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Genetically Modified T Cells for Acute Myeloid Leukemia
Study Summary
This trial is testing a new cancer treatment involving genetically modified T cells. The goal is to see if it is safe and effective against AML.
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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- My organs are functioning well.I have AML and there are no curative treatments left for me.I am able to get out of my bed or chair and move around.I had a bone marrow transplant, no signs of GVHD, and I'm not on immunosuppression.I am HIV positive.I have no medical reasons preventing me from undergoing leukapheresis.My AML is not in complete remission and may be partially responsive or unresponsive to treatment.My bilirubin levels are below 2.0mg/dl, or below 3.0mg/dl if I have Gilbert's syndrome.I do not have unstable heart rhythm issues.My AML has returned and has a specific genetic feature (t(15:17)).My AML has returned after a stem cell transplant.I have a donor ready for a stem cell transplant if needed.I have severe heart condition limitations.I have a history of optic neuritis or an immune-related brain disease not caused by leukemia or its treatment.I have been checked for brain involvement due to my symptoms.My tests show I have the JAK2 V617F mutation.I had a stem cell transplant over 3 months ago and my disease has returned.I have an active hepatitis B or C infection.I am currently using steroids or immunosuppressants, but not for asthma or as hormone replacement.I am 18 years old or older.I am allergic to some ingredients in the study medication.I have a history of blood cell disorder.
- Group 1: Treatment Arm
- 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 the FDA granted approval to CART123 cells, cyclophosphamide, and fludarabine?
"The safety of CART123 cells; cyclophosphamide; fludarabine has been provisionally rated at a 1 by Power due to the fact that this is an early-stage clinical trial and there is limited data available on its efficacy or security."
What medical conditions are CART123 cells; cyclophosphamide; fludarabine typically prescribed to treat?
"CART123 cells, cyclophosphamide, and fludarabine are all viable treatments for multiple sclerosis, mixed-cell type lymphoma, and acute myelocytic leukemia."
Are there any available slots for participants in this clinical experiment?
"Unfortunately, this research program is no longer searching for participants. The trial was first published on December 6th 2018 and last updated June 29th 2022. If you are looking for other studies that might be relevant to your needs, there are 1,470 active trials recruiting patients with leukemia or myeloid cells as well as 889 involving CART123; cyclophosphamide; fludarabine combinations currently open."
What is the participant capacity of this clinical study?
"The recruitment phase for this medical trial is now closed. It was initially published on December 6th 2018 and its last update was on June 29th 2022. If you are still looking, there currently 1470 trials searching for participants with leukemia or myeloid conditions; 889 studies seeking individuals to receive CART123 cells, cyclophosphamide and fludarabine treatments also exist."
Have there been any other experiments focusing on the combination of CART123 cells, cyclophosphamide, and fludarabine?
"Presently, 889 clinical trials exploring the use of CART123 cells; cyclophosphamide; fludarabine are in progress. Of these studies, 161 hold a Phase 3 status and 28443 locations host them - with many based out of Philadelphia, Pennsylvania."
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