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Antibody Drug Conjugate
Loncastuximab Tesirine + Rituximab for Lymphoma (LOTIS 5 Trial)
Phase 3
Recruiting
Research Sponsored by ADC Therapeutics S.A.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pathologic diagnosis of DLBCL, as defined by the 2016 World Health Organization classification or high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements
Relapsed or refractory disease following at least one multi-agent systemic treatment regimen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
LOTIS 5 Trial Summary
This trial will compare a new immunotherapy drug to the current standard of care for treating a certain type of blood cancer.
Who is the study for?
Adults with Diffuse Large B-Cell Lymphoma who have relapsed or didn't respond to previous treatments can join. They must be in good enough health for the trial, not planning a stem cell transplant, and agree to use effective contraception. People can't join if they're pregnant/breastfeeding, recently used experimental drugs/vaccines, had certain recent treatments including loncastuximab tesirine or R-GemOx, have uncontrolled diseases like HIV/HBV/HCV or severe heart conditions.Check my eligibility
What is being tested?
The study is testing whether combining Loncastuximab Tesirine with Rituximab is more effective than standard immunochemotherapy for treating Diffuse Large B-Cell Lymphoma. Participants will either receive this new combination therapy or the usual treatment involving Gemcitabine and Oxaliplatin.See study design
What are the potential side effects?
Possible side effects include allergic reactions to medication components, organ inflammation from immune responses, blood count changes leading to increased infection risk, fatigue, digestive issues due to chemotherapy agents like Gemcitabine and Oxaliplatin.
LOTIS 5 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My diagnosis is DLBCL or high-grade B-cell lymphoma with specific gene rearrangements.
Select...
My condition did not improve after receiving a combination of treatments.
Select...
I can take care of myself and perform daily activities.
LOTIS 5 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free Survival (PFS)
Secondary outcome measures
Average Concentration of Loncastuximab Tesirine Before Infusion
Average Concentration of Loncastuximab Tesirine at the End of Infusion
Complete Response Rate (CRR)
+15 moreLOTIS 5 Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Part 2: Loncastuximab Tesirine + Rituximab (Lonca-R)Experimental Treatment2 Interventions
Randomized participants will receive Lonca-R on Day 1 of each cycle for up to 8 cycles, where 1 cycle is 3 weeks. Lonca-R will be administered via an intravenous infusion of loncastuximab tesirine 150 µg/kg + rituximab 375 mg/m^2 every Q3W for 2 cycles, then loncastuximab tesirine 75 µg/kg + rituximab 375 mg/m^2 Q3W for up to 6 additional cycles.
Group II: Part 1: Loncastuximab Tesirine + Rituximab (Lonca-R)Experimental Treatment2 Interventions
Part 1 consists of a non-randomized safety run-in period evaluating the study drug for the first 20 participants.
Participants will receive Lonca-R on Day 1 of each cycle for up to 8 cycles, where 1 cycle is 3 weeks. Lonca-R will be administered via an intravenous infusion of loncastuximab tesirine 150 µg/kg + rituximab 375 mg/m^2 Q3W for 2 cycles, then loncastuximab tesirine 75 µg/kg + rituximab 375 mg/m^2 Q3W for up to 6 additional cycles.
Group III: Part 2: Standard Immunochemotherapy (R-GemOx)Active Control3 Interventions
Randomized participants will receive R-GemOx consisting of rituximab, gemcitabine and oxaliplatin as a standard immunochemotherapy treatment on Day 1 or Day 2 of each cycle for up to 8 cycles, where 1 Cycle is 2 weeks. R-GemOx will be administered via an intravenous infusion of rituximab 375 mg/m^2 + gemcitabine 1000 mg/m^2 + oxaliplatin 100 mg/m^2 every 2 weeks (Q2W) for up to 8 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
1999
Completed Phase 4
~1880
Loncastuximab Tesirine
2022
Completed Phase 2
~50
Find a Location
Who is running the clinical trial?
ADC Therapeutics S.A.Lead Sponsor
28 Previous Clinical Trials
1,947 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with Burkitt lymphoma.My diagnosis is DLBCL or high-grade B-cell lymphoma with specific gene rearrangements.My condition did not improve after receiving a combination of treatments.I am not eligible for stem cell transplantation due to my health, age, or other medical conditions.I have had a stem cell transplant from a donor within the last 60 days.My lymphoma affects my brain or spinal cord.I do not have uncontrolled high blood pressure or severe heart issues.I have abnormal fluid buildup in my body.I have been treated with loncastuximab tesirine before.I have been treated with R-GemOx before.I have not had major surgery in the last 4 weeks.I have not received a live vaccine in the last 4 weeks.I am experiencing symptoms of graft-versus-host disease.I have another type of cancer that is currently active.I had a stem cell transplant using my own cells within the last 30 days.I can take care of myself and perform daily activities.My organ functions are within normal ranges according to recent tests.I still have side effects from past treatments that haven't gone away.I am 18 years old or older.I have a long QT syndrome or my heart's electrical recovery time is 480 ms or longer.I have a lymphatic system disorder after receiving a transplant.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the status of Loncastuximab Tesirine's FDA approval?
"This clinical trial is a Phase 3, meaning that while there is data supporting efficacy, there is also multiple rounds of data supporting safety. Therefore, our team has given Loncastuximab Tesirine a safety score of 3."
Answered by AI
What indications is Loncastuximab Tesirine commonly used to treat?
"Loncastuximab Tesirine is most commonly used to treat diffuse large b-cell lymphoma (dlbcl), but can also be used as part of the treatment plan for small cell lung cancer (sclc), head and neck carcinoma, and cervical cancers."
Answered by AI
Are there still positions open for participants in this trial?
"This research study is currently recruiting patients, as indicated by the listing on clinicaltrials.gov. This trial was first announced on September 16th, 2020 with the last update on October 26th, 2020."
Answered by AI
At how many locations is this experiment being conducted?
"To minimise the burden of travel on participants, the 17 clinical trial sites are located in La Jolla, Redlands, and Montréal as well as 14 other cities."
Answered by AI
What is the background of Loncastuximab Tesirine in medical research?
"At present, there are 1164 concurrent clinical trials for Loncastuximab Tesirine globally, with the majority of these (336) being in Phase 3. The vast majority of these clinical trials are located in Guangzhou, Guangdong; however, there are 51462 total locations running studies for Loncastuximab Tesirine."
Answered by AI
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