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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 32
- Locations
- 17
- Primary Endpoint
- Percentage of Participants With Overall Response
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Daratumumab (Drug)
Outcomes
Primary Outcomes
Percentage of Participants With Overall Response
Time Frame: 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 Outcomes
- Progression Free Survival (PFS)(Up to 2 years and 11 months)
- Duration of Response (DoR)(Up to 2 years and 11 months)
- Time to Response(Up to 2 years and 11 months)
- 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 Laboratory Parameters(Up to 2 years and 11 months)
- Percentage of Participants With Complete Response (CR)(Up to 2 years and 11 months)
- Number of Participants With Clinically Significant Change in Physical Finding(Up to 2 years and 11 months)
- Overall Survival (OS)(Up to 2 years and 11 months)
- Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities(Up to 2 years and 11 months)
- Number of Participants With Treatment Emergent Adverse Events (TEAE) as a Measure of Safety and Tolerability(Up to 2 years and 11 months)