Trials / Completed
CompletedNCT02939014
Brentuximab Vedotin in Chinese Participants With Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL) or Systemic Anaplastic Large Cell Lymphoma (sALCL)
A Phase 2, Single-Arm, Open-label Study of Brentuximab Vedotin in Chinese Patients With Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL) or Systemic Anaplastic Large Cell Lymphoma (sALCL)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- Takeda · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics (PK) of brentuximab vedotin as a single agent in Chinese participants with relapsed/refractory CD30+ Hodgkin Lymphoma (HL) or Systemic Anaplastic Large Cell Lymphoma (sALCL).
Detailed description
The drug being tested in this study is called brentuximab vedotin. This study will look at efficacy, safety and PK of brentuximab vedotin in Chinese participants with relapsed/refractory CD30+ HL or sALCL. The study will enroll approximately 30 patients. Participants will receive: • Brentuximab vedotin 1.8 mg/kg All participants will be administered IV infusion on Day 1 each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles. This multi-center trial will be conducted in China only. The overall time to participate in this study is 3.5 years. Participants will make multiple visits to the clinic, and will be followed for overall survival (OS) every 12 weeks until death, withdrawal of consent, 18 months after end of treatment (EOT) or study closure, whichever occurs first.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Brentuximab Vedotin | Brentuximab vedotin IV infusion |
Timeline
- Start date
- 2016-11-07
- Primary completion
- 2018-08-02
- Completion
- 2020-02-03
- First posted
- 2016-10-19
- Last updated
- 2021-02-24
- Results posted
- 2019-09-06
Locations
7 sites across 1 country: China
Source: ClinicalTrials.gov record NCT02939014. Inclusion in this directory is not an endorsement.