ONO-4685-05:A Phase I Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in T Cell Lymphoma and CLL/S
- Conditions
- Relapsed or refractory T-cell lymphoma and chronic lymphocytic leukemia/small lymphocytic lymphoma
- Registration Number
- JPRN-jRCT2011230051
- Lead Sponsor
- Osawa Masahiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 108
1.Patients with histopathologically confirmed diagnosis of one of the following subtypes as defined by the 2017 revision of the WHO classification of lymphoid malignancies:
Peripheral T-cell lymphoma(PTCL)
- Angioimmunoblastic T-cell lymphoma(AITL)
- Peripheral T-cell lymphoma, NOS(PTCL-NOS)
- Nodal peripheral T-cell lymphoma with TFH phenotype(nodal PTCL with TFH)
- Follicular T-cell lymphoma(FTCL)
Cutaneous T-cell lymphoma(CTCL)
- Mycosis fungoides(MF)
- Sezary syndrome
Chronic lymphocytic leukemia/small lymphocytic lymphoma(CLL/SLL)
2.Relapsed or refractory patients with tumors for which no established standard therapy is available, or refractory or intolerant to existing standard therapy
judged by principal investigatoror subinvestigator
3.ECOG PS 0~2
4.Life expectancy of at least 3 months
1.Patients with severe complications.
2.Patients with multiple cancers.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and tolerability
- Secondary Outcome Measures
Name Time Method Efficacy, pharmacokinetics and immunogenicity