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Alkylating agents
Loncastuximab Tesirine for Lymphoma
Phase 1
Waitlist Available
Led By George Georges
Research Sponsored by Fred Hutchinson 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 time from receiving loncastuximab tesirine to the first observation of disease progression or death from any cause, whichever occurs first, assessed at 2 years post-autologous stem cell transplantation (asct)
Awards & highlights
Study Summary
This trial is testing a new cancer drug combo & its side effects. It's for people with DLBCL that has come back or didn't respond to treatment before.
Eligible Conditions
- Lymphoma
- Follicular Lymphoma
- Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma
- Diffuse Large B-Cell Lymphoma
- Large B-Cell Lymphoma
- B-Cell Lymphoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from receiving loncastuximab tesirine to death from any cause, assessed at 2 years post-asct
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from receiving loncastuximab tesirine to death from any cause, assessed at 2 years post-asct
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of dose-limiting toxicity (Part 1)
Incidence of toxicity requiring dose delay or modification (Part 2)
Secondary outcome measures
Overall survival
Progression-free survival
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (loncastuximab tesirine, BEAM chemotherapy)Experimental Treatment6 Interventions
PART I (CONDITIONING): Patients receive loncastuximab tesirine IV on day -7, carmustine IV over 2 hours on day -7, etoposide IV over 1-2 hours BID days -6, -5, -4, and -3, cytarabine IV over 1 hour BID on days -6, -5, -4, and -3, and melphalan IV over 15-20 minutes on day -2. Patients undergo peripheral blood ASCT per standard practice on day 0.
PART II (MAINTENANCE): Beginning 30-90 days after ASCT, patients receive loncastuximab tesirine IV Q3V for up to 9 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Autologous Hematopoietic Stem Cell Transplantation
2017
Completed Phase 3
~1730
Cytarabine
2016
Completed Phase 3
~3310
Carmustine
1990
Completed Phase 3
~1790
Melphalan
2008
Completed Phase 3
~1500
Etoposide
2010
Completed Phase 3
~2440
Loncastuximab Tesirine
2022
Completed Phase 2
~50
Find a Location
Who is running the clinical trial?
Fred Hutchinson Cancer CenterLead Sponsor
556 Previous Clinical Trials
1,343,268 Total Patients Enrolled
100 Trials studying Lymphoma
6,537 Patients Enrolled for Lymphoma
ADC TherapeuticsUNKNOWN
1 Previous Clinical Trials
24 Total Patients Enrolled
1 Trials studying Lymphoma
24 Patients Enrolled for Lymphoma
George GeorgesPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
7 Previous Clinical Trials
137 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies for participants in this experiment?
"This clinical trial is no longer recruiting, as per the data on clinicaltrials.gov; it was posted on December 7th 2022 and last edited November 7th 2022. Despite this study's conclusion, there are over two thousand six hundred sixty one other trials in search of participants right now."
Answered by AI
Has Loncastuximab Tesirine been granted clearance by the FDA?
"Little evidence exists that loncastuximab tesirine is both efficacious and safe, so the safety rating for this drug was assigned a score of 1."
Answered by AI
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