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

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Lymphoma, Follicular	Biological: Rituximab; Biological: CT-P10; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Prednisone	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	146 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	A Phase 3, Randomised, Parallel-Group, Active-Controlled, Double-Blind Study to Demonstrate Equivalence of Pharmacokinetics and Noninferiority of Efficacy for CT-P10 in Comparison With Rituxan, Each Administered in Combination With Cyclophosphamide, Vincristine, and Prednisone (CVP) in Patients With Advanced Follicular Lymphoma
Study Start Date :	June 2014
Actual Primary Completion Date :	January 2016
Estimated Study Completion Date :	June 2020

Arms and Interventions

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Arm	Intervention/treatment
Experimental: CT-P10-CVP (Cyclophosphamide, Vincristine, Prednisone); Drug: CT-P10 (375 mg/m2 IV) given day 1 Drug: Cyclophosphamide (750 mg/m2 IV) given day 1 Drug: Vincristine (1.4 mg/m2 IV) given day 1 Drug: Prednisone (40 mg/m2 Oral) given days 1-5 CT-P10 will be administered upto maximum of 8 cycles during the Core Study Period with CVP (cyclophosphamide, vincristine, prednisone) every 3 weeks. CT-P10 or Rituxan will be administered alone as maintenance in patients who have a response during the Core Study Period.	Biological: CT-P10; Other Name: Rituximab; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Prednisone; Other Name: Prednisolone
Active Comparator: Rituximab-CVP (Cyclophosphamide, Vincristine, Prednisone); Drug: Rituximab (375 mg/m2 IV) given day 1 Drug: Cyclophosphamide (750 mg/m2 IV) given day 1 Drug: Vincristine (1.4 mg/m2 IV) given day 1 Drug: Prednisone (40 mg/m2 Oral) given days 1-5 Rituximab will be administered upto maximum of 8 cycles during the Core Study Period with CVP (cyclophosphamide, vincristine, prednisone) every 3 weeks. CT-P10 or Rituxan will be administered alone as maintenance in patients who have a response during the Core Study Period.	Biological: Rituximab; Other Name: Rituxan; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Prednisone; Other Name: Prednisolone

Outcome Measures

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Primary Outcome Measures :

1. Pharmacokinetics [ Time Frame: Week 12 ]
   • AUCtau: Area under the serum concentration-time curve at steady state
   • CmaxSS: Maximum serum concentration at steady state

Secondary Outcome Measures :

1. Efficacy [ Time Frame: Week 24 ]

   Overall response rate(CR + CRu + PR)

   • CR: complete response
   • CRu: unconfirmed complete response
   • PR: partial response

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Locations

Spain
Hospital Universitario Germans Trias i Pujol
Barcelona, Badalona, Spain, 08916

Sponsors and Collaborators

Celltrion

More Information

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Additional Information:

Related Info 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kim WS, Buske C, Ogura M, Jurczak W, Sancho JM, Zhavrid E, Kim JS, Hernández-Rivas JÁ, Prokharau A, Vasilica M, Nagarkar R, Osmanov D, Kwak LW, Lee SJ, Lee SY, Bae YJ, Coiffier B. Efficacy, pharmacokinetics, and safety of the biosimilar CT-P10 compared with rituximab in patients with previously untreated advanced-stage follicular lymphoma: a randomised, double-blind, parallel-group, non-inferiority phase 3 trial. Lancet Haematol. 2017 Aug;4(8):e362-e373. doi: 10.1016/S2352-3026(17)30120-5. Epub 2017 Jul 14.

Responsible Party:	Celltrion
ClinicalTrials.gov Identifier:	NCT02162771 History of Changes
Other Study ID Numbers:	CT-P10 3.3; 2013-004493-96 ( EudraCT Number )
First Posted:	June 13, 2014
Last Update Posted:	August 28, 2017
Last Verified:	August 2017

Studies a U.S. FDA-regulated Drug Product:		Yes

Keywords provided by Celltrion:

Advanced Follicular Lymphoma

Additional relevant MeSH terms:

Lymphoma; Lymphoma, Follicular; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin; Cyclophosphamide; Rituximab; Prednisone; Vincristine; Immunosuppressive Agents; Immunologic Factors

Physiological Effects of Drugs; Antirheumatic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Myeloablative Agonists; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents, Phytogenic; Tubulin Modulators; Antimitotic Agents