Liposome-encapsulated Daunorubicin-Cytarabine, Fludarabine Phosphate, Cytarabine, and Filgrastim in Treating Younger Patients With Relapsed or Refractory Acute Myeloid Leukemia
Public ClinicalTrials.gov record NCT02642965. 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 Phase 1/2 Study of CPX-351 (NSC# 775341) Alone Followed by Fludarabine, Cytarabine, and G-CSF (FLAG) for Children With Relapsed Acute Myeloid Leukemia (AML)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase I/II trial studies the side effects and best dose of liposome-encapsulated daunorubicin-cytarabine when given with fludarabine phosphate, cytarabine, and filgrastim and to see how well they work in treating younger patients with acute myeloid leukemia that has come back after treatment (relapsed) or is not responding to treatment (is refractory). Liposome-encapsulated daunorubicin-cytarabine is made up of two chemotherapy drugs, cytarabine and daunorubicin hydrochloride, and works to stop cancer cell growth by blocking the cells from dividing. Drugs used in chemotherapy, such as fludarabine phosphate 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. Filgrastim may increase the production of blood cells and may help the immune system recover from the side effects of chemotherapy. Giving liposome-encapsulated daunorubicin-cytarabine followed by fludarabine phosphate, cytarabine, and filgrastim may be a better treatment for patients with relapsed acute myeloid leukemia and may cause fewer side effects to the heart, a common effect of other chemotherapy treatments for acute myeloid leukemia.
Study identification
- NCT ID
- NCT02642965
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 38 participants
Conditions and interventions
Conditions
Interventions
- Cytarabine Drug
- Filgrastim Biological
- Fludarabine Phosphate Drug
- Laboratory Biomarker Analysis Other
- Liposome-encapsulated Daunorubicin-Cytarabine Drug
- Pharmacological Study Other
Drug · Biological · Other
Eligibility (public fields only)
- Age range
- 1 Year to 21 Years
- 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
- May 2, 2016 (Actual)
- Primary completion
- Dec 31, 2018 (Actual)
- Completion
- Jun 30, 2023 (Actual)
- Last update posted
- Sep 8, 2023
2016 – 2023
United States locations
- U.S. sites
- 67
- U.S. states
- 34
- U.S. cities
- 62
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital of Alabama | Birmingham | Alabama | 35233 | — |
| Phoenix Childrens Hospital | Phoenix | Arizona | 85016 | — |
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202-3591 | — |
| Kaiser Permanente Downey Medical Center | Downey | California | 90242 | — |
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | — |
| Loma Linda University Medical Center | Loma Linda | California | 92354 | — |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | — |
| Valley Children's Hospital | Madera | California | 93636 | — |
| UCSF Benioff Children's Hospital Oakland | Oakland | California | 94609 | — |
| Children's Hospital of Orange County | Orange | California | 92868 | — |
| University of California Davis Comprehensive Cancer Center | Sacramento | California | 95817 | — |
| UCSF Medical Center-Mission Bay | San Francisco | California | 94158 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | — |
| Alfred I duPont Hospital for Children | Wilmington | Delaware | 19803 | — |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | — |
| University of Florida Health Science Center - Gainesville | Gainesville | Florida | 32610 | — |
| Nemours Children's Clinic-Jacksonville | Jacksonville | Florida | 32207 | — |
| Nemours Children's Clinic - Pensacola | Pensacola | Florida | 32504 | — |
| Johns Hopkins All Children's Hospital | St. Petersburg | Florida | 33701 | — |
| Children's Healthcare of Atlanta - Egleston | Atlanta | Georgia | 30322 | — |
| Lurie Children's Hospital-Chicago | Chicago | Illinois | 60611 | — |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | — |
| Ascension Saint Vincent Indianapolis Hospital | Indianapolis | Indiana | 46260 | — |
| University of Kentucky/Markey Cancer Center | Lexington | Kentucky | 40536 | — |
| Eastern Maine Medical Center | Bangor | Maine | 04401 | — |
| Maine Children's Cancer Program | Scarborough | Maine | 04074 | — |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | 21287 | — |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| C S Mott Children's Hospital | Ann Arbor | Michigan | 48109 | — |
| Ascension Saint John Hospital | Detroit | Michigan | 48236 | — |
| University of Minnesota/Masonic Cancer Center | Minneapolis | Minnesota | 55455 | — |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| Children's Mercy Hospitals and Clinics | Kansas City | Missouri | 64108 | — |
| 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 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | — |
| NYU Winthrop Hospital | Mineola | New York | 11501 | — |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York | 10016 | — |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| State University of New York Upstate Medical University | Syracuse | New York | 13210 | — |
| Mission Hospital | Asheville | North Carolina | 28801 | — |
| Children's Hospital Medical Center of Akron | Akron | Ohio | 44308 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| Rainbow Babies and Childrens Hospital | Cleveland | Ohio | 44106 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | — |
| Saint Jude Children's Research Hospital | Memphis | Tennessee | 38105 | — |
| The Children's Hospital at TriStar Centennial | Nashville | Tennessee | 37203 | — |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | 75390 | — |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center | Houston | Texas | 77030 | — |
| Children's Hospital of San Antonio | San Antonio | Texas | 78207 | — |
| Primary Children's Hospital | Salt Lake City | Utah | 84113 | — |
| University of Vermont and State Agricultural College | Burlington | Vermont | 05405 | — |
| Children's Hospital of The King's Daughters | Norfolk | Virginia | 23507 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
| Providence Sacred Heart Medical Center and Children's Hospital | Spokane | Washington | 99204 | — |
| University of Wisconsin Carbone Cancer Center | Madison | Wisconsin | 53792 | — |
| 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 6 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02642965, 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 Sep 8, 2023 · Synced Oct 17, 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 NCT02642965 live on ClinicalTrials.gov.