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

August 31, 2015 updated by: Hoffmann-La Roche

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

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

99

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 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.
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)
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • ML21526

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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