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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02927925
• Other study ID #: CR108237
• Secondary ID: 54767414NKT2001
• Status: Completed
• Phase: Phase 2
• Start date: February 14, 2017
• Est. completion date: January 7, 2020

Study information

• Verified date: December 2020
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 7, 2020
• Est. primary completion date: January 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell

Intervention

Drug:
• Daratumumab
Participants will receive daratumumab 16 mg/kg as intravenous infusion.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing
China	Cancer Hospital, Chinese Academy of Medical Sciences	Beijing
China	Sun Yat-Sen University Cancer Center	Guangzhou
China	1st Affiliated Hospital of Zhejiang University Medical College	Hangzhou
China	Ruijin Hospital, Shanghai Jiao Tong University	Shanghai
Hong Kong	Queen Mary Hospital, University of Hong Kong	Hong Kong
Korea, Republic of	National Cancer Center	Goyang-si
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul St. Mary's Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Singapore	National Cancer Centre Singapore	Singapore
Singapore	Singapore General Hospital	Singapore
Taiwan	Changhua Christian Hospital	Changhua
Taiwan	China Medical University Hospital	Taichung
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

China,  Hong Kong,  Korea, Republic of,  Singapore,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 2 years and 11 months
Secondary	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.	Up to 2 years and 11 months
Secondary	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.	Up to 2 years and 11 months
Secondary	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.	Up to 2 years and 11 months
Secondary	Time to Response	Time to response was defined as the duration from the date of the first dose of daratumumab to the earliest date that a response (CR/PR based on BICR) is first documented. CR was defined as 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.	Up to 2 years and 11 months
Secondary	Overall Survival (OS)	OS was defined as the duration from the date of the first daratumumab dose to the date of death.	Up to 2 years and 11 months
Secondary	Number of Participants With Treatment Emergent Adverse Events (TEAE) as a Measure of Safety and Tolerability	An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAE were defined as AEs with onset during the treatment period or that are a consequence of a pre-existing condition that has worsened since baseline.	Up to 2 years and 11 months
Secondary	Number of Participants With Clinically Significant Change in Vital Signs	Number of participants with clinically significant change in vital signs (blood pressure, temperature, pulse rate, and weight) was reported.	Up to 2 years and 11 months
Secondary	Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities	Number of participants with clinically significant ECG abnormalities were reported.	Up to 2 years and 11 months
Secondary	Number of Participants With Clinically Significant Change in Physical Finding	Number of participants with clinically significant change in physical finding was reported.	Up to 2 years and 11 months
Secondary	Number of Participants With Clinically Significant Change in Laboratory Parameters	Number of participants with clinically significant change in hematology (WBC, hemoglobin, platelets, neutrophils, and lymphocytes) and biochemistry (alanine transaminase [ALT], aspartate transaminase [AST], sodium, potassium, bilirubin, alkaline phosphatase, calcium laboratory parameters were reported.	Up to 2 years and 11 months