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CAR T-Cell Therapy for Acute Lymphoblastic Leukemia
Study Summary
This trial is for patients with relapsed or refractory CD19+ acute lymphoblastic leukemia (ALL) who are between the ages of 0 and 30. The trial will test the safety and effectiveness of a new treatment called chimeric antigen receptor (CAR) T cell therapy. In this therapy, patient's own immune cells are collected and then manufactured to be more effective at killing cancer cells. The product will be made at the St. Jude Children's Research Hospital's Good Manufacturing Practice (GMP) facility. The trial will test different doses of the therapy to find the largest safe dose, as well as how long the therapy lasts in the
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.Trial Design
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Who is running the clinical trial?
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- You have a condition that weakens your immune system.I am 21 years old or younger.You have a type of leukemia called CD19+ ALL and have one or more of the following: your cancer has not responded to at least two rounds of chemotherapy, your cancer has not responded to additional treatment after previous attempts, your cancer has relapsed multiple times, you have relapsed after a bone marrow transplant, you need a bone marrow transplant but are not eligible, you are under 21 years old, you have a good performance score, you are expected to live for at least 12 more weeks, you are eligible for or have already undergone apheresis.You have had allergic reactions to products that contain murine protein in the past.My cancer has spread to my brain, with or without symptoms.You have a condition that weakens your immune system.I haven't taken high doses of steroids in the week before my CAR T-cell treatment.I have not taken immunosuppressive drugs in the last 14 days.I have not had chemotherapy injected into my spine within the last week.You have a type of leukemia called CD19+ ALL and meet any of the following conditions: your disease has not responded to the usual chemotherapy treatments, you have relapsed multiple times, you have failed to respond to other treatments or you are unable to undergo a stem cell transplant. You are under 21 years old and have a life expectancy of at least 8 weeks. You also need to meet certain health criteria such as having adequate heart, kidney, and lung function, and normal blood count levels. Women who may become pregnant must have a negative pregnancy test and agree to use birth control during and after treatment. Your cancer cells must have certain characteristics for you to be eligible for this study. You must also agree to long-term follow-up.I do not have any severe, uncontrolled infections.I do not have a severe infection right now.I have a history of HIV infection.My brain or spinal cord disease has caused changes in my nervous system.I have an active neurological condition that is not under control.I have a history of HIV infection.You have had allergic reactions to products that contain murine protein.
- Group 1: SJCAR19 Therapy
- 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
Has prior research been conducted utilizing SJCAR19 product, which is a CD19-specific CAR engineered autologous T-cell?
"Currently, 893 clinical trials related to CD19- specific CAR engineered autologous T-cells (SJCAR19 product) are being conducted worldwide. Of these studies, 161 have progressed to Phase 3. Philadelphia is the primary region hosting such trials but 28460 locations across the globe are running similar research projects."
Is there an opportunity to participate in the current iteration of this research?
"Affirmative. According to clinicaltrials.gov, this medical experiment is recruiting participants and was initially posted on July 24th 2018; moreover, the listing was recently revised on November 10th 2022. The study requires 35 individuals from 1 site for enrolment."
What is the aggregate enrollment rate for this investigation?
"Affirmative, clinicaltrials.gov reports that this trial is actively recruiting participants as of now. It was initially posted on the 24th July 2018 and last updated on 10th November 2022. 35 patients are being sought from 1 medical centre."
What indications is SJCAR19 product, a CD19-specific CAR engineered autologous T-cell therapy, employed to address?
"A variety of maladies, including multiple sclerosis, acute myelocytic leukemia and retinoblastoma can be treated with the SJCAR19 product; a CD19-specific CAR engineered autologous T-cell."
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