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LymphomaPhase 2NCT02927925

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

A Phase 2 study testing Daratumumab in people with Lymphoma, run by Janssen Research & Development, LLC at 17 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma
What is being tested?
Daratumumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
17 sitesin 5 countries
Study dates
14 Feb 2017to 7 Jan 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

17 sites in 5 countries.

17 sites in 5 countries

South Korea6 sites

  • National Cancer Center

    Goyang-si, 10408

  • Severance Hospital

    Seoul, 03722

  • Samsung Medical Center

    Seoul, 06351

  • Seoul St. Mary's Hospital

    Seoul, 06591

  • Seoul National University Hospital

    Seoul, 3080

  • Asan Medical Center

    Seoul, 5505

Other trials in South Korea

China5 sites

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, 100021

  • Beijing Cancer Hospital

    Beijing, 100142

  • Sun Yat-Sen University Cancer Center

    Guangzhou, 510060

  • 1st Affiliated Hospital of Zhejiang University Medical College

    Hangzhou, 310003

  • Ruijin Hospital, Shanghai Jiao Tong University

    Shanghai, 200025

Other trials in China

Taiwan3 sites

  • Changhua Christian Hospital

    Changhua, 50006

  • China Medical University Hospital

    Taichung, 40447

  • National Taiwan University Hospital

    Taipei, 10002

Other trials in Taiwan

Singapore2 sites

  • Singapore General Hospital

    Singapore, 169608

  • National Cancer Centre Singapore

    Singapore, 169610

Other trials in Singapore

Hong Kong1 site

  • Queen Mary Hospital, University of Hong Kong

    Hong Kong

Other trials in Hong Kong

About this study

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

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
Being tested
Daratumumab
Medical subject headings
Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DaratumumabDrug

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

Study groups in NCT02927925
Study groupRoleWhat they receive
DaratumumabExperimentalParticipants 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.
Receives: Drug: Daratumumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 2 years and 11 months

Secondary outcomes (10)

  1. 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.

    Measured: Up to 2 years and 11 months

  2. 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.

    Measured: Up to 2 years and 11 months

  3. 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.

    Measured: Up to 2 years and 11 months

  4. 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.

    Measured: Up to 2 years and 11 months

  5. Overall Survival (OS)

    OS was defined as the duration from the date of the first daratumumab dose to the date of death.

    Measured: Up to 2 years and 11 months

  6. 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.

    Measured: Up to 2 years and 11 months

  7. 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.

    Measured: Up to 2 years and 11 months

  8. Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities

    Number of participants with clinically significant ECG abnormalities were reported.

    Measured: Up to 2 years and 11 months

  9. Number of Participants With Clinically Significant Change in Physical Finding

    Number of participants with clinically significant change in physical finding was reported.

    Measured: Up to 2 years and 11 months

  10. 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.

    Measured: Up to 2 years and 11 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2016 (estimated)
  2. Study start14 Feb 2017
  3. Primary completion2 Jan 2020
  4. Study completion7 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02927925
Sponsor's protocol ID
CR108237
Other IDs
54767414NKT2001
Status last verified
Dec 2020
First submitted
6 Oct 2016
Last updated
14 Jan 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 38233570

  • 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.

    PubMed 33588922

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Daratumumab in people with Lymphoma, run by Janssen Research & Development, LLC at 17 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in South Korea, China, Taiwan, Singapore, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Overall Response (time frame: Up to 2 years and 11 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02927925, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2021.

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