To Compare Efficacy and Safety Between CT-P10 and Rituxan in Patients With Low Tumour Burden Follicular Lymphoma

• Sponsor: Celltrion (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02260804
• Collaborator: (none)
• Enrollment: 258
• Location: 1
• Arms: 2
• Actual Duration (Months): 45.8
• Patients Per Site Per Month: 5.6

Study Details

Study Description

Brief Summary

To demonstrate that CT-P10 is similar to Rituxan in terms of efficacy as determined by overall response rate at 7 months

Condition or Disease	Intervention/Treatment	Phase
Follicular Lymphoma	Biological: CT-P10; Biological: Rituxan	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 258 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 Compare Efficacy and Safety Between CT-P10 and Rituxan in Patients With Low Tumour Burden Follicular Lymphoma
• Actual Study Start Date: Nov 9, 2015
• Actual Primary Completion Date: Jan 4, 2018
• Actual Study Completion Date: Sep 4, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CT-P10 CT-P10, intervention 375mg/m2, intravenous, 4 cycles in induction period and additional 12 cycles in maintenance period	Biological: CT-P10; 375mg/m2, IV on day1 of 4 cycles in induction period, and 12 cycles in maintenance period.
Active Comparator: Rituxan 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.	Biological: Rituxan; 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.

Outcome Measures

Primary Outcome Measures

1. Primary Efficacy Endpoint - Overall Response Rate by 7 Months [During the Month 7 (up to Maintenance Cycle 3; Week 28)]

   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.

Secondary Outcome Measures

1. Secondary Efficacy Endpoint - ORR Over the Study Period [up to 27 months]

   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.

2. Secondary PD Endpoint - B-cell Kinetics (B-cell Depletion and Recovery) [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).]

   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.

3. 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)]

4. 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)]

5. Secondary Efficacy Endpoint - Progression-free Survival (PFS) [Overall study period (Baseline, Month 3, 7, 13, 19 27, and every 6 months thereafter).]

   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.

6. Secondary Efficacy Endpoint - Overall Survival (OS) [Overall study period (median follow-up of 29.2 months)]

   Overall survival was defined as the interval between randomization and death from any cause. Locally reviewed data was used for the secondary efficacy analyses.

7. Secondary Efficacy Endpoint - Time-to Progression (TTP) [Overall study period (Baseline, Month 3, 7, 13, 19 27, and every 6 months thereafter).]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Confirmed diagnosis of low tumour burden, CD20+ follicular lymphoma

• Ann Arbor Stage II, III or IV

Exclusion Criteria:

• Has receive rituximab

• Allergies or hypersensitivity to murine, chimeric, human or humanised proteins

• Previous treatment for NHL

• Any malignancy

• Current or recent treatment with any other investigational medicinal product or device

• pregnant or lactating

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Severance Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Celltrion

Investigators

• Study Director: SungHyun Kim, Celltrion

Study Documents (Full-Text)

• Study Protocol - Jun 28, 2017
• Statistical Analysis Plan - Oct 17, 2019

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Celltrion
• ClinicalTrials.gov Identifier: NCT02260804
• Other Study ID Numbers: CT-P10 3.4
• First Posted: Oct 9, 2014
• Last Update Posted: Apr 8, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Lymphoma; Lymphoma, Follicular; Rituximab

Study Results

Participant Flow

Pre-assignment Detail	A total of 402 participants were screened for the study. Of those, 144 participants failed screening and 258 participants were enrolled in the study.

Arm/Group Title	CT-P10	Rituxan
Arm/Group Description	CT-P10 375mg/m2, IV, 4 cycles in induction period and additional 12 cycles in maintenance period	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.
Period Title: Induction Study Period
STARTED	130	128
COMPLETED	128	128
NOT COMPLETED	2	0
Period Title: Induction Study Period
STARTED	123	120
COMPLETED	111	105
NOT COMPLETED	12	15
Period Title: Induction Study Period
STARTED	110	103
COMPLETED	101	97
NOT COMPLETED	9	6

Baseline Characteristics

Arm/Group Title	CT-P10	Rituxan	Total
Arm/Group Description	CT-P10 375mg/m2, IV, 4 cycles in induction period and additional 12 cycles in maintenance period	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.	Total of all reporting groups
Overall Participants	130	128	258
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.7 (12.68)	57.7 (11.53)	57.7 (12.10)
Sex: Female, Male (Count of Participants)
Female	64 49.2%	71 55.5%	135 52.3%
Male	66 50.8%	57 44.5%	123 47.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	12 9.2%	10 7.8%	22 8.5%
Not Hispanic or Latino	110 84.6%	116 90.6%	226 87.6%
Unknown or Not Reported	8 6.2%	2 1.6%	10 3.9%

Outcome Measures

1. Primary Outcome

Title	Primary Efficacy Endpoint - Overall Response Rate by 7 Months
Description	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.
Time Frame	During the Month 7 (up to Maintenance Cycle 3; Week 28)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	CT-P10	Rituxan
Arm/Group Description	CT-P10 375mg/m2, IV, 4 cycles in induction period and additional 12 cycles in maintenance period	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.
Measure Participants	130	128
Count of Participants [Participants]	108 83.1%	104 81.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CT-P10
	Comments
	Type of Statistical Test	Equivalence
	Comments	The equivalence margin of ±17% was predefined.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	1.8
	Confidence Interval	(2-Sided) 90%; -6.43 to 10.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Secondary Efficacy Endpoint - ORR Over the Study Period
Description	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.
Time Frame	up to 27 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	CT-P10	Rituxan
Arm/Group Description	CT-P10 375mg/m2, IV, 4 cycles in induction period and additional 12 cycles in maintenance period	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.
Measure Participants	130	128
Count of Participants [Participants]	109 83.8%	112 87.5%

3. Secondary Outcome

Title	Secondary PD Endpoint - B-cell Kinetics (B-cell Depletion and Recovery)
Description	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.
Time Frame	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).

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	CT-P10	Rituxan
Arm/Group Description	CT-P10 375mg/m2, IV, 4 cycles in induction period and additional 12 cycles in maintenance period	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.
Measure Participants	128	128
Baseline	95.0	120.0
Induction Cycle 1 (1hr after end of infusion)	20.0	20.0
Induction Cycle 2 (predose)	20.0	20.0
Induction Cycle 3 (predose)	20.0	20.0
Induction Cycle 4 (predose)	20.0	20.0
EOT1 (anytime)	20.0	20.0
Maintenance Cycle 1 (predose)	20.0	20.0
Maintenance Cycle 1 (1hr after end of infusion)	20.0	20.0
Maintenance Cycle 2 (predose)	20.0	20.0
Maintenance Cycle 2 (1hr after end of infusion)	20.0	20.0
Maintenance Cycle 3 (predose)	20.0	20.0

4. Secondary Outcome

Title	Secondary PK Endpoints - Cmax
Time Frame	1, 2, 3, 4, 12, 20 weeks (predose, 1 hr post dose), EOT1/EOT2 (anytime during the day) and 28 week (predose)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	CT-P10	Rituxan
Arm/Group Description	CT-P10 375mg/m2, IV, 4 cycles in induction period and additional 12 cycles in maintenance period	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.
Measure Participants	128	128
Induction Cycle 1	212.86 (50.64)	217.38 (56.33)
Induction Cycle 2	283.35 (53.84)	285.98 (62.26)
Induction Cycle 3	327.32 (71.05)	341.59 (77.95)
Induction Cycle 4	373.46 (70.50)	383.05 (83.86)
Maintenance Cycle 1	256.97 (65.61)	265.03 (53.73)
Maintenance Cycle 2	239.70 (65.72)	249.86 (69.02)

5. Secondary Outcome

Title	Secondary PK Endpoints - Ctrough
Time Frame	1, 2, 3, 4, 12, 20 weeks (predose, 1 hr post dose), EOT1/EOT2 (anytime during the day) and 28 week (predose)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	CT-P10	Rituxan
Arm/Group Description	CT-P10 375mg/m2, IV, 4 cycles in induction period and additional 12 cycles in maintenance period	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.
Measure Participants	128	128
Induction Cycle 1	64.66 (24.88)	72.94 (40.39)
Induction Cycle 2	113.23 (34.60)	120.92 (36.02)
Induction Cycle 3	149.53 (43.65)	161.80 (43.91)
Induction Cycle 4	34.78 (33.58)	31.38 (19.15)
Maintenance Cycle 1	22.68 (37.22)	21.35 (20.90)
Maintenance Cycle 2	16.96 (9.61)	18.37 (10.86)

6. Secondary Outcome

Title	Secondary Efficacy Endpoint - Progression-free Survival (PFS)
Description	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.
Time Frame	Overall study period (Baseline, Month 3, 7, 13, 19 27, and every 6 months thereafter).

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	CT-P10	Rituxan
Arm/Group Description	CT-P10 375mg/m2, IV, 4 cycles in induction period and additional 12 cycles in maintenance period	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.
Measure Participants	130	128
12 months	0.93 0.7%	0.89 0.7%
24 months	0.88 0.7%	0.83 0.6%
36 months	0.80 0.6%	0.68 0.5%

7. Secondary Outcome

Title	Secondary Efficacy Endpoint - Overall Survival (OS)
Description	Overall survival was defined as the interval between randomization and death from any cause. Locally reviewed data was used for the secondary efficacy analyses.
Time Frame	Overall study period (median follow-up of 29.2 months)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	CT-P10	Rituxan
Arm/Group Description	CT-P10 375mg/m2, IV, 4 cycles in induction period and additional 12 cycles in maintenance period	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.
Measure Participants	130	128
12 months	0.98 0.8%	0.98 0.8%
24 months	0.98 0.8%	0.98 0.8%
36 months	0.98 0.8%	0.97 0.8%
42 months	0.98 0.8%	0.97 0.8%

8. Secondary Outcome

Title	Secondary Efficacy Endpoint - Time-to Progression (TTP)
Description	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.
Time Frame	Overall study period (Baseline, Month 3, 7, 13, 19 27, and every 6 months thereafter).

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	CT-P10	Rituxan
Arm/Group Description	CT-P10 375mg/m2, IV, 4 cycles in induction period and additional 12 cycles in maintenance period	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.
Measure Participants	130	128
12 months	0.94 0.7%	0.89 0.7%
24 months	0.89 0.7%	0.84 0.7%
36 months	0.82 0.6%	0.68 0.5%

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 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.
Arm/Group Title	CT-P10		Rituxan
Arm/Group Description	CT-P10 375mg/m2, IV, 4 cycles in induction period and additional 12 cycles in maintenance period		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.
All Cause Mortality
	CT-P10		Rituxan
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/130 (2.3%)		3/128 (2.3%)
Serious Adverse Events
	CT-P10		Rituxan
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/130 (10.8%)		14/128 (10.9%)
Cardiac disorders
Angina unstable	0/130 (0%)		1/128 (0.8%)
Atrial fibrillation	0/130 (0%)		1/128 (0.8%)
Bradycardia	1/130 (0.8%)		0/128 (0%)
Myocardial infarction	1/130 (0.8%)		0/128 (0%)
Endocrine disorders
Hyperparathyroidism	0/130 (0%)		1/128 (0.8%)
Gastrointestinal disorders
Constipation	1/130 (0.8%)		0/128 (0%)
Crohn's disease	1/130 (0.8%)		0/128 (0%)
Gastric haemorrhage	1/130 (0.8%)		0/128 (0%)
Gastritis	1/130 (0.8%)		0/128 (0%)
Intestinal polyp	0/130 (0%)		1/128 (0.8%)
Pancreatitis	0/130 (0%)		1/128 (0.8%)
Peptic ulcer perforation	0/130 (0%)		1/128 (0.8%)
General disorders
Chest discomfort	1/130 (0.8%)		0/128 (0%)
Infections and infestations
Localised infection	0/130 (0%)		1/128 (0.8%)
Pneumonia	0/130 (0%)		2/128 (1.6%)
Urinary tract infection	0/130 (0%)		1/128 (0.8%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma	1/130 (0.8%)		0/128 (0%)
Breast cancer	1/130 (0.8%)		0/128 (0%)
Nasal neoplasm benign	0/130 (0%)		1/128 (0.8%)
Squamous cell carcinoma of lung	1/130 (0.8%)		0/128 (0%)
Nervous system disorders
Cerebral infarction	1/130 (0.8%)		0/128 (0%)
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous	1/130 (0.8%)		0/128 (0%)
Renal and urinary disorders
Acute kidney injury	0/130 (0%)		1/128 (0.8%)
Reproductive system and breast disorders
Genital prolapse	0/130 (0%)		1/128 (0.8%)
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease	0/130 (0%)		1/128 (0.8%)
Pulmonary embolism	1/130 (0.8%)		0/128 (0%)
Respiratory failure	1/130 (0.8%)		0/128 (0%)
Surgical and medical procedures
Gastrointestinal surgery	1/130 (0.8%)		0/128 (0%)
Other (Not Including Serious) Adverse Events
	CT-P10		Rituxan
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	93/130 (71.5%)		86/128 (67.2%)
Blood and lymphatic system disorders
Neutropenia	10/130 (7.7%)		7/128 (5.5%)
Gastrointestinal disorders
Abdominal pain	6/130 (4.6%)		7/128 (5.5%)
Diarrhoea	9/130 (6.9%)		11/128 (8.6%)
Nausea	7/130 (5.4%)		11/128 (8.6%)
General disorders
Fatigue	10/130 (7.7%)		13/128 (10.2%)
Infections and infestations
Herpes virus infection	7/130 (5.4%)		5/128 (3.9%)
Influenza	3/130 (2.3%)		8/128 (6.3%)
Lower respiratory tract infection	6/130 (4.6%)		11/128 (8.6%)
Upper respiratory tract infection	31/130 (23.8%)		29/128 (22.7%)
Urinary tract infection	9/130 (6.9%)		13/128 (10.2%)
Injury, poisoning and procedural complications
Infusion related reaction	42/130 (32.3%)		39/128 (30.5%)
Investigations
Alanine aminotransferase increased	7/130 (5.4%)		3/128 (2.3%)
Musculoskeletal and connective tissue disorders
Back pain	8/130 (6.2%)		5/128 (3.9%)
Nervous system disorders
Headache	6/130 (4.6%)		7/128 (5.5%)
Respiratory, thoracic and mediastinal disorders
Cough	9/130 (6.9%)		12/128 (9.4%)
Vascular disorders
Hypertension	10/130 (7.7%)		6/128 (4.7%)

Limitations/Caveats

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.

More Information

Certain Agreements

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

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.