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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 belowSelect...
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
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Targeted therapies for T-Cell Lymphoma, such as ALK inhibitors (e.g., brigatinib, lorlatinib), work by specifically targeting genetic mutations or proteins that drive cancer cell growth and survival. Immunotherapies, including checkpoint inhibitors like pembrolizumab, enhance the body's immune response against cancer cells by blocking proteins that inhibit immune activity.
These treatments are crucial for T-Cell Lymphoma patients as they offer more precise and potentially effective options compared to traditional chemotherapy, often with fewer side effects. By directly targeting cancer-specific pathways or boosting the immune system, these therapies can improve outcomes and quality of life for patients.
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have an active infection like HIV or hepatitis B/C.I have a cancer type other than T-cell lymphoma.I still have side effects from previous cancer treatments that haven't improved.I have PTCL with at least one tumor that can be measured.My diagnosis is a specific type of T-cell lymphoma.I am able to care for myself and perform daily activities.I have been treated with drugs that target the immune system.I have undergone at least 2 different treatments for my condition.My kidney, liver, and bone marrow are functioning well.I am not pregnant or breastfeeding.I am 18 years old or older.My cancer has spread to my brain or spinal cord.I have been diagnosed with Adult T-cell leukemia/lymphoma.My cutaneous T-cell lymphoma can be measured for treatment response.I have had tuberculosis within the last 2 years.I have had a stem cell transplant from a donor.
Research Study Groups:
This trial has the following groups:- Group 1: ONO-4685 monotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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