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

Follicular Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02461290
• Other study ID #: ML21526
• Status: Completed
• Phase: N/A
• First received: May 29, 2015
• Last updated: August 31, 2015
• Start date: April 2008
• Est. completion date: November 2013

Study information

• Verified date: August 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Agency for Medicines:Medical Devices of Serbia
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Follicular Lymphoma
• Lymphoma
• Lymphoma, Follicular

Intervention

Radiation:
• Chemotherapy

Drug:
• Rituximab

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Up to 3 years (at Screening, Baseline, end of induction therapy, and in accordance with routine practice)	No
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.	Up to 18 months (at Screening, Baseline, end of induction therapy, and in accordance with routine practice)	No
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.	Up to 18 months (at Screening, Baseline, end of induction therapy, and in accordance with routine practice)	No
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.	At 1, 2, and 3 years	No