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loncastuximab tesirine for B-Cell Lymphoma
Phase 2
Waitlist Available
Led By Dipenkumar Modi, M.D.
Research Sponsored by Barbara Ann Karmanos Cancer Institute
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 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
Awards & highlights
Study Summary
This trial is testing a new drug, loncastuximab tesirine, to see if it can help treat people with a certain type of blood cancer.
Eligible Conditions
- Diffuse Large B Cell Lymphoma (DLBCL)
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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
Follow Up ~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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy Outcome Measure
Safety Outcome Measure
Trial Design
1Treatment groups
Experimental Treatment
Group I: Loncastuximab tesirineExperimental Treatment1 Intervention
Patients will start loncastuximab tesirine for maintenance therapy between day 30 and 60 following autoSCT and will receive a total of 6 months of therapy (8 cycles). Patients will receive IV infusion of loncastuximab tesirine 150 μg/kg at Q3W for the first 2 cycles followed by 75 μg/kg at Q3W for the remaining 6 cycles.
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Who is running the clinical trial?
Barbara Ann Karmanos Cancer InstituteLead Sponsor
163 Previous Clinical Trials
9,256 Total Patients Enrolled
Dipenkumar Modi, M.D.Principal InvestigatorBarbara Ann Karmanos Cancer Institute
3 Previous Clinical Trials
153 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have relapsed refractory DLBCL and meet one or more of the following high-risk features: failed to achieve complete remission after first chemotherapy treatment, early relapse within 12 months of initial treatment, failed to achieve complete remission after salvage chemotherapy and positive PET-CT results, have specific genetic mutations confirmed by FISH or IHC testing, have high IPI score or advanced stage of disease. You are eligible for autologous stem cell transplantation and have available biopsy specimens and pathology reports. You have an ECOG performance status of 0-2, a life expectancy of at least 6 months, and are willing to comply with study procedures. If you are a woman of childbearing potential, you must use contraception during and after the study. If you are a man with a female partner of childbearing potential, you must also use contraception during and after the study.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals eligible to apply for this clinical research right now?
"Affirmative. Data listed on clinicaltrials.gov clearly indicates that recruitment for this medical experiment, which was first published on April 8th 2022, is still open. The trial seeks 36 participants from a single site."
Answered by AI
What is the current enrollment count of this clinical trial?
"Indeed, the data hosted on clinicaltrials.gov signals that this medical experiment is actively recruiting patients. This project was initially posted on April 8th 2022 and recently updated June 24th of this year. The trial necessitates 36 individuals to partake from a single research centre."
Answered by AI
What potential adverse effects could result from consuming loncastuximab tesirine?
"Our evaluation of loncastuximab tesirine's safety puts it at a 2, as this is only in the Phase 2 trial stage and there has been no evidence found that supports efficacy."
Answered by AI
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