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Individualized Treatment for Relapsed/Refractory AML

This study is looking at ways to find the best treatment for people with acute myeloid leukemia (AML) that has come back or hasn't responded to previous treatments (relapsed/refractory AML). Researchers are using two main tools: HopeSeq, which looks at over 500 genes and 160 gene changes, and high-throughput drug screening (HTS). HTS tests how your own AML cells react to about 135 different drugs and drug combinations. The goal is to see if these tests can help doctors choose the most effective treatment for each individual patient. To join, you must be at least 18 years old and have AML that has relapsed or is refractory. The study is currently unclear about its recruitment status.

Study design
This is an observational study, meaning researchers will gather information without giving new treatments. It plans to include 18 participants.
What's involved
You would need to agree to use stored tissue from past diagnostic biopsies. Bone marrow, blood, or other involved fluids will be used for testing.
Compensation
Not stated in the trial record.
Follow-up
The main goal is to see if the HopeSeq and CDST tests can be obtained within 18 days after your sample is collected.

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NCT07613385

Individualized AML Treatment

Recruiting
Not specifiedAges 18+Observational
City of Hope Medical Center
~18 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:Observational

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility - Obtaining HopeSeq and CDST
Measured over Up to 18 days after sample acquisition

Conditions

Relapsed/Refractory Acute Myeloid Leukemia (AML)

Explore related trials

Acute Myeloid Leukemia

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Pamela Becker, MD · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

Who to contact

Pamela Becker, MD
[email protected]
626-218-2405
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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).

What this trial measures

  • Feasibility - Obtaining HopeSeq and CDSTUp to 18 days after sample acquisition

    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.