Relapsed or Refractory T Cell Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Conditions
Brief summary
A Phase I Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in T Cell Lymphoma and CLL/SLL
Interventions
DRUGONO-4685
ONO-4685 is administered by IV infusion. The administration of ONO-4685 will be continued until disease progression or unacceptable toxicity is observed.
Sponsors
Ono Pharmaceutical Co. Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicities(DLT) | Up to 3 Weeks |
| Incidence and severity of AEs and SAEs | Through study completion, an average of 1 year |
| Laboratory abnormality profile of ONO-4685 as measured by incidence and severity of clinical laboratory abnormalities | Through study completion, an average of 1 year |
| Body temperature | Through study completion, an average of 1 year |
| Pulse rate | Through study completion, an average of 1 year |
| Systolic/diastolic blood pressure | Through study completion, an average of 1 year |
| Change of weight during the trial period | Through study completion, an average of 1 year |
| Chest X-ray test | Through study completion, an average of 1 year |
| ECG parameters by 12 lead ECG(pulse rate) | Through study completion, an average of 1 year |
| ECG parameters by 12 lead ECG(RR) | Through study completion, an average of 1 year |
| ECG parameters by 12 lead ECG(QT interval) | Through study completion, an average of 1 year |
| ECG parameters by 12 lead ECG(corrected QT intervals [QTcF, QTcB]) | Through study completion, an average of 1 year |
| ECG parameters by 12 lead ECG(PR interval) | Through study completion, an average of 1 year |
| ECG parameters by 12 lead ECG(QRS) | Through study completion, an average of 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Volume of distribution(Vd) | Through study completion, an average of 1 year |
| Best overall response (BOR) | Through study completion, an average of 1 year |
| Anti-ONO-4685 antibody | Through study completion, an average of 1 year |
| clearance(CL) | Through study completion, an average of 1 year |
| Overall response rate (ORR) | Through study completion, an average of 1 year |
| Complete response rate (CRR) | Through study completion, an average of 1 year |
| Duration of response (DOR) | Through study completion, an average of 1 year |
| Progression Free Survival(PFS) | Through study completion, an average of 1 year |
| Time to response (TTR) | Through study completion, an average of 1 year |
| Overall Survival(OS) | Through study completion, an average of 1 year |
| The percent change of tumor volume | Through study completion, an average of 1 year |
| Pharmacokinetics(Cmax) | Through study completion, an average of 1 year |
| Pharmacokinetics(Tmax) | Through study completion, an average of 1 year |
| Pharmacokinetics(AUC) | Through study completion, an average of 1 year |
| Pharmacokinetics(Ceoi) | Through study completion, an average of 1 year |
| Pharmacokinetics(T1/2) | Through study completion, an average of 1 year |
| Pharmacokinetics(Ctrough) | Through study completion, an average of 1 year |
Countries
Japan
Contacts
Primary ContactNorth America Clinical Trial Support Desk
Backup ContactInternational Clinical Trial Support Desk
Outcome results
None listed