Oncology Group performance status; presence of B symptoms (fever 38°C in absence of infection for more than 8 days, night sweats, weight loss exceeding 10% in 6 months); evaluation of tumor mass (Groupe d'Etudes des Lymphomes Folliculaires criteria); number of nodal sites; number and location of extranodal sites; Ann-Arbor stage (I to IV); any histological documentation: type of biopsy (nodal, extranodal, bone marrow); histological type (progression of follicular non-Hodgkin's lymphomas or transformation); latest available hemoglobin, neutrophils, normal or leukemic lymphocytes, platelets, lactate dehydrogenase, and total gamma globulins level. | Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed = those who received at least one infusion of MabThera and completed maintenance therapy with MabThera when associated with observation period. | Posted | Median | Full Range | months | Maintenance/observation Phase: 67.8 months |
|
|
|
| Primary | Percentage of Participants With Prescription of Injection Prophylaxis | Participants was prescribed with either of the following infection prophylaxis treatment: anti-pneumocystosis agents, antiviral agents, or immunoglobulins. | Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed=all participants having had maintenance/observation period before the first study disease progression. | Posted | Number | percentage of participants | Maintenance/observation Phase: 67.8 months |
|
|
|
| Primary | Percentage of Participants With Injection Prophylaxis Treatment | Participants received anti-pneumocystosis agents, antiviral agents, or immunoglobulins as infection prophylaxis. One participant could receive more than one infection prophylaxis treatment. | Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number participants analyzed= all participants having had maintenance/observation period before the first study disease progression and received infection prophylaxis treatment. | Posted | Number | percentage of participants | Maintenance/observation Phase: 67.8 months |
|
|
|
| Primary | Percentage of Participants With Modalities of the Therapeutic Decision at First Study Disease Progression | The therapeutic management of participants was decided by either "pluri-disciplinary consultation meeting," "Only the physician in charge of the participant," "Discussion between physicians," or "Punctual consultation of an external physician." Percentage of participants with each of these modalities of therapeutic decision was reported. | Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants with at least one disease progression over the study period. | Posted | Number | percentage of participants | Up to 6 years |
|
|
|
| Primary | Number of Participants With Therapeutic Management After the First Study Disease Progression | After the first disease progression the participants received chemotherapy, immunotherapy, radio immunotherapy, stem cell transplantation, or radiation therapy for therapeutic management of the refractory/relapsed follicular non-Hodgkin's lymphoma. One participant could receive more than one type of treatment after the first study disease progression. | Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants with at least one disease progression over the study period. | Posted | Number | participants | Up to 6 years |
|
|
|
| Secondary | MabThera Regimen: Dose of MabThera | All participants who received MabThera treatment before the first disease progression were reported. | All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants who received at least one cycle of MabThera and available with valid data for this outcome. | Posted | Mean | Standard Deviation | milligram (mg) | Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months) |
|
|
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| Secondary | MabThera Regimen: Infusion Duration | All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants who received at least one cycle of MabThera and available with valid data. | Posted | Mean | Standard Deviation | minutes (mn) | Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months) |
|
|
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| Secondary | MabThera Regimen: Number of Cycles of MabThera | All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants who received at least one cycle of MabThera and available with valid data for this outcome. | Posted | Mean | Standard Deviation | number of cycles | Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months) |
|
|
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| Secondary | MabThera Regimen: Time Between Cycles | All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants who received at least one cycle of MabThera and available with valid data. | Posted | Mean | Standard Deviation | days | Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months) |
|
|
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| Secondary | Percentage of Participants With Discontinuations and Modifications of MabThera During Maintenance Phase | All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants who received at least one MabThera infusion over the maintenance therapy period. n=number of evaluable participants for each category. | Posted | Number | percentage of participants | Maintenance phase : 67.8 months |
|
|
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| Secondary | Function Assessment of Chronic Illness Therapy-General (FACT-G) With Lymphoma-Specific Additional Concerns Subscale (Lym) Total Score | The FACT-G with Lymphoma-Specific Additional Concerns Subscale (Lym) total score was calculated by adding the score obtained on the FACT-G (physical well-being, scored 0-28; social well-being, scored 0-28; functional well-being, scored 0-28; emotional well-being, scored 0-24), to the score obtained on the LYM subscale (15 items; responses to each item range from 0, "Not at all" to 4, "Very much"). Total score ranges from 0 to 168. Higher scores indicated a better participant-reported outcome/quality of life over the past week when responding to the items. | All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. n=number of evaluable questionnaires for each category. | Posted | Mean | Standard Deviation | score on scale | Up to 6 years (assessed at start, mid and end of induction [induction: 18.7 months], at each infusion during maintenance [maintenance phase: 67.8 months], and at disease progression [maximum up to 6 years]) | Total number of assessable questionnaire | Participants |
|
|
|
| Secondary | Number and Type of Hospitalization Associated With MabThera Perfusion | Number and type of hospitalization (a day hospitalization, short-lasting hospitalization, and short-stay hospitalization) was reported. | All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. | Posted | Number | hospitalizations | Up to 6 years | cycles with MabThera | Participants |
|
|
|
| 94 |
| 243 |
| 134 |
| 243 |
| Urinary tract infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Pneumocystis jiroveci pneumonia | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Abdominal infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Anal abscess | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Aspergillosis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Conjunctivitis infective | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Haemophilus infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Hepatitis B | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Onychomycosis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Oropharyngeal candidiasis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Pneumonia cytomegaloviral | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Progressive multifocal leukoencephalopathy | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Pyelonephritis acuts | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Reiter's syndrome | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Ureapasma infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Non-systematic Assessment |
|
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Non-systematic Assessment |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Non-systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Non-systematic Assessment |
|
| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Non-systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Non-systematic Assessment |
|
| Colon cancer metastic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Non-systematic Assessment |
|
| Hair follicle tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Non-systematic Assessment |
|
| Laryngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Non-systematic Assessment |
|
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Non-systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Non-systematic Assessment |
|
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Non-systematic Assessment |
|
| Metastatic bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Non-systematic Assessment |
|
| Metastic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Non-systematic Assessment |
|
| Neoplasm skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Non-systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Non-systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Non-systematic Assessment |
|
| Refractory cytopenia with multilineage dysplasia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Non-systematic Assessment |
|
| Skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Disease progression | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Death | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Hypothermia | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Febrile bone marrow aplasia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Agranulocytosis | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Sinus polyp | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Cardiac disorder | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Abdominal adhesions | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Colitits ulcerative | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Peritonitis | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Small intestinal perforation | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Aneurysm | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Arterial stenosis | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Cerebrovascular accident | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Ischaemic stroke | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Jugular vein thrombosis | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Hypogammaglobulinaemia | Immune system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
|
| Gastroenteritis radiation | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| VIIth nerve paralysis | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Renal colic | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Blindness | Eye disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Optic neuropathy | Eye disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| CD4 lymphocytes decreased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
|
| Inguinal hernia repair | Surgical and medical procedures | MedDRA 13.0 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
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.
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Title | Measurements |
|---|---|
|
| Partial response <50% |
|
| Stability |
|
| Progression |
|
| Number of disease progressions: 2 |
|
| Number of disease progressions: 3 |
|
| Number of disease progressions: 4 |
|
| Tumor burden: Low (n=32, 38) |
|
| GELF criteria: at least 3 nodal sites (n=32, 38) |
|
| GELF criteria: Any nodal/extra-nodal mass(n=32,38) |
|
| GELF criteria: B symptoms (n=32, 38) |
|
| GELF criteria: Splenomegaly (n=32, 38) |
|
| GELF criteria: Pleural/ascites effusion (n=32, 38) |
|
| GELF criteria: Cytopenia (n=32, 38) |
|
| GELF criteria: None (n=32, 38) |
|
| GELF criteria: Not available (n=32, 38) |
|
| Ann-Arbor stage I (n=35, 39) |
|
| Ann-Arbor stage II (n=35, 39) |
|
| Ann-Arbor stage III (n=35, 39) |
|
| Ann-Arbor stage IV (n=35, 39) |
|
| Ann-Arbor stage data not available (n=35, 39) |
|
| Ann-Arbor stage not assessable (n=35, 39) |
|
| At least one cycle of MabThera as monotherapy |
|
| All cycles with MabThera as monotherapy |
|
| At least one cycle of MabThera in combination |
|
| All cycles with MabThera in combination |
|
| Title | Measurements |
|---|---|
|
| Radio-immunotherapy |
|
| Chemotherapy alone |
|
| Radiation therapy |
|
| Title | Measurements |
|---|---|
|
| CVP |
|
| Regimen including ifosfamide - etoposide |
|
| Other chemotherapy |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Discussion between physicians |
|
| Punctual consultation with an external physician |
|
| Immunotherapy |
|
| Radio immunotherapy |
|
| Stem cell transplantation |
|
| Radiation therapy |
|
| Title | Measurements |
|---|---|
|
| At least 1 dose modification: No (n=121) |
|
| At least 1 duration modification: Yes (n=121) |
|
| At least 1 duration modification: No (n=121) |
|
| Number (No.) of dose modifications: 0 (n=121) |
|
| No. of dose modifications: 1 (n=121) |
|
| No. of dose modifications: 2 (n=121) |
|
| No. of dose modifications: 3 (n=121) |
|
| No. of dose modifications: 4 (n=121) |
|
| No. of dose modifications: 5 (n=121) |
|
| No. of dose modifications: 6 (n=121) |
|
| No. of infusion duration modifications: 0 (n=121) |
|
| No. of infusion duration modifications: 1 (n=121) |
|
| No. of infusion duration modifications: 2 (n=121) |
|
| No. of infusion duration modifications: 3 (n=121) |
|
| No of infusion duration modifications: 4 (n=121) |
|
| No. of infusion duration modifications: 5 (n=121) |
|
| No. of infusion duration modifications: 6 (n=121) |
|
| No. of infusion duration modifications: 7 (n=121) |
|
| No. of infusion duration modifications: 8 (n=121) |
|
| No. of infusion duration modifications: 9 (n=121) |
|
| Title | Measurements |
|---|---|
|
| Functional well-being (n=659) |
|
| Other worrying participants (n=662) |
|
| Global score (n=663) |
|
| Short-stay hospitalization |
|