Completed
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
What is being tested
Daratumumab
Drug
Who is being recruted
Hemic and Lymphatic Diseases+5
+ Immune System Diseases
+ Immunoproliferative Disorders
Over 18 Years
+12 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Study Start: February 2017
Summary
Principal SponsorJanssen Research & Development, LLC
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: February 14, 2017
Actual date on which the first participant was enrolled.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).
Official TitleAn 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
Principal SponsorJanssen Research & Development, LLC
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
32 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Hemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphomaLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic Type
Criteria
4 inclusion criteria required to participate
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
8 exclusion criteria prevent from participating
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
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalParticipants 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.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 17 locations
Suspended
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, ChinaOpen Cancer Hospital, Chinese Academy of Medical Sciences in Google MapsSuspended
Beijing Cancer Hospital
Beijing, ChinaSuspended
Sun Yat-Sen University Cancer Center
Guangzhou, ChinaSuspended
1st Affiliated Hospital of Zhejiang University Medical College
Hangzhou, ChinaCompleted17 Study Centers