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A Phase I Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in T Cell Lymphoma and CLL/SLL

RECRUITINGPhase 1Sponsored by Ono Pharmaceutical Co. Ltd
Actively Recruiting
PhasePhase 1
SponsorOno Pharmaceutical Co. Ltd
Started2023-10-01
Est. completion2029-01-31
Eligibility
Age18 Years+
Healthy vol.Accepted

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

Age: 18 Years+Healthy volunteers accepted
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 investigator or 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.

Conditions2

CancerRelapsed or Refractory T Cell Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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