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Targeted Total Marrow Irradiation for Leukemia
Study Summary
This trial will use a new treatment for leukemia that includes targeted total marrow irradiation and graft-versus-host disease prophylaxis.
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.Find a Location
Who is running the clinical trial?
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- My vital organs are functioning well.My health is significantly impaired; I need assistance for self-care.My cancer has specific genetic features considered high-risk.My cancer has high-risk genetic features like the FLT3 mutation.You have other health problems that could interfere with the study.I was diagnosed with MDS before turning 21.My acute lymphoblastic leukemia is in its first remission and is considered high risk.My donor matches me in at least half of the required genetic markers.My leukemia is Philadelphia-like ALL.My leukemia has returned or didn't respond to treatment.My cancer has high-risk genetic features.I am older than 35.My MDS has at least one high-risk feature.I have a history of cirrhosis.I need blood transfusions more than once a week due to severe blood cell shortages.I have a bone marrow disorder related to previous cancer treatment.My leukemia is of a mixed or dual type.My diagnosis is listed as eligible for the trial.My cancer has specific genetic features considered high-risk.I am between 18 and 75 years old.My AML is in its first remission and is considered high-risk.My condition did not improve after DNA-methyltransferase inhibitor therapy.I am unable to sign the consent form myself.My AML developed from a previous blood disorder.I have had radiation on more than 20% of my bone marrow areas.My cancer has high-risk genetic features like BCOR or p53 mutations.
- 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
What is the upper limit on participants in this clinical trial?
"Affirmative. Clinicaltrials.gov shows that this clinical trial, which was first uploaded on January 27th 2020 is currently searching for participants to join the study. The total number of patients needed are 27, who will be recruited from one medical facility."
What key aims is this clinical trial attempting to attain?
"Over the course of a year, this clinical trial will primarily measure GVHD relapse-free survival. Secondary metrics include event free-survival (EFS), progression at one year post transplantation and engraftment rates 30 days into the study."
Am I eligible to join the investigation?
"This clinical trial is seeking 27 leukemia patients, ranging in age from 18 to 75 years old. In accordance with the protocol requirements, participants must possess a related donor who shares at least one allele of each HLA loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1 and HLADQB1; alternatively an unrelated donor that mismatches at least one of these loci will be accepted as long as they share 5/10 genetic markers. Additionally applicants should have relapsed or refractory acute leukemia (including AML or ALL in CR2 and primary refractory leukemia"
Are participants being accepted for this study at the current time?
"Clinicaltrials.gov reveals that recruitment for this trial is ongoing and has been since the study was first published on January 27th 2020, with a final update taking place October 13th 2022."
What potential risks might be associated with this particular treatment?
"The perceived safety of this treatment has been rated at a 2 by Power, as the Phase 2 trial only provides evidence for its security and not its efficacy."
Is the study recruiting participants who are 45 years of age and older?
"The age cutoff for this trial is 18 years old and 75, as dictated by the requirements listed in the eligibility criteria."
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