Clinical trial · Interventional
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
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
NCT02927925CI-TRIAL-00049441completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Daratumumab | Drug | Daratumumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Daratumumab
- description
- 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.
- interventionNames
- Drug: Daratumumab
Primary outcomes (1)
- measure
- Percentage of Participants With Overall Response
- timeFrame
- Up to 2 years and 11 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDQing 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
- DERIVEDHuang 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