Individualized AML Treatment

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCity of Hope Medical Center

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Observational

    Other intervention

    This is a non-interventional study

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: R/R AML1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 18 days after sample acquisition

Secondary outcomes

1

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.

Time frame
Up to 18 days of sample acquisition
2

Proportion of patients with successful initiation of treatment

Successful initiation of treatment

Time frame
Up to 1 year
3

Average time to successful initiation of treatment

Time from sample acquisition to successful initiation of treatment

Time frame
Up to 1 year
4

Degree of cytoreduction

Bone marrow percent cellularity and percent leukemia by morphology and flow cytometry compared to pre-treatment level

Time frame
Up to 2-5 weeks after treatment

Other outcomes

Sponsors and contacts

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