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Trial of Loncastuximab Tesirine in High Risk Diffuse Large B-cell Lymphoma Post Transplant
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
No Placebo-Only Group
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
- Cancer
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Efficacy Outcome Measure
Safety Outcome Measure
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
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
164 Previous Clinical Trials
9,248 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.