Recruiting

HTS & HopeSeq

Sponsor:

City of Hope Medical Center

Code:

NCT07613385

Conditions

Relapsed/Refractory Acute Myeloid Leukemia (AML)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Observational

Study Details

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)

Study ID

NCT07613385

Start date

Jan 28, 2026

Status verified date

Aug, 2026

Completion date

Jun 1, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

18 participants

Anticipated

Interventions and Outcome Measures

Arms

R/R AML

Adults with relapsed/refractory acute myeloid leukemia

Interventions

Observational

This is a non-interventional study

Primary outcome measure

  • Feasibility - Obtaining HopeSeq and CDST [ Time Frame: Up to 18 days after sample acquisition ]

Central Contacts and Locations

Central contacts

Pamela Becker, MD

626-218-2405pbecker@coh.org

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Pamela Becker, MD

626-218-2405pbecker@coh.org

More Information

Sponsor

City of Hope Medical Center

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Keywords

  • Feasibility study
  • Acute myeloid leukemia
  • Individualized treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-08-21.