Your session is about to expire
← Back to Search
CAR T-cell Therapy
Loncastuximab Tesirine for Non-Hodgkin's Lymphoma
Phase 2
Recruiting
Led By Paolo Strati, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if a new drug, loncastuximab tesirine, can help control large B-cell lymphoma that has returned or is resistant to CAR T-cell therapy. The safety and possible effects of the new drug will also be studied.
Who is the study for?
Adults with certain types of large B-cell lymphoma that didn't respond well to CAR T-cell therapy can join this trial. They should have partially responded to the previous treatment, be in good physical condition, and not have had any other cancer treatments since. People with heart issues, blood clots, severe allergies to study drugs, or active infections can't participate. Women who could get pregnant must test negative for pregnancy and agree to use birth control.
What is being tested?
The trial is testing whether a drug called Loncastuximab Tesirine (lonca) can help control large B-cell lymphoma after CAR T-cell therapy has been given. It's for patients whose cancer hasn't fully responded and will look at how safe lonca is and what effects it might have.
What are the potential side effects?
While the specific side effects of Loncastuximab Tesirine are not listed here, similar medications often cause symptoms like fatigue, allergic reactions during infusion into the body, liver problems, low blood cell counts increasing infection risk, and potential harm to an unborn baby.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Loncastuximab TesirineExperimental Treatment1 Intervention
Participants will receive Loncastuximab Tesirine (lonca) by vein.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Loncastuximab Tesirine
2022
Completed Phase 2
~50
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,069 Previous Clinical Trials
1,802,654 Total Patients Enrolled
Paolo Strati, MDPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
79 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an autoimmune disease that has damaged my organs or needed strong medication in the last 2 years.I have fluid buildup needing drainage or causing breathing issues.I am currently pregnant or breastfeeding.I do not have any severe infections requiring strong antibiotics or antifungals.My white blood cell count is healthy without needing medication for the last 3 days.I am receiving an FDA-approved CAR T-cell therapy for my condition.I am capable of becoming pregnant and have a negative pregnancy test.I received CAR T-cell therapy as my last treatment before joining this study.I haven't had a heart attack or other major heart issues in the last year.I am 18 years old or older.I am not willing to use birth control.My cancer responded well to CAR T-cell therapy within 30 days.I haven't had cancer treatment after my CAR T-cell therapy, except for palliative radiotherapy.It has been over 30 days since my last CAR T-cell therapy infusion.My lymphoma has not spread to my brain or spinal cord.My heart pumps well and I don't have serious fluid around it.I haven't had serious blood clots or lung blockages in the last month.I am able to care for myself and perform daily activities.I have HIV, hepatitis B, or C but my viral load is undetectable.I do not have any health issues that could affect the study's results.My CLL has transformed into a more aggressive form.I have previously been treated with lonca.My condition is a type of aggressive B-cell lymphoma that has returned or didn't respond to treatment.I had no lasting effects from previous immune-related side effects.My kidneys are functioning well enough (creatinine clearance over 30 mL/min).My heart is affected by lymphoma.I have been cancer-free for at least a year, except for nonmelanoma skin cancer or carcinoma in situ.
Research Study Groups:
This trial has the following groups:- Group 1: Loncastuximab Tesirine
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Learn More About These Treatments
Share this study with friends
Copy Link
Messenger