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/SLL

JRCT ID: jRCT2011230051

Registered date:19/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Relapsed or refractory T-cell lymphoma and chronic lymphocytic leukemia/small lymphocytic lymphoma
• Date of first enrollment: 19/11/2023
• Target sample size: 108
• Study type: Interventional
• Intervention(s): ONO-4685 Given as Monotherapy

Outcome(s)

• Primary Outcome: Safety and tolerability
• Secondary Outcome: Efficacy, pharmacokinetics and immunogenicity

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude criteria

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

Related Information

• Primary Sponsor: Osawa Masahiro