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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

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ClinicalTrials.gov Identifier: NCT02927925
Recruitment Status : Recruiting
First Posted : October 7, 2016
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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).

Condition or disease Intervention/treatment Phase
Lymphoma Drug: Daratumumab Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 14, 2017
Estimated Primary Completion Date : August 22, 2019
Estimated Study Completion Date : November 22, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Daratumumab

Arm Intervention/treatment
Experimental: 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.
Drug: Daratumumab
Participants will receive daratumumab 16 mg/kg as intravenous infusion.




Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: From the date of the first daratumumab dose to the date of any response (approximately up to 2.7 years) ]
    ORR is defined as the percentage of participants who achieve 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).


Secondary Outcome Measures :
  1. Complete Response (CR) Rate [ Time Frame: From the date of the first daratumumab dose to the date of any response (approximately up to 2.7 years) ]
    Complete response (CR) rate is defined as the proportion of participants who achieve CR based on BICR per Revised Criteria for Response Assessment of Hodgkin and non-Hodgkin lymphoma.

  2. Progression Free Survival (PFS) [ Time Frame: From the date of the first daratumumab dose to the date of progression/relapse or death, whichever comes first (approximately up to 2.7 years) ]
    Progression free survival (PFS) is defined as the duration from the date of the first daratumumab dose to the date of progression/relapse based on BICR or death, whichever comes first.

  3. Duration of Response (DoR) [ Time Frame: From the date of the initial documentation of a response to the date of first documented evidence of progressive disease or death (approximately up to 2.7 years) ]
    Duration of response (DoR) will be duration from the date of the initial documentation of a response to the date of first documented evidence of progressive disease (PD) based on BICR (PD; or relapse for participants who experience CR) or death.

  4. Time to Response [ Time Frame: From the date of the first dose of daratumumab to the earliest date that a response (CR/PR) is first documented (approximately up to 2.7 years) ]
    Time to response is defined as the duration from the date of the first dose of daratumumab to the earliest date that a response (CR/PR) is first documented, based on BICR.

  5. Overall Survival (OS) [ Time Frame: From the date of the first daratumumab dose to the date of death (approximately up to 2.7 years) ]
    Overall survival (OS) is defined as the duration from the date of the first daratumumab dose to the date of death.

  6. Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to 30 days after last dose of study drug (approximately up to 2.7 years) ]
    Safety and Tolerability



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Active infection with hepatitis B or hepatitis C
  • Abnormal laboratory values according to protocol defined parameters at screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02927925


Contacts
Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
China
Cancer Hospital, Chinese Academy of Medical Sciences Not yet recruiting
Beijing, China, 100021
Beijing Cancer Hospital Recruiting
Beijing, China, 100142
Sun Yat-Sen University Cancer Center Recruiting
Guangzhou, China, 510060
1st Affiliated Hospital of Zhejiang University Medical College Recruiting
Hangzhou, China, 310003
Ruijin Hospital, Shanghai Jiao Tong University Recruiting
Shanghai, China, 200025
Hong Kong
Queen Mary Hospital Recruiting
Hong Kong, Hong Kong
Korea, Republic of
National Cancer Center Recruiting
Goyang-Si, Korea, Republic of, 10408
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Severance Hospital Recruiting
Seoul, Korea, Republic of, 03722
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Seoul St. Mary's Hospital Recruiting
Seoul, Korea, Republic of, 06591
Singapore
Singapore General Hospital Recruiting
Singapore, Singapore, 169608
National Cancer Centre Singapore Recruiting
Singapore, Singapore, 169610
Taiwan
Changhua Christian Hospital Recruiting
Changhua, Taiwan, 50006
China Medical University Hospital Recruiting
Taichung, Taiwan, 40447
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10002
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Additional Information:
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02927925     History of Changes
Other Study ID Numbers: CR108237
54767414NKT2001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: October 7, 2016    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Daratumumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs