Individualized AML Treatment

NCT07613385 | Recruiting DMC

• 1 other identifier: 24673
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Relapsed/Refractory Acute Myeloid Leukemia (AML)

Keywords

Feasibility study; Acute myeloid leukemia; Individualized treatment

Outcome Measures

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.

  Up to 18 days after sample acquisition

Secondary Outcomes (6)

• Proportion of participants with successful CDST HTS reports

  Up to 18 days of sample acquisition

• Proportion of patients with successful initiation of treatment

  Up to 1 year

• Average time to successful initiation of treatment

  Up to 1 year

• Degree of cytoreduction

  Up to 2-5 weeks after treatment

• Preliminary estimate of remission

  Up to 1 year

Study Arms (1)

R/R AML

Adults with relapsed/refractory acute myeloid leukemia

Other: Observational

Interventions

Observational OTHER

This is a non-interventional study

R/R AML

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with relapsed/refractory acute myeloid leukemia

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• City of Hope Medical Center: lead

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Pamela Becker, MD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pamela Becker, MD

CONTACT

626-218-2405; pbecker@coh.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 29, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)