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Alkylating agents
Loncastuximab Tesirine + Rituximab for Diffuse Large B-Cell Lymphoma
Phase 2
Recruiting
Led By Joseph M Tuscano
Research Sponsored by Joseph Tuscano
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 first dose to off study, assessed up to 3 years
Awards & highlights
Study Summary
This trial evaluates a combination of treatments to treat high-risk B-cell lymphoma. It uses a monoclonal antibody and drugs to kill cancer cells and reduce inflammation.
Who is the study for?
This trial is for adults with untreated high-risk diffuse large B-cell lymphoma, confirmed by specific criteria. Participants must have measurable disease, be in relatively good health (ECOG <=2), and have a life expectancy of at least 6 months. They should not have had certain previous treatments or conditions that could affect the study results.Check my eligibility
What is being tested?
The trial tests loncastuximab tesirine and rituximab followed by DA-EPOCH-R chemotherapy to see if it's more effective for treating high-risk diffuse large B-cell lymphoma than standard therapies. It combines targeted therapy with traditional chemotherapy.See study design
What are the potential side effects?
Potential side effects include reactions to monoclonal antibodies like infusion reactions, organ inflammation from targeted therapy drugs, common chemo side effects such as nausea, hair loss, fatigue, increased infection risk due to lowered immunity, and blood-related issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ first dose to off study, assessed up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first dose to off study, assessed up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete response rate
Secondary outcome measures
Incidence of adverse events
Overall response rate (complete response + partial response)
Overall survival rate
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (Lonca-R, DA-EPOCH-R)Experimental Treatment7 Interventions
Patients receive rituximab IV, loncastuximab tesirine IV, etoposide IV, doxorubicin IV, vincristine IV, prednisone PO, and cyclophosphamide IV on study. Patients also undergo collection of blood samples and bone marrow aspiration and biopsy at screening and CT or PET/CT at screening, throughout the study, and during follow up.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
1999
Completed Phase 4
~1880
Prednisone
2014
Completed Phase 4
~2370
Vincristine
2003
Completed Phase 4
~2910
Cyclophosphamide
1995
Completed Phase 3
~3770
Doxorubicin
2012
Completed Phase 3
~7940
Etoposide
2010
Completed Phase 3
~2440
Loncastuximab Tesirine
2022
Completed Phase 2
~50
Find a Location
Who is running the clinical trial?
ADC TherapeuticsUNKNOWN
1 Previous Clinical Trials
Joseph TuscanoLead Sponsor
7 Previous Clinical Trials
158 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,669 Previous Clinical Trials
40,926,377 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a skin condition like eczema, psoriasis, or vitiligo.I have a serious liver condition.I am not on strong immune system suppressing drugs.My kidneys are functioning well enough to clear creatinine.I have abnormal fluid buildup in my body.I have not had severe infections in the last 4 weeks.I do not have any unmanaged ongoing illnesses.I am 18 years old or older.I have not taken certain medications recently.My DLBCL is confirmed and untreated.I can take care of myself and am up and about more than 50% of my waking hours.I have active tuberculosis.I agree to use birth control during the study.My lymphoma has spread to my brain or spinal cord and is not under control.I have used specific treatments before.I have not had major surgery in the last 28 days.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (Lonca-R, DA-EPOCH-R)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are people still allowed to sign up for this experiment?
"This particular trial, which was posted on December 1st of last year, is no longer actively recruiting patients. Although this specific study may not be looking for candidates, there are 1810 other trials that are currently enrolling participants."
Answered by AI
How does the treatment (Lonca-R, DA-EPOCH-R) impact patients safety?
"This treatment, known as Lonca-R or DA-EPOCH-R, is currently in Phase 2 clinical trials. While there is some safety data available from past studies, its efficacy has not yet been proven."
Answered by AI
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