NCT02521493Active, not recruitingPhase 3
Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome
Risk-Stratified Therapy for Acute Myeloid Leukemia in Down Syndrome
Source: ClinicalTrials.gov · Last updated 19 Aug 2026
Brief summary (registry, in English)
This phase III trial studies response-based chemotherapy in treating newly diagnosed acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome. Drugs used in chemotherapy 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. Response-based chemotherapy separates patients into different risk groups and treats them according to how they respond to the first course of treatment (Induction I). Response-based treatment may be effective in treating acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome while reducing the side effects.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 280 (actual)
- First submitted
- 10 Aug 2015
- Start date
- 23 Dec 2015
- Primary completion date
- 30 Jun 2024
- Lead sponsor
- Children's Oncology Group
- Diseases
- Myeloproliferative neoplasms, Myelodysplastic syndromes, Acute myeloid leukemia, Childhood cancers
- NCT number
- NCT02521493
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 280
- From 23 Dec 2015 to the primary completion date, 30 Jun 2024
- 191 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior therapy
- Patients =\< 30 days from the last dose of cytarabine used for treatment of TMD
Other
- Patients with promyelocytic leukemia (French-American-British \[FAB\] M3)
Who the study is looking for
- Patients must have constitutional trisomy 21 (Down syndrome) or trisomy 21 mosaicism (by karyotype or fluorescence in situ hybridization \[FISH\])
- Patient has one of the following:
- Patient has previously untreated de novo AML and meets the criteria for AML with \>= 20% bone marrow blasts as set out in the World Health Organization (WHO) Myeloid Neoplasm classification
- Attempts to obtain bone marrow either by aspirate or biopsy must be made unless clinically prohibitive; in cases where it is clinically prohibitive, peripheral blood with an excess of 20% blasts and in which adequate flow cytometric and cytogenetics/FISH testing is feasible can be substituted for the marrow exam at diagnosis
- Patient has cytopenias and/or bone marrow blasts but does not meet the criteria for the diagnosis of AML (WHO Myeloid Neoplasm classification) because of \< 20% marrow blasts and meets the criteria for a diagnosis of myelodysplastic syndrome (MDS)
- For patients who do not meet criteria for AML or MDS as outlined above; patient has a history of transient myeloproliferative disorder (which may or may not have required chemotherapy intervention and:
- Is \> 8 weeks since resolution of transient myeloproliferative disease (TMD) with \>= 5% blasts, OR
- Has an increasing blast count (\>= 5%) in serial bone marrow aspirates performed at least 4 weeks apart
- Children who have previously received chemotherapy, radiation therapy or any anti-leukemic therapy are not eligible for this protocol, with the exception of cytarabine for the treatment of TMD
- There are no minimal organ function requirements for enrollment on this study
- Note: Previous cardiac repair with sufficient cardiac function is not an exclusion criteria
- Each patient's parents or legal guardians must sign a written informed consent
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human subjects research must be met
Age in the registry: 91 days to 3 years · Sex: All · Does not accept healthy volunteers
Sites (191)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| John Hunter Children's Hospital Coordinator of this site? Confirm its status | Hunter Regional Mail Centre | Australia | Unknown status |
| Royal Children's Hospital Coordinator of this site? Confirm its status | Parkville | Australia | Unknown status |
| Perth Children's Hospital Coordinator of this site? Confirm its status | Perth | Australia | Unknown status |
| Princess Margaret Hospital for Children Coordinator of this site? Confirm its status | Perth | Australia | Unknown status |
| Sydney Children's Hospital Coordinator of this site? Confirm its status | Randwick | Australia | Unknown status |
| The Children's Hospital at Westmead Coordinator of this site? Confirm its status | Westmead | Australia | Unknown status |
| IWK Health Centre Coordinator of this site? Confirm its status | Halifax | Canada | Unknown status |
| McMaster Children's Hospital at Hamilton Health Sciences Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| Kingston Health Sciences Centre Coordinator of this site? Confirm its status | Kingston | Canada | Unknown status |
| Children's Hospital Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| The Montreal Children's Hospital of the MUHC Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Centre Hospitalier Universitaire Sainte-Justine Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Children'S Hospital Of Eastern Ontario Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| Hospital for Sick Children Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| British Columbia Children's Hospital Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| CancerCare Manitoba Coordinator of this site? Confirm its status | Winnipeg | Canada | Unknown status |
| Christchurch Hospital Coordinator of this site? Confirm its status | Christchurch | New Zealand | Unknown status |
| Starship Children's Hospital Coordinator of this site? Confirm its status | Grafton | New Zealand | Unknown status |
| San Jorge Children's Hospital Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| University Pediatric Hospital Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| King Faisal Specialist Hospital and Research Centre Coordinator of this site? Confirm its status | Riyadh | Saudi Arabia | Unknown status |
| Children's Hospital Medical Center of Akron Coordinator of this site? Confirm its status | Akron | United States | Unknown status |
| Albany Medical Center Coordinator of this site? Confirm its status | Albany | United States | Unknown status |
| Presbyterian Hospital Coordinator of this site? Confirm its status | Albuquerque | United States | Unknown status |
| University of New Mexico Cancer Center Coordinator of this site? Confirm its status | Albuquerque | United States | Unknown status |
| Texas Tech University Health Sciences Center-Amarillo Coordinator of this site? Confirm its status | Amarillo | United States | Unknown status |
| Providence Alaska Medical Center Coordinator of this site? Confirm its status | Anchorage | United States | Unknown status |
| C S Mott Children's Hospital Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Mission Hospital Coordinator of this site? Confirm its status | Asheville | United States | Unknown status |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Children's Hospital Colorado Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Dell Children's Medical Center of Central Texas Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Sinai Hospital of Baltimore Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Johns Hopkins University/Sidney Kimmel Cancer Center Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Eastern Maine Medical Center Coordinator of this site? Confirm its status | Bangor | United States | Unknown status |
| Walter Reed National Military Medical Center Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
| Children's Hospital of Alabama Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Saint Luke's Cancer Institute - Boise Coordinator of this site? Confirm its status | Boise | United States | Unknown status |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Tufts Children's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Roswell Park Cancer Institute Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
| University of Vermont and State Agricultural College Coordinator of this site? Confirm its status | Burlington | United States | Unknown status |
| UNC Lineberger Comprehensive Cancer Center Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| West Virginia University Charleston Division Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Carolinas Medical Center/Levine Cancer Institute Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Novant Health Presbyterian Medical Center Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| T C Thompson Children's Hospital Coordinator of this site? Confirm its status | Chattanooga | United States | Unknown status |
| University of Chicago Comprehensive Cancer Center Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| University of Illinois Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Lurie Children's Hospital-Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Cleveland Clinic Foundation Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Rainbow Babies and Childrens Hospital Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| University of Missouri Children's Hospital Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| Nationwide Children's Hospital Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Driscoll Children's Hospital Coordinator of this site? Confirm its status | Corpus Christi | United States | Unknown status |
| UT Southwestern/Simmons Cancer Center-Dallas Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Medical City Dallas Hospital Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Geisinger Medical Center Coordinator of this site? Confirm its status | Danville | United States | Unknown status |
| Dayton Children's Hospital Coordinator of this site? Confirm its status | Dayton | United States | Unknown status |
| Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Blank Children's Hospital Coordinator of this site? Confirm its status | Des Moines | United States | Unknown status |
| Henry Ford Health Saint John Hospital Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Wayne State University/Karmanos Cancer Institute Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Kaiser Permanente Downey Medical Center Coordinator of this site? Confirm its status | Downey | United States | Unknown status |
| Duke University Medical Center Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Michigan State University Coordinator of this site? Confirm its status | East Lansing | United States | Unknown status |
| El Paso Children's Hospital Coordinator of this site? Confirm its status | El Paso | United States | Unknown status |
| Inova Fairfax Hospital Coordinator of this site? Confirm its status | Falls Church | United States | Unknown status |
| Sanford Broadway Medical Center Coordinator of this site? Confirm its status | Fargo | United States | Unknown status |
| Hurley Medical Center Coordinator of this site? Confirm its status | Flint | United States | Unknown status |
| Broward Health Medical Center Coordinator of this site? Confirm its status | Fort Lauderdale | United States | Unknown status |
| Golisano Children's Hospital of Southwest Florida Coordinator of this site? Confirm its status | Fort Myers | United States | Unknown status |
| Cook Children's Medical Center Coordinator of this site? Confirm its status | Fort Worth | United States | Unknown status |
| UF Health Cancer Institute - Gainesville Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Coordinator of this site? Confirm its status | Grand Rapids | United States | Unknown status |
| Saint Vincent Hospital Cancer Center Green Bay Coordinator of this site? Confirm its status | Green Bay | United States | Unknown status |
| East Carolina University Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| BI-LO Charities Children's Cancer Center Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| Hackensack University Medical Center Coordinator of this site? Confirm its status | Hackensack | United States | Unknown status |
| Connecticut Children's Medical Center Coordinator of this site? Confirm its status | Hartford | United States | Unknown status |
| Penn State Children's Hospital Coordinator of this site? Confirm its status | Hershey | United States | Unknown status |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Coordinator of this site? Confirm its status | Hollywood | United States | Unknown status |
| Kapiolani Medical Center for Women and Children Coordinator of this site? Confirm its status | Honolulu | United States | Unknown status |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Ascension Saint Vincent Indianapolis Hospital Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Riley Hospital for Children Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| University of Iowa/Holden Comprehensive Cancer Center Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| University of Mississippi Medical Center Coordinator of this site? Confirm its status | Jackson | United States | Unknown status |
| Nemours Children's Clinic-Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Bronson Methodist Hospital Coordinator of this site? Confirm its status | Kalamazoo | United States | Unknown status |
| Children's Mercy Hospitals and Clinics Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| East Tennessee Childrens Hospital Coordinator of this site? Confirm its status | Knoxville | United States | Unknown status |
| Summerlin Hospital Medical Center Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Sunrise Hospital and Medical Center Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| University Medical Center of Southern Nevada Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Coordinator of this site? Confirm its status | Lebanon | United States | Unknown status |
| University of Kentucky/Markey Cancer Center Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| Arkansas Children's Hospital Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| Loma Linda University Medical Center Coordinator of this site? Confirm its status | Loma Linda | United States | Unknown status |
| Miller Children's and Women's Hospital Long Beach Coordinator of this site? Confirm its status | Long Beach | United States | Unknown status |
| Children's Hospital Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Norton Children's Hospital Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Palms West Radiation Therapy Coordinator of this site? Confirm its status | Loxahatchee Groves | United States | Unknown status |
| Covenant Children's Hospital Coordinator of this site? Confirm its status | Lubbock | United States | Unknown status |
| UMC Cancer Center / UMC Health System Coordinator of this site? Confirm its status | Lubbock | United States | Unknown status |
| Valley Children's Hospital Coordinator of this site? Confirm its status | Madera | United States | Unknown status |
| University of Wisconsin Carbone Cancer Center - University Hospital Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| Saint Jude Children's Research Hospital Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| Banner Children's at Desert Coordinator of this site? Confirm its status | Mesa | United States | Unknown status |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Nicklaus Children's Hospital Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Children's Hospital of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| NYU Langone Hospital - Long Island Coordinator of this site? Confirm its status | Mineola | United States | Unknown status |
| University of Minnesota/Masonic Cancer Center Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Children's Hospitals and Clinics of Minnesota - Minneapolis Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Morristown Medical Center Coordinator of this site? Confirm its status | Morristown | United States | Unknown status |
| Vanderbilt University/Ingram Cancer Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| The Children's Hospital at TriStar Centennial Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital Coordinator of this site? Confirm its status | New Brunswick | United States | Unknown status |
| Yale University Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Children's Hospital New Orleans Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| Ochsner Medical Center Jefferson Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Mount Sinai Hospital Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| NYP/Weill Cornell Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Children's Hospital of The King's Daughters Coordinator of this site? Confirm its status | Norfolk | United States | Unknown status |
| UCSF Benioff Children's Hospital Oakland Coordinator of this site? Confirm its status | Oakland | United States | Unknown status |
| Kaiser Permanente-Oakland Coordinator of this site? Confirm its status | Oakland | United States | Unknown status |
| Advocate Children's Hospital-Oak Lawn Coordinator of this site? Confirm its status | Oak Lawn | United States | Unknown status |
| University of Oklahoma Health Sciences Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| Children's Hospital of Orange County Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| Arnold Palmer Hospital for Children Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| AdventHealth Orlando Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Nemours Children's Hospital Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Lucile Packard Children's Hospital Stanford University Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
| Advocate Children's Hospital-Park Ridge Coordinator of this site? Confirm its status | Park Ridge | United States | Unknown status |
| Saint Joseph's Regional Medical Center Coordinator of this site? Confirm its status | Paterson | United States | Unknown status |
| Sacred Heart Hospital Coordinator of this site? Confirm its status | Pensacola | United States | Unknown status |
| Nemours Children's Clinic - Pensacola Coordinator of this site? Confirm its status | Pensacola | United States | Unknown status |
| OSF Children's Hospital of Illinois Coordinator of this site? Confirm its status | Peoria | United States | Unknown status |
| Children's Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Saint Christopher's Hospital for Children Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Phoenix Childrens Hospital Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Children's Hospital of Pittsburgh of UPMC Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Legacy Emanuel Children's Hospital Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Oregon Health and Science University Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Rhode Island Hospital Coordinator of this site? Confirm its status | Providence | United States | Unknown status |
| Renown Regional Medical Center Coordinator of this site? Confirm its status | Reno | United States | Unknown status |
| VCU Massey Comprehensive Cancer Center Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| University of Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Corewell Health Children's Coordinator of this site? Confirm its status | Royal Oak | United States | Unknown status |
| Sutter Medical Center Sacramento Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| University of California Davis Comprehensive Cancer Center Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Primary Children's Hospital Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Children's Hospital of San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Methodist Children's Hospital of South Texas Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| University of Texas Health Science Center at San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Rady Children's Hospital - San Diego Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| Naval Medical Center -San Diego Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| UCSF Medical Center-Mission Bay Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Memorial Health University Medical Center Coordinator of this site? Confirm its status | Savannah | United States | Unknown status |
| Seattle Children's Hospital Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Sanford USD Medical Center - Sioux Falls Coordinator of this site? Confirm its status | Sioux Falls | United States | Unknown status |
| Providence Sacred Heart Medical Center and Children's Hospital Coordinator of this site? Confirm its status | Spokane | United States | Unknown status |
| Baystate Medical Center Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Southern Illinois University School of Medicine Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Mercy Hospital Saint Louis Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Stony Brook University Medical Center Coordinator of this site? Confirm its status | Stony Brook | United States | Unknown status |
| Johns Hopkins All Children's Hospital Coordinator of this site? Confirm its status | St. Petersburg | United States | Unknown status |
| State University of New York Upstate Medical University Coordinator of this site? Confirm its status | Syracuse | United States | Unknown status |
| Mary Bridge Children's Hospital and Health Center Coordinator of this site? Confirm its status | Tacoma | United States | Unknown status |
| Madigan Army Medical Center Coordinator of this site? Confirm its status | Tacoma | United States | Unknown status |
| Saint Joseph's Hospital/Children's Hospital-Tampa Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Montefiore Medical Center - Moses Campus Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Coordinator of this site? Confirm its status | Toledo | United States | Unknown status |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Coordinator of this site? Confirm its status | Torrance | United States | Unknown status |
| New York Medical College Coordinator of this site? Confirm its status | Valhalla | United States | Unknown status |
| MedStar Georgetown University Hospital Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
| Children's National Medical Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
| Saint Mary's Medical Center Coordinator of this site? Confirm its status | West Palm Beach | United States | Unknown status |
| Alfred I duPont Hospital for Children Coordinator of this site? Confirm its status | Wilmington | United States | Unknown status |
| Wake Forest University Health Sciences Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
| UMass Memorial Medical Center - University Campus Coordinator of this site? Confirm its status | Worcester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.