Investigating the safety of ONO-4685 for T Cell Lymphoma and CLL/SLL
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)
This study is testing a new drug called ONO-4685 to see if it is safe and works for people with relapsed T Cell Lymphoma and Chronic Lymphocytic Leukemia who have run out of other treatment options.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ono Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 14 sites (Nagoya, Aichi-ken and 13 other locations) |
| Trial ID | NCT06547528 on ClinicalTrials.gov |
What this trial studies
This Phase I clinical trial evaluates the tolerability and safety of ONO-4685 as a monotherapy for patients with relapsed or refractory T Cell Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. The study aims to enroll patients who have histopathologically confirmed diagnoses and have exhausted standard treatment options. Participants will be monitored for adverse effects and overall response to the treatment. The trial is designed to gather preliminary data on the drug's safety profile and potential efficacy.
Who should consider this trial
Good fit: Ideal candidates include patients with specific subtypes of T Cell Lymphoma or CLL/SLL who have relapsed or are refractory to existing therapies.
Not a fit: Patients with severe complications or multiple cancers may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with limited treatment alternatives.
How similar studies have performed: While this approach is novel for ONO-4685, similar studies have shown promise in targeting T Cell Lymphoma and CLL/SLL with new therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Nagoya, Aichi-ken and 13 other locations
- Aichi Cancer Center Hospital — Nagoya, Aichi-ken, Japan (Recruiting)
- Nagoya University Hospital — Nagoya, Aichi-ken, Japan (Recruiting)
- Akita University Hospital — Akita, Akita, Japan (Recruiting)
- National Cancer Center Hospital East — Kashiwa-shi, Chiba, Japan (Recruiting)
- Kyushu University Hospital — Fukuoka, Fukuoka, Japan (Recruiting)
- Hokkaido University Hospital — Sapporo, Hokkaido, Japan (Recruiting)
- Tokai University Hospital — Isehara-shi, Kanagawa, Japan (Recruiting)
- Kumamoto University Hospital — Kumamoto, Kumamoto, Japan (Recruiting)
- University Hospital Kyoto Prefectural University of Medicine — Kyoto, Kyoto, Japan (Recruiting)
- Tohoku University Hospital — Sendai, Miyagi, Japan (Recruiting)
- Okayama University Hospital — Okayama, Okayama-ken, Japan (Recruiting)
- Kindai University Hospital — Osaka Sayama-shi, Osaka, Japan (Recruiting)
- Osaka University Hospital — Osaka-fu, Osaka, Japan (Not_yet_recruiting)
- Cancer Institute Hospital of JFCR — Koto-ku, Tokyo, Japan (Recruiting)
Study contacts
- Study coordinator: North America Clinical Trial Support Desk
- Email: clinical_trial@ono-pharma.com
- Phone: +18665877745(Toll-Free)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.