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

Roche

Status: Completed

Conditions: Follicular Lymphoma

Treatments: Radiation: Chemotherapy; Drug: Rituximab

Study type: Observational

Funder types: Industry

Identifiers

NCT02461290

ML21526

Details and patient eligibility

About

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

Enrollment: 99 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

99 participants in 1 patient group

Combination Therapy

Description:

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

Treatment:

Drug: Rituximab

Radiation: Chemotherapy