Clinical trial NCT02927925: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2016-10-07
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Percentage of Participants With Overall Response
timeFrame: Up to 2 years and 11 months
Secondary outcomes:
measure: Percentage of Participants With Complete Response (CR)
timeFrame: Up to 2 years and 11 months
measure: Progression Free Survival (PFS)
timeFrame: Up to 2 years and 11 months
measure: Duration of Response (DoR)
timeFrame: Up to 2 years and 11 months
measure: Time to Response
timeFrame: Up to 2 years and 11 months
measure: Overall Survival (OS)
timeFrame: Up to 2 years and 11 months
measure: Number of Participants With Treatment Emergent Adverse Events (TEAE) as a Measure of Safety and Tolerability
timeFrame: Up to 2 years and 11 months
measure: Number of Participants With Clinically Significant Change in Vital Signs
timeFrame: Up to 2 years and 11 months
measure: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
timeFrame: Up to 2 years and 11 months
measure: Number of Participants With Clinically Significant Change in Physical Finding
timeFrame: Up to 2 years and 11 months
measure: Number of Participants With Clinically Significant Change in Laboratory Parameters
timeFrame: Up to 2 years and 11 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center
city: Hangzhou
country: China
facility: 1st Affiliated Hospital of Zhejiang University Medical College
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital, University of Hong Kong
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
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.