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

• 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: Celltrion
• Information provided by (Responsible Party): Celltrion

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Lymphoma, Follicular
• Interventions: Biological: Rituxan; Biological: CT-P10; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Prednisone
• Enrollment: 140

Participant Flow

Recruitment Details
Pre-assignment Details	A total of 184 participants were screened for the study. Of those, 44 participants failed screening and 140 participants were enrolled in the study.

Arm/Group Title	CT-P10	Rituxan
Arm/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.	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.
Period Title: Core Study Period (Part 2)
Started	70	70
Completed	62	62
Not Completed	8	8
Reason Not Completed
Progressive Disease	2	3
Adverse Event	4	1
Withdrawal by Subject	1	2
Physician Decision	0	2
Death	1	0
Period Title: Maintenance Study Period (Part 2)
Started	62	60 [1]
Completed	46	38
Not Completed	16	22
Reason Not Completed
Progressive Disease	11	13
Adverse Event	3	3
Death	2	1
Withdrawal by Subject	0	3
Protocol Violation	0	1
Stable Disease	0	1
[1] Two subjects did not enter this period due to Withdrawal by subject and Non-responder, 1 for each.

Baseline Characteristics

Arm/Group Title		CT-P10	Rituxan	Total
Arm/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.	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.	Total of all reporting groups
Overall Number of Baseline Participants		70	70	140
Baseline Analysis Population Description		All randomized patients (ITT population)
Age, Continuous; Median (Full Range); Unit of measure: Years
	Number Analyzed	70 participants	70 participants	140 participants
		57.0; (30 to 85)	58.5; (26 to 84)	57.5; (26 to 85)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	70 participants	70 participants	140 participants
	Female	40 57.1%	37 52.9%	77 55.0%
	Male	30 42.9%	33 47.1%	63 45.0%

Outcome Measures

1. Primary Outcome

Title	Area Under the Serum Concentration-time Curve at Steady State (AUCtau)
Description	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.
Time Frame	Core Cycle 4 (Week 12)

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Population consisted of all patients who had at least 1 posttreatment PK concentration result after receiving at least 1 dose of study drug (CT-P10 or Rituxan) in Part 1. Patients considered outliers identified by a robust regression model (95% CI) were excluded from the analysis.

Arm/Group Title	CT-P10	Rituxan
Arm/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.	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.
Overall Number of Participants Analyzed	50	56
Geometric Mean (Standard Error); Unit of Measure: h*ug/mL
	41002.43 (1.136)	40099.08 (1.143)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CT-P10, Rituxan
	Comments	Equivalence in AUCtau between CT-P10 and Rituxan
	Type of Statistical Test	Equivalence
	Comments	The 90% CIs of the ratios of geometric means of log-transformed values were used to assess the bioequivalence between CT-P10 and Rituxan (bioequivalence range of 80% to 125%)
Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	Country, gender, race, the value of ECOG status and the FLIPI score (0 to 2 versus 3 to 5) at baseline were fitted as covariates.
Method of Estimation	Estimation Parameter	Ratio of geometric least square means
	Estimated Value	102.25
	Confidence Interval	(2-Sided) 90%; 94.05 to 111.17
	Estimation Comments	[Not Specified]

2. Primary Outcome

Title	Maximum Serum Concentration at Steady State (Cmax,ss)
Description	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.
Time Frame	Core Cycle 4 (Week 12)

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Population consisted of all patients who had at least 1 posttreatment PK concentration result after receiving at least 1 dose of study drug (CT-P10 or Rituxan) in Part 1. Patients considered outliers identified by a robust regression model (95% CI) were excluded from the analysis.

Arm/Group Title	CT-P10	Rituxan
Arm/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.	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.
Overall Number of Participants Analyzed	53	56
Geometric Mean (Standard Error); Unit of Measure: ug/mL
	256.19 (1.115)	254.49 (1.120)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CT-P10, Rituxan
	Comments	Equivalence in Cmax,ss between CT-P10 and Rituxan
	Type of Statistical Test	Equivalence
	Comments	The 90% CIs of the ratios of geometric means of log-transformed transformed values were used to assess the bioequivalence between CT-P10 and Rituxan (bioequivalence range of 80% to 125%)
Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	Country, gender, race, the value of ECOG status and the FLIPI score (0 to 2 versus 3 to 5) at baseline were fitted as covariates.
Method of Estimation	Estimation Parameter	Ratio of geometric least square means
	Estimated Value	100.67
	Confidence Interval	(2-Sided) 90%; 93.84 to 108.00
	Estimation Comments	[Not Specified]

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Efficacy population consisted of all patients who had at least 1 response evaluation after receiving at least 1 treatment cycle in the Core Study Period without any major protocol deviation that was relevant to the efficacy endpoint in Part 2.

Arm/Group Title	CT-P10	Rituxan
Arm/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.	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.
Overall Number of Participants Analyzed	66	68
Measure Type: Count of Participants; Unit of Measure: Participants
	64 97.0%	63 92.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CT-P10, Rituxan
	Comments	[Not Specified]
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority margin of -7% was predefined.
Method of Estimation	Estimation Parameter	Point estimate difference
	Estimated Value	4.3
	Estimation Comments	[Not Specified]

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Pharmacodynamic (PD) population consisted of all patients who had at least 1 posttreatment PD result after receiving at least 1 dose of study drug (CT-P10 or Rituxan) without any major protocol deviation that was relevant to the PD endpoint in Part 2.

Arm/Group Title		CT-P10	Rituxan
Arm/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.	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.
Overall Number of Participants Analyzed		70	70
Median (Full Range); Unit of Measure: cells/uL
Core Cycle 1 (Predose)	Number Analyzed	56 participants	57 participants
		92.5; (20 to 2890)	62.0; (20 to 2890)
Core Cycle 1 (1 hour after the end of infusion)	Number Analyzed	44 participants	55 participants
		20.0; (20 to 1108)	20.0; (20 to 51)
Core Cycle 2 (Predose)	Number Analyzed	60 participants	60 participants
		20.0; (20 to 1750)	20.0; (20 to 2890)
Core Cycle 3 (Predose)	Number Analyzed	63 participants	62 participants
		20.0; (20 to 231)	20.0; (20 to 35)
Core Cycle 4 (Predose)	Number Analyzed	59 participants	61 participants
		20.0; (20 to 51)	20.0; (20 to 20)
Core Cycle 5 (Predose)	Number Analyzed	60 participants	57 participants
		20.0; (20 to 20)	20.0; (20 to 20)
Core Cycle 6 (Predose)	Number Analyzed	60 participants	61 participants
		20.0; (20 to 33)	20.0; (20 to 20)
Core Cycle 7 (Predose)	Number Analyzed	60 participants	63 participants
		20.0; (20 to 24)	20.0; (20 to 20)
Core Cycle 8 (Predose)	Number Analyzed	61 participants	59 participants
		20.0; (20 to 20)	20.0; (20 to 20)

Adverse Events

Time Frame	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 last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months).
Adverse Event Reporting Description	All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
Arm/Group Title	CT-P10	Rituxan
Arm/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.	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.
All-Cause Mortality
	CT-P10	Rituxan
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	CT-P10	Rituxan
	Affected / at Risk (%)	Affected / at Risk (%)
Total	24/70 (34.29%)	13/70 (18.57%)
Blood and lymphatic system disorders
Anaemia † 1	1/70 (1.43%)	0/70 (0.00%)
Febrile neutropenia † 1	2/70 (2.86%)	3/70 (4.29%)
Leukopenia † 1	0/70 (0.00%)	1/70 (1.43%)
Neutropenia † 1	1/70 (1.43%)	1/70 (1.43%)
Pancytopenia † 1	1/70 (1.43%)	0/70 (0.00%)
Cardiac disorders
Atrial fibrillation † 1	1/70 (1.43%)	0/70 (0.00%)
Tachycardia † 1	0/70 (0.00%)	1/70 (1.43%)
Gastrointestinal disorders
Constipation † 1	1/70 (1.43%)	0/70 (0.00%)
Diarrhea † 1	0/70 (0.00%)	1/70 (1.43%)
Ileus † 1	0/70 (0.00%)	1/70 (1.43%)
Small intestinal perforation † 1	1/70 (1.43%)	0/70 (0.00%)
General disorders
Pyrexia † 1	0/70 (0.00%)	1/70 (1.43%)
Hepatobiliary disorders
Cholecystitis † 1	1/70 (1.43%)	0/70 (0.00%)
Immune system disorders
Anaphylactic shock † 1	1/70 (1.43%)	0/70 (0.00%)
Infections and infestations
Abdominal infection † 1	1/70 (1.43%)	0/70 (0.00%)
Appendicitis † 1	1/70 (1.43%)	0/70 (0.00%)
Campylobacter gastroenteritis † 1	1/70 (1.43%)	0/70 (0.00%)
Encephalitis † 1	0/70 (0.00%)	1/70 (1.43%)
Herpes virus infection † 1	1/70 (1.43%)	0/70 (0.00%)
Lower respiratory tract infection † 1	1/70 (1.43%)	2/70 (2.86%)
Pneumonia † 1	4/70 (5.71%)	1/70 (1.43%)
Sialodenitis † 1	1/70 (1.43%)	0/70 (0.00%)
Upper respiratory tract infection † 1	0/70 (0.00%)	2/70 (2.86%)
Injury, poisoning and procedural complications
Fracture † 1	1/70 (1.43%)	0/70 (0.00%)
Injury † 1	1/70 (1.43%)	0/70 (0.00%)
Post procedural fistula † 1	1/70 (1.43%)	0/70 (0.00%)
Subdural haematoma † 1	0/70 (0.00%)	1/70 (1.43%)
Investigations
Liver function test abnormal † 1	1/70 (1.43%)	0/70 (0.00%)
Metabolism and nutrition disorders
Hypoalbuminaemia † 1	1/70 (1.43%)	0/70 (0.00%)
Hypocalcaemia † 1	1/70 (1.43%)	0/70 (0.00%)
Hypomagnesaemia † 1	1/70 (1.43%)	0/70 (0.00%)
Tumour lysis syndrome † 1	1/70 (1.43%)	0/70 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric † 1	1/70 (1.43%)	0/70 (0.00%)
Hepatocellular carcinoma † 1	1/70 (1.43%)	0/70 (0.00%)
Invasive lobular breast carcinoma † 1	1/70 (1.43%)	0/70 (0.00%)
Prostate cancer metastatic † 1	1/70 (1.43%)	0/70 (0.00%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome † 1	0/70 (0.00%)	1/70 (1.43%)
Chronic obstructive pulmonary disease † 1	2/70 (2.86%)	1/70 (1.43%)
Pleural effusion † 1	1/70 (1.43%)	0/70 (0.00%)
Pulmonary embolism † 1	1/70 (1.43%)	0/70 (0.00%)
Respiratory failure † 1	1/70 (1.43%)	0/70 (0.00%)
Vascular disorders
Deep vein thrombosis † 1	1/70 (1.43%)	0/70 (0.00%)
Hypertension † 1	1/70 (1.43%)	0/70 (0.00%)
Peripheral ischaemia † 1	0/70 (0.00%)	1/70 (1.43%)
Thrombophlebitis † 1	0/70 (0.00%)	1/70 (1.43%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA (18.1)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	CT-P10	Rituxan
	Affected / at Risk (%)	Affected / at Risk (%)
Total	58/70 (82.86%)	57/70 (81.43%)
Blood and lymphatic system disorders
Anaemia † 1	6/70 (8.57%)	5/70 (7.14%)
Neutropenia † 1	27/70 (38.57%)	20/70 (28.57%)
Gastrointestinal disorders
Abdominal pain † 1	8/70 (11.43%)	11/70 (15.71%)
Constipation † 1	12/70 (17.14%)	10/70 (14.29%)
Diarrhoea † 1	6/70 (8.57%)	7/70 (10.00%)
Nausea † 1	9/70 (12.86%)	7/70 (10.00%)
Stomatitis † 1	2/70 (2.86%)	4/70 (5.71%)
General disorders
Asthenia † 1	5/70 (7.14%)	8/70 (11.43%)
Fatigue † 1	6/70 (8.57%)	8/70 (11.43%)
Oedema † 1	5/70 (7.14%)	3/70 (4.29%)
Pyrexia † 1	3/70 (4.29%)	6/70 (8.57%)
Infections and infestations
Fungal infection † 1	4/70 (5.71%)	4/70 (5.71%)
Influenza † 1	2/70 (2.86%)	4/70 (5.71%)
Lower respiratory tract infection † 1	7/70 (10.00%)	1/70 (1.43%)
Sinusitis † 1	5/70 (7.14%)	2/70 (2.86%)
Upper respiratory tract infection † 1	14/70 (20.00%)	18/70 (25.71%)
Urinary tract infection † 1	6/70 (8.57%)	6/70 (8.57%)
Injury, poisoning and procedural complications
Fracture † 1	4/70 (5.71%)	1/70 (1.43%)
Infusion related reaction † 1	16/70 (22.86%)	19/70 (27.14%)
Metabolism and nutrition disorders
Decreased appetite † 1	0/70 (0.00%)	6/70 (8.57%)
Hyperglycaemia † 1	2/70 (2.86%)	5/70 (7.14%)
Musculoskeletal and connective tissue disorders
Arthralgia † 1	7/70 (10.00%)	4/70 (5.71%)
Back pain † 1	2/70 (2.86%)	12/70 (17.14%)
Myalgia † 1	6/70 (8.57%)	2/70 (2.86%)
Nervous system disorders
Dizziness † 1	4/70 (5.71%)	5/70 (7.14%)
Headache † 1	4/70 (5.71%)	6/70 (8.57%)
Hypoaesthesia † 1	6/70 (8.57%)	2/70 (2.86%)
Neuropathy peripheral † 1	10/70 (14.29%)	12/70 (17.14%)
Paraesthesia † 1	3/70 (4.29%)	8/70 (11.43%)
Psychiatric disorders
Insomnia † 1	2/70 (2.86%)	6/70 (8.57%)
Respiratory, thoracic and mediastinal disorders
Cough † 1	6/70 (8.57%)	5/70 (7.14%)
Dyspnoea † 1	4/70 (5.71%)	1/70 (1.43%)
Oropharyngeal pain † 1	1/70 (1.43%)	4/70 (5.71%)
Skin and subcutaneous tissue disorders
Alopecia † 1	10/70 (14.29%)	5/70 (7.14%)
Vascular disorders
Hypertension † 1	6/70 (8.57%)	3/70 (4.29%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA (18.1)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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.

Results Point of Contact

• Name/Title: Dr. Sung Hyun Kim
• Organization: CELLTRION, Inc.
• Phone: +82-32-850-5000
• EMail: contact@celltrion.com

Publications of Results:

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
• Other Study ID Numbers: CT-P10 3.3; 2013-004493-96 ( EudraCT Number )
• First Submitted: May 29, 2014
• First Posted: June 13, 2014
• Results First Submitted: December 26, 2019
• Results First Posted: January 29, 2020
• Last Update Posted: January 29, 2020