ClinicalTrials.gov record
Azacitidine and Combination Chemotherapy in Treating Infants With Acute Lymphoblastic Leukemia and KMT2A Gene Rearrangement
ClinicalTrials.gov ID: NCT02828358
Public ClinicalTrials.gov record NCT02828358. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Groupwide Pilot Study to Test the Tolerability and Biologic Activity of the Addition of Azacitidine (IND# 133688, NSC# 102816) to Chemotherapy in Infants With Acute Lymphoblastic Leukemia (ALL) and KMT2A(MLL) Gene Rearrangement
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This pilot phase II trial studies the side effects of azacitidine and combination chemotherapy in infants with acute lymphoblastic leukemia and KMT2A gene rearrangement. Drugs used in chemotherapy, such as methotrexate, prednisolone, daunorubicin hydrochloride, cytarabine, dexamethasone, vincristine sulfate, pegaspargase, hydrocortisone sodium succinate, azacitidine, cyclophosphamide, mercaptopurine, leucovorin calcium, and thioguanine 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. Giving more than one drug may kill more cancer cells.
Study identification
- NCT ID
- NCT02828358
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 78 participants
Conditions and interventions
Conditions
Interventions
- Azacitidine Drug
- Biospecimen Collection Procedure
- Computed Tomography Procedure
- Cyclophosphamide Drug
- Cytarabine Drug
- Daunorubicin Drug
- Daunorubicin Hydrochloride Drug
- Dexamethasone Drug
- Echocardiography Procedure
- Hydrocortisone Sodium Succinate Drug
- Leucovorin Drug
- Leucovorin Calcium Drug
- Magnetic Resonance Imaging Procedure
- Mercaptopurine Drug
- Methotrexate Drug
- Multigated Acquisition Scan Procedure
- Pegaspargase Drug
- Prednisolone Drug
- Thioguanine Drug
- Vincristine Drug
- Vincristine Sulfate Drug
Drug · Procedure
Eligibility (public fields only)
- Age range
- Up to 364 Days
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 1, 2017 (Actual)
- Primary completion
- Sep 30, 2020 (Actual)
- Completion
- Dec 31, 2024 (Actual)
- Last update posted
- Feb 27, 2025
2017 – 2024
United States locations
- U.S. sites
- 157
- U.S. states
- 47
- U.S. cities
- 131
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital of Alabama | Birmingham | Alabama | 35233 | — |
| USA Health Strada Patient Care Center | Mobile | Alabama | 36604 | — |
| Providence Alaska Medical Center | Anchorage | Alaska | 99508 | — |
| Banner Children's at Desert | Mesa | Arizona | 85202 | — |
| Phoenix Childrens Hospital | Phoenix | Arizona | 85016 | — |
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202-3591 | — |
| Kaiser Permanente Downey Medical Center | Downey | California | 90242 | — |
| Loma Linda University Medical Center | Loma Linda | California | 92354 | — |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | — |
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | — |
| Valley Children's Hospital | Madera | California | 93636 | — |
| UCSF Benioff Children's Hospital Oakland | Oakland | California | 94609 | — |
| Kaiser Permanente-Oakland | Oakland | California | 94611 | — |
| Children's Hospital of Orange County | Orange | California | 92868 | — |
| Lucile Packard Children's Hospital Stanford University | Palo Alto | California | 94304 | — |
| University of California Davis Comprehensive Cancer Center | Sacramento | California | 95817 | — |
| UCSF Medical Center-Mission Bay | San Francisco | California | 94158 | — |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Torrance | California | 90502 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center | Denver | Colorado | 80218 | — |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | — |
| Yale University | New Haven | Connecticut | 06520 | — |
| Alfred I duPont Hospital for Children | Wilmington | Delaware | 19803 | — |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | — |
| Golisano Children's Hospital of Southwest Florida | Fort Myers | Florida | 33908 | — |
| University of Florida Health Science Center - Gainesville | Gainesville | Florida | 32610 | — |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital | Hollywood | Florida | 33021 | — |
| Nemours Children's Clinic-Jacksonville | Jacksonville | Florida | 32207 | — |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | 33136 | — |
| Nicklaus Children's Hospital | Miami | Florida | 33155 | — |
| AdventHealth Orlando | Orlando | Florida | 32803 | — |
| Arnold Palmer Hospital for Children | Orlando | Florida | 32806 | — |
| Nemours Children's Hospital | Orlando | Florida | 32827 | — |
| Nemours Children's Clinic - Pensacola | Pensacola | Florida | 32504 | — |
| Johns Hopkins All Children's Hospital | St. Petersburg | Florida | 33701 | — |
| Saint Joseph's Hospital/Children's Hospital-Tampa | Tampa | Florida | 33607 | — |
| Saint Mary's Medical Center | West Palm Beach | Florida | 33407 | — |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital | Atlanta | Georgia | 30329 | — |
| Memorial Health University Medical Center | Savannah | Georgia | 31404 | — |
| Kapiolani Medical Center for Women and Children | Honolulu | Hawaii | 96826 | — |
| Saint Luke's Cancer Institute - Boise | Boise | Idaho | 83712 | — |
| Lurie Children's Hospital-Chicago | Chicago | Illinois | 60611 | — |
| University of Illinois | Chicago | Illinois | 60612 | — |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | — |
| Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| Advocate Children's Hospital-Oak Lawn | Oak Lawn | Illinois | 60453 | — |
| Advocate Children's Hospital-Park Ridge | Park Ridge | Illinois | 60068 | — |
| Saint Jude Midwest Affiliate | Peoria | Illinois | 61637 | — |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62702 | — |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | — |
| Ascension Saint Vincent Indianapolis Hospital | Indianapolis | Indiana | 46260 | — |
| Blank Children's Hospital | Des Moines | Iowa | 50309 | — |
| University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa | 52242 | — |
| University of Kentucky/Markey Cancer Center | Lexington | Kentucky | 40536 | — |
| Norton Children's Hospital | Louisville | Kentucky | 40202 | — |
| Children's Hospital New Orleans | New Orleans | Louisiana | 70118 | — |
| Ochsner Medical Center Jefferson | New Orleans | Louisiana | 70121 | — |
| Eastern Maine Medical Center | Bangor | Maine | 04401 | — |
| Maine Children's Cancer Program | Scarborough | Maine | 04074 | — |
| Sinai Hospital of Baltimore | Baltimore | Maryland | 21215 | — |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | 21287 | — |
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889-5600 | — |
| Tufts Children's Hospital | Boston | Massachusetts | 02111 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| UMass Memorial Medical Center - University Campus | Worcester | Massachusetts | 01655 | — |
| C S Mott Children's Hospital | Ann Arbor | Michigan | 48109 | — |
| Henry Ford Health Saint John Hospital | Detroit | Michigan | 48236 | — |
| Michigan State University Clinical Center | East Lansing | Michigan | 48824 | — |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital | Grand Rapids | Michigan | 49503 | — |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | — |
| Corewell Health Children's | Royal Oak | Michigan | 48073 | — |
| University of Minnesota/Masonic Cancer Center | Minneapolis | Minnesota | 55455 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| University of Missouri Children's Hospital | Columbia | Missouri | 65212 | — |
| Children's Mercy Hospitals and Clinics | Kansas City | Missouri | 64108 | — |
| Cardinal Glennon Children's Medical Center | St Louis | Missouri | 63104 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Mercy Hospital Saint Louis | St Louis | Missouri | 63141 | — |
| Children's Hospital and Medical Center of Omaha | Omaha | Nebraska | 68114 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| University Medical Center of Southern Nevada | Las Vegas | Nevada | 89102 | — |
| Sunrise Hospital and Medical Center | Las Vegas | Nevada | 89109 | — |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation | Las Vegas | Nevada | 89135 | — |
| Summerlin Hospital Medical Center | Las Vegas | Nevada | 89144 | — |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center | Lebanon | New Hampshire | 03756 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Morristown Medical Center | Morristown | New Jersey | 07960 | — |
| Saint Peter's University Hospital | New Brunswick | New Jersey | 08901 | — |
| Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08903 | — |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | — |
| Saint Joseph's Regional Medical Center | Paterson | New Jersey | 07503 | — |
| Albany Medical Center | Albany | New York | 12208 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | — |
| NYU Langone Hospital - Long Island | Mineola | New York | 11501 | — |
| The Steven and Alexandra Cohen Children's Medical Center of New York | New Hyde Park | New York | 11040 | — |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York | 10016 | — |
| Mount Sinai Hospital | New York | New York | 10029 | — |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | — |
| State University of New York Upstate Medical University | Syracuse | New York | 13210 | — |
| New York Medical College | Valhalla | New York | 10595 | — |
| Mission Hospital | Asheville | North Carolina | 28801 | — |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | — |
| Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina | 28203 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| East Carolina University | Greenville | North Carolina | 27834 | — |
| Sanford Broadway Medical Center | Fargo | North Dakota | 58122 | — |
| Children's Hospital Medical Center of Akron | Akron | Ohio | 44308 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| Dayton Children's Hospital | Dayton | Ohio | 45404 | — |
| ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital | Toledo | Ohio | 43606 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Legacy Emanuel Children's Hospital | Portland | Oregon | 97227 | — |
| Lehigh Valley Hospital-Cedar Crest | Allentown | Pennsylvania | 18103 | — |
| Lehigh Valley Hospital - Muhlenberg | Bethlehem | Pennsylvania | 18017 | — |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | — |
| Penn State Children's Hospital | Hershey | Pennsylvania | 17033 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Saint Christopher's Hospital for Children | Philadelphia | Pennsylvania | 19134 | — |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | — |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | — |
| Prisma Health Richland Hospital | Columbia | South Carolina | 29203 | — |
| BI-LO Charities Children's Cancer Center | Greenville | South Carolina | 29605 | — |
| Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota | 57117-5134 | — |
| T C Thompson Children's Hospital | Chattanooga | Tennessee | 37403 | — |
| East Tennessee Childrens Hospital | Knoxville | Tennessee | 37916 | — |
| The Children's Hospital at TriStar Centennial | Nashville | Tennessee | 37203 | — |
| Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | 37232 | — |
| Dell Children's Medical Center of Central Texas | Austin | Texas | 78723 | — |
| Driscoll Children's Hospital | Corpus Christi | Texas | 78411 | — |
| Medical City Dallas Hospital | Dallas | Texas | 75230 | — |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | 75390 | — |
| El Paso Children's Hospital | El Paso | Texas | 79905 | — |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | — |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center | Houston | Texas | 77030 | — |
| Covenant Children's Hospital | Lubbock | Texas | 79410 | — |
| UMC Cancer Center / UMC Health System | Lubbock | Texas | 79415 | — |
| Children's Hospital of San Antonio | San Antonio | Texas | 78207 | — |
| Methodist Children's Hospital of South Texas | San Antonio | Texas | 78229 | — |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | — |
| Scott and White Memorial Hospital | Temple | Texas | 76508 | — |
| Primary Children's Hospital | Salt Lake City | Utah | 84113 | — |
| University of Vermont and State Agricultural College | Burlington | Vermont | 05405 | — |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | — |
| Children's Hospital of The King's Daughters | Norfolk | Virginia | 23507 | — |
| Carilion Children's | Roanoke | Virginia | 24014 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
| Providence Sacred Heart Medical Center and Children's Hospital | Spokane | Washington | 99204 | — |
| West Virginia University Charleston Division | Charleston | West Virginia | 25304 | — |
| West Virginia University Healthcare | Morgantown | West Virginia | 26506 | — |
| Saint Vincent Hospital Cancer Center Green Bay | Green Bay | Wisconsin | 54301 | — |
| University of Wisconsin Carbone Cancer Center - University Hospital | Madison | Wisconsin | 53792 | — |
| Marshfield Medical Center-Marshfield | Marshfield | Wisconsin | 54449 | — |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 13 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02828358, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 27, 2025 · Synced Oct 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02828358 live on ClinicalTrials.gov.