Status:
RECRUITING
A Phase I Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in T Cell Lymphoma and CLL/SLL
Lead Sponsor:
Ono Pharmaceutical Co. Ltd
Conditions:
Relapsed or Refractory T Cell Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
A Phase I Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in T Cell Lymphoma and CLL/SLL
Eligibility Criteria
Inclusion
- 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)
- 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 investigator or subinvestigator
- ECOG PS 0\~2
- Life expectancy of at least 3 months
Exclusion
- Patients with severe complications.
- Patients with multiple cancers.
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2029
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT06547528
Start Date
October 1 2023
End Date
April 30 2029
Last Update
June 3 2025
Active Locations (14)
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1
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, Japan
2
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
3
Akita University Hospital
Akita, Akita, Japan
4
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan