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

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ClinicalTrials.gov Identifier: NCT02162771
Recruitment Status : Active, not recruiting
First Posted : June 13, 2014
Last Update Posted : August 28, 2017
Sponsor:
Information provided by (Responsible Party):
Celltrion

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 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


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




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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162771


Locations
Spain
Hospital Universitario Germans Trias i Pujol
Barcelona, Badalona, Spain, 08916
Sponsors and Collaborators
Celltrion

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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    Key Record Dates
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