A Frontline Therapy Trial in Participants with Advanced Classical Hodgkin Lymphoma
- Conditions
- Advanced classical Hodgkin Lymphoma
- Registration Number
- JPRN-jRCT2080222441
- Lead Sponsor
- Takeda Pharmaceutical Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 1334
1) Treatment-naive participants with Ann Arbor Stage III or IV Hodgkin Lymphoma(HL).
2) Histologically confirmed classical HL according to the current World Health Organization (WHO) classification.
3) Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (=<)2
4) Bidimensional measurable disease as documented by radiographic technique per the International Working Group Revised Criteria for Response Assessment for Malignant Lymphoma.
1) Nodular lymphocyte predominant Hodgkin lymphoma
2) Cerebral/meningeal disease, including signs and symptoms of progressive multifocal leukoencephalopathy (PML)
3) Sensory or motor peripheral neuropathy
4) Prior immunosuppressive chemotherapy, therapeutic radiation, or any immunotherapy within 12 weeks of first study drug dose.
5) Known human immunodeficiency virus (HIV) positive
6) Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection
Please note that there are additional exclusion criteria. The study center will determine if you meet all of the criteria.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Modified progression free survival (mPFS) per independent review facility (IRF)<br>Time Frame: Date of randomization to mPFS event, for approximately 3 to 5 years
- Secondary Outcome Measures
Name Time Method efficacy<br>Overall survival (OS)<br>Time Frame: Date of randomization to the date of death, for approximately 5 to 7 years<br>Date of randomization to the date of death