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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 October 2017
Main ID:	NCT02461290
Date of registration:	29/05/2015
Prospective Registration:	No
Primary sponsor:	Hoffmann-La Roche
Public title:	Rituximab Therapy in Follicular Lymphoma in Combination With Chemotherapy - REFLECT 1
Scientific title:	Open, Noninterventional, Multicentre Trial of Rituximab in Combination With Chemotherapy (CVP, CHOP or FCM) Chemotherapy in Patients With Follicular Lymphoma
Date of first enrolment:	April 2008
Target sample size:	99
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02461290
Study type:	Observational
Study design:
Phase:	N/A

Countries of recruitment
Serbia

Contacts

Name:	Clinical Trials
Address:
Telephone:
Email:
Affiliation:	Hoffmann-La Roche

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Follicular Lymphoma

Intervention(s)

Radiation: Chemotherapy

Drug: Rituximab

Primary Outcome(s)

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)]

Secondary Outcome(s)

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)]

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)]

Percentage of Participants Alive at 1, 2, and 3 Years [Time Frame: At 1, 2, and 3 years]

Secondary ID(s)

ML21526

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	30/09/2015
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT02461290

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