To Demonstrate Equivalence of Pharmacokinetics and Noninferiority of Efficacy for CT-P10 in Comparison With Rituxan

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-14

Study Completion Date

2018-12-29

Brief Summary

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This study is a Phase 3 prospective, randomised, parallel-group, active controlled, double blind, multicentre, international study with 2 coprimary endpoints designed to demonstrate equivalence in pharmacokinetics (Part 1), as well as noninferiority in efficacy (Part 2), of CT-P10 to Rituxan when coadministered with CVP and to assess efficacy and safety in patients with advanced (stage III-IV) FL. Part 1 and Part 2 of the study will run in parallel.

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Detailed Description

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Conditions

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Lymphoma, Follicular

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CT-P10

Patient treated with CT-P10 (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 \[max 2 mg\] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period.

Patients having responses during Core Study Period treated with CT-P10 (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period.

Group Type EXPERIMENTAL

CT-P10

Intervention Type BIOLOGICAL

Cyclophosphamide

Intervention Type DRUG

Vincristine

Intervention Type DRUG

Prednisone

Intervention Type DRUG

Rituxan

Patient treated with Rituxan (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 \[max 2 mg\] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period.

Patients having responses during Core Study Period treated with Rituxan (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period.

Group Type ACTIVE_COMPARATOR

Rituxan

Intervention Type BIOLOGICAL

Cyclophosphamide

Intervention Type DRUG

Vincristine

Intervention Type DRUG

Prednisone

Intervention Type DRUG

Interventions

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Rituxan

Intervention Type BIOLOGICAL

CT-P10

Intervention Type BIOLOGICAL

Cyclophosphamide

Intervention Type DRUG

Vincristine

Intervention Type DRUG

Prednisone

Intervention Type DRUG

Other Intervention Names

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Rituximab Rituximab Prednisolone

Eligibility Criteria

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Inclusion Criteria

1. Patient is male or female older than 18 years.
2. Patient has histologically confirmed FL according to the World Health Organization 2008 classification (Jaffe 2009); grades 1 to 3a based on local laboratory review.
3. Patient has at least 1 measurable tumour mass that has not previously been irradiated, and the mass must be:

* greater than 1.5 cm in the longest dimension or
* between 1.1 and 1.5 cm in the longest dimension and greater than 1.0 cm in the shortest axis
4. Patient has confirmed CD20+ lymphoma, as assessed by local laboratory review. (Tissue obtained within 6 months before Day 1 of Cycle 1 will be reviewed by a central independent reviewer to detect pathological type.)
5. Patient has Ann Arbor stage III or IV disease.

Exclusion Criteria

1. Patient has received rituximab (or a rituximab biosimilar), cyclophosphamide, or vincristine.
2. Patient has allergies or hypersensitivity to murine, chimeric, human or humanised proteins, cyclophosphamide, vincristine, or prednisone.
3. Patient has evidence of histological transformation to high-grade or diffuse large B-cell lymphoma.
4. Patient has known central nervous system involvement.
5. Patient has received previous treatment for NHL:

* Previous treatment including chemotherapy, radiotherapy, immunotherapy, and/or surgery (except previous biopsy)
* All doses of corticoid therapy for treatment of NHL
* Corticoid therapy during the previous 4 weeks from Day 1 of Cycle 1 with prednisone \>20 mg per day for the treatment for any purpose

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No