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NCT02464657 · ClinicalTrials.gov registry record · Phase 1
Study of Idarubicin, Cytarabine, and Nivolumab in Patients With High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
NCT02464657: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT02464657 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 44 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02464657, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to find the highest tolerable dose of nivolumab that can be give in combination with idarubicin and cytarabine in patients with MDS and AML. The safety and effectiveness of this drug combination will also be studied. This is an investigational study. Nivolumab is not FDA-approved or commercially available. Idarubicin is FDA-approved and commercially available for the treatment of patients with AML. Cytarabine is FDA approved and commercially available for treatment of patient with AML. The use of these drugs in combination is investigational. The study doctor can explain how the drugs are designed to work. Up to 75 patients will take part in this study. All will be enrolled at MD Anderson.
Interventions
- DRUG Nivolumab
- DRUG Dexamethasone
- DRUG Cytarabine
- DRUG Idarubicin
- DRUG Solu-medrol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2015-07 |
| Est. Completion | 2020-05-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02464657
The ClinicalTrials.gov registry entry for NCT02464657 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 44 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 5 interventions - of which Nivolumab is the first listed.
NCT02464657 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02464657 about?
NCT02464657 is a clinical study titled "Study of Idarubicin, Cytarabine, and Nivolumab in Patients With High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)". The goal of this clinical research study is to find the highest tolerable dose of nivolumab that can be give in combination with idarubicin and cytarabine in patients with MDS and AML. The safety and effectiveness of this drug combination will also be studied. This is an investigational study. Nivo...
What is the current status of trial NCT02464657?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2015-07. Estimated completion is 2020-05-07.
What interventions are being tested in trial NCT02464657?
The interventions under investigation include: Nivolumab (DRUG), Dexamethasone (DRUG), Cytarabine (DRUG), Idarubicin (DRUG), Solu-medrol (DRUG).
Who is sponsoring clinical trial NCT02464657?
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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