Dose Expansion Phase (Part 2) for Non-Hodgkin's Lymphoma

Phase-Based Progress Estimates
AMR Kansas City, Kansas City, MONon-Hodgkin's Lymphoma+1 MoreONO-7018 - Drug
All Sexes
What conditions do you have?

Study Summary

This trial will test a new drug's safety and effectiveness in people. It has two parts and will be conducted at multiple sites.

Eligible Conditions
  • Non-Hodgkin Lymphoma
  • Chronic B-Cell Leukemia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: Through study completion, an average of 1 year

Year 1
Antitumor Activity of ONO-7018 (Duration of Response [DOR])
Antitumor Activity of ONO-7018 (Overall Response Rate [ORR])
Antitumor Activity of ONO-7018 (Overall Survival [OS])
Antitumor Activity of ONO-7018 (Progression Free Survival [PFS])
Incidence, causality, and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Up to 3 weeks
Estimate of Maximum Tolerated Dose (MTD)
Up to 48 weeks
Plasma Concentration of ONO-7018

Trial Safety

Safety Progress

1 of 3

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Trial Design

2 Treatment Groups

Dose Expansion Phase (Part 2)
1 of 2
Dose Escalation Phase (Part 1)
1 of 2

Experimental Treatment

54 Total Participants · 2 Treatment Groups

Primary Treatment: Dose Expansion Phase (Part 2) · No Placebo Group · Phase 1

Dose Expansion Phase (Part 2)
Experimental Group · 1 Intervention: ONO-7018 · Intervention Types: Drug
Dose Escalation Phase (Part 1)
Experimental Group · 1 Intervention: ONO-7018 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 1 year

Who is running the clinical trial?

Ono Pharmaceutical Co. LtdLead Sponsor
151 Previous Clinical Trials
94,392 Total Patients Enrolled
Project LeaderStudy DirectorOno Pharma USA Inc
7 Previous Clinical Trials
1,945 Total Patients Enrolled
Takeyuki IwataStudy DirectorOno Pharmaceutical Co. Ltd

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a condition that has not responded to other treatments and there are no other known treatments available that can help you.

Frequently Asked Questions

Is this trial still recruiting participants?

"According to, this trial is actively seeking participants. It was originally posted on February 13th of 2023 and has most recently been updated as of February 15th of the same year." - Anonymous Online Contributor

Unverified Answer

Has the Dose Expansion Phase (Part 2) of this treatment been given regulatory approval?

"The amount of clinical data available for Dose Expansion Phase (Part 2) is limited, so it was rated a 1 on our team's scale. This indicates that this trial has only reached the initial phase in demonstrating efficacy and safety." - Anonymous Online Contributor

Unverified Answer

What is the aggregate amount of participants included in this experiment?

"Yes, the information on confirms that this research is actively looking for participants. This trial was posted online on February 13th 2023 and latest updated two days later. Currently 54 individuals need to be recruited from 9 varied sites." - Anonymous Online Contributor

Unverified Answer

How many medical facilities have been chosen to administer this experiment?

"Patients can access this trial at 9 different sites such as Emory University Hospital in Atlanta, AMR Kansas City in Kansas City and Summit Medical Group in Florham Park. An additional 6 locations are also available for patients to receive the treatment." - Anonymous Online Contributor

Unverified Answer

What are the essential aims of this research endeavor?

"The study's sponsor, Ono Pharmaceutical Co. Ltd., is basing their primary outcome measure on the Maximum Tolerated Dose (MTD), which will be estimated over an average one-year interval. Additionally, they'll also evaluate secondary outcomes such as Antitumor Activity of ONO-7018 through Overall Response Rate (ORR) and Progression Free Survival (PFS). Lastly, they intend to assess overall survival in relation to this medication." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.