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NCT04915612 · ClinicalTrials.gov registry record · Phase 1
Liposomal Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin for the Treatment of Relapsed Refractory Pediatric Patients With Acute Myeloid Leukemia
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT04915612: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT04915612 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 1 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04915612, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
This phase I trial studies the best dose and side effects of liposomal cytarabine, daunorubicin, and gemtuzumab ozogamicin in treating pediatric patients with acute myeloid leukemia that has returned after treatment (relapsed) or does not respond to treatment (refractory). Chemotherapy drugs, such as liposomal cytarabine and daunorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Gemtuzumab ozogamicin is a monoclonal antibody, called gemtuzumab, linked to a toxic agent called ozogamicin. Gemtuzumab attaches to CD33 positive cancer cells in a targeted way and delivers ozogamicin to kill them. Giving liposomal cytarabine and daunorubicin and gemtuzumab ozogamicin may help to control the disease.
Interventions
- DRUG Gemtuzumab Ozogamicin
- DRUG Liposome-encapsulated Daunorubicin-Cytarabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2021-05-21 |
| Est. Completion | 2025-01-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04915612
The ClinicalTrials.gov registry entry for NCT04915612 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Gemtuzumab Ozogamicin is the first listed.
NCT04915612 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04915612 about?
NCT04915612 is a clinical study titled "Liposomal Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin for the Treatment of Relapsed Refractory Pediatric Patients With Acute Myeloid Leukemia". This phase I trial studies the best dose and side effects of liposomal cytarabine, daunorubicin, and gemtuzumab ozogamicin in treating pediatric patients with acute myeloid leukemia that has returned after treatment (relapsed) or does not respond to treatment (refractory). Chemotherapy drugs, such a...
What is the current status of trial NCT04915612?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2021-05-21. Estimated completion is 2025-01-30.
What interventions are being tested in trial NCT04915612?
The interventions under investigation include: Gemtuzumab Ozogamicin (DRUG), Liposome-encapsulated Daunorubicin-Cytarabine (DRUG).
Who is sponsoring clinical trial NCT04915612?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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