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

NCT02927925 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: CR10823754767414NKT2001
• Study Type: interventional
• Target: 32
• Locations: 5 countries
• Sites: 17

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).

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Percentage of Participants With Complete Response (CR)

  Up to 2 years and 11 months

• 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

• Overall Survival (OS)

  Up to 2 years and 11 months

Study Arms (1)

Daratumumab

EXPERIMENTAL

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.

Drug: Daratumumab

Interventions

Daratumumab DRUG

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

Daratumumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (17)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, 100021, China

Location

Beijing Cancer Hospital

Beijing, 100142, China

Location

Sun Yat-Sen University Cancer Center

Guangzhou, 510060, China

Location

1st Affiliated Hospital of Zhejiang University Medical College

Hangzhou, 310003, China

Location

Ruijin Hospital, Shanghai Jiao Tong University

Shanghai, 200025, China

Location

Queen Mary Hospital, University of Hong Kong

Hong Kong, Hong Kong

Location

Singapore General Hospital

Singapore, 169608, Singapore

Location

National Cancer Centre Singapore

Singapore, 169610, Singapore

Location

National Cancer Center

Goyang-si, 10408, South Korea

Location

Severance Hospital

Seoul, 03722, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Seoul St. Mary's Hospital

Seoul, 06591, South Korea

Location

Seoul National University Hospital

Seoul, 3080, South Korea

Location

Asan Medical Center

Seoul, 5505, South Korea

Location

Changhua Christian Hospital

Changhua, 50006, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Related Publications (2)

• Qing M, Zhou T, Perova T, Abraham Y, Sweeney C, Krevvata M, Zhang X, Qi M, Gao G, Kim TM, Yao M, Cho SG, Eom HS, Lim ST, Yeh SP, Kwong YL, Yoon DH, Kim JS, Kim WS, Zhou L, Attar R, Verona RI. Immune profiling of patients with extranodal natural killer/T cell lymphoma treated with daratumumab. Ann Hematol. 2024 Jun;103(6):1989-2001. doi: 10.1007/s00277-023-05603-w. Epub 2024 Jan 18.

  PMID: 38233570 DERIVED

• Huang H, Zhu J, Yao M, Kim TM, Yoon DH, Cho SG, Eom HS, Lim ST, Yeh SP, Song Y, Kwong YL, Kim JS, Jin J, Shi Y, Kim H, Qing M, Zhou T, Gao G, Dong Z, Qi M, Kim WS. Daratumumab monotherapy for patients with relapsed or refractory natural killer/T-cell lymphoma, nasal type: an open-label, single-arm, multicenter, phase 2 study. J Hematol Oncol. 2021 Feb 15;14(1):25. doi: 10.1186/s13045-020-01020-y.

  PMID: 33588922 DERIVED

MeSH Terms

Conditions

Lymphoma

Interventions

daratumumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Global Medical Head
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2016
• First Posted: October 7, 2016
• Study Start: February 14, 2017
• Primary Completion: January 2, 2020
• Study Completion: January 7, 2020
• Last Updated: January 14, 2021
• Results First Posted: January 14, 2021

Record last verified: 2020-12

Locations

CN (5); TW (3); HK (1); SG (2); KR (6)