50 Participants Needed

Loncastuximab Tesirine for Marginal Zone Lymphoma

Recruiting at 3 trial locations
PA
Overseen ByPhilip Arlen, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Miami
Must be taking: Anti-CD20 antibodies
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a medication called loncastuximab tesirine in patients with immune cell cancers. The medication works by finding and sticking to cancer cells, then releasing a poison to kill them. Researchers want to see if this treatment is effective and safe for these patients. Loncastuximab tesirine is a recently approved treatment for a type of immune cell cancer that has returned or not responded to previous treatments.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are currently receiving anticancer therapy or have taken certain anticancer medications or investigational drugs within specific time frames before the trial starts. It's best to discuss your current medications with the trial team.

Is Loncastuximab Tesirine safe for humans?

Loncastuximab Tesirine, also known as Zynlonta, has been shown to have a tolerable safety profile in clinical trials for diffuse large B-cell lymphoma, with common side effects including low white blood cell counts, low platelet counts, and elevated liver enzymes. It has been safely used even in patients with severe liver issues, but always consult with a healthcare provider for personal medical advice.12345

What makes the drug Loncastuximab Tesirine unique for treating marginal zone lymphoma?

Loncastuximab Tesirine is unique because it is an antibody-drug conjugate, which means it combines an antibody that specifically targets cancer cells with a powerful chemotherapy drug, allowing for direct delivery to the cancer cells and potentially reducing damage to healthy cells.678910

What data supports the effectiveness of the drug Loncastuximab Tesirine for treating Marginal Zone Lymphoma?

Loncastuximab Tesirine has shown effectiveness in treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL), with a response rate of about 48% in clinical trials. While it is not specifically approved for Marginal Zone Lymphoma, its success in similar B-cell lymphomas suggests potential effectiveness.123411

Who Is on the Research Team?

IL

Izidore Lossos, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Marginal Zone Lymphoma who've had at least one prior systemic therapy including an anti-CD20 antibody. They should have measurable disease or specific criteria met for non-measurable disease, and be able to undergo biopsies if needed. Key exclusions include recent cancer treatments, other malignancies within the last 3 years, certain heart conditions, liver cirrhosis, autoimmune disorders requiring strong immunosuppression, active infections or HIV/HBV/HCV infection.

Inclusion Criteria

I've had treatment including an anti-CD20 antibody for my condition but it didn't fully work.
I have a conjunctival eye lesion that is at least 1 cm wide or I have multiple lesions.
I meet one of the required criteria to start treatment.
See 10 more

Exclusion Criteria

Pregnancy or breastfeeding
Conditions interfering with study participation or interpretation of data
I am unable to make my own medical decisions.
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients will be treated with loncastuximab tesirine for a total of 6 cycles on Day 1 (+/-3) of each 21 day (3 week) cycle

18 weeks
6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Loncastuximab Tesirine
Trial Overview The study tests two doses of Loncastuximab tesirine (150 µg/Kg and 75µg/Kg) in patients with relapsed/refractory Marginal Zone Lymphoma to evaluate its effectiveness and safety. It's an open-label trial meaning everyone knows which treatment they're getting.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Loncastuximab tesirine Cycles 1-6Experimental Treatment2 Interventions
Patients will be treated with loncastuximab tesirine for a total of 6 cycles on Day 1 (+/-3) of each 21 day (3 week) cycle. The total duration of treatment is approximately 18 weeks (4.5 months)

Loncastuximab Tesirine is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Zynlonta for:
  • Diffuse large B-cell lymphoma (DLBCL)
  • DLBCL arising from low-grade lymphoma
  • High-grade B-cell lymphoma
🇪🇺
Approved in European Union as Zynlonta for:
  • Diffuse large B-cell lymphoma (DLBCL)
  • DLBCL arising from low-grade lymphoma
  • High-grade B-cell lymphoma

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials
976
Recruited
423,000+

ADC Therapeutics S.A.

Industry Sponsor

Trials
32
Recruited
2,700+

Published Research Related to This Trial

Loncastuximab tesirine-lpyl, an anti-CD19 antibody-drug conjugate, has shown a 48.3% overall response rate in patients with relapsed, refractory diffuse large B-cell lymphoma during the phase II LOTIS-2 trial, indicating its efficacy as a treatment option.
The drug demonstrated a tolerable safety profile with common side effects including neutropenia and thrombocytopenia, and no new safety concerns were identified in the phase II trial, suggesting it is safe for further testing in various non-Hodgkin lymphoma subtypes.
Loncastuximab tesirine for diffuse large B-cell lymphoma.Zurko, J., Hamadani, M.[2021]
Loncastuximab tesirine, an antibody-drug conjugate targeting CD19, has shown promising efficacy in treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL), with overall response rates of 42.3% in LOTIS-1 and 48.3% in LOTIS-2 trials.
The treatment has an acceptable safety profile, with common side effects including anemia, neutropenia, fatigue, and nausea, making it a viable option for patients who have not responded to previous therapies.
Loncastuximab tesirine: an effective therapy for relapsed or refractory diffuse large B-cell lymphoma.Xu, B.[2022]
In a phase 2 trial involving 145 patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), loncastuximab tesirine demonstrated a significant overall response rate of 48.3%, indicating its effectiveness as a treatment option for this challenging patient population.
The treatment was associated with an acceptable safety profile, with serious adverse events occurring in 39% of patients, but none were directly linked to loncastuximab tesirine, suggesting it may be a safe option for heavily pretreated patients.
Loncastuximab tesirine in relapsed or refractory diffuse large B-cell lymphoma (LOTIS-2): a multicentre, open-label, single-arm, phase 2 trial.Caimi, PF., Ai, W., Alderuccio, JP., et al.[2021]

Citations

Loncastuximab tesirine for diffuse large B-cell lymphoma. [2021]
Loncastuximab tesirine: an effective therapy for relapsed or refractory diffuse large B-cell lymphoma. [2022]
Loncastuximab tesirine in relapsed or refractory diffuse large B-cell lymphoma (LOTIS-2): a multicentre, open-label, single-arm, phase 2 trial. [2021]
Loncastuximab tesirine in relapsed or refractory diffuse large B-cell lymphoma: a review of clinical data. [2022]
Loncastuximab Tesirine: First Approval. [2021]
Safety of loncastuximab tesirine-lpyl in diffuse large B-cell lymphoma with severe hepatic dysfunction. [2023]
Possible novel agents in marginal zone lymphoma. [2021]
A roadmap for clinical trial design in marginal zone lymphoma. [2023]
Rituximab plus cladribine versus R-CHOP in frontline management of marginal zone lymphoma in China: a propensity-score matched multicenter study. [2022]
Rare lymphomas in routine practice - Treatment and outcome in marginal zone lymphoma in the prospective German Tumour Registry Lymphatic Neoplasms. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Current Treatments in Marginal Zone Lymphoma. [2022]
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