Phase 2
Completed N=32
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
Source: ClinicalTrials.gov NCT02927925 ↗Enrolled (actual)
32
Serious AEs
53.1%
Results posted
Jan 2021
Primary outcomePrimary: Percentage of Participants With Overall Response — 25.0 percentage of participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Overall Response |
25.0 | — |
| SECONDARY Percentage of Participants With Complete Response (CR) |
3.1 | — |
| SECONDARY Progression Free Survival (PFS) |
53.0 | — |
| SECONDARY Duration of Response (DoR) |
55.0 | — |
| SECONDARY Time to Response |
52.0 | — |
| SECONDARY Overall Survival (OS) |
141.0 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAE) as a Measure of Safety and Tolerability |
26 | — |
| SECONDARY Number of Participants With Clinically Significant Change in Vital Signs |
— | — |
| SECONDARY Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities |
2 | — |
| SECONDARY Number of Participants With Clinically Significant Change in Physical Finding |
— | — |
| SECONDARY Number of Participants With Clinically Significant Change in Laboratory Parameters |
0; 0; 0; 0; 0; 0 | — |
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
Data sourced from ClinicalTrials.gov (NCT02927925). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.