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Trial Title:
A Phase I Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in T Cell Lymphoma and CLL/SLL
NCT ID:
NCT06547528
Condition:
Relapsed or Refractory T Cell Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Conditions: Official terms:
Lymphoma
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ONO-4685
Description:
ONO-4685 is administered by IV infusion. The administration of ONO-4685 will be continued
until disease progression or unacceptable toxicity is observed.
Arm group label:
ONO-4685
Summary:
A Phase I Study to Investigate the Tolerability and Safety of ONO-4685 Given as
Monotherapy in T Cell Lymphoma and CLL/SLL
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Aichi Cancer Center Hospital
Address:
City:
Nagoya-shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
Nagoya University Hospital
Address:
City:
Nagoya-shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
Akita University Hospital
Address:
City:
Akita-shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Kashiwa-shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
Kyushu University Hospital
Address:
City:
Fukuoka-shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
Hokkaido University Hospital
Address:
City:
Sapporo-shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
Tokai University Hospital
Address:
City:
Isehara-shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
Kumamoto University Hospital
Address:
City:
Kumamoto-shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
University Hospital Kyoto Prefectural University of Medicine
Address:
City:
Kyoto-shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
Tohoku University Hospital
Address:
City:
Sendai-shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
Okayama University Hospital
Address:
City:
Okayama-shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
Kindai University Hospital
Address:
City:
Osaka Sayama-shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
Osaka University Hospital
Address:
City:
Osaka-fu
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Cancer Institute Hospital of JFCR
Address:
City:
Koto-ku
Country:
Japan
Status:
Recruiting
Start date:
October 1, 2023
Completion date:
April 30, 2029
Lead sponsor:
Agency:
Ono Pharmaceutical Co. Ltd
Agency class:
Industry
Source:
Ono Pharmaceutical Co. Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06547528
