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A Phase I Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in T Cell Lymphoma and CLL/SLL

ConditionRelapsed or Refractory T Cell Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorOno Pharmaceutical Co., Ltd.

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Patients with severe complications.

Patients with multiple cancers.

Trial design

Design model

Single group

Treatments tested in this trial

  • ONO-4685

    Drug

    ONO-4685 is administered by IV infusion. The administration of ONO-4685 will be continued until disease progression or unacceptable toxicity is observed.

Treatment groups

108 Participants
are divided into 1 treatment group
Group A: ONO-4685Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose-limiting toxicities(DLT)

Time frame
Up to 3 Weeks
2

Incidence and severity of AEs and SAEs

Time frame
Through study completion, an average of 1 year
3

Laboratory abnormality profile of ONO-4685 as measured by incidence and severity of clinical laboratory abnormalities

Time frame
Through study completion, an average of 1 year
4

Body temperature

Time frame
Through study completion, an average of 1 year

Secondary outcomes

1

Best overall response (BOR)

Time frame
Through study completion, an average of 1 year
2

Overall response rate (ORR)

Time frame
Through study completion, an average of 1 year
3

Complete response rate (CRR)

Time frame
Through study completion, an average of 1 year
4

Duration of response (DOR)

Time frame
Through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ono Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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