About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Documented informed consent of the participant and/or legally authorized representative.
Agreement to allow the use of archival tissue from diagnostic tumor biopsies
Age: ≥ 18 years
ECOG ≤ 3 (Appendix A)
Disqualifiers
Treatment with any chemotherapeutic agent necessary to control AML burden is permitted between day -18 and -1.
Must not have received or planning to receive live vaccine while being on study
Patients with t(15;17) karyotypic abnormality or acute promyelocytic leukemia (FAB class M3-AML)
Active central nervous system (CNS) disease (OK if treated and responding)
Trial population
Adults with relapsed/refractory acute myeloid leukemia
Trial design
Cohort
Prospective
Treatments tested in this trial
Observational
Other interventionThis is a non-interventional study
Treatment groups
Trial outcomes
Primary outcomes
Feasibility - Obtaining HopeSeq and CDST
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.
Secondary outcomes
Proportion of participants with successful CDST HTS reports
Samples received with sufficient cell numbers and viability to perform CDST HTS 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 in at least 70% of participants.
Proportion of patients with successful initiation of treatment
Successful initiation of treatment
Average time to successful initiation of treatment
Time from sample acquisition to successful initiation of treatment
Degree of cytoreduction
Bone marrow percent cellularity and percent leukemia by morphology and flow cytometry compared to pre-treatment level
Sponsors and contacts
Click on the lead sponsor to view all of their trials.