Individualized AML Treatment using patient-specific drug screening

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will use high-throughput screening on patients’ leukemia cells to see how they respond to about 135 drugs and combinations, guided by extensive genomic and transcriptomic profiling. The HopeSeq sequencing and RNA sequencing inform potential drug choices, while the Cancer Drug Sensitivity Test provides a rapid diagnostic readout. Turnaround times for sequencing are about 8–14 days, with the HTS result reported in roughly 5–7 days. The goal is to tailor treatments for each patient based on functional and molecular data collected from samples collected during routine procedures.

Why it matters

Who can join: the full rules

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).

Where it's running

• City of Hope Medical Center
  Duarte, California, United States Recruiting

Study contacts

• Principal investigator: Pamela Becker, MD — City of Hope Medical Center
• Study coordinator: Pamela Becker, MD
• Email: pbecker@coh.org
• Phone: 626-218-2405

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.