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

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

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

Study Overview

• Status: Completed
• Conditions: Follicular Lymphoma
• Intervention / Treatment: Drug: Rituximab; Radiation: Chemotherapy

• Study Type: Observational
• Enrollment (Actual): 99

Contacts and Locations

Study Locations

• Serbia
  • Belgrade, Serbia, 11000
  • Belgrade, Serbia, 11080
  • Kragujevac, Serbia, 34000
  • NIS, Serbia, 18000
  • Novi Sad, Serbia, 21000
  • Sremska Kamenica, Serbia, 21204

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with follicular lymphoma

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Combination Therapy; Rituximab 375mg/m2, on day 1 of each cycle of chemotherapy, total of 8 infusions. Chemotherapy according to standard regimens.	Drug: Rituximab; Other Names: MabThera; Radiation: Chemotherapy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: May 29, 2015
• First Submitted That Met QC Criteria: June 1, 2015
• First Posted (Estimate): June 3, 2015

Study Record Updates

• Last Update Posted (Estimate): September 30, 2015
• Last Update Submitted That Met QC Criteria: August 31, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, Follicular; Physiological Effects of Drugs; Antirheumatic Agents; Antineoplastic Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Rituximab
• Other Study ID Numbers: ML21526