Individualized AML Treatment

StatusRecruiting
PhaseNot specified
Started

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Trial flagged as At Risk
Primary completion moved at least 5 months later Dec 31, 2027 → Jun 22, 2028
See other at-risk trials from City of Hope Medical Center

Record History

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  1. Minor Primary completion pushed from Dec 31, 2027 to Jun 22, 2028 Show 5 more changesShow less
    • Enrollment increased: 18 → 20 participants
    • Study completion date: Jun 1, 2028 to Jun 22, 2028
    • Eligibility criteria expanded, about 24 words
    • Secondary endpoints: details revised at 3 of 6 entries
    • Study description revised
  2. Minor Start date: Jan 1, 2026 to Jan 28, 2026v3
  3. Minor Study description revisedv2
  4. Minor Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Every patient responds differently to their cancer treatment, and some treatments work better for some patients more than others. For patients with relapsed, refractory ( R/R) AML, there may be fewer approved treatment options remaining. In this research study, the investigators are testing whether high throughput drug screening (HTS) in combination with robust molecular testing by HopeSeq (includes DNA sequencing for \>500 genes and 160 gene rearrangements and RNAseq for \>5,000 genes) can help doctors determine which treatment might work best for each individual patient. HTS tests how the patient's own AML cells respond to different treatment options including individual drugs and triple drug regimens and recommends for the best treatment options for an individual patient. Participants will provide extra bone marrow and/or blood at the time of routine procedure, and these extra sample(s) will be tested using the Cancer Drug Sensitivity Test ( CDST) HTS, CLIA approved in Washington state since 2014. A committee (the Functional Molecular Tumor Board) will review the HopeSeq and HTS results, past treatments, and clinical description, and give a recommendation for the best AML treatment options for each individual patient. The patient's doctor will get a copy of the recommendation and discuss treatment options with the patient. The patient and their doctor will decide on the best treatment plan for the patient, one which will be approved by insurance. Patients will not be treated with any drugs as part of this study. Then at 6 and 12 months, there will be retrospective review of medical records to determine how will the testing predicted the response, drug sensitivity or resistance, and overall and disease-free survival will be monitored.
Trial Details
NCT Number NCT07613385
Lead Sponsor City of Hope Medical Center
Conditions
(from sponsor)
Relapsed/Refractory Acute Myeloid Leukemia (AML)
Related terms Leukemia, Myeloid, Acute
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov