Treatment (loncastuximab tesirine) for Relapse

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Fred Hutch/University of Washington Cancer Consortium, Seattle, WA
Relapse+19 More
Loncastuximab Tesirine - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This phase II trial tests whether loncastuximab tesirine works to shrink tumors in patients with B-cell malignancies that have come back (relapsed) or does not respond to treatment (refractory). Loncastuximab tesirine is a monoclonal antibody, called loncastuximab, linked to a chemotherapy drug, called tesirine. Loncastuximab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD19 receptors, and delivers tesirine to kill them.

Eligible Conditions

  • Relapse
  • Refractory Follicular Lymphoma
  • Recurrent Neoplastic Post-Transplant Lymphoproliferative Disorder
  • post-transplant lymphoproliferative disorder (PTLD)
  • Recurrent Diffuse Large B-Cell Lymphoma
  • Refractory B-Cell Non-Hodgkin Lymphoma
  • Refractory Diffuse Large B Cell Lymphoma (DLBCL)
  • Refractory Neoplastic Post-Transplant Lymphoproliferative Disorder
  • Recurrent Follicular Lymphoma
  • Recurrent B-Cell Non-Hodgkin Lymphoma
  • Refractory Mantle Cell Lymphoma
  • Recurrent Mantle Cell Lymphoma

Treatment Effectiveness

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Up to 5 years

Year 5
Progression free survival
Year 5
Overall survival
Year 5
Duration or response
Up to 5 years
Clinical benefit rate
Overall response rate (ORR)
Day 30
Incidence of grade 3-5 drug-related toxicity
Rate of discontinuation due to adverse events
Rates of grade 3-5 adverse event

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Treatment (loncastuximab tesirine)
1 of 1
Experimental Treatment

40 Total Participants · 1 Treatment Group

Primary Treatment: Treatment (loncastuximab tesirine) · No Placebo Group · Phase 2

Treatment (loncastuximab tesirine)
Biological
Experimental Group · 1 Intervention: Loncastuximab Tesirine · Intervention Types: Biological

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
Closest Location: Fred Hutch/University of Washington Cancer Consortium · Seattle, WA
Photo of Seattle  1Photo of Seattle  2Photo of Seattle  3
2018First Recorded Clinical Trial
0 TrialsResearching Relapse
140 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have CD19+ relapsed/refractory PTLD.
You have been treated with a chimeric antigen receptor T-cell therapy or allogeneic transplant.
You have a male or female patient aged 18 years or older.
You have received at least 1 prior therapy for B-NHL, and no alternative therapy with a more favorable benefit/risk ratio.
You have a white blood cell count (WBC) of at least 1.0 x 10^3/uL and are not due to a lymphoma.
Platelet count > 75 x 10^3/uL without transfusion in the prior 7 days, unless due to disease including splenomegaly in which case platelet count must be > 50 x 10^3/uL.
You have had at least 1 prior therapy, and no alternative with a more favorable benefit/risk ratio in the judgment of the treating investigator.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.