Study of ADCT-402 in Patients With Relapsed or Refractory B-cell Lineage Non Hodgkin Lymphoma (B-… (NCT02669017) | Clinical Trial Compass
CompletedPhase 1
Study of ADCT-402 in Patients With Relapsed or Refractory B-cell Lineage Non Hodgkin Lymphoma (B-NHL)
United States, Italy, United Kingdom183 participantsStarted 2016-03
Plain-language summary
This study evaluates ADCT-402 in participants with Relapsed or Refractory B-cell Lineage Non Hodgkin Lymphoma (B-NHL). Participants will participate in a dose escalation phase (Part 1) and dose expansion (Part 2). In Part 2, participants will receive the dose level identified in Part 1.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female participants, ages 18 years or older with pathologically confirmed relapsed or refractory B-cell lineage NHL who have failed or are intolerant to established therapy, or for whom no other treatment options are available.
* Refractory or relapsed B-cell NHL (per World health Organization \[WHO\] Classification system).
* Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block.
* Measurable disease, as defined by the 2014 Lugano Classification.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
* Absolute neutrophil count (ANC) ≥1000/μL.
* Platelet count of ≥75000/μL.
* Hemoglobin ≥9.0 g/dL without transfusion within the 2 weeks prior to Day 1.
* Serum/plasma creatinine ≤1.5 mg/dL.
* Serum/plasma alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤2 times the upper limit of normal (ULN); ≤ 5 times ULN if there is liver or bone involvement.
* Total serum/plasma bilirubin ≤1.5 times ULN.
* Negative blood or urine beta-human chorionic gonadotropin (β-HCG) pregnancy test within 7 days prior to Day 1 for women of childbearing potential.
* Males, and female participants who are biologically capable of having children, must agree to use a medically acceptable method of birth control.
Exclusion Criteria:
* Participants who have any option for other treatment for B-cell NHL at the current state of disease.
* Active graft-versus-host disease.
* Autologous or allogenic tr…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
Timeframe: Q3W schedule: Day 1 to End of Cycle 1 (3 weeks); Q6W schedule: Day 1 to End of Cycle 1 (6 weeks)
2
Recommended Dose of ADCT-402 for Part 2
Timeframe: Q3W schedule: Day 1 to End of Cycle 1 (3 weeks); Q6W schedule: Day 1 to End of Cycle 1 (6 weeks)
3
Number of Participants Reporting at Least One Treatment Emergent Adverse Event (TEAE)
Timeframe: Day 1 to End of Study (a maximum of 18 months)
4
Number of Participants Reporting at Least One Treatment Emergent Serious Adverse Event (SAE)
Timeframe: Day 1 to End of Study (a maximum of 18 months)