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ONO-4685 for Lymphoma

Phase 1

Recruiting

Research Sponsored by Ono Pharmaceutical Co. Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with PTCL must have at least 1 measurable lesion

Patients with histologically or cytologically confirmed diagnosis of specific subtypes of T-cell lymphoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

Study Summary

This trial will test a new drug, ONO-4685, on patients with T cell lymphoma who haven't responded to other treatments. They will be monitoring how well the patients tolerate the drug and how it affects their cancer.

Who is the study for?

Adults over 18 with relapsed or refractory T cell lymphoma, who've had at least two prior treatments and have measurable disease, can join this trial. They must not be pregnant, have a central nervous system involvement, HIV, hepatitis B or C infections, recent tuberculosis infection, severe allergies to monoclonal antibodies or corticosteroids.Check my eligibility

What is being tested?

The trial is testing ONO-4685's safety and effectiveness for patients with specific types of T cell lymphoma that haven't responded well to previous treatments. It will look at how the body processes the drug and its preliminary success in treating the cancer.See study design

What are the potential side effects?

While specific side effects of ONO-4685 are not listed here, common ones for drugs like it include immune-related reactions, infusion-related symptoms such as fever or chills, fatigue, skin issues like rash or itching and potential liver function changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have PTCL with at least one tumor that can be measured.

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My diagnosis is a specific type of T-cell lymphoma.

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I am able to care for myself and perform daily activities.

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I have undergone at least 2 different treatments for my condition.

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I am 18 years old or older.

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My cutaneous T-cell lymphoma can be measured for treatment response.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Estimate of Maximum Tolerate Dose (MTD)

Incidence, nature, and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs).

Secondary outcome measures

Antitumor Activity of ONO-4685

Plasma Concentration of Anti-Drug Antibody (ADA)

Plasma Concentration of ONO-4685

Trial Design

1Treatment groups

Experimental Treatment

Group I: ONO-4685 monotherapyExperimental Treatment1 Intervention

Patients with relapsed or refractory T cell Lymphoma who meet eligibility criteria will be enrolled to receive ONO-4685 monotherapy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ONO-4685

2019

Completed Phase 1

~80

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ono Pharmaceutical Co. LtdLead Sponsor

154 Previous Clinical Trials

94,306 Total Patients Enrolled

Ryota ShiibashiStudy DirectorOno Pharma USA Inc

Project LeaderStudy DirectorOno Pharma USA Inc

12 Previous Clinical Trials

2,396 Total Patients Enrolled

Media Library

ONO-4685 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05079282 — Phase 1

T-Cell Lymphoma Research Study Groups: ONO-4685 monotherapy

T-Cell Lymphoma Clinical Trial 2023: ONO-4685 Highlights & Side Effects. Trial Name: NCT05079282 — Phase 1

ONO-4685 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05079282 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still availability for participants in this investigation?

"Clinicaltrials.gov confirms that this research is actively seeking volunteers, having initially been posted on December 10th 2021 and modified most recently on September 20th 2022."

Answered by AI

Does the Food and Drug Administration have a stamp of approval for ONO-4685?

"Despite its promise, ONO-4685 received a score of 1 due to the scarcity of clinical data confirming safety and efficacy during Phase 1 trials."

Answered by AI

Is there a limit to the number of volunteers engaged in this research?

"Affirmative, clinicaltrials.gov information indicates that the trial is still inviting participants. It was initially published on December 10th 2021 and revised lastly on September 20th 2022. A total of 86 individuals will be admitted across ten sites."

Answered by AI

How broadly is this research effort being implemented within the metropolitan area?

"This clinical trial is currently taking place across 13 medical centres, including UT Southwestern Medical Center in Dallas, TX, University of California Irvine Medical Center - Chao Family Comprehensive Cancer Centre in Orange, CA., and MD Anderson in Houston, OR."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of ONO-4685 in Patients With Relapsed or Refractory T Cell Lymphoma

2021. "Study of ONO-4685 in Patients With Relapsed or Refractory T Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05079282.

All > T Cell Lymphoma