← Back to Search

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

Must not have

Pathologic diagnosis of Burkitt lymphoma

Lymphoma with active CNS involvement

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been diagnosed with Burkitt lymphoma.

Select...

My lymphoma affects my brain or spinal cord.

Select...

I do not have uncontrolled high blood pressure or severe heart issues.

Select...

I have abnormal fluid buildup in my body.

Select...

I have been treated with loncastuximab tesirine before.

Select...

I have been treated with R-GemOx before.

Select...

I am experiencing symptoms of graft-versus-host disease.

Select...

I have another type of cancer that is currently active.

Select...

I had a stem cell transplant using my own cells within the last 30 days.

Select...

I have a long QT syndrome or my heart's electrical recovery time is 480 ms or longer.

Select...

I have a lymphatic system disorder after receiving a transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

~2990

Loncastuximab Tesirine

2022

Completed Phase 2

~50