RECRUITINGPhase 1INTERVENTIONAL
A Phase I Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in 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)
About This Trial
A Phase I Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in T Cell Lymphoma and CLL/SLL
Who May Be Eligible (Plain English)
Who May Qualify:
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. expected to live at least 3 months
Who Should NOT Join This Trial:
1. Patients with severe complications.
2. Patients with multiple cancers.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
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.
Locations (14)
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, Japan
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
Akita University Hospital
Akita, Akita, Japan
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Tokai University Hospital
Isehara-shi, Kanagawa, Japan
Kumamoto University Hospital
Kumamoto, Kumamoto, Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, Kyoto, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Okayama University Hospital
Okayama, Okayama-ken, Japan
Kindai University Hospital
Osaka Sayama-shi, Osaka, Japan
Osaka University Hospital
Osaka-fu, Osaka, Japan
Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan