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Loncastuximab Tesirine in Combination With Chemotherapy Prior to Stem Cell Transplant for the Treatment of Recurrent or Refractory Diffuse Large B-Cell Lymphoma

NCT05228249 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2023-01-13

No results posted yet for this study

Summary

This phase I trial studies the side effects and best dose of loncastuximab tesirine in combination with carmustine, etoposide, cytarabine, and melphalan (BEAM) chemotherapy regimen in treating patients with diffuse large B-cell lymphoma that has come back (recurrent) or has not responded to treatment (refractory). Loncastuximab tesirine is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Chemotherapy drugs, such as carmustine, etoposide, cytarabine, and melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with loncastuximab tesirine may kill more cancer cells.

Conditions

  • Recurrent Diffuse Large B-Cell Lymphoma
  • Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
  • Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
  • Recurrent Primary Mediastinal (Thymic) Large B-Cell Lymphoma
  • Recurrent Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma
  • Refractory Diffuse Large B-Cell Lymphoma
  • Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
  • Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
  • Refractory Primary Mediastinal (Thymic) Large B-Cell Lymphoma
  • Refractory Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma

Interventions

PROCEDURE

Autologous Hematopoietic Stem Cell Transplantation

Undergo peripheral blood ASCT

DRUG

Carmustine

Given IV

DRUG

Cytarabine

Given IV

DRUG

Etoposide

Given IV

BIOLOGICAL

Loncastuximab Tesirine

Given IV

DRUG

Melphalan

Given IV

Sponsors & Collaborators

  • ADC Therapeutics

    collaborator UNKNOWN

  • Fred Hutchinson Cancer Center

    lead OTHER

Principal Investigators

  • Victor Chow · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-30
Primary Completion
2025-10-01
Completion
2027-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05228249 on ClinicalTrials.gov