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JNJ-75276617 + Chemotherapy for Acute Leukemia
Study Summary
This trial is testing a new drug, JNJ-75276617, to see if it is effective in treating pediatric and young adult patients with leukemia that has come back or does not respond to treatment.
Timeline
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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- I have been diagnosed with a specific type of leukemia linked to Down syndrome.I had a bone marrow transplant from a donor within the last 2 months.My acute leukemia has specific genetic changes.I have been diagnosed with a bone marrow failure syndrome.I haven't had specific cancer treatments like CAR-T or blinatumomab recently.I have ongoing graft-versus-host disease that is not well-managed.I have previously been treated with menin-KMT2A inhibitors.I received immune-suppressing therapy after a bone marrow transplant within the last 30 days.I can do most activities without help, regardless of my age.
- Group 1: Arm B: >=2 Years Old
- Group 2: Arm A: <2 Years Old
- 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
How many healthcare institutions are conducting this experiment?
"There are 12 different locations across the country that will be facilitating this trial, including but not limited to University of Utah in Salt Lake City, Dana-Farber Cancer Institute in Boston, and Memorial Sloan Kettering in New york."
Has JNJ-75276617 been given regulatory approval by the FDA?
"The safety of JNJ-75276617 has been accorded a score of 1 due to the limited amount of clinical information available from Phase 1 trials."
Is this trial still looking for participants?
"Unfortunately, according to the information available on clinicaltrials.gov, this trial is no longer recruiting participants. The study was first announced December 22nd 2022 and had its last update November 3rd of the same year. Though not currently enrolling individuals into this particular medical assessment, 1601 other trials are actively seeking patients at present."
Does the eligibility criteria for this clinical investigation encompass individuals over 40 years old?
"This clinical trial is seeking participants aged between 30 days and 30 years. Additionally, 495 trials are in progress for minors and 1272 research projects are being conducted on geriatric individuals."
What is the ultimate goal of this investigation?
"This clinical trial, which will take up to 3 years and 5 months, is primarily measuring the number of participants who experience dose-limiting toxicity (DLT). Secondary objectives include assessing plasma concentration levels of JNJ-75276617 as well as counting the amount of participants with depletion or differentiation in leukemic blasts."
Does my profile fulfill the criteria for enrollment into this experiment?
"This clinical trial is seeking 80 individuals aged between 30 days and 30 years, diagnosed with leukemia. To be considered for enrollment, patients must also meet the following criteria: possessing certain genetic mutations of KMT2A or NPM1 or NUP98/NUP214 gene alterations; having a Lansky performance status score above 50 (for those under 16) or Karnofsky scale higher than 50% (for those over 16); estimated glomerular filtration rate exceeding 60 mL/min per 1.73 meters squared based on Schwartz formula assessment at the bedside."
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