Rituximab Therapy in Follicular Lymphoma in Combination With Chemotherapy - REFLECT 1

Study Overview
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Brief Summary
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The primary objective is to evaluate the safety profile and tolerability of rituximab in combination with different chemotherapy regimens.

Official Title
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Open, Noninterventional, Multicentre Trial of Rituximab in Combination With Chemotherapy (CVP, CHOP or FCM) Chemotherapy in Patients With Follicular Lymphoma

Conditions
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Follicular Lymphoma

Intervention / Treatment
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* Radiation: Chemotherapy
* Drug: Rituximab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Combination Therapy<br>Rituximab 375mg/m2, on day 1 of each cycle of chemotherapy, total of 8 infusions. Chemotherapy according to standard regimens. | Radiation: Chemotherapy<br> <br> Drug: Rituximab<br> <br> * Other names: MabThera;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 3 years (at Screening, Baseline, end of induction therapy, and in accordance with routine practice) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 18 months (at Screening, Baseline, end of induction therapy, and in accordance with routine practice) | 
| 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. | Up to 18 months (at Screening, Baseline, end of induction therapy, and in accordance with routine practice) | 
| 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. | At 1, 2, and 3 years |