Back to resultsA Study to Assess the Clinical Efficacy and Safety of Daratumumab in Participants With Relapsed or Refractory Natural Killer/T-Cell Lymphoma (NKTCL), Nasal Type
Primary Purpose
Lymphoma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Daratumumab
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma
Eligibility Criteria
Inclusion Criteria:
- Documented as histologically confirmed extranodal natural killer/T-cell lymphomas (NK/T)-cell lymphoma, nasal type according to the World Health Organization (WHO) classification and the pathology report will be verified by the Sponsor
- Failed at least 1 line of chemotherapy and who, according to treating physician or investigator, is not candidate to receive other treatment modalities
- At least 1 measurable site of disease
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2 and life expectancy greater than or equal to (>=) 3 months
Exclusion Criteria:
- Received daratumumab or other antiCD38 therapies previously
- Previous allogenic stem cell transplant or autologous stem cell transplantation within 12 weeks before the first administration of the study drug
- Clinical symptoms of central nervous system involvement
- Known chronic obstructive pulmonary disease, known moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification
- Clinically significant cardiac disease, including:Myocardial infarction within 6 months before the first study agent administration, or unstable or uncontrolled disease/condition related to or affecting cardiac function (eg, unstable angina, congestive heart failure, New York Heart Association Class III-IV); Uncontrolled cardiac arrhythmia (Common Terminology Criteria for Adverse Events [CTCAE] [most recent version] Grade 3 or higher) or clinically significant ECG abnormalities; Screening 12-lead ECG showing a baseline QT interval as corrected QTc >470 msec
- Seropositive for human immunodeficiency virus
- Seropositive for hepatitis B or hepatitis C
- Abnormal laboratory values according to protocol defined parameters at screening
Sites / Locations
- Cancer Hospital, Chinese Academy of Medical Sciences
- Beijing Cancer Hospital
- Sun Yat-Sen University Cancer Center
- 1st Affiliated Hospital of Zhejiang University Medical College
- Ruijin Hospital, Shanghai Jiao Tong University
- Queen Mary Hospital, University of Hong Kong
- National Cancer Center
- Severance Hospital
- Samsung Medical Center
- Seoul St. Mary's Hospital
- Seoul National University Hospital
- Asan Medical Center
- Singapore General Hospital
- National Cancer Centre Singapore
- Changhua Christian Hospital
- China Medical University Hospital
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Daratumumab
Arm Description
Participants will receive daratumumab 16 milligram per kilogram (mg/kg) by intravenous (IV) infusion once weekly for 8 weeks, then every 2 weeks for 16 weeks, then every 4 weeks thereafter until study drug discontinuation due to progressive disease (PD), consent withdrawal or unacceptable toxicity.
Outcomes
Primary Outcome Measures
Percentage of Participants With Overall Response
Overall response was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) per Revised Criteria for Response Assessment of Hodgkin and non-Hodgkin lymphoma: LUGANO classification based on blinded independent central review (BICR). As per Revised Response Criteria for Malignant Lymphoma, Lymph node measurements were taken from Computed Tomography (CT), CT portion of the Positron Emission Tomography/Computed Tomography (PET/CT), where applicable. CR: complete disappearance of all evidence of disease; PR as a greater than (>) 50 percent (%) decrease in the sum of the products of the maximal perpendicular diameters of measured lesions (SPD) and no new sites.
Secondary Outcome Measures
Percentage of Participants With Complete Response (CR)
CR was defined as the percentage of participants who achieved CR as per Revised Criteria for Response Assessment of Hodgkin and non-Hodgkin lymphoma: LUGANO classification based on BICR. CR was a complete disappearance of all evidence of disease.
Progression Free Survival (PFS)
PFS was defined as the duration from the date of the first daratumumab dose to the date of progression/relapse or death, whichever came first. Progressive disease (PD) was defined as any new lesion greater than (>) 1.5 centimeter (cm) in any axis or greater than or equal to (>=) 50 percent (%) increase in previously involved sites.
Duration of Response (DoR)
DoR was defined as duration from the date of the initial documentation of a response to the date of first documented evidence of progressive disease (PD) (or relapse for participants who experienced CR). PD was defined as any new lesion >1.5 cm in any axis or >= 50% increase in previously involved sites.
Time to Response
Time to response was defined as the duration from the date of the first dose of daratumumab to the earliest date that a response (CR/PR based on BICR) is first documented. CR was defined as complete disappearance of all evidence of disease; PR as a greater than (>) 50 percent (%) decrease in the sum of the products of the maximal perpendicular diameters of measured lesions (SPD) and no new sites.
Overall Survival (OS)
OS was defined as the duration from the date of the first daratumumab dose to the date of death.
Number of Participants With Treatment Emergent Adverse Events (TEAE) as a Measure of Safety and Tolerability
An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAE were defined as AEs with onset during the treatment period or that are a consequence of a pre-existing condition that has worsened since baseline.
Number of Participants With Clinically Significant Change in Vital Signs
Number of participants with clinically significant change in vital signs (blood pressure, temperature, pulse rate, and weight) was reported.
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
Number of participants with clinically significant ECG abnormalities were reported.
Number of Participants With Clinically Significant Change in Physical Finding
Number of participants with clinically significant change in physical finding was reported.
Number of Participants With Clinically Significant Change in Laboratory Parameters
Number of participants with clinically significant change in hematology (WBC, hemoglobin, platelets, neutrophils, and lymphocytes) and biochemistry (alanine transaminase [ALT], aspartate transaminase [AST], sodium, potassium, bilirubin, alkaline phosphatase, calcium laboratory parameters were reported.
Full Information
NCT ID
NCT02927925
First Posted
October 6, 2016
Last Updated
December 18, 2020
Sponsor
Janssen Research & Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT02927925
Brief Title
A Study to Assess the Clinical Efficacy and Safety of Daratumumab in Participants With Relapsed or Refractory Natural Killer/T-Cell Lymphoma (NKTCL), Nasal Type
Official Title
An Open Label, Phase 2 Study to Assess the Clinical Efficacy and Safety of Daratumumab in Patients With Relapsed or Refractory Natural Killer/T-Cell Lymphoma, Nasal Type
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
February 14, 2017 (Actual)
Primary Completion Date
January 2, 2020 (Actual)
Study Completion Date
January 7, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the clinical efficacy and safety of daratumumab in relapsed or refractory natural killer/T-cell lymphomas (NKTCL).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Daratumumab
Arm Type
Experimental
Arm Description
Participants will receive daratumumab 16 milligram per kilogram (mg/kg) by intravenous (IV) infusion once weekly for 8 weeks, then every 2 weeks for 16 weeks, then every 4 weeks thereafter until study drug discontinuation due to progressive disease (PD), consent withdrawal or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Daratumumab
Intervention Description
Participants will receive daratumumab 16 mg/kg as intravenous infusion.
Primary Outcome Measure Information:
Title
Percentage of Participants With Overall Response
Description
Overall response was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) per Revised Criteria for Response Assessment of Hodgkin and non-Hodgkin lymphoma: LUGANO classification based on blinded independent central review (BICR). As per Revised Response Criteria for Malignant Lymphoma, Lymph node measurements were taken from Computed Tomography (CT), CT portion of the Positron Emission Tomography/Computed Tomography (PET/CT), where applicable. CR: complete disappearance of all evidence of disease; PR as a greater than (>) 50 percent (%) decrease in the sum of the products of the maximal perpendicular diameters of measured lesions (SPD) and no new sites.
Time Frame
Up to 2 years and 11 months
Secondary Outcome Measure Information:
Title
Percentage of Participants With Complete Response (CR)
Description
CR was defined as the percentage of participants who achieved CR as per Revised Criteria for Response Assessment of Hodgkin and non-Hodgkin lymphoma: LUGANO classification based on BICR. CR was a complete disappearance of all evidence of disease.
Time Frame
Up to 2 years and 11 months
Title
Progression Free Survival (PFS)
Description
PFS was defined as the duration from the date of the first daratumumab dose to the date of progression/relapse or death, whichever came first. Progressive disease (PD) was defined as any new lesion greater than (>) 1.5 centimeter (cm) in any axis or greater than or equal to (>=) 50 percent (%) increase in previously involved sites.
Time Frame
Up to 2 years and 11 months
Title
Duration of Response (DoR)
Description
DoR was defined as duration from the date of the initial documentation of a response to the date of first documented evidence of progressive disease (PD) (or relapse for participants who experienced CR). PD was defined as any new lesion >1.5 cm in any axis or >= 50% increase in previously involved sites.
Time Frame
Up to 2 years and 11 months
Title
Time to Response
Description
Time to response was defined as the duration from the date of the first dose of daratumumab to the earliest date that a response (CR/PR based on BICR) is first documented. CR was defined as complete disappearance of all evidence of disease; PR as a greater than (>) 50 percent (%) decrease in the sum of the products of the maximal perpendicular diameters of measured lesions (SPD) and no new sites.
Time Frame
Up to 2 years and 11 months
Title
Overall Survival (OS)
Description
OS was defined as the duration from the date of the first daratumumab dose to the date of death.
Time Frame
Up to 2 years and 11 months
Title
Number of Participants With Treatment Emergent Adverse Events (TEAE) as a Measure of Safety and Tolerability
Description
An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAE were defined as AEs with onset during the treatment period or that are a consequence of a pre-existing condition that has worsened since baseline.
Time Frame
Up to 2 years and 11 months
Title
Number of Participants With Clinically Significant Change in Vital Signs
Description
Number of participants with clinically significant change in vital signs (blood pressure, temperature, pulse rate, and weight) was reported.
Time Frame
Up to 2 years and 11 months
Title
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
Description
Number of participants with clinically significant ECG abnormalities were reported.
Time Frame
Up to 2 years and 11 months
Title
Number of Participants With Clinically Significant Change in Physical Finding
Description
Number of participants with clinically significant change in physical finding was reported.
Time Frame
Up to 2 years and 11 months
Title
Number of Participants With Clinically Significant Change in Laboratory Parameters
Description
Number of participants with clinically significant change in hematology (WBC, hemoglobin, platelets, neutrophils, and lymphocytes) and biochemistry (alanine transaminase [ALT], aspartate transaminase [AST], sodium, potassium, bilirubin, alkaline phosphatase, calcium laboratory parameters were reported.
Time Frame
Up to 2 years and 11 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Documented as histologically confirmed extranodal natural killer/T-cell lymphomas (NK/T)-cell lymphoma, nasal type according to the World Health Organization (WHO) classification and the pathology report will be verified by the Sponsor
Failed at least 1 line of chemotherapy and who, according to treating physician or investigator, is not candidate to receive other treatment modalities
At least 1 measurable site of disease
Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2 and life expectancy greater than or equal to (>=) 3 months
Exclusion Criteria:
Received daratumumab or other antiCD38 therapies previously
Previous allogenic stem cell transplant or autologous stem cell transplantation within 12 weeks before the first administration of the study drug
Clinical symptoms of central nervous system involvement
Known chronic obstructive pulmonary disease, known moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification
Clinically significant cardiac disease, including:Myocardial infarction within 6 months before the first study agent administration, or unstable or uncontrolled disease/condition related to or affecting cardiac function (eg, unstable angina, congestive heart failure, New York Heart Association Class III-IV); Uncontrolled cardiac arrhythmia (Common Terminology Criteria for Adverse Events [CTCAE] [most recent version] Grade 3 or higher) or clinically significant ECG abnormalities; Screening 12-lead ECG showing a baseline QT interval as corrected QTc >470 msec
Seropositive for human immunodeficiency virus
Seropositive for hepatitis B or hepatitis C
Abnormal laboratory values according to protocol defined parameters at screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Cancer Hospital, Chinese Academy of Medical Sciences
City
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Sun Yat-Sen University Cancer Center
City
Guangzhou
ZIP/Postal Code
510060
Country
China
Facility Name
1st Affiliated Hospital of Zhejiang University Medical College
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Facility Name
Ruijin Hospital, Shanghai Jiao Tong University
City
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Queen Mary Hospital, University of Hong Kong
City
Hong Kong
Country
Hong Kong
Facility Name
National Cancer Center
City
Goyang-si
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
3080
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
5505
Country
Korea, Republic of
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
National Cancer Centre Singapore
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
Changhua Christian Hospital
City
Changhua
ZIP/Postal Code
50006
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
33588922
Citation
Huang H, Zhu J, Yao M, Kim TM, Yoon DH, Cho SG, Eom HS, Lim ST, Yeh SP, Song Y, Kwong YL, Kim JS, Jin J, Shi Y, Kim H, Qing M, Zhou T, Gao G, Dong Z, Qi M, Kim WS. Daratumumab monotherapy for patients with relapsed or refractory natural killer/T-cell lymphoma, nasal type: an open-label, single-arm, multicenter, phase 2 study. J Hematol Oncol. 2021 Feb 15;14(1):25. doi: 10.1186/s13045-020-01020-y.
Results Reference
derived
Learn more about this trial
A Study to Assess the Clinical Efficacy and Safety of Daratumumab in Participants With Relapsed or Refractory Natural Killer/T-Cell Lymphoma (NKTCL), Nasal Type
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