Clinical trial NCT02312037: Expanded Access /Compassionate Use Protocol For Relapsed Or Refractory CD33 Positive AML Patients In The USA Without Access To Comparable Or Alternative Therapy
Official 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
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: CD33 Positive Acute Myelogenous Leukemia
Keywords: Relapsed CD33 AML
Refractory CD33 AML
Relapsed CD33 APL
Refractory CD33 APL
Relapsed CD33 MDS
Refractory CD33 MDS
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-12-09
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: 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

Detailed description: Contact:

B1761026@iconplc.com

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham/Children's of Alabama
state: Alabama
city: Anchorage
country: United States
facility: Alaska Oncology & Hematology, LLC
state: Alaska
city: Anchorage
country: United States
facility: Providence Alaska Medical Center
state: Alaska
city: Anchorage
country: United States
facility: Providence Cancer Center
state: Alaska
city: Mesa
country: United States
facility: Banner Pediatric Specialists Hematology/Oncology Clinic
state: Arizona
city: Mesa
country: United States
facility: Cardon Children's Medical Center.
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Los Angeles
country: United States
facility: Children's Hospital Of Los Angeles - University Of Southern California School Of Medicine
state: California
city: Oakland
country: United States
facility: Kaiser Permanente - Oakland Medical Center
state: California
city: Oakland
country: United States
facility: Kaiser Permanente - Oakland
state: California
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
city: Roseville
country: United States
facility: Kaiser Permanente - Roseville
state: California
city: San Diego
country: United States
facility: UCSD/ Rady Children's Hospital
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente - Santa Clara
state: California
city: New Haven
country: United States
facility: c/o Thomas Ferencz, RPh, BCOP, Smilow Cancer Hospital at Yale-New Haven
state: Connecticut
city: New Haven
country: United States
facility: Smilow Cancer Hospital at Yale-New Haven
state: Connecticut
city: New Haven
country: United States
facility: Yale New-Haven Hospital & Smilow Cancer Center
state: Connecticut
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Trumbull
country: United States
facility: Yale Medical Group
state: Connecticut
city: Wilmington
country: United States
facility: Nemours - A.I. duPont Hospital for Children
state: Delaware
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Hollywood
country: United States
facility: JDCH pediatric Oncology and Hematology
state: Florida
city: Hollywood
country: United States
facility: Joe Dimaggio Children's Hospital
state: Florida
city: Hollywood
country: United States
facility: Memorial Regional Hospital
state: Florida
city: Jacksonville
country: United States
facility: Nemours Children's Clinic
state: Florida
city: Jacksonville
country: United States
facility: Baptist Medical Center/Wolfson Children's Hospital
state: Florida
city: Orlando
country: United States
facility: Blood and Marrow Transplant Center
state: Florida
city: Orlando
country: United States
facility: Cancer Institute of Florida
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Cancer Institute
state: Florida
city: Orlando
country: United States
facility: Nemours Children's Hospital
state: Florida
city: Pembroke Pines
country: United States
facility: Memorial Cancer Institute at Memorial Hospital West
state: Florida
city: Pembroke Pines
country: United States
facility: Memorial Hospital West
state: Florida
city: Saint Petersburg
country: United States
facility: Johns Hopkins All Children's Hospital IDS Pharmacy
state: Florida
city: Saint Petersburg
country: United States
facility: Johns Hopkins All Children's Hospital
state: Florida
city: Saint Petersburg
country: United States
facility: Johns Hopkins All Children's Outpatient Care Pediatric Hematology/Oncology Department
state: Florida
city: Tampa
country: United States
facility: H.Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta at Egleston
state: Georgia
city: Atlanta
country: United States
facility: The Blood & Marrow Transplant Group Of Georgia
state: Georgia
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta at Scottish Rite
state: Georgia
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Chicago
country: United States
facility: Investigational Drugs Service Pharmacy, Attn. Judy Pi, PharmD, Ami Patel, PharmD
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago Medical Center
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Maywood
country: United States
facility: Cardinal Bernardin Cancer Center/Loyola University Medical Center
state: Illinois
city: Maywood
country: United States
facility: Loyola University Chicago, performing research at Loyola University Medical Center
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Riley Hospital for Children
state: Indiana
city: Indianapolis
country: United States
facility: IU Health Pharmacy
state: Indiana
city: Indianapolis
country: United States
facility: Indiana Blood and Marrow Transplantation - Administrative Offices
state: Indiana
city: Indianapolis
country: United States
facility: Indiana Blood and Marrow Transplantation
state: Indiana
city: Indianapolis
country: United States
facility: St.Francis Hospital
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Hospital
state: Kansas
city: Westwood
country: United States
facility: The University of Kansas Cancer Center and Medical Pavilion
state: Kansas
city: Westwood
country: United States
facility: The University of Kansas Cancer Center and Medical Pavillion
state: Kansas
city: Westwood
country: United States
facility: University of Kansas Cancer Center
state: Kansas
city: Lexington
country: United States
facility: UK Healthcare Markey Cancer Center
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins University IDS Pharmacy
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Southaven
country: United States
facility: The West Clinic, P.C. dba West Cancer Center
state: Mississippi
city: Creve Coeur
country: United States
facility: Siteman Cancer Center - West County
state: Missouri
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University Infusion Center Pharmacy
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine, Siteman Cancer Center
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Siteman Cancer Center - South County
state: Missouri
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Hospital
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: East Setauket
country: United States
facility: North Shore Hematology Oncology Associates, P.C.
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College - New York-Presbyterian Hospital
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College - New York-Presbyterian Hospital
state: New York
city: Rochester
country: United States
facility: University of Rochester Cancer Center Pharmacy
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Greenville
country: United States
facility: Brody School of Medicine at ECU
state: North Carolina
city: Greenville
country: United States
facility: Vidant Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals of Cleveland Rainbow Babies & Children's Hospital
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Hershey
country: United States
facility: Milton Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University (Tju) - Jefferson University Physicians (Jup)
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University, Investigative Drug Service
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Trials Office (Clinical)
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Trials Office (Regulatory)
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Philadelphia
country: United States
facility: St. Christopher's Hospital for Children
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Health Network, Cancer Institute, West Penn Hospital
state: Pennsylvania
city: Germantown
country: United States
facility: The West Clinic, P.C. dba West Cancer Center
state: Tennessee
city: Knoxville
country: United States
facility: East Tennessee Children's Hospital
state: Tennessee
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
city: Memphis
country: United States
facility: Baptist Memorial Hospital
state: Tennessee
city: Memphis
country: United States
facility: The West Clinic, P.C. dba West Cancer Center
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Center for Blood Cancer
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology - Nashville
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Nashville
country: United States
facility: The Children's Hospital at TriStar Centennial
state: Tennessee
city: Nashville
country: United States
facility: TriStar Centennial Medical Center/Sarah Cannon Cener for Blood Cancer
state: Tennessee
city: Nashville
country: United States
facility: TriStar Centennial Medical Center
state: Tennessee
city: Nashville
country: United States
facility: TriStar Medical Group Children's Specialist
state: Tennessee
city: Nashville
country: United States
facility: VA Tennessee Valley Healthcare System - Nashville Campus
state: Tennessee
city: Nashville
country: United States
facility: Monroe Carell Jr. Children's Hospital at Vanderbilt
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center - The Vanderbilt Clinic
state: Tennessee
city: Austin
country: United States
facility: Children's Blood and Cancer Center
state: Texas
city: Austin
country: United States
facility: Dell Children's Medical Center of Central Texas
state: Texas
city: Austin
country: United States
facility: Dell Children's Medical Center
state: Texas
city: El Paso
country: United States
facility: El Paso Children's Hospital
state: Texas
city: El Paso
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
city: Fort Worth
country: United States
facility: Cook Children's Hematology/Oncology Center
state: Texas
city: Fort Worth
country: United States
facility: Cook Children's Medical Center
state: Texas
city: Grapevine
country: United States
facility: Cook Children's Hematology/Oncology Center - Grapevine
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital Attn: Investigational Pharmacy Services
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Houston
country: United States
facility: Houston Methodist Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Hospital
state: Utah
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute-University of Utah
state: Utah
city: Salt Lake City
country: United States
facility: Primary Children's Hospital
state: Utah
city: Charlottesville
country: United States
facility: Cancer Center IDS Pharmacy Attn: Lauren Benusa, Pharm D.
state: Virginia
city: Charlottesville
country: United States
facility: Emily Couric Clinical Cancer Center
state: Virginia
city: Charlottesville
country: United States
facility: UVA Health System
state: Virginia
city: Hampton
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Norfolk
country: United States
facility: Children's Hospital of the King's Daughters
state: Virginia
city: Virginia Beach
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center First Hill, IDS Pharmacy
state: Washington
city: Seattle
country: United States
facility: Seattle Children's IDS Pharmacy - Attn. Laura Winter
state: Washington
city: Seattle
country: United States
facility: Seattle Children's
state: Washington
city: Seattle
country: United States
facility: Lisa Nakatsu, RPh
state: Washington
city: Appleton
country: United States
facility: Fox Valley Hematology & Oncology, SC
state: Wisconsin
city: Green Bay
country: United States
facility: Aurora BayCare Medical Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Oshkosh
country: United States
facility: Fox Valley Hematology & Oncology, SC
state: Wisconsin
city: Wauwatosa
country: United States
facility: Aurora Health Care, Aurora Cancer Care
state: Wisconsin
city: West Allis
country: United States
facility: Aurora Health Care, Aurora Cancer Care
state: Wisconsin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Wang ES, Aplenc R, Chirnomas D, Dugan M, Fazal S, Iyer S, Lin TL, Nand S, Pierce KJ, Shami PJ, Vermette JJ, Abboud CN. Safety of gemtuzumab ozogamicin as monotherapy or combination therapy in an expanded-access protocol for patients with relapsed or refractory acute myeloid leukemia. Leuk Lymphoma. 2020 Aug;61(8):1965-1973. doi: 10.1080/10428194.2020.1742897. Epub 2020 May 20.