To Compare Efficacy and Safety Between CT-P10 and Rituxan in Patients With Low Tumour Burden Follicular Lymphoma

Celltrion Healthcare

Status and phase: Completed; Phase 3

Conditions: Follicular Lymphoma

Treatments: Biological: Rituxan; Biological: CT-P10

Study type: Interventional

Funder types: Industry

Identifiers

NCT02260804

CT-P10 3.4

Details and patient eligibility

About

To demonstrate that CT-P10 is similar to Rituxan in terms of efficacy as determined by overall response rate at 7 months

Enrollment: 258 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of low tumour burden, CD20+ follicular lymphoma
• Ann Arbor Stage II, III or IV

Exclusion criteria

• Has receive rituximab
• Allergies or hypersensitivity to murine, chimeric, human or humanised proteins
• Previous treatment for NHL
• Any malignancy
• Current or recent treatment with any other investigational medicinal product or device
• pregnant or lactating

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

258 participants in 2 patient groups

CT-P10

Experimental group

Description:

CT-P10, intervention 375mg/m2, intravenous, 4 cycles in induction period and additional 12 cycles in maintenance period

Treatment:

Biological: CT-P10

Rituxan

Active Comparator group

Description:

Rituxan, 375mg/m2 intravenous, 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period.

Treatment:

Biological: Rituxan