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To demonstrate that CT-P10 is similar to Rituxan in terms of efficacy as determined by overall response rate at 7 months
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-P10 | Experimental | CT-P10, intervention 375mg/m2, intravenous, 4 cycles in induction period and additional 12 cycles in maintenance period |
|
| Rituxan | Active Comparator | Rituxan, 375mg/m2 intravenous, 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-P10 | Biological | 375mg/m2, IV on day1 of 4 cycles in induction period, and 12 cycles in maintenance period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Efficacy Endpoint - Overall Response Rate by 7 Months | ORR was defined as the proportion of patients with the best response of complete response (CR), unconfirmed CR (CRu), or partial response (PR) by central review. Per 1999 IWG criteria, the disease status was assessed by using contrasted CT and/or MRI, 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. | During the Month 7 (up to Maintenance Cycle 3; Week 28) |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Efficacy Endpoint - ORR Over the Study Period | ORR was defined as the proportion of patients with the best response of complete response (CR), unconfirmed CR (CRu), or partial response (PR). Per 1999 IWG criteria, the disease status was assessed by using contrasted CT and/or MRI, 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| SungHyun Kim | Celltrion | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34686445 | Derived | Kwak LW, Sancho JM, Cho SG, Nakazawa H, Suzumiya J, Tumyan G, Kim JS, Menne T, Mariz J, Ilyin N, Jurczak W, Lopez Martinez A, Samoilova O, Zhavrid E, Yanez Ruiz E, Trneny M, Popplewell L, Ogura M, Kim WS, Lee SJ, Kim SH, Ahn KY, Buske C. Efficacy and Safety of CT-P10 Versus Rituximab in Untreated Low-Tumor-Burden Follicular Lymphoma: Final Results of a Randomized Phase III Study. Clin Lymphoma Myeloma Leuk. 2022 Feb;22(2):89-97. doi: 10.1016/j.clml.2021.08.005. Epub 2021 Aug 28. | |
| 30389036 |
| Label | URL |
|---|---|
| Related Info | View source |
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A total of 402 participants were screened for the study. Of those, 144 participants failed screening and 258 participants were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | CT-P10 | CT-P10 375mg/m2, IV, 4 cycles in induction period and additional 12 cycles in maintenance period |
| FG001 | Rituxan | Rituxan, 375mg/m2, IV, 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Induction Study Period |
|
| ||||||||||||||||||
| 1st Year of the Maintenance Period (MP1) |
| |||||||||||||||||||
| 2nd Year of the Maintenance Period (MP2) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CT-P10 | CT-P10 375mg/m2, IV, 4 cycles in induction period and additional 12 cycles in maintenance period |
| BG001 | Rituxan | Rituxan, 375mg/m2, IV, 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Primary Efficacy Endpoint - Overall Response Rate by 7 Months | ORR was defined as the proportion of patients with the best response of complete response (CR), unconfirmed CR (CRu), or partial response (PR) by central review. Per 1999 IWG criteria, the disease status was assessed by using contrasted CT and/or MRI, 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. | The ITT population consisted of all patients enrolled and randomly assigned to receive a study drug, regardless of whether or not any study drug dosing was completed. | Posted | Count of Participants | Participants | During the Month 7 (up to Maintenance Cycle 3; Week 28) |
|
Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from the last dose of the study drug, regardless of the relationship to the study drug. data from the overall study period (median follow-up of 29.2 months) are presented.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CT-P10 | CT-P10 375mg/m2, IV, 4 cycles in induction period and additional 12 cycles in maintenance period |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina unstable | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
In this study, TTE endpoints were secondary endpoints and were not powered. As medians of PFS, TTP, and OS were not reached in both treatment groups, longer follow-up is needed to ascertain the median time for TTE parameters of PFS, TTP, and OS.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sung Hyun Kim | CELLTRION, Inc. | +82-32-850-5000 | contact@celltrion.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 28, 2017 | Jan 11, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 17, 2019 | Jan 12, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
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| ID | Term |
|---|---|
| C000626854 | CT-P10 |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Rituxan | Biological | 375mg/m2, IV on day1 of 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period. |
|
| up to 27 months |
| Secondary PD Endpoint - B-cell Kinetics (B-cell Depletion and Recovery) | B-cell kinetics were demonstrated by median values of B-cell counts. Any values below the LLoQ were set as LLoQ which was 20 cells/μL. | Baseline, Induction Cycle 1 (predose, 1 hr postdose), Induction Cycle 2 to 4 (predose), EOT1/EOT2 (anytime), Maintenance Cycle 1 to 2 (predose, 1hr postdose) and Maintenance Cycle 3 (predose). |
| Secondary PK Endpoints - Cmax | 1, 2, 3, 4, 12, 20 weeks (predose, 1 hr post dose), EOT1/EOT2 (anytime during the day) and 28 week (predose) |
| Secondary PK Endpoints - Ctrough | 1, 2, 3, 4, 12, 20 weeks (predose, 1 hr post dose), EOT1/EOT2 (anytime during the day) and 28 week (predose) |
| Secondary Efficacy Endpoint - Progression-free Survival (PFS) | PFS was defined as the interval between randomization and disease progression/relapse by IWG 1999 (at least a 50% increase of any single nodal after smallest decrease) or death from any cause, whichever occurred first. Locally reviewed data was used for the secondary efficacy analyses. | Overall study period (Baseline, Month 3, 7, 13, 19 27, and every 6 months thereafter). |
| Secondary Efficacy Endpoint - Overall Survival (OS) | Overall survival was defined as the interval between randomization and death from any cause. Locally reviewed data was used for the secondary efficacy analyses. | Overall study period (median follow-up of 29.2 months) |
| Secondary Efficacy Endpoint - Time-to Progression (TTP) | Time to progression was defined as the interval between randomization and disease progression/relapse by IWG 1999 (at least a 50% increase of any single nodal after smallest decrease) or death as a result of lymphoma, whichever occurred first. Locally reviewed data was used for the secondary efficacy analyses. | Overall study period (Baseline, Month 3, 7, 13, 19 27, and every 6 months thereafter). |
| Derived |
| Ogura M, Sancho JM, Cho SG, Nakazawa H, Suzumiya J, Tumyan G, Kim JS, Lennard A, Mariz J, Ilyin N, Jurczak W, Lopez Martinez A, Samoilova O, Zhavrid E, Yanez Ruiz E, Trneny M, Popplewell L, Coiffier B, Buske C, Kim WS, Lee SJ, Lee SY, Bae YJ, Kwak LW. Efficacy, pharmacokinetics, and safety of the biosimilar CT-P10 in comparison with rituximab in patients with previously untreated low-tumour-burden follicular lymphoma: a randomised, double-blind, parallel-group, phase 3 trial. Lancet Haematol. 2018 Nov;5(11):e543-e553. doi: 10.1016/S2352-3026(18)30157-1. |
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Title |
|---|
| Description |
|---|
| OG000 | CT-P10 | CT-P10 375mg/m2, IV, 4 cycles in induction period and additional 12 cycles in maintenance period |
| OG001 | Rituxan | Rituxan, 375mg/m2, IV, 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period. |
|
|
|
| Secondary | Secondary Efficacy Endpoint - ORR Over the Study Period | ORR was defined as the proportion of patients with the best response of complete response (CR), unconfirmed CR (CRu), or partial response (PR). Per 1999 IWG criteria, the disease status was assessed by using contrasted CT and/or MRI, 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. | The ITT population consisted of all patients enrolled and randomly assigned to receive a study drug, regardless of whether or not any study drug dosing was completed. | Posted | Count of Participants | Participants | up to 27 months |
|
|
|
| Secondary | Secondary PD Endpoint - B-cell Kinetics (B-cell Depletion and Recovery) | B-cell kinetics were demonstrated by median values of B-cell counts. Any values below the LLoQ were set as LLoQ which was 20 cells/μL. | The PD population consisted of all patients who received at least 1 dose (full) of study drug and had at least 1 posttreatment PD result. | Posted | Median | Inter-Quartile Range | cells/uL | Baseline, Induction Cycle 1 (predose, 1 hr postdose), Induction Cycle 2 to 4 (predose), EOT1/EOT2 (anytime), Maintenance Cycle 1 to 2 (predose, 1hr postdose) and Maintenance Cycle 3 (predose). |
|
|
|
| Secondary | Secondary PK Endpoints - Cmax | The PK population consisted of all patients who received at least 1 dose (full) of study drug and had at least 1 posttreatment PK result. | Posted | Mean | Standard Deviation | μg/mL | 1, 2, 3, 4, 12, 20 weeks (predose, 1 hr post dose), EOT1/EOT2 (anytime during the day) and 28 week (predose) |
|
|
|
| Secondary | Secondary PK Endpoints - Ctrough | The PK population consisted of all patients who received at least 1 dose (full) of study drug and had at least 1 posttreatment PK result. | Posted | Mean | Standard Deviation | μg/mL | 1, 2, 3, 4, 12, 20 weeks (predose, 1 hr post dose), EOT1/EOT2 (anytime during the day) and 28 week (predose) |
|
|
|
| Secondary | Secondary Efficacy Endpoint - Progression-free Survival (PFS) | PFS was defined as the interval between randomization and disease progression/relapse by IWG 1999 (at least a 50% increase of any single nodal after smallest decrease) or death from any cause, whichever occurred first. Locally reviewed data was used for the secondary efficacy analyses. | The ITT population consisted of all patients enrolled and randomly assigned to receive a study drug, regardless of whether or not any study drug dosing was completed. | Posted | Number | 95% Confidence Interval | Proportion of Participants | Overall study period (Baseline, Month 3, 7, 13, 19 27, and every 6 months thereafter). |
|
|
|
| Secondary | Secondary Efficacy Endpoint - Overall Survival (OS) | Overall survival was defined as the interval between randomization and death from any cause. Locally reviewed data was used for the secondary efficacy analyses. | The ITT population consisted of all patients enrolled and randomly assigned to receive a study drug, regardless of whether or not any study drug dosing was completed. | Posted | Number | 95% Confidence Interval | Proportion of Participants | Overall study period (median follow-up of 29.2 months) |
|
|
|
| Secondary | Secondary Efficacy Endpoint - Time-to Progression (TTP) | Time to progression was defined as the interval between randomization and disease progression/relapse by IWG 1999 (at least a 50% increase of any single nodal after smallest decrease) or death as a result of lymphoma, whichever occurred first. Locally reviewed data was used for the secondary efficacy analyses. | The ITT population consisted of all patients enrolled and randomly assigned to receive a study drug, regardless of whether or not any study drug dosing was completed. | Posted | Number | 95% Confidence Interval | Proportion of Participants | Overall study period (Baseline, Month 3, 7, 13, 19 27, and every 6 months thereafter). |
|
|
|
| 3 |
| 130 |
| 14 |
| 130 |
| 93 |
| 130 |
| EG001 | Rituxan | Rituxan, 375mg/m2, IV, 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period. | 3 | 128 | 14 | 128 | 86 | 128 |
| Atrial fibrillation | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hyperparathyroidism | Endocrine disorders | MedDRA 18.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Intestinal polyp | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Peptic ulcer perforation | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Nasal neoplasm benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Genital prolapse | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Gastrointestinal surgery | Surgical and medical procedures | MedDRA 18.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Herpes virus infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
A confidentiality and non-disclosure agreement (CDA) was executed between Celltrion, Inc. and some PIs who have participated in publications funded by the sponsor for academic purposes for a period that is more than 180 days from the time submitted to the sponsor for review.
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Induction Cycle 1 (1hr after end of infusion) |
|
|
| Induction Cycle 2 (predose) |
|
|
| Induction Cycle 3 (predose) |
|
|
| Induction Cycle 4 (predose) |
|
|
| EOT1 (anytime) |
|
|
| Maintenance Cycle 1 (predose) |
|
|
| Maintenance Cycle 1 (1hr after end of infusion) |
|
|
| Maintenance Cycle 2 (predose) |
|
|
| Maintenance Cycle 2 (1hr after end of infusion) |
|
|
| Maintenance Cycle 3 (predose) |
|
|
| Induction Cycle 2 |
|
|
| Induction Cycle 3 |
|
|
| Induction Cycle 4 |
|
|
| Maintenance Cycle 1 |
|
|
| Maintenance Cycle 2 |
|
|
| Induction Cycle 2 |
|
|
| Induction Cycle 3 |
|
|
| Induction Cycle 4 |
|
|
| Maintenance Cycle 1 |
|
|
| Maintenance Cycle 2 |
|
|
| 36 months |
|
| 36 months |
|
| 42 months |
|
| 36 months |
|