CD33 Positive Acute Myelogenous Leukemia Clinical Trial
— AMLOfficial title:
GEMTUZUMAB OZOGAMICIN (MYLOTARG (REGISTERED)) EXPANDED ACCESS PROTOCOL FOR TREATMENT OF PATIENTS IN THE UNITED STATES WITH RELAPSED/REFRACTORY ACUTE MYELOGENOUS LEUKEMIA WHO MAY BENEFIT FROM TREATMENT AND HAVE NO ACCESS TO OTHER COMPARABLE/ALTERNATIVE THERAPY
| NCT number | NCT02312037 |
| Other study ID # | B1761026 |
| Secondary ID | |
| Status | No longer available |
| Phase | |
| First received | |
| Last updated |
| Verified date | August 2019 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Expanded Access |
An expanded access/compassionate use protocol that allows access to Mylotarg for
relapsed/refractory AML CD33 positive patients in the USA.
Contact: B1761026@iconplc.com
| Status | No longer available |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 3 Months and older |
| Eligibility |
Inclusion Criteria: - Confirmed diagnosis of relapsed/refractory AML (defined as >=5% marrow blasts by morphology), including MDS, with persisting rising blasts and no other comparable or satisfactory alternative therapy available. If bone marrow has <5% blasts by morphology but the patient has evidence of relapse with extra-medullary disease progression. In select cases presenting with conversion of MRD from negative to positive, treatment with GO may be allowed where no alternative treatments are feasible. OR - Confirmed diagnosis of relapsed or refractory APL with persisting or rising leukemic burden (either by morphology, cytogenetic analysis or by molecular techniques), and no other comparable or satisfactory alternative therapy available. - Documentation that malignant cells express CD33 4) Age >=3 months 5) Adequate non-hematologic organ function Exclusion Criteria: - Untreated AML and MDS or AML and MDS in complete remission. - Patients with a known history of VOD/SOS. - Patients with a known hypersensitivity to Mylotarg or its parts: hP67.6 antibody, calicheamicin derivatives or other ingredients. - Participation in other studies involving investigational drug(s) (Phases 1-4) during study participation. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Alaska Oncology & Hematology, LLC | Anchorage | Alaska |
| United States | Providence Alaska Medical Center | Anchorage | Alaska |
| United States | Providence Cancer Center | Anchorage | Alaska |
| United States | Fox Valley Hematology & Oncology, SC | Appleton | Wisconsin |
| United States | Children's Healthcare of Atlanta at Egleston | Atlanta | Georgia |
| United States | Children's Healthcare of Atlanta at Scottish Rite | Atlanta | Georgia |
| United States | Northside Hospital | Atlanta | Georgia |
| United States | The Blood & Marrow Transplant Group Of Georgia | Atlanta | Georgia |
| United States | Children's Blood and Cancer Center | Austin | Texas |
| United States | Dell Children's Medical Center | Austin | Texas |
| United States | Dell Children's Medical Center of Central Texas | Austin | Texas |
| United States | Johns Hopkins University | Baltimore | Maryland |
| United States | Johns Hopkins University IDS Pharmacy | Baltimore | Maryland |
| United States | University of Alabama at Birmingham/Children's of Alabama | Birmingham | Alabama |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | Roswell Park Cancer Institute | Buffalo | New York |
| United States | Cancer Center IDS Pharmacy Attn: Lauren Benusa, Pharm D. | Charlottesville | Virginia |
| United States | Emily Couric Clinical Cancer Center | Charlottesville | Virginia |
| United States | UVA Health System | Charlottesville | Virginia |
| United States | Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois |
| United States | Investigational Drugs Service Pharmacy, Attn. Judy Pi, PharmD, Ami Patel, PharmD | Chicago | Illinois |
| United States | The University of Chicago | Chicago | Illinois |
| United States | The University of Chicago Medical Center | Chicago | Illinois |
| United States | University of Chicago Medical Center | Chicago | Illinois |
| United States | University Hospitals of Cleveland Rainbow Babies & Children's Hospital | Cleveland | Ohio |
| United States | Nationwide Children's Hospital | Columbus | Ohio |
| United States | Siteman Cancer Center - West County | Creve Coeur | Missouri |
| United States | Geisinger Medical Center | Danville | Pennsylvania |
| United States | North Shore Hematology Oncology Associates, P.C. | East Setauket | New York |
| United States | El Paso Children's Hospital | El Paso | Texas |
| United States | Texas Tech University Health Sciences Center | El Paso | Texas |
| United States | Cook Children's Hematology/Oncology Center | Fort Worth | Texas |
| United States | Cook Children's Medical Center | Fort Worth | Texas |
| United States | The West Clinic, P.C. dba West Cancer Center | Germantown | Tennessee |
| United States | Cook Children's Hematology/Oncology Center - Grapevine | Grapevine | Texas |
| United States | Aurora BayCare Medical Center | Green Bay | Wisconsin |
| United States | Brody School of Medicine at ECU | Greenville | North Carolina |
| United States | Vidant Medical Center | Greenville | North Carolina |
| United States | Virginia Oncology Associates | Hampton | Virginia |
| United States | Milton Hershey Medical Center | Hershey | Pennsylvania |
| United States | JDCH pediatric Oncology and Hematology | Hollywood | Florida |
| United States | Joe Dimaggio Children's Hospital | Hollywood | Florida |
| United States | Memorial Regional Hospital | Hollywood | Florida |
| United States | Houston Methodist Cancer Center | Houston | Texas |
| United States | Houston Methodist Hospital | Houston | Texas |
| United States | Texas Children's Hospital | Houston | Texas |
| United States | Texas Children's Hospital Attn: Investigational Pharmacy Services | Houston | Texas |
| United States | Indiana Blood and Marrow Transplantation | Indianapolis | Indiana |
| United States | Indiana Blood and Marrow Transplantation - Administrative Offices | Indianapolis | Indiana |
| United States | Indiana University Riley Hospital for Children | Indianapolis | Indiana |
| United States | IU Health Pharmacy | Indianapolis | Indiana |
| United States | St.Francis Hospital | Indianapolis | Indiana |
| United States | Baptist Medical Center/Wolfson Children's Hospital | Jacksonville | Florida |
| United States | Nemours Children's Clinic | Jacksonville | Florida |
| United States | Children's Mercy Hospital | Kansas City | Missouri |
| United States | University of Kansas Hospital | Kansas City | Kansas |
| United States | East Tennessee Children's Hospital | Knoxville | Tennessee |
| United States | UK Healthcare Markey Cancer Center | Lexington | Kentucky |
| United States | Children's Hospital Of Los Angeles - University Of Southern California School Of Medicine | Los Angeles | California |
| United States | Cardinal Bernardin Cancer Center/Loyola University Medical Center | Maywood | Illinois |
| United States | Loyola University Chicago, performing research at Loyola University Medical Center | Maywood | Illinois |
| United States | Loyola University Medical Center | Maywood | Illinois |
| United States | Baptist Memorial Hospital | Memphis | Tennessee |
| United States | St. Jude Children's Research Hospital | Memphis | Tennessee |
| United States | The West Clinic, P.C. dba West Cancer Center | Memphis | Tennessee |
| United States | Banner Pediatric Specialists Hematology/Oncology Clinic | Mesa | Arizona |
| United States | Cardon Children's Medical Center. | Mesa | Arizona |
| United States | Children's Hospital of Wisconsin | Milwaukee | Wisconsin |
| United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
| United States | Monroe Carell Jr. Children's Hospital at Vanderbilt | Nashville | Tennessee |
| United States | Sarah Cannon Center for Blood Cancer | Nashville | Tennessee |
| United States | Sarah Cannon Research Institute | Nashville | Tennessee |
| United States | Sarah Cannon Research Institute | Nashville | Tennessee |
| United States | Tennessee Oncology - Nashville | Nashville | Tennessee |
| United States | Tennessee Oncology, PLLC | Nashville | Tennessee |
| United States | The Children's Hospital at TriStar Centennial | Nashville | Tennessee |
| United States | TriStar Centennial Medical Center | Nashville | Tennessee |
| United States | TriStar Centennial Medical Center/Sarah Cannon Cener for Blood Cancer | Nashville | Tennessee |
| United States | TriStar Medical Group Children's Specialist | Nashville | Tennessee |
| United States | VA Tennessee Valley Healthcare System - Nashville Campus | Nashville | Tennessee |
| United States | Vanderbilt University Medical Center - The Vanderbilt Clinic | Nashville | Tennessee |
| United States | Robert Wood Johnson University Hospital | New Brunswick | New Jersey |
| United States | Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey |
| United States | c/o Thomas Ferencz, RPh, BCOP, Smilow Cancer Hospital at Yale-New Haven | New Haven | Connecticut |
| United States | Smilow Cancer Hospital at Yale-New Haven | New Haven | Connecticut |
| United States | Yale New-Haven Hospital & Smilow Cancer Center | New Haven | Connecticut |
| United States | Yale University | New Haven | Connecticut |
| United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
| United States | Weill Cornell Medical College - New York-Presbyterian Hospital | New York | New York |
| United States | Weill Cornell Medical College - New York-Presbyterian Hospital | New York | New York |
| United States | Children's Hospital of the King's Daughters | Norfolk | Virginia |
| United States | Kaiser Permanente - Oakland | Oakland | California |
| United States | Kaiser Permanente - Oakland Medical Center | Oakland | California |
| United States | Children's Hospital of Orange County | Orange | California |
| United States | Blood and Marrow Transplant Center | Orlando | Florida |
| United States | Cancer Institute of Florida | Orlando | Florida |
| United States | Florida Hospital Cancer Institute | Orlando | Florida |
| United States | Nemours Children's Hospital | Orlando | Florida |
| United States | Fox Valley Hematology & Oncology, SC | Oshkosh | Wisconsin |
| United States | Memorial Cancer Institute at Memorial Hospital West | Pembroke Pines | Florida |
| United States | Memorial Hospital West | Pembroke Pines | Florida |
| United States | St. Christopher's Hospital for Children | Philadelphia | Pennsylvania |
| United States | The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
| United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
| United States | Thomas Jefferson University (Tju) - Jefferson University Physicians (Jup) | Philadelphia | Pennsylvania |
| United States | Thomas Jefferson University, Investigative Drug Service | Philadelphia | Pennsylvania |
| United States | Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Trials Office (Clinical) | Philadelphia | Pennsylvania |
| United States | Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Trials Office (Regulatory) | Philadelphia | Pennsylvania |
| United States | Phoenix Children's Hospital | Phoenix | Arizona |
| United States | Allegheny Health Network, Cancer Institute, West Penn Hospital | Pittsburgh | Pennsylvania |
| United States | Mayo Clinic | Rochester | Minnesota |
| United States | University of Rochester Cancer Center Pharmacy | Rochester | New York |
| United States | University of Rochester Medical Center | Rochester | New York |
| United States | Kaiser Permanente - Roseville | Roseville | California |
| United States | Barnes-Jewish Hospital | Saint Louis | Missouri |
| United States | Siteman Cancer Center - South County | Saint Louis | Missouri |
| United States | Washington University Infusion Center Pharmacy | Saint Louis | Missouri |
| United States | Washington University School of Medicine | Saint Louis | Missouri |
| United States | Washington University School of Medicine, Siteman Cancer Center | Saint Louis | Missouri |
| United States | Johns Hopkins All Children's Hospital | Saint Petersburg | Florida |
| United States | Johns Hopkins All Children's Hospital IDS Pharmacy | Saint Petersburg | Florida |
| United States | Johns Hopkins All Children's Outpatient Care Pediatric Hematology/Oncology Department | Saint Petersburg | Florida |
| United States | Huntsman Cancer Hospital | Salt Lake City | Utah |
| United States | Huntsman Cancer Institute-University of Utah | Salt Lake City | Utah |
| United States | Primary Children's Hospital | Salt Lake City | Utah |
| United States | UCSD/ Rady Children's Hospital | San Diego | California |
| United States | Kaiser Permanente - Santa Clara | Santa Clara | California |
| United States | Lisa Nakatsu, RPh | Seattle | Washington |
| United States | Seattle Children's | Seattle | Washington |
| United States | Seattle Children's IDS Pharmacy - Attn. Laura Winter | Seattle | Washington |
| United States | Swedish Medical Center First Hill, IDS Pharmacy | Seattle | Washington |
| United States | The West Clinic, P.C. dba West Cancer Center | Southaven | Mississippi |
| United States | H.Lee Moffitt Cancer Center and Research Institute | Tampa | Florida |
| United States | Yale Medical Group | Trumbull | Connecticut |
| United States | Virginia Oncology Associates | Virginia Beach | Virginia |
| United States | Children's National Medical Center | Washington | District of Columbia |
| United States | Aurora Health Care, Aurora Cancer Care | Wauwatosa | Wisconsin |
| United States | Aurora Health Care, Aurora Cancer Care | West Allis | Wisconsin |
| United States | The University of Kansas Cancer Center and Medical Pavilion | Westwood | Kansas |
| United States | The University of Kansas Cancer Center and Medical Pavillion | Westwood | Kansas |
| United States | University of Kansas Cancer Center | Westwood | Kansas |
| United States | Nemours - A.I. duPont Hospital for Children | Wilmington | Delaware |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States,