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

Completed

• Conditions: Follicular Lymphoma
• Interventions: Radiation: Chemotherapy; Drug: Rituximab

• Registration Number: NCT02461290
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Study First Submitted: 2015-05-29
• Study First Submitted QC: 2015-06-01
• Study First Posted: 2015-06-03
• Status Verified: 2015-08
• Results First Submitted: 2015-08-31
• Results First Submitted QC: 2015-08-31
• Last Update Submitted: 2015-08-31
• Results First Posted: 2015-09-30
• Last Update Posted: 2015-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Combination Therapy	Chemotherapy	Rituximab 375mg/m2, on day 1 of each cycle of chemotherapy, total of 8 infusions. Chemotherapy according to standard regimens.
Combination Therapy	Rituximab	Rituximab 375mg/m2, on day 1 of each cycle of chemotherapy, total of 8 infusions. Chemotherapy according to standard regimens.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.