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A Study of Tislelizumab as Monotherapy in Relapsed or Refractory Classical Hodgkin Lymphoma

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ClinicalTrials.gov Identifier: NCT03209973
Recruitment Status : Completed
First Posted : July 6, 2017
Results First Posted : October 12, 2020
Last Update Posted : March 16, 2021
Sponsor:
Information provided by (Responsible Party):
BeiGene

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Classical Hodgkin Lymphoma
Intervention Drug: Tislelizumab
Enrollment 70
Recruitment Details 70 participants were enrolled at 11 sites in China. The first participant dose date was on 21April2017. Data cut off date for the primary outcome measure was 26Nov2018.
Pre-assignment Details  
Arm/Group Title Tislelizumab
Hide Arm/Group Description Tislelizumab 200 mg administered intravenously (IV) every-3-weeks (Q3W)
Period Title: Overall Study
Started 70
Completed 66
Not Completed 4
Reason Not Completed
Patient withdrew consent             3
Death             1
Arm/Group Title Tislelizumab
Hide Arm/Group Description Tislelizumab 200 mg administered intravenously (IV) every-3-weeks (Q3W)
Overall Number of Baseline Participants 70
Hide Baseline Analysis Population Description
Safety Analysis Set: All participants who received any dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 70 participants
36.2  (12.73)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
<65 Number Analyzed 70 participants
66
  94.3%
≥ 65 and < 75 years Number Analyzed 70 participants
4
   5.7%
≥ 75 Number Analyzed 70 participants
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants
Female
30
  42.9%
Male
40
  57.1%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
China Number Analyzed 70 participants
70
 100.0%
1.Primary Outcome
Title Overall Response Rate (ORR)
Hide Description ORR is defined as the proportion of participants who achieve a best response of Complete Response (CR) or Partial Response (PR), as assessed by IRC per the Lugano Classification
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Safety Analysis Set: All participants in the safety analysis set who had confirmed classical Hodgkin lymphoma.
Arm/Group Title Tislelizumab
Hide Arm/Group Description:
Tislelizumab 200 mg administered intravenously (IV) every-3-weeks (Q3W)
Overall Number of Participants Analyzed 70
Measure Type: Count of Participants
Unit of Measure: Participants
61
  87.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tislelizumab
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments 1-sided p-value was based on exact test of BGB-A317 versus historical rate of 0.35
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Clopper-Pearson
Estimated Value 87.1
Confidence Interval (2-Sided) 95%
77 to 93.9
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description From the first dose of BGB-A317 to the date of progressive disease (PD) or death, whichever occurs first
Time Frame Up to 2years
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Duration of Response (DOR)
Hide Description From the date that response criteria are first met to the date that PD is objectively documented or death, whichever occurs first
Time Frame Up to 2 years
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Rate of Complete Response Rate (CRR)
Hide Description [Not Specified]
Time Frame Up to 2 years
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Time to Response (TTR)
Hide Description From the date of the first dose of BGB-A317 to the time the response criteria are first met
Time Frame Up to 2years
Outcome Measure Data Not Reported
Time Frame Up to 2 years
Adverse Event Reporting Description Safety Analysis Set
 
Arm/Group Title Tislelizumab
Hide Arm/Group Description Tislelizumab 200 mg administered intravenously (IV) every-3-weeks (Q3W) for up to 2 years
All-Cause Mortality
Tislelizumab
Affected / at Risk (%)
Total   1/70 (1.43%)    
Hide Serious Adverse Events
Tislelizumab
Affected / at Risk (%) # Events
Total   12/70 (17.14%)    
Blood and lymphatic system disorders   
Thrombocytopenia  1  1/70 (1.43%)  7
Gastrointestinal disorders   
Ascites  1  1/70 (1.43%)  1
General disorders   
Pyrexia  1  2/70 (2.86%)  2
Infections and infestations   
Pneumonia  1  1/70 (1.43%)  2
Urinary tract infection  1  1/70 (1.43%)  1
Investigations   
Blood glucose increased  1  1/70 (1.43%)  1
Musculoskeletal and connective tissue disorders   
Osteoarthritis  1  1/70 (1.43%)  1
Renal and urinary disorders   
Focal segmental glomerulosclerosis  1  1/70 (1.43%)  1
Renal tubular injury  1  1/70 (1.43%)  1
Respiratory, thoracic and mediastinal disorders   
Interstitial lung disease  1  1/70 (1.43%)  2
Organising pneumonia  1  1/70 (1.43%)  1
Pneumonitis  1  2/70 (2.86%)  2
Skin and subcutaneous tissue disorders   
Erythema nodosum  1  1/70 (1.43%)  1
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tislelizumab
Affected / at Risk (%) # Events
Total   65/70 (92.86%)    
Blood and lymphatic system disorders   
Anaemia  1  7/70 (10.00%)  13
Leukopenia  1  4/70 (5.71%)  8
Endocrine disorders   
Hypothyroidism  1  23/70 (32.86%)  50
Gastrointestinal disorders   
Diarrhoea  1  7/70 (10.00%)  9
Nausea  1  4/70 (5.71%)  5
Vomiting  1  4/70 (5.71%)  4
General disorders   
Asthenia  1  5/70 (7.14%)  9
Chills  1  4/70 (5.71%)  4
Pyrexia  1  40/70 (57.14%)  50
Infections and infestations   
Influenza  1  4/70 (5.71%)  6
Lung infection  1  4/70 (5.71%)  4
Upper respiratory tract infection  1  23/70 (32.86%)  55
Viral upper respiratory tract infection  1  4/70 (5.71%)  7
Investigations   
Alanine aminotransferase increased  1  12/70 (17.14%)  22
Aspartate aminotransferase increased  1  8/70 (11.43%)  10
Bilirubin conjugated increased  1  4/70 (5.71%)  6
Blood bilirubin increased  1  7/70 (10.00%)  9
Blood creatine phosphokinase increased  1  6/70 (8.57%)  11
Neutrophil count decreased  1  10/70 (14.29%)  38
Platelet count decreased  1  6/70 (8.57%)  15
Weight decreased  1  8/70 (11.43%)  16
Weight increased  1  24/70 (34.29%)  70
White blood cell count decreased  1  13/70 (18.57%)  37
Metabolism and nutrition disorders   
Hyperlipidaemia  1  5/70 (7.14%)  5
Hyperuricaemia  1  7/70 (10.00%)  9
Hypokalaemia  1  4/70 (5.71%)  4
Musculoskeletal and connective tissue disorders   
Back pain  1  4/70 (5.71%)  7
Pain in extremity  1  5/70 (7.14%)  6
Nervous system disorders   
Headache  1  5/70 (7.14%)  5
Respiratory, thoracic and mediastinal disorders   
Cough  1  13/70 (18.57%)  14
Skin and subcutaneous tissue disorders   
Pruritus  1  13/70 (18.57%)  16
Rash  1  10/70 (14.29%)  14
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
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.
BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information & may request a further delay to protect its IP rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: BeiGene
Phone: +1-877-828-5568
EMail: clinicaltrials@beigene.com
Layout table for additonal information
Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03209973    
Other Study ID Numbers: BGB-A317-203
CTR20170119 ( Registry Identifier: Center for drug evaluation, CFDA )
First Submitted: May 25, 2017
First Posted: July 6, 2017
Results First Submitted: August 12, 2020
Results First Posted: October 12, 2020
Last Update Posted: March 16, 2021