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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

Phase 1
Recruiting
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
Inclusion Criteria

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

Exclusion Criteria

1.Patients with severe complications.
2.Patients with multiple cancers.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Safety and tolerability
Secondary Outcome Measures
NameTimeMethod
Efficacy, pharmacokinetics and immunogenicity
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