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

Celltrion Healthcare

Status and phase: Completed; Phase 3

Conditions: Lymphoma, Follicular

Treatments: Drug: Prednisone; Drug: Cyclophosphamide; Biological: Rituxan; Biological: CT-P10; Drug: Vincristine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02162771

2013-004493-96 (EudraCT Number)

CT-P10 3.3

Details and patient eligibility

About

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.

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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140 participants in 2 patient groups

CT-P10

Experimental group

Description:

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.

Treatment:

Drug: Cyclophosphamide

Biological: CT-P10

Drug: Vincristine

Drug: Prednisone

Rituxan

Active Comparator group

Description:

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.

Treatment:

Drug: Cyclophosphamide

Biological: Rituxan

Drug: Vincristine

Drug: Prednisone