Loncastuximab + Roflumilast for B-Cell Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for people with diffuse large B-cell lymphoma (DLBCL), a type of blood cancer. The aim is to assess the safety, tolerability, and effectiveness of the treatment in stopping or shrinking the cancer. Participants will receive a combination of medications, including loncastuximab (an antibody-drug conjugate) and roflumilast (a phosphodiesterase-4 inhibitor), to monitor their response. The trial seeks individuals with untreated DLBCL who are at high risk of a poor outcome. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I need to stop my current medications to join the trial?
The trial requires you to stop using certain medications, including specific antibiotics, antifungals, and other drugs like St. John's Wort. If you're taking any of these, you may need to stop them before joining the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that loncastuximab is effective and generally safe for patients with hard-to-treat B-cell lymphoma. It has been especially well-tolerated by patients who have tried many other treatments. Roflumilast has been tested as a repurposed drug for B-cell cancers and found to be safe. It works by blocking a specific enzyme that might aid cancer cell growth.
This trial uses both drugs together. Past research suggests they are manageable and tolerable in similar situations. However, this combination is still under investigation, and the trial will gather more information on how patients handle this treatment mix.12345Why are researchers excited about this trial's treatments?
Loncastuximab combined with Roflumilast is unique because it offers a targeted approach to treating B-cell lymphoma. Unlike the standard R-CHOP regimen, which broadly attacks cancer cells, Loncastuximab specifically targets CD19, a protein on the surface of B-cells, potentially leading to more precise cancer cell destruction. Additionally, Roflumilast, an oral medication typically used for respiratory conditions, may enhance the immune response and reduce inflammation, adding a new dimension to the treatment. Researchers are excited because this combination could improve outcomes with fewer side effects, offering a promising new option for patients with high-risk diffuse large B-cell lymphoma.
What evidence suggests that Loncastuximab and Roflumilast might be effective treatments for diffuse large B-cell lymphoma?
In this trial, participants with high-risk diffuse large B-cell lymphoma (DLBCL) will receive a combination of treatments. Research has shown that loncastuximab can effectively treat patients with relapsed or hard-to-treat DLBCL, with about 32% of patients who had already received many treatments responding well to it. Roflumilast, another medication included in this trial, has proven safe and helpful when used with other treatments for high-risk DLBCL. It has shown promise when combined with standard chemotherapy. Together, these treatments aim to improve outcomes for patients with high-risk DLBCL by potentially increasing the response to treatment and slowing the disease's progression.36789
Who Is on the Research Team?
Adolfo E Diaz Duque, MD
Principal Investigator
The University of Texas Health Science Center at San Antonio
Ricardo Aguiar, MD
Principal Investigator
The University of Texas Health Science Center at San Antonio
Are You a Good Fit for This Trial?
This trial is for adults with untreated high-risk diffuse large B-cell lymphoma (DLBCL). Participants must have a heart function test showing at least 45% efficiency, be able to swallow pills, and have an acceptable general health status. They should not have had previous treatments for lymphoma or other current cancers, except certain localized ones. People with severe allergies to the study drugs or significant medical conditions that increase risk are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Chemotherapy Free Treatment
Participants receive 2 cycles of chemotherapy free therapy composed of Loncastuximab, Rituximab, and Roflumilast
Chemoimmunotherapy
Participants receive 6 cycles of chemoimmunotherapy with R-CHOP, Loncastuximab, and Roflumilast
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Loncastuximab
- Roflumilast
Trial Overview
The trial tests a combination of drugs: Loncastuximab and Roflumilast added to the standard R-CHOP therapy in patients with DLBCL. It's a phase I study focusing on safety, how well patients tolerate the treatment, tumor response rate, and progression-free survival estimates.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Eligible subjects will receive 2 cycles of chemotherapy free therapy composed of Loncastuximab 0.15 mg/kg, Rituximab 375 mg/m2, and Roflumilast 500 ug po daily; followed by 6 cycles of chemoimmunotherapy with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) at standard of care (SOC) doses, and Roflumilast 500 ug po daily. Loncastuximab at a dose of 0.075 mg/kg will be added to other chemoimmunotherapy agents only for the first three (3) out of six (6) cycles
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Health Science Center at San Antonio
Lead Sponsor
Citations
Outcomes with loncastuximab tesirine following CAR T ...
OS at 12 months was 95%. In this study, we found that lonca monotherapy was an effective treatment option in R/R DLBCL in 3 L and 4 L settings ...
Loncastuximab in high-risk and heavily pretreated relapsed ...
The complete response rate was 14% and overall response rate was 32%. The median event-free survival and overall survival were 2.1 and 4.6 ...
3.
ir.adctherapeutics.com
ir.adctherapeutics.com/press-releases/press-release-details/2025/ADC-Therapeutics-Announces-Updated-Data-from-LOTIS-7-Clinical-Trial-Presented-at-the-European-Hematology-Association-2025-Congress/default.aspxADC Therapeutics Announces Updated Data from LOTIS-7 ...
ZYNLONTA® in combination with glofitamab (COLUMVI®) in patients with r/r DLBCL demonstrated clinically meaningful benefit with overall ...
Loncastuximab in high-risk and heavily pretreated ...
The median event-free survival and overall survival were 2.1 and 4.6 months, respectively. Those with bulky disease and high-grade B-cell ...
Study Results | ZYNLONTA® (loncastuximab tesirine-lpyl ...
ZYNLONTA® Delivered Results for Some People with Relapsed/Refractory (R/R) DLBCL · ZYNLONTA® was specifically studied in adults who needed their next DLBCL ...
long-term efficacy and safety from the phase II LOTIS-2 study
Lonca continued to demonstrate durable, long-term responses with manageable safety and tolerability in patients with CR.
long-term efficacy and safety from the phase II LOTIS-2 study
Lonca demonstrated single-agent antitumor activity and had an acceptable safety profile in heavily pretreated patients with R/R DLBCL with an overall response ...
8.
onclive.com
onclive.com/view/loncastuximab-tesirine-plus-glofitamab-shows-early-safety-and-efficacy-in-r-r-dlbclLoncastuximab Tesirine Plus Glofitamab Shows Early ...
Loncastuximab tesirine and glofitamab combination showed a 93.3% overall response rate in relapsed/refractory DLBCL patients, with an 86.7% ...
9.
ashpublications.org
ashpublications.org/blood/article/142/Supplement%201/4469/503507/Loncastuximab-Tesirine-Demonstrated-SubstantialLoncastuximab Tesirine Demonstrated Substantial Single ...
Conclusions: Lonca demonstrated substantial and clinically meaningful single-agent efficacy and was well-tolerated in heavily pretreated Chinese ...
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