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CAR T-Cell Therapy for Acute Myeloid Leukemia
Study Summary
This trial is testing a new treatment, CD123-CAR T-cell therapy, for patients with AML/myelodysplastic syndrome (MDS), T- or B- acute lymphoblastic leukemia (ALL) or blastic plasmacytoid dendritic cell neoplasia (BPDCN). The goal is to find the maximum safe dose of CD123-CAR T cells to give to these patients.
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 are expected to live for at least 8 more weeks.My bilirubin levels are within normal range, except I have Gilbert's syndrome.I am 21 years old or younger.I have not received rituximab therapy in the last 30 days.I cannot receive the specific chemotherapy drugs fludarabine and cyclophosphamide due to health reasons.My liver enzymes are within 5 times the normal limit.My T-cell therapy product meets the required safety standards.I have a history of HIV infection.I had a bone marrow transplant from a donor, have no ongoing transplant-related complications, and haven't received donor immune cells in the last 28 days.My heart pumps well enough, meeting the required efficiency.My lung function is good, either by FVC test or oxygen levels.I have not taken any medication in the last 14 days that could affect my upcoming CAR T-cell therapy.I have recovered from severe side effects of my previous treatments.My kidney function is within the required range.I have been diagnosed with a specific type of leukemia (APL).I am 21 years old or younger.I can do most activities but may need help.My disease shows CD123 positivity.I have a history of HIV infection.I have received chemotherapy directly into my spinal canal within the last week.I cannot take the specific chemotherapy drugs fludarabine or cyclophosphamide due to health reasons.I haven't taken high doses of steroids in the week before my planned CAR T-cell therapy.I do not have any severe ongoing infections like hepatitis B or C.I am not pregnant or breastfeeding and agree to use birth control.I do not have any severe ongoing infections.You must have a compatible person who can donate healthy stem cells for the transplant.I have an active brain or spinal cord disease.
- Group 1: CD123-CAR T cell 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
Are there other research studies that have assessed the efficacy of this remedy?
"Currently, 1159 medical studies are active for this treatment and 222 of them have reached Phase 3. Philadelphia is the epicentre of these investigations; however, there are 36802 sites worldwide running trials related to it."
Has this particular therapy been given a thumbs-up by the FDA?
"The safety of this procedure has been determined to be a 1 due to being in the preliminary Phase 1 trial, implying that there is only limited data available regarding efficacy and security."
How many participants are actively involved in this medical study?
"Affirmative, the details on clinicaltrials.gov demonstrate that this experiment is currently seeking participants. The trial was initially published on May 27th 2020 and recently modified on May 10th 2022. 32 volunteers are needed from 3 distinct locations to complete this research."
Are there still opportunities for individuals to participate in this study?
"The trial is currently seeking participants, as per clinicaltrials.gov; the initiation of this medical study was on May 27th 2020 and it has been recently updated on May 10th 2022."
What medical issue does this treatment typically address?
"This therapeutic intervention is used by physicians to treat lung cancer and other maladies, including multiple sclerosis, b-cell lymphomas, and polyangium."
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