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NCT03983824 · ClinicalTrials.gov registry record · 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

A Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 1
Development phase
48
Enrollment target
15
Study locations

NCT03983824: Active Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia, sponsored by National Cancer Institute (NCI).

NCT03983824 is a Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 48 participants, roughly in line with the 47-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target. The trial reports 15 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03983824, a Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
48 participants
Enrollment target
15
Study locations

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.

Primary Outcome

Coded according to the Common Terminology Criteria for Adverse Events version 5.

Conditions Studied

Refractory Acute Myeloid Leukemia Recurrent Acute Myeloid Leukemia

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
National Cancer Institute (NCI)

3,257 total trials

What the registry record for NCT03983824 still lists

NCT03983824 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, roughly in line with the 47-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target.

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.

NCT03983824 lists 15 locations in 6 states (California, Florida, Ohio).

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.

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).

Who is sponsoring clinical trial NCT03983824?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Refractory Acute Myeloid Leukemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03983824's enrollment target sits among peer trials

48 26th of 63 higher than 38 of 63 other Refractory Acute Myeloid Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Refractory Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT03983824, the US trial registry maintained by the National Library of Medicine. NCT03983824 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.