Follicular Lymphoma
Conditions
Brief summary
The primary objective is to evaluate the safety profile and tolerability of rituximab in combination with different chemotherapy regimens.
Interventions
RADIATIONChemotherapy
DRUGRituximab
Sponsors
Hoffmann-La Roche
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* New diagnosed Stage III/IV NHLs * Grades 1, 2 follicular lymphoma need to be treated * mCD20 positive * Have an expected survival of 3 months or more * ECOG 0-2 grade * Normal renal function * ALT less than double normal level
Exclusion criteria
* Presence of CNS lymphoma * Severe infectious disease or organic disease * Having another malignant tumor * Pregnant or breast-feeding female * Organic heart disease, heart failure, II or higher grade AV bundle block. * Subject is allergic to Rituximab * Known HIV infection or chronic HBV infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With an Adverse Event (AE), Serious AE, or Death Related to AE | Up to 3 years (at Screening, Baseline, end of induction therapy, and in accordance with routine practice) | The safety and tolerability of rituximab was evaluated by collection of AEs, including clinically significant abnormalities and changes in laboratory data. An AE was defined as any untoward medical occurrence in a study participant regardless of the suspected cause. Serious AEs were those which, at any dose, met one or more of the following criteria: resulted in fatality, were life-threatening, necessitated new or prolonged existing hospitalization, produced persistent or significant disability, resulted in a congenital anomaly or birth defect, were considered medically significant, or required intervention to prevent any of the aforementioned outcomes. Those specific serious AEs which resulted in fatality were also reported separately. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Complete Remission (CR) or Partial Remission (PR) According to International Working Group Response Criteria for Non-Hodgkin's Lymphoma (NHL) | Up to 18 months (at Screening, Baseline, end of induction therapy, and in accordance with routine practice) | Tumor response was evaluated according to criteria published by Cheson et al (1999). According to consensus recommendations, CR was defined as disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. PR was defined as greater than or equal to (≥) 50 percent (%) decrease in sum of the products of greatest diameters (SPD) of the six largest dominant lymph nodes, no increase in size of other nodes, no increase in liver or spleen volume, a ≥50% decrease in SPD of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease. The percentage of participants achieving CR or PR was calculated as \[number of participants meeting the above criteria divided by the number analyzed\] multiplied by 100. |
| Percentage of Participants With CR According to International Working Group Response Criteria for NHL | Up to 18 months (at Screening, Baseline, end of induction therapy, and in accordance with routine practice) | Tumor response was evaluated according to criteria published by Cheson et al (1999). According to consensus recommendations, CR was defined as disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. The percentage of participants achieving CR was calculated as \[number of participants meeting the above criteria divided by the number analyzed\] multiplied by 100. |
| Percentage of Participants Alive at 1, 2, and 3 Years | At 1, 2, and 3 years | Participants were followed for survival for up to 3 years. The overall survival rate at 1, 2, and 3 years was calculated as \[number of participants alive divided by the number analyzed\] multiplied by 100. |
Countries
Serbia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rituximab + Chemotherapy Participants with Stage III or IV, previously untreated FL received rituximab in combination with chemotherapy, which was prescribed in accordance with local labeling and standard practice at the study site. Chemotherapy regimens included CVP, CHOP, or FCM. Rituximab was administered as 375 mg/m\^2 via IV infusion on Day 1 of each 21-day cycle for 8 cycles of induction therapy. Because the study was noninterventional, the rituximab regimen was also at the discretion of the prescribing physician. | 99 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Withdrawn for Inadequate Clinical Stage | 7 |
Baseline characteristics
| Characteristic | Rituximab + Chemotherapy |
|---|---|
| Age, Continuous | 55.8 years STANDARD_DEVIATION 10.8 |
| Sex: Female, Male Female | 56 Participants |
| Sex: Female, Male Male | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 24 / 99 |
| serious Total, serious adverse events | 10 / 99 |
Outcome results
Primary
Number of Participants With an Adverse Event (AE), Serious AE, or Death Related to AE
The safety and tolerability of rituximab was evaluated by collection of AEs, including clinically significant abnormalities and changes in laboratory data. An AE was defined as any untoward medical occurrence in a study participant regardless of the suspected cause. Serious AEs were those which, at any dose, met one or more of the following criteria: resulted in fatality, were life-threatening, necessitated new or prolonged existing hospitalization, produced persistent or significant disability, resulted in a congenital anomaly or birth defect, were considered medically significant, or required intervention to prevent any of the aforementioned outcomes. Those specific serious AEs which resulted in fatality were also reported separately.
Time frame: Up to 3 years (at Screening, Baseline, end of induction therapy, and in accordance with routine practice)
Population: ITT Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rituximab + Chemotherapy | Number of Participants With an Adverse Event (AE), Serious AE, or Death Related to AE | Any AE | 34 participants |
| Rituximab + Chemotherapy | Number of Participants With an Adverse Event (AE), Serious AE, or Death Related to AE | Serious AE | 10 participants |
| Rituximab + Chemotherapy | Number of Participants With an Adverse Event (AE), Serious AE, or Death Related to AE | Death related to AE | 7 participants |
Secondary
Percentage of Participants Alive at 1, 2, and 3 Years
Participants were followed for survival for up to 3 years. The overall survival rate at 1, 2, and 3 years was calculated as \[number of participants alive divided by the number analyzed\] multiplied by 100.
Time frame: At 1, 2, and 3 years
Population: ITT Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rituximab + Chemotherapy | Percentage of Participants Alive at 1, 2, and 3 Years | At 1 year | 94.2 percentage of participants |
| Rituximab + Chemotherapy | Percentage of Participants Alive at 1, 2, and 3 Years | At 2 years | 92.6 percentage of participants |
| Rituximab + Chemotherapy | Percentage of Participants Alive at 1, 2, and 3 Years | At 3 years | 92.6 percentage of participants |
Secondary
Percentage of Participants With Complete Remission (CR) or Partial Remission (PR) According to International Working Group Response Criteria for Non-Hodgkin's Lymphoma (NHL)
Tumor response was evaluated according to criteria published by Cheson et al (1999). According to consensus recommendations, CR was defined as disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. PR was defined as greater than or equal to (≥) 50 percent (%) decrease in sum of the products of greatest diameters (SPD) of the six largest dominant lymph nodes, no increase in size of other nodes, no increase in liver or spleen volume, a ≥50% decrease in SPD of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease. The percentage of participants achieving CR or PR was calculated as \[number of participants meeting the above criteria divided by the number analyzed\] multiplied by 100.
Time frame: Up to 18 months (at Screening, Baseline, end of induction therapy, and in accordance with routine practice)
Population: Data Analysis Population: All enrolled participants who provided complete and evaluable outcome data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rituximab + Chemotherapy | Percentage of Participants With Complete Remission (CR) or Partial Remission (PR) According to International Working Group Response Criteria for Non-Hodgkin's Lymphoma (NHL) | 73.2 percentage of participants |
Secondary
Percentage of Participants With CR According to International Working Group Response Criteria for NHL
Tumor response was evaluated according to criteria published by Cheson et al (1999). According to consensus recommendations, CR was defined as disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. The percentage of participants achieving CR was calculated as \[number of participants meeting the above criteria divided by the number analyzed\] multiplied by 100.
Time frame: Up to 18 months (at Screening, Baseline, end of induction therapy, and in accordance with routine practice)
Population: Data Analysis Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rituximab + Chemotherapy | Percentage of Participants With CR According to International Working Group Response Criteria for NHL | 61.6 percentage of participants |