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
- Registration Number
- NCT02927925
- Lead Sponsor
- Janssen Research & Development, LLC
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Daratumumab Daratumumab 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Overall Response Up to 2 years and 11 months 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
Name Time Method Progression Free Survival (PFS) Up to 2 years and 11 months 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) Up to 2 years and 11 months 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 Up to 2 years and 11 months 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.
Number of Participants With Clinically Significant Change in Vital Signs Up to 2 years and 11 months 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 Change in Laboratory Parameters Up to 2 years and 11 months 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.
Number of Participants With Clinically Significant Change in Physical Finding Up to 2 years and 11 months Number of participants with clinically significant change in physical finding was reported.
Percentage of Participants With Complete Response (CR) Up to 2 years and 11 months 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.
Overall Survival (OS) Up to 2 years and 11 months OS was defined as the duration from the date of the first daratumumab dose to the date of death.
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities Up to 2 years and 11 months Number of participants with clinically significant ECG abnormalities were reported.
Number of Participants With Treatment Emergent Adverse Events (TEAE) as a Measure of Safety and Tolerability Up to 2 years and 11 months 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.
Trial Locations
- Locations (17)
Cancer Hospital, Chinese Academy of Medical Sciences
🇨🇳Beijing, China
Beijing Cancer Hospital
🇨🇳Beijing, China
Sun Yat-Sen University Cancer Center
🇨🇳Guangzhou, China
1st Affiliated Hospital of Zhejiang University Medical College
🇨🇳Hangzhou, China
Ruijin Hospital, Shanghai Jiao Tong University
🇨🇳Shanghai, China
National Cancer Center
🇰🇷Goyang-si, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
National Cancer Centre Singapore
🇸🇬Singapore, Singapore
China Medical University Hospital
🇨🇳Taichung, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Singapore General Hospital
🇸🇬Singapore, Singapore
Changhua Christian Hospital
🇨🇳Changhua, Taiwan
Queen Mary Hospital, University of Hong Kong
ðŸ‡ðŸ‡°Hong Kong, Hong Kong