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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02162771
Recruitment Status : Completed
First Posted : June 13, 2014
Results First Posted : January 29, 2020
Last Update Posted : January 29, 2020
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: Rituxan Biological: CT-P10 Drug: Cyclophosphamide Drug: Vincristine Drug: Prednisone Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 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
Actual Study Start Date : July 14, 2014
Actual Primary Completion Date : January 12, 2016
Actual Study Completion Date : December 29, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma Steroids
Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: 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.

Biological: CT-P10
Other Name: Rituximab

Drug: Cyclophosphamide
Drug: Vincristine
Drug: Prednisone
Other Name: Prednisolone

Active Comparator: 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.

Biological: Rituxan
Other Name: Rituximab

Drug: Cyclophosphamide
Drug: Vincristine
Drug: Prednisone
Other Name: Prednisolone




Primary Outcome Measures :
  1. Area Under the Serum Concentration-time Curve at Steady State (AUCtau) [ Time Frame: Core Cycle 4 (Week 12) ]

    AUCtau: Area under the plasma drug concentration-time curve within a dosing interval at steady state.

    PK sampling was done at pre-dose and 1 hour after the end of infusion (EOI) at Core Cycles 1-3 and 5-8. At Core Cycle 4 (i.e. steady state), intensive PK samplings were done as follows: predose, EOI, 1 hour after EOI, 24 hour after EOI, 168 hour after EOI, 336 hour after EOI, 504 hour after EOI. Lastly, one sample at any time of the end of treatment (EOT) 1 visit was obtained.


  2. Maximum Serum Concentration at Steady State (Cmax,ss) [ Time Frame: Core Cycle 4 (Week 12) ]

    Cmax,ss: Maximum concentration of drug in plasma at steady state on administering a fixed dose at equal dosing intervals.

    PK sampling was done at pre-dose and 1 hour after the end of infusion (EOI) at Core Cycles 1-3 and 5-8. At Core Cycle 4 (i.e. steady state), intensive PK samplings were done as follows: predose, EOI, 1 hour after EOI, 24 hour after EOI, 168 hour after EOI, 336 hour after EOI, 504 hour after EOI. Lastly, one sample at any time of the end of treatment (EOT) 1 visit was obtained.


  3. Overall Response Rate (ORR) According to the 1999 International Working Group (IWG) Criteria [ Time Frame: During the Core Study Period (up to 8 cycles; Week 24) ]

    ORR was defined as the proportion of patients with the best response of complete response (CR), unconfirmed complete response (CRu), or partial response (PR) by central review.

    Per 1999 IWG criteria, the disease status was assessed by using contrasted CT, and CR, CRu, and PR were defined as followings; CR=Disappearance of all clinical/radiographic evidence of disease: regression of lymph nodes to normal size, absence of B-symptoms, bone marrow involvement, and organomegaly, and normal LDH level; CRu=Regression of measurable disease: >=75% decrease in SPD of target lesions and in each target lesions. no increase in the size of non-target lesions, neither new lesion nor organomegaly measured; PR=Regression of measurable disease: >=50% decrease in SPD of target lesions and no evidence of disease progression.



Secondary Outcome Measures :
  1. B-cell Kinetics (B-cell Depletion and Recovery) [ Time Frame: Cycles 1 to 8 during the Core Study Period ]
    B-cell kinetics were demonstrated by median values of B-cell counts (Lower limit of quantification was 20 cells/uL).



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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
Additional Information:
Publications of Results:
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Responsible Party: Celltrion
ClinicalTrials.gov Identifier: NCT02162771    
Other Study ID Numbers: CT-P10 3.3
2013-004493-96 ( EudraCT Number )
First Posted: June 13, 2014    Key Record Dates
Results First Posted: January 29, 2020
Last Update Posted: January 29, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Keywords provided by Celltrion:
Advanced Follicular Lymphoma
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Prednisone
Prednisolone
Cyclophosphamide
Rituximab
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
Antineoplastic Agents, Immunological
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Phytogenic