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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 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.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2020-05-05 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 1 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 47-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
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 reports 15 study locations spanning 6 distinct geographic areas - top geographies include 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.
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