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NCT07613385 · ClinicalTrials.gov registry record
Individualized AML Treatment
A clinical trial, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- 18
- Enrollment target
NCT07613385: Recruiting study, sponsored by City of Hope Medical Center.
NCT07613385 is a clinical trial that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 18 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07613385 is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- 18 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Success in obtaining HopeSeq Heme Comprehensive (HopeSeq) and Cancer Drug Sensitivity Test Diagnostic (CDST) High Throughput Screen (HTS) reports and interpretation of results by the Functional Molecular Tumor Board (FMTB) Success of performing HOPESEQ and CDST HTS and obtaining an individualized treatment recommendation from the FMTB based on multiomic data within 18 days from sample acquisition.
Interventions
- OTHER Observational
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2026-01-01 |
| Est. Completion | 2028-06-01 |
What NCT07613385 shows while recruiting
NCT07613385 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 18 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Observational is the first listed.
NCT07613385 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07613385 about?
NCT07613385 is a clinical study titled "Individualized AML Treatment". 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 ...
What is the current status of trial NCT07613385?
This trial is currently recruiting. The enrollment target is 18 participants. The study started on 2026-01-01. Estimated completion is 2028-06-01.
What interventions are being tested in trial NCT07613385?
The interventions under investigation include: Observational (OTHER).
Who is sponsoring clinical trial NCT07613385?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
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