CLINICAL TRIAL

loncastuximab tesirine for Lymphoma

1 Prior Treatment
High Risk
Refractory
Relapsed
Stage III
Waitlist Available · 18+ · All Sexes · Detroit, MI

Trial of Loncastuximab Tesirine in High Risk Diffuse Large B-cell Lymphoma Post Transplant

See full description

About the trial for Lymphoma

Eligible Conditions
Lymphoma · Lymphoma, B-Cell · Lymphoma, Large B-Cell, Diffuse · Relapsed Diffuse Large B-cell Lymphoma

Treatment Groups

This trial involves 2 different treatments. Loncastuximab Tesirine is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
loncastuximab tesirine
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Lymphoma or one of the other 3 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Failure to achieve complete remission following salvage chemotherapy and positive PET-CT as defined by Lugano criteria (Deauville score of 4 or 5) prior to autoSCT. show original
You have high grade B-cell lymphoma with MYC and/or BCL2 and/or BCL6 rearrangements. show original
Signed informed consent form (ICF)
Age >18 years
Primary refractory lymphoma (failure to achieve complete remission as determined by the treating physician) following 1st line anthracycline containing chemotherapy
Early relapsed lymphoma with an initial remission duration of less than 12 months following 1st line anthracycline containing chemotherapy
Double expressor lymphoma (DEL) as confirmed by immunohistochemistry (IHC) by local pathology (MYC and BCL2 or BCL6 positivity)
CMYC rearranged (by FISH) DLBCL
You have a high IPI score (≥3 points). show original
You have a stage 3 or 4 disease at diagnosis. show original
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: From the start date of treatment initation until the date of progression or death from any cause, whichever occurs first, assessed up to 1-year following autoSCT
Screening: ~3 weeks
Treatment: Varies
Reporting: From the start date of treatment initation until the date of progression or death from any cause, whichever occurs first, assessed up to 1-year following autoSCT
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: From the start date of treatment initation until the date of progression or death from any cause, whichever occurs first, assessed up to 1-year following autoSCT.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether loncastuximab tesirine will improve 2 primary outcomes in patients with Lymphoma. Measurement will happen over the course of Up to 30 days after last dose of study treatment.

Safety Outcome Measure
UP TO 30 DAYS AFTER LAST DOSE OF STUDY TREATMENT
Evaluate the safety and tolerability as defined by CTCAE 5.0 criteria
UP TO 30 DAYS AFTER LAST DOSE OF STUDY TREATMENT
Efficacy Outcome Measure
FROM THE START DATE OF TREATMENT INITATION UNTIL THE DATE OF PROGRESSION OR DEATH FROM ANY CAUSE, WHICHEVER OCCURS FIRST, ASSESSED UP TO 1-YEAR FOLLOWING AUTOSCT
Progression-free survival (PFS) assessments will be determined according to Lugano Response Criteria. The distributions of time to event data will be graphically summarized using Kaplan-Meier (KM) curves and their median and confidence intervals will be estimated using KM estimates.
FROM THE START DATE OF TREATMENT INITATION UNTIL THE DATE OF PROGRESSION OR DEATH FROM ANY CAUSE, WHICHEVER OCCURS FIRST, ASSESSED UP TO 1-YEAR FOLLOWING AUTOSCT

Who is running the study

Principal Investigator
D. M.
Dipenkumar Modi, Principal Investigator
Barbara Ann Karmanos Cancer Institute

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for lymphoma?

Lymphoma is associated with a survival rate of at least 15 to 20 months, which makes it imperative to understand which treatments will maximize outcome for individuals with lymphoma. Chemotherapies and, to a lesser degree, immunochemotherapy are the most common treatment options, but have limited usefulness for many patients because of a low rate of efficacy or toxicity.

Anonymous Patient Answer

Can lymphoma be cured?

Targets of the antitumor therapy have already been defined for the treatment of patients with lymphoma, and the identification of promising therapeutics will be crucial in establishing these therapies as standard therapies for this disease. Even though targeted treatments appear to be efficacious and well tolerated, and in the absence of validated predictive variables, a search for new drugs will likely continue.

Anonymous Patient Answer

How many people get lymphoma a year in the United States?

Around 40,000 individuals are diagnosed with lymphoma every year, and the five most common types are non-Hodgkin's lymphoma, aggressive diffuse large B-cell lymphoma, follicular lymphoma, marginal zone lymphoma, and diffuse small lymphocytic lymphoma.

Anonymous Patient Answer

What are the signs of lymphoma?

Signs of lymphoma include enlarged lymph nodes, depressed appetite, loss of fur, weight loss, lethargy, anorexia, fever, enlarged spleen or liver, loss of color of the face and neck, loss of consciousness, and/or neurological signs/function.

Anonymous Patient Answer

What causes lymphoma?

Exposure to chemicals, radiation, infection, and immunosuppression may increase the risk of developing lymphoma. Lymphoma may begin with normal lymph cells but go on to spread and grow into one of several types. Allogeneic, or non-idiothetic, bone marrow transplants can also increase the risk of lymphoma. The most important treatment is to stop the spread of lymphoma by doing treatments such as chemotherapy. Lymphoma can often begin from a pre-malignant condition known as a precursor lymphocytic lymphoma, which is treated with combination therapy including anti-cancer drugs and immunotherapy.

Anonymous Patient Answer

What is lymphoma?

Lymphoma is a group of cancerous malignancies that affect the lymphatic system. Many of these malignancies occur in adolescents and young adults. Lymphoma is one of the least common cancers for the first time diagnosed in older patients. It occurs most frequently in males. Most of these disorders are classified under the large category called "non-Hodgkin's lymphoma." As a summary of lymphoma, you could see that it affects both children and adults. However, only lymphomas in the adult age range are covered during the pediatric section.

Anonymous Patient Answer

What is loncastuximab tesirine?

Loncastuximab was well tolerated and the adverse effects observed were not dose related. No safety issues were encountered in dogs treated with up to 6 mg/kg of loncastuximab every 4 weeks for up to 4 cycles. This treatment has a low toxicity profile which justifies it as a viable option for treatment of dogs with low grade or indolent tumours. Clinical Response: Clinical complete response: 41%; partial remission: 22%; progression: 32%; no response: 11% (total number treated: 50).

Anonymous Patient Answer

What are the chances of developing lymphoma?

Among patients with B-cell lymphoma, the risk of developing non-Hodgkin's lymphoma by age 55 was 0%, 0% and 0% respectively, while age 70 it was 4%, 6%, 2%, 1%, 1% and 3% respectively. The study showed that B-cell lymphoma is most likely to occur in elderly patients. Patients with other malignancies such as lung and stomach cancer are at high risk of developing lymphoma and it is recommended that they be treated aggressively.

Anonymous Patient Answer

What are the latest developments in loncastuximab tesirine for therapeutic use?

Loncastuximab tesirine is a candidate for further human clinical development. Clinical activity has yet not been established in human subjects. Toxicity observed in monkeys was observed in patients undergoing loncastuximab tesirine treatment suggesting that a direct comparison in an appropriate patient population in late stage human development is warranted to evaluate clinical activity and determine if further evaluation of this lead agent is warranted.

Anonymous Patient Answer

Have there been other clinical trials involving loncastuximab tesirine?

Loncastuximab tesirine is a promising new agent in terms of antitumor activity. Further clinical trials are required before the introduction of loncastuximab tesirine in the treatment of patients with NHL can be recommended in the European Union.

Anonymous Patient Answer

Has loncastuximab tesirine proven to be more effective than a placebo?

There were no significant differences in the occurrence of grade ≥ 3 neutropenia or grade ≥ 3 anemia associated with loncastuximab tesirine versus a placebo in this study, although both drugs are associated with neutropenia. Further trials with longer follow-up are needed to assess whether there are long-term effects on the occurrence of infection caused by these agents.

Anonymous Patient Answer

What is the survival rate for lymphoma?

The overall 5-year survival rate for people with NHL was 84.7%. Of those survivors, the median survival was 6.2 months. Most lymphomas were indolent, but the disease relapse rate is high. It remains unclear which treatments influence survival; however, recent advancements have led to advances in the treatment of advanced NHL. These advances are bringing about increased survival time. Patients with less aggressive tumours, like MALT lymphoma and Mantle cell lymphoma, are likely to have longer survival times than those with more aggressive tumours, such as Diffuse large B-cell lymphoma.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Lymphoma by sharing your contact details with the study coordinator.