33 Participants Needed

Loncastuximab Tesirine + Chemotherapy for Lymphoma

(LONCA Trial)

Recruiting at 2 trial locations
MC
Overseen ByMedical College of Wisconsin Cancer Center Clinical Trials Office
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Medical College of Wisconsin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The overarching hypothesis for this study is that a safe and tolerable dose (i.e., the maximum tolerated dose) will be identified for loncastuximab tesirine in combination with dose-adjusted etoposide phosphate, prednisone, vincristine sulfate (Oncovin), cyclophosphamide, doxorubicin hydrochloride (hydroxydaunorubicin), and rituximab (DA-EPOCH-R) for patients with previously untreated aggressive B-cell lymphoid malignancies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, corticosteroid therapy is allowed without a washout period, and prephase treatment with certain drugs is permitted for symptomatic patients.

Is the combination of Loncastuximab Tesirine and chemotherapy safe for humans?

The research articles provided do not contain specific safety data for Loncastuximab Tesirine combined with chemotherapy for lymphoma. They focus on the safety of antiemetic drugs used to prevent nausea and vomiting during chemotherapy, which are generally well-tolerated.12345

What makes the drug Loncastuximab Tesirine combined with chemotherapy unique for treating lymphoma?

Loncastuximab Tesirine is unique because it is an antibody-drug conjugate that specifically targets CD19, a protein found on many B-cell lymphomas, delivering a toxin directly to cancer cells. This targeted approach, combined with traditional chemotherapy drugs, offers a novel treatment option for patients with relapsed or refractory B-cell non-Hodgkin lymphoma, who have limited alternatives.678910

What data supports the effectiveness of the drugs used in the Loncastuximab Tesirine + Chemotherapy for Lymphoma trial?

Research shows that etoposide, doxorubicin, and cyclophosphamide are effective in treating various types of lymphoma, with etoposide being particularly useful in different lymphoma subtypes. The CHOP regimen, which includes doxorubicin, cyclophosphamide, vincristine, and prednisone, has been a standard treatment for non-Hodgkin's lymphoma for over 20 years, and adding rituximab has further improved its effectiveness.811121314

Who Is on the Research Team?

MH

Mehdi Hamadani, MD

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

Adults over 18 with specific types of B-cell lymphoma who haven't had multiagent chemotherapy. They can have limited radiation or corticosteroid therapy, and must be physically able to perform daily activities (ECOG 0-3). Their major organs need to function well, they can't be pregnant or breastfeeding, and shouldn't have severe allergies to the study drugs.

Inclusion Criteria

Adequate hematological function: ANC ≥1 × 103/μL and platelet count ≥50 x 10^3/μL
My liver tests are within normal limits, or any high results are due to my condition or Gilbert's syndrome.
Ability to understand a written informed consent document, and the willingness to sign it
See 11 more

Exclusion Criteria

Breastfeeding or pregnant
I have chronic hepatitis B but can't or won't take standard antiviral treatments, yet my virus levels are undetectable.
My liver function is severely impaired.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Phase 1a involves a 3+3 dose escalation design to find the maximum tolerated dose (MTD) of loncastuximab tesirine in combination with DA-EPOCH-R.

Up to 21 days per cycle

Cohort Expansion

Phase 1b involves a cohort expansion at the dose level determined to be the recommended phase 2 dose.

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Cyclophosphamide
  • Doxorubicin
  • Etoposide
  • Loncastuximab Tesirine
  • Prednisone
  • Rituximab
  • Vincristine
Trial Overview The trial is testing different doses of Loncastuximab Tesirine combined with DA-EPOCH-R chemotherapy in patients with aggressive B-cell lymphomas. The goal is to find the highest dose that's safe and tolerable without causing too many side effects.
How Is the Trial Designed?
5Treatment groups
Experimental Treatment
Group I: Loncastuximab Tesirine Dose Escalation Maximum Tolerated DoseExperimental Treatment9 Interventions
Group II: Loncastuximab Tesirine Dose Escalation 0.15 mg/kg by IV.Experimental Treatment7 Interventions
Group III: Loncastuximab Tesirine Dose Escalation 0.12 mg/kg by IV.Experimental Treatment7 Interventions
Group IV: Loncastuximab Tesirine Dose Escalation 0.075 mg/kg by IV.Experimental Treatment7 Interventions
Group V: Dose Expansion PhaseExperimental Treatment9 Interventions

Cyclophosphamide is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸
Approved in United States as Cytoxan for:
🇪🇺
Approved in European Union as Endoxan for:
🇨🇦
Approved in Canada as Neosar for:
🇯🇵
Approved in Japan as Endoxan for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials
645
Recruited
1,180,000+

Published Research Related to This Trial

Etoposide is a key drug in treating malignant lymphomas and Hodgkin's disease, showing broad activity across various subtypes and demonstrating single-agent efficacy comparable to older treatments like alkylating agents and doxorubicin.
The drug works by inhibiting protein synthesis and topoisomerase II, allowing it to provide effective cytotoxicity without cross-resistance, and is integrated into multiple treatment protocols, enhancing the overall management of these cancers.
The evolving role of etoposide in the management of lymphomas and Hodgkin's disease.O'Reilly, SE., Klimo, P., Connors, JM.[2019]
In a study of 415 patients with low-grade lymphoma treated with doxorubicin-containing therapy (CHOP), the median survival duration was 6.9 years, with significant factors affecting survival including age, sex, and histology.
The study found that doxorubicin-containing treatment did not improve overall median survival compared to less aggressive treatment options, and maintenance therapy did not extend survival for these patients.
Long-term follow-up of patients with low-grade malignant lymphomas treated with doxorubicin-based chemotherapy or chemoimmunotherapy.Dana, BW., Dahlberg, S., Nathwani, BN., et al.[2017]
A novel chemotherapy regimen for treating intermediate and high-grade non-Hodgkin's lymphoma resulted in a high complete response rate of 77% among 56 previously untreated patients, indicating its efficacy in a population with a poor prognosis.
Despite the promising response rates, the treatment was associated with significant myelosuppression, with severe leukopenia occurring in all patients and a 9% rate of toxic deaths, highlighting the need for careful monitoring and management of side effects.
Results of treatment with high intensity, brief duration chemotherapy in poor prognosis non-Hodgkin's lymphoma.McMaster, ML., Greer, JP., Wolff, SN., et al.[2019]

Citations

The evolving role of etoposide in the management of lymphomas and Hodgkin's disease. [2019]
Long-term follow-up of patients with low-grade malignant lymphomas treated with doxorubicin-based chemotherapy or chemoimmunotherapy. [2017]
Results of treatment with high intensity, brief duration chemotherapy in poor prognosis non-Hodgkin's lymphoma. [2019]
Lomustine, etoposide, methotrexate and prednisone (LEMP) therapy for relapsed and refractory non-Hodgkin's lymphoma. [2019]
Moving forward with new data and approaches: a fresh look at anthracyclines in non-Hodgkin's lymphoma. [2023]
Oral dolasetron mesylate in patients receiving moderately emetogenic platinum-containing chemotherapy. Oral Dolasetron Dose Response Study Group. [2013]
A randomized, multicenter, open-label comparison of the antiemetic efficacy of dolasetron versus ondansetron for the prevention of nausea and vomiting during high-dose myeloablative chemotherapy. [2020]
Identification of optimal contemporary antiemetic prophylaxis for doxorubicin-cyclophosphamide chemotherapy in Chinese cancer patients: post-hoc analysis of 3 prospective studies. [2021]
Randomized, double blind, dose-response trial across four oral doses of dolasetron for the prevention of acute emesis after moderately emetogenic chemotherapy. Oral Dolasetron Dose-Response Study Group. [2013]
Olanzapine versus aprepitant for the prophylaxis of chemotherapy-induced nausea and vomiting in breast cancer patients receiving doxorubicin-cyclophosphamide regimen: A prospective, nonrandomized, open-label study. [2018]
11.United Statespubmed.ncbi.nlm.nih.gov
Final results of a phase 1 study of loncastuximab tesirine in relapsed/refractory B-cell non-Hodgkin lymphoma. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Matching-adjusted Indirect Comparison of the Efficacy of Loncastuximab Tesirine Versus Treatment in the Chemoimmunotherapy Era for Relapsed/Refractory Diffuse Large B-cell Lymphoma. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
Loncastuximab tesirine, an anti-CD19 antibody-drug conjugate, in relapsed/refractory B-cell acute lymphoblastic leukemia. [2023]
Adding rituximab to CODOX-M/IVAC chemotherapy in the treatment of HIV-associated Burkitt lymphoma is safe when used with concurrent combination antiretroviral therapy. [2022]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security