Autologous Hematopoietic Stem Cell Transplantation for Recurrent Diffuse Large B-Cell Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
City of Hope Medical Center, Duarte, CA
Recurrent Diffuse Large B-Cell Lymphoma+13 More
Autologous Hematopoietic Stem Cell Transplantation - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This phase I trial studies the safety and side effects of cytomegalovirus (CMV) specific CD19-chimeric antigen receptor (CAR) T-cells along with the CMV-modified vaccinia Ankara (MVA) triplex vaccine following a stem cell transplant in treating patients with high grade B-cell non-Hodgkin lymphoma. CAR T-cells are a type of treatment in which a patient's T-cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T-cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T-cells are grown in the laboratory and given to the patient by infusion. Vaccines such as CMV-MVA triplex are made from gene-modified viruses and may help the body build an effective immune response to kill cancer cells. Giving CMV-specific CD19-CAR T-cells plus the CMV-MVA triplex vaccine following a stem cell transplant may help prevent the cancer from coming back.

Eligible Conditions

  • Recurrent Diffuse Large B-Cell Lymphoma
  • Mantle Cell Lymphoma (MCL)
  • B-Lymphocytes
  • Recurrent Mantle Cell Lymphoma
  • Lymphoma, Non-Hodgkin
  • Diffuse Large B-Cell Lymphoma (DLBCL)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Recurrent Diffuse Large B-Cell Lymphoma

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Up to 15 years

Year 15
Overall survival (OS)
Year 15
Progression-free survival (PFS)
Up to 15 years
Clinically significant CMV reactivation
Incidence of adverse events
Short- and long-term CMV-specific CD19-CAR T cell expansion and persistence
Up to 56 days
Achievement of proposed 10×10^6 cytomegalovirus (CMV)-specific CD19-chimeric antigen receptor (CAR) T cells per product and meeting product release requirements for enrolled participants

Trial Safety

Safety Progress

1 of 3

Other trials for Recurrent Diffuse Large B-Cell Lymphoma

Trial Design

1 Treatment Group

Treatment (CMV-specific CD19-CAR T cells, triplex vaccine)
1 of 1
Experimental Treatment

15 Total Participants · 1 Treatment Group

Primary Treatment: Autologous Hematopoietic Stem Cell Transplantation · No Placebo Group · Phase 1

Treatment (CMV-specific CD19-CAR T cells, triplex vaccine)Experimental Group · 4 Interventions: Anti-CD19-CAR CMV-specific T-lymphocytes, Autologous Hematopoietic Stem Cell Transplantation, Multi-peptide CMV-Modified Vaccinia Ankara Vaccine, Myeloablative Conditioning · Intervention Types: Biological, Procedure, Biological, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Autologous Hematopoietic Stem Cell Transplantation
2007
Completed Phase 3
~1630

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 15 years
Closest Location: City of Hope Medical Center · Duarte, CA
Photo of Duarte 1Photo of Duarte 2Photo of Duarte 3
2002First Recorded Clinical Trial
8 TrialsResearching Recurrent Diffuse Large B-Cell Lymphoma
142 CompletedClinical Trials

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
12,930 Previous Clinical Trials
41,294,445 Total Patients Enrolled
45 Trials studying Recurrent Diffuse Large B-Cell Lymphoma
1,993 Patients Enrolled for Recurrent Diffuse Large B-Cell Lymphoma
City of Hope Medical CenterLead Sponsor
501 Previous Clinical Trials
2,246,380 Total Patients Enrolled
8 Trials studying Recurrent Diffuse Large B-Cell Lymphoma
248 Patients Enrolled for Recurrent Diffuse Large B-Cell Lymphoma
Leslie L PopplewellPrincipal InvestigatorCity of Hope Medical Center
1 Previous Clinical Trials
8 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a diagnosis of intermediate or high-grade B cell NHL in first relapse after achieving CR or did not achieve CR after a first line therapy.

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.