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ACTIVE NOT RECRUITING Phase 1

Testing the Addition of an Anti-cancer Drug, M3814, to the Usual Treatment (Mitoxantrone, Etoposide, and Cytarabine) for Relapsed or Refractory Acute Myeloid Leukemia

NCT03983824 · View on ClinicalTrials.gov ↗

Study Summary

This phase I trial studies the best dose and side effects of M3814 when given in combination with mitoxantrone, etoposide, and cytarabine in treating patients with acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory). M3814 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as mitoxantrone and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Giving M3814 in combination with mitoxantrone, etoposide, and cytarabine may lower the chance of the acute myeloid leukemia growing or spreading.

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Bone Marrow Biopsy
  • PROCEDURE Echocardiography Test
  • DRUG Cytarabine
  • DRUG Etoposide Phosphate

Study Locations (15)

California

  • City of Hope Comprehensive Cancer Center — Duarte
  • Los Angeles General Medical Center — Los Angeles
  • USC / Norris Comprehensive Cancer Center — Los Angeles
  • USC Norris Oncology/Hematology-Newport Beach — Newport Beach
  • Keck Medical Center of USC Pasadena — Pasadena
  • University of California Davis Comprehensive Cancer Center — Sacramento

Florida

  • UM Sylvester Comprehensive Cancer Center at Coral Gables — Coral Gables
  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach — Deerfield Beach
  • University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami
  • UM Sylvester Comprehensive Cancer Center at Plantation — Plantation

Ohio

  • University of Cincinnati Cancer Center-UC Medical Center — Cincinnati
  • University of Cincinnati Cancer Center-West Chester — West Chester

Massachusetts

  • Beth Israel Deaconess Medical Center — Boston

New York

  • Mount Sinai Hospital — New York

Oklahoma

  • University of Oklahoma Health Sciences Center — Oklahoma City

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2020-05-05
Est. Completion 2026-06-30
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

2,390 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03983824

The ClinicalTrials.gov registry entry for NCT03983824 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Refractory Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions — of which Biospecimen Collection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03983824 reports 15 study locations spanning 6 distinct geographic areas — top geographies include California, Florida, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03983824 about?

NCT03983824 is a clinical study titled "Testing the Addition of an Anti-cancer Drug, M3814, to the Usual Treatment (Mitoxantrone, Etoposide, and Cytarabine) for Relapsed or Refractory Acute Myeloid Leukemia". This phase I trial studies the best dose and side effects of M3814 when given in combination with mitoxantrone, etoposide, and cytarabine in treating patients with acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory). M3814 may stop the growth of cancer ...

What is the current status of trial NCT03983824?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2020-05-05. Estimated completion is 2026-06-30.

What conditions does trial NCT03983824 study?

This clinical trial studies the following conditions: Refractory Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03983824?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Echocardiography Test (PROCEDURE), Cytarabine (DRUG), Etoposide Phosphate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03983824?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03983824 being conducted?

This trial has 15 study locations across California, Florida, Massachusetts, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial