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CAR T-Cells + CMV Vaccine for Non-Hodgkin's Lymphoma
Study Summary
This trial is testing the safety of CMV-specific CD19-CAR T-cells in combination with the CMV-MVA triplex vaccine following a stem cell transplant in people with high grade B-cell non-Hodgkin lymphoma.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 665 Patients • NCT00567567Trial Design
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Who is running the clinical trial?
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- I do not have any uncontrolled serious illnesses.I have had a stem cell transplant using my own or a donor's cells.I am a woman who can have children and my pregnancy test is negative.My white blood cell count is healthy without medical help.I have Gilbert syndrome but my total bilirubin is 3.0 or less.My hemoglobin level is at least 8 g/dl without transfusions or growth factors.My platelet count is high enough without transfusions or growth factors.My kidney function is within the required range and I am not on dialysis.I have B cell NHL and am in my first relapse or didn't achieve complete remission after first treatment.I am not on high-dose steroids or long-term immunosuppressants, but I may use low-dose or topical steroids.I have a bleeding disorder like von Willebrand's disease or hemophilia.My white blood cell count is high enough without medical help.I am capable of having children and have not been surgically sterilized.I am capable of having children and have not been surgically sterilized.My platelet count is above the required level without transfusions or growth factors.I have not had a platelet transfusion in the last week.My hemoglobin level is at least 8 g/dl without transfusions or growth factors.My kidney function is within the required range and I am not on dialysis.My heart rhythm problem is not stable even with medication.I am HIV positive.I am 18 years old or older.I have B cell NHL in first relapse and may need a stem cell transplant.I am currently taking antibiotics for an infection.I do not have an active autoimmune disease that needs systemic treatment.I have no allergies or adverse reactions to specific cancer treatments or vaccines.I am not currently on any experimental treatments or undergoing chemotherapy, biological therapy, or radiation.I am able to care for myself but may not be able to do active work.I am not pregnant or breastfeeding.My cancer is confirmed to be a type of CD19+ malignancy.I had cancer before, but it was either removed surgically with the aim of curing it, was a type of skin cancer, or has been inactive for 3+ years.I don't have any conditions that would prevent me from undergoing a stem cell transplant.I have active viral hepatitis.I am 18 years old or older.I am able to care for myself but may not be able to do active work.My cancer is confirmed to be a type of CD19+ with intermediate or high severity.I have no allergies or adverse reactions to specific cancer treatments, steroids, or certain vaccines.You give permission to use tissue samples from previous biopsies for the study.I haven't received growth factors in the last 14 days.I had a CNS disease, but it's now in complete remission.I have not had a stroke or brain bleed in the last 6 months.
- Group 1: Treatment (CMV-specific CD19-CAR T cells, triplex vaccine)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any vacant spots left in this trial?
"Per the clinicaltrials.gov listing, this research study is actively recruiting patients; it was first announced on November 2nd 2022 and has recently been updated as of October 7th 2022."
Has Autologous Hematopoietic Stem Cell Transplantation been officially sanctioned by the U.S. Food and Drug Administration?
"Due to the limited evidence of safety and efficacy, Autologous Hematopoietic Stem Cell Transplantation was assigned a score of 1 on our team's scale from one to three."
How many individuals have joined the clinical trial thus far?
"Indeed, the data found on clinicaltrials.gov reveals that this medical study is still recruiting participants. This trial was initially posted in November 2nd 2022 and most recently amended on October 7th 2022; 15 patients are needed from a single site."
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