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Chemotherapy
Cell Therapy for Non-Hodgkin's Lymphoma
Phase 1 & 2
Waitlist Available
Led By Elizabeth L Budde, MD,PhD
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
History of relapse after achieving first remission with primary therapy, or failure to achieve remission with primary therapy
Karnofsky performance scale (KPS) >= 70%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial is testing a new treatment for lymphoma that uses genetically engineered cells to try to kill the cancer.
Who is the study for?
This trial is for adults with high-risk B-cell non-Hodgkin lymphoma who've had a relapse or didn't respond to initial treatment. They must be fit enough for stem cell transplant (Karnofsky score ≥70%), not pregnant, and have a life expectancy over 16 weeks. Excluded are those with HIV, prior transplants, active autoimmune diseases needing steroids, hepatitis B/C infection, or on other trials.Check my eligibility
What is being tested?
The study tests genetically engineered lymphocyte therapy after stem cell transplant in patients with aggressive lymphoma. It includes rituximab and chemotherapy before the transplant and factors like filgrastim to help move stem cells from bone marrow into the blood for collection.See study design
What are the potential side effects?
Possible side effects include immune system reactions due to engineered lymphocytes, infusion-related symptoms from rituximab, bone marrow suppression by chemotherapy, and complications related to stem cell transplantation such as infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer returned after initial treatment or didn't respond to the first treatment.
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I am able to care for myself but may not be able to do active work.
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I am eligible for a stem cell transplant using my own cells.
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My biopsy was reviewed and confirmed to be a type of intermediate grade B-cell NHL.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Days of Quantifiable CD19 CAR Post T-cell Infusion
Number of Participants With Dose Limiting Toxicities (DLTs)
Woodchuck Hepatitis Virus Post-transcriptional Regulatory Element (WPRE) Detection Above Background
Secondary outcome measures
Failure to Engraft
Progression-free Survival at 1 Year
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (cellular adoptive immunotherapy following PBSCT)Experimental Treatment7 Interventions
Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with G-CSF and/or plerixafor. Some patients may also receive rituximab IV within 4 weeks of transplant. Patients receive standard myeloablative conditioning followed by autologous PBSCT. Patients then undergo infusion of ex vivo expanded autologous TCM-enriched CD8+ T cells expressing CD19-specific CAR on day 2 or 3 after transplant.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
FDA approved
Autologous Hematopoietic Stem Cell Transplantation
2017
Completed Phase 3
~1800
Filgrastim
FDA approved
Peripheral Blood Stem Cell Transplantation
1997
Completed Phase 3
~1330
Plerixafor
FDA approved
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
569 Previous Clinical Trials
1,924,680 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,687 Previous Clinical Trials
40,930,363 Total Patients Enrolled
Elizabeth L Budde, MD,PhDPrincipal InvestigatorCity of Hope Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I rely on corticosteroids for my health condition.I have an active hepatitis B or C infection.I don't have any health issues that would prevent me from undergoing a stem cell transplant.I have had a stem cell transplant from a donor or myself.I am scheduled for a treatment that combines radiation therapy and immunotherapy.My cancer returned after initial treatment or didn't respond to the first treatment.I am on medication to suppress my immune system due to an autoimmune disease.I am able to care for myself but may not be able to do active work.I am eligible for a stem cell transplant using my own cells.My biopsy was reviewed and confirmed to be a type of intermediate grade B-cell NHL.I understand the risks and benefits of this study and passed the understanding test.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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