Clinical trialNCT03092674CompletedPhase 2/PHASE3Interventional

Azacitidine With or Without Nivolumab or Midostaurin, or Decitabine and Cytarabine Alone in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

SponsorNational Cancer Institute (NCI)Enrollment76Acute Myeloid LeukemiaMyelodysplastic SyndromeMyelodysplastic Syndrome/Acute Myeloid Leukemia

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This randomized phase II/III trial studies how well azacitidine with or without nivolumab or midostaurin, or decitabine and cytarabine alone work in treating older patients with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome. Drugs used in chemotherapy, such as azacitidine, decitabine, 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. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Midostaurin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving azacitidine with or without nivolumab or midostaurin, or decitabine and cytarabine alone may kill more cancer cells.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Laura C Michaelis
SWOG Cancer Research Network
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

506 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Alaska Breast Care and Surgery Llc
Anchorage, Alaska, United States
Alaska Oncology and Hematology Llc
Anchorage, Alaska, United States
Alaska Women'S Cancer Care
Anchorage, Alaska, United States
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, United States
Anchorage Oncology Centre
Anchorage, Alaska, United States
Katmai Oncology Group
Anchorage, Alaska, United States
Providence Alaska Medical Center
Anchorage, Alaska, United States
Banner University Medical Center - Tucson
Tucson, Arizona, United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States
University of Arizona Cancer Center-Orange Grove Campus
Tucson, Arizona, United States
Chi Saint Vincent Cancer Center Hot Springs
Hot Springs, Arkansas, United States
John L Mcclellan Memorial Veterans Hospital
Little Rock, Arkansas, United States
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, United States
Providence Saint Joseph Medical Center/disney Family Cancer Center
Burbank, California, United States
Kaiser Permanente-Fremont
Fremont, California, United States
Fresno Cancer Center
Fresno, California, United States
Kaiser Permanente-Fresno
Fresno, California, United States
Fremont - Rideout Cancer Center
Marysville, California, United States
Kaiser Permanente-Modesto
Modesto, California, United States
Kaiser Permanente Oakland-Broadway
Oakland, California, United States
Kaiser Permanente-Oakland
Oakland, California, United States
Stanford Cancer Institute Palo Alto
Palo Alto, California, United States
Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cordova, California, United States
Kaiser Permanente-Redwood City
Redwood City, California, United States
Kaiser Permanente-Richmond
Richmond, California, United States
Rohnert Park Cancer Center
Rohnert Park, California, United States
Kaiser Permanente-Roseville
Roseville, California, United States
the Permanente Medical Group-Roseville Radiation Oncology
Roseville, California, United States
Kaiser Permanente Downtown Commons
Sacramento, California, United States
Kaiser Permanente Sacramento Medical Center
Sacramento, California, United States
Kaiser Permanente-South Sacramento
Sacramento, California, United States
South Sacramento Cancer Center
Sacramento, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Kaiser Permanente-San Francisco
San Francisco, California, United States
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, United States
Stanford Cancer Center South Bay
San Jose, California, United States
Kaiser Permanente San Leandro
San Leandro, California, United States
Kaiser Permanente-San Rafael
San Rafael, California, United States
Kaiser San Rafael-Gallinas
San Rafael, California, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States

466 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Azacitidine →Cytarabine →Decitabine →Midostaurin →Nivolumab →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 2 Feb 2018
Primary completion: 1 Aug 2023
Completion: 26 Jun 2024
Last update posted: 16 Jan 2025
Registered enrollment: 76
Registry id: NCT03092674

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.