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

Janssen Research & Development, LLC32 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lymphoma

Interventions

DaratumumabDRUG

Participants will receive daratumumab 16 mg/kg as intravenous infusion.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (17)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China

Beijing Cancer Hospital

Beijing, China

Outcomes

Primary Outcomes

Percentage of Participants With Overall Response

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.

Time frame: Up to 2 years and 11 months

Secondary Outcomes

Percentage of Participants With Complete Response (CR)

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.

Time frame: Up to 2 years and 11 months

Progression Free Survival (PFS)

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.

Time frame: Up to 2 years and 11 months

Duration of Response (DoR)

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 frame: Up to 2 years and 11 months

Data from ClinicalTrials.gov

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