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Recruiting NCT06547528

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

Phase I Interventional Relapsed or Refractory T Cell Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ONO-4685.
Who it may be relevant to
Registry conditions: Relapsed or Refractory T Cell Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Open-label, Uncontrolled, Phase I Dose Escalation Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in Patients With Relapsed or Refractory T Cell Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

Overview

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

Interventions

  • Drug ONO-4685
    ONO-4685 is administered by IV infusion. The administration of ONO-4685 will be continued until disease progression or unacceptable toxicity is observed.

Primary outcome measures

  • Dose-limiting toxicities(DLT) [Time frame: Up to 3 Weeks]
  • Incidence and severity of AEs and SAEs [Time frame: Through study completion, an average of 1 year]
  • Laboratory abnormality profile of ONO-4685 as measured by incidence and severity of clinical laboratory abnormalities [Time frame: Through study completion, an average of 1 year]
  • Body temperature [Time frame: Through study completion, an average of 1 year]
  • Pulse rate [Time frame: Through study completion, an average of 1 year]
  • Systolic/diastolic blood pressure [Time frame: Through study completion, an average of 1 year]
  • Change of weight during the trial period [Time frame: Through study completion, an average of 1 year]
  • Chest X-ray test [Time frame: Through study completion, an average of 1 year]
  • ECG parameters by 12 lead ECG(pulse rate) [Time frame: Through study completion, an average of 1 year]
  • ECG parameters by 12 lead ECG(RR) [Time frame: Through study completion, an average of 1 year]
Secondary outcome measures (12)
  • Best overall response (BOR) [Time frame: Through study completion, an average of 1 year]
  • Overall response rate (ORR) [Time frame: Through study completion, an average of 1 year]
  • Complete response rate (CRR) [Time frame: Through study completion, an average of 1 year]
  • Duration of response (DOR) [Time frame: Through study completion, an average of 1 year]
  • Progression Free Survival(PFS) [Time frame: Through study completion, an average of 1 year]
  • Time to response (TTR) [Time frame: Through study completion, an average of 1 year]
  • Overall Survival(OS) [Time frame: Through study completion, an average of 1 year]
  • The percent change of tumor volume [Time frame: Through study completion, an average of 1 year]
  • Pharmacokinetics(Cmax) [Time frame: Through study completion, an average of 1 year]
  • Pharmacokinetics(Tmax) [Time frame: Through study completion, an average of 1 year]
  • Pharmacokinetics(AUC) [Time frame: Through study completion, an average of 1 year]
  • Pharmacokinetics(Ceoi) [Time frame: Through study completion, an average of 1 year]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • Patients with severe complications.
  • Patients with multiple cancers.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Japan · 14 centers
  • Aichi Cancer Center Hospital — Nagoya
  • Nagoya University Hospital — Nagoya
  • Akita University Hospital — Akita
  • National Cancer Center Hospital East — Kashiwa-shi
  • Kyushu University Hospital — Fukuoka
  • Hokkaido University Hospital — Sapporo
  • Tokai University Hospital — Isehara-shi
  • Kumamoto University Hospital — Kumamoto
  • … and 6 more centers

Identifiers

NCT: NCT06547528 · ONO-4685-05

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗