A Study to Assess the Clinical Efficacy and Safety of Daratumumab in Participants With Relapsed o… (NCT02927925) | Clinical Trial Compass
CompletedPhase 2
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
China32 participantsStarted 2017-02-14
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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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 clinica…