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Individualized AML Treatment

Feasibility Study of Individualized Treatment Recommendations for Acute Myeloid Leukemia Based on High Throughput Screening and Genomics Data

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether drug tests on a patient's own cancer cells, along with gene tests, can help doctors choose treatment for acute myeloid leukemia (AML), a blood cancer. It is for adults whose AML came back or did not respond to treatment. The study uses extra blood or bone marrow samples but does not give cancer drugs.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older and have confirmed AML.
  • You or your legal representative must give consent. You must allow use of stored tissue from earlier cancer biopsies.
  • AML must have come back or not responded after at least 1 treatment plan for high-risk AML, or at least 2 for low- or middle-risk AML.
  • Be able to do at least some self-care, even if you spend more than half the day in bed or a chair.
  • Have enough cancer cells in blood or bone marrow for testing. Cells from a bone marrow biopsy or a sample from AML outside the marrow may also be used.
  • Be expected to live more than 100 days.
  • Side effects from past cancer treatment must have gone away or become mild, except for hair loss.

Who can't join

  • Have received or plan to receive a live vaccine while in the study.
  • Have acute promyelocytic leukemia, a type of AML, or the chromosome change called t(15;17).
  • Have active cancer in the brain or spinal cord, unless it has been treated and is responding.
  • Have active graft-versus-host disease, when donor cells attack your body.
  • Have unstable heart disease, a heart attack within the past 6 months, or uncontrolled irregular heartbeat or high blood pressure.
  • Have an uncontrolled serious illness or active infection.
  • Be pregnant or breastfeeding.
  • Have another condition or active cancer that makes study procedures unsafe, or be unable to follow all study steps, in the study doctor's judgment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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) * Patients with histologically confirmed AML according to ICC or WHO criteria, and * Refractory/relapsed (R/R) to prior treatment with one or more regimens if adverse risk or two or more regimens if favorable/intermediate risk (Appendix B) * Sufficient bone marrow and/or peripheral blood sample (archival or fresh) to run the high throughput screening (HTS; Estimate sufficient if circulating blast count of 5,000 or greater or cellular marrow with greater than or equal to 20% blasts.) Otherwise, * Sufficient cells flushed from bone marrow biopsy, if bone marrow is not aspirable, OR * Extramedullary disease, if it is possible to obtain a fluid or biopsy sample from that location * Expected survival is greater than 100 days. * Fully recovered from the acute toxic effects (except alopecia) to ≤ Grade 1 to prior anti-cancer therapy Exclusion Criteria: * 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) * Active graft vs host disease (GVHD) * Unstable cardiac disease as defined by one of the following: * Cardiac events such as myocardial infarction (MI) within the past 6 months * Uncontrolled atrial fibrillation or hypertension * Clinically significant uncontrolled illness * Uncontrolled active infection * Females only: Pregnant or breastfeeding * Any other condition or active malignancy that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures. * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics).

Study sites (1)

CA