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Brentuximab Vedotin for Relapsed/Refractory CD30-positive Non-Hodgkin Lymphomas

NCT02280785 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2018-09-06

No results posted yet for this study

Summary

Brentuximab vedotin is an antibody-drug conjugate targeting CD30, one of surface antigens expressed in lymphoma cells. Fanale MA, et al. reported the results of a phase I study with weekly dosing of brentuximab vedotin in patients with relapsed/refractory CD30-positive hematologic malignancies (Clin Cancer Res. 2012) showed tumor regression in 85% of patients. Thus, the overall objective response rate was 59% (24/44) including 34% (n = 14) of complete remissions. This study mainly included Hodgkin lymphoma (n = 38) and anaplastic large cell lymphoma (n = 5). However, its efficacy in other types of NHL has never been reported although this study enrolled one patient with peripheral T-cell lymphoma not otherwise specified (PTCL-NOS).

CD30 (TNFRSF8) is a transmembrane glycoprotein of the tumor necrosis factor receptor (TNFR) superfamily, and it is involved in signal transduction via the activation of the NF-κB pathway and the mitogen-activated protein kinases (MAPKs), ultimately modulating cell growth, proliferation and apoptosis. CD30 is a non-lineage-specific activation marker expressed by scattered B and T immunoblasts. In addition, a subset of cases in virtually all T-cell lymphoma entities may also express CD30 but at variable and generally lower levels. In fact, a recent study in 22 patients with extranodal NK/T-cell lymphoma showed 75% of positive rate of CD30 expression (75%). Moreover, CD30 expression was also documented in the tumor sample of EB virus positive diffuse large B-cell lymphomas (EBV + DLBCL) of the elderly (28.9%, 11/38). Therefore, Brentuximab vedotin may have potential benefits for patients with CD30-positive NHL other than anaplastic large cell lymphoma such as CD30-positive PTCLs, NOS. Considering the role of CD30 in signal transduction pathway associated with tumor growth and proliferation, its expression may be associated with tumor aggressiveness. In accordance with this, it is more likely that relapse or refractory NHLs may have CD30 expression, and the potential benefits of this promising agent as a salvage therapy deserve to be further investigated in these patients who have high risk of treatment failure. Thus, we designed a phase II study for relapsed or refractory NHL patients. This study is to explore the safety and activity of dosing once every 3 weeks of Brentuximab vedotin in patients with relapsed or refractory CD30-positive NHL other than anaplastic large cell lymphoma.

Conditions

Interventions

DRUG

Brentuximab vedotin

Brentuximab vedotin must not be administered as an IV push or bolus. It must be administered in 100ml-250ml of 0.9% saline by intravenous infusion over 30 minutes once every 3 weeks.

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Samsung Medical Center

    lead OTHER

Principal Investigators

  • Cheolwon Suh, M.D. · Asan Medical Center

  • JinSeok Kim, M.D. · Severance Hospital

  • HyeonSeok Eom, M.D. · National Cancer Center of Korea

  • HyeJin Kang, M.D. · Korea Cancer Center Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2017-12-31
Completion
2018-09-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02280785 on ClinicalTrials.gov