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Proteasome Inhibitor

Dose escalation for AITL

Phase 1
Recruiting
Research Sponsored by Arvinas Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eligible participants aged ≥18 years
Have relapsed/refractory mature B-cell non-Hodgkin lymphoma (NHL) and ≥2 prior systemic therapies, or histologically confirmed AITL that has recurred or progressed following institutional standard-of-care therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 2 years
Awards & highlights

Study Summary

This trial will test a new drug called ARV-393 to see if it is safe and can help treat advanced non-Hodgkin's lymphoma that has not responded to previous treatments. The

Who is the study for?
This trial is for individuals with advanced non-Hodgkin's lymphoma that has come back or hasn't responded to treatment. Participants should have specific types of this cancer, like AITL, B-Cell Lymphoma, or T-Cell Lymphoma. Details on who can join are not fully listed here.Check my eligibility
What is being tested?
The study is testing ARV-393, a new drug given as an oral tablet. It aims to see if it's safe and effective against certain non-Hodgkin's lymphomas by targeting a protein linked to tumor growth.See study design
What are the potential side effects?
Since ARV-393 is being tested for the first time in humans, potential side effects are unknown but may relate to its action on breaking down proteins involved in tumor growth.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My B-cell non-Hodgkin lymphoma has not responded to 2 or more treatments, or my AITL has worsened after standard treatment.
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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Dose limiting toxicities during Cycle 1 (28 days)
Number of participants with abnormal vital signs, abnormal ECG readings ( QT interval) and abnormal laboratory parameters.
Percentage of participants with Adverse Events characterized by severity, seriousness, and relationship to study drug as a measure of safety and tolerability
+1 more
Secondary outcome measures
Area under the plasma concentration-time curve (AUC) for ARV-393
Complete response rate (CRR)
Duration of response (DOR)
+6 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Dose escalationExperimental Treatment1 Intervention
Dose escalation will begin at Dose Level 1. Dose escalation or de-escalation decision will be recommended by the cohort review committee.

Find a Location

Who is running the clinical trial?

Arvinas Inc.Lead Sponsor
3 Previous Clinical Trials
619 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit of participants engaging in this research endeavor?

"Indeed, the information available on clinicaltrials.gov indicates an active search for suitable participants. The study was first listed on April 30th, 2024 and last revised on the same date. A total of 112 individuals are sought from 8 distinct sites to partake in this trial."

Answered by AI

What are the primary objectives of this scientific study?

"As per the information disclosed by the trial sponsor, Arvinas Inc., the primary aim of this study will involve assessing the percentage of participants experiencing Adverse Events within a 28-day period starting from their initial dosing with the investigational drug. This evaluation will consider aspects such as severity, seriousness, and any potential correlation to the study medication in order to gauge safety and tolerability levels. Furthermore, secondary endpoints will include analyzing Time to maximum concentration (Tmax) for ARV-393 - denoting when peak concentrations occur after administration; Minimum concentration (Cmin) for ARV-393 - representing lowest observed concentrations post-dosing"

Answered by AI

Are multiple facilities conducting this medical research within the city?

"Presently, this research is actively enlisting participants at 8 different medical facilities. These sites are scattered across various regions such as Nashville, New Brunswick, and New york among other undisclosed locations. Opting for the nearest site could reduce travel commitments upon enrollment."

Answered by AI

What are the safety implications of increasing medication dosage for individuals?

"Given that this is a Phase 1 trial with restricted evidence on safety and effectiveness, our team at Power rated the safety of Dose escalation as 1."

Answered by AI

Are there any ongoing opportunities for patients to participate in this medical study?

"Indeed, the details on clinicaltrials.gov specify that this clinical trial is actively seeking candidates. The trial was initially listed on 4/30/2024 and last revised on the same day. Recruitment aims to enroll 112 patients across 8 locations."

Answered by AI
~75 spots leftby Dec 2025