A Phase II Trial of Azacitidine (NSC-102816) Plus Gemtuzumab Ozogamicin (NSC-720568) as Induction and Post-Remission Therapy in Patients of Age 60 and Older With Previously Untreated Non-M3 Acute Myeloid Leukemia

Trial Information
Who is this study for? Adult patients with Acute Myeloid Leukemia
Status: Active, not recruiting
Location: See all (177) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
Summary

This phase II trial is studying the side effects of giving azacitidine together with gemtuzumab ozogamicin to see how well it works in treating older patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Azacitidine may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as gemtuzumab ozogamicin, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving azacitidine together with gemtuzumab ozogamicin may kill more cancer cells.

Am I eligible for this trial?
Participation Requirements
Sex:
All
Minimum Age:
60
Healthy Volunteers:
No

• Morphologically confirmed diagnosis of acute myeloid leukemia (AML) with classification other than WHO acute promyelocytic leukemia (FAB M3), based on bone marrow examination performed within 14 days prior to registration; patients with World Health Organization (WHO) acute promyelocytic leukemia (FAB M3) or blastic transformation of chronic myelogenous leukemia are not eligible

• Zubrod performance status 0-3

• No known hypersensitivity to azacitidine, mannitol, hydroxyurea, orgemtuzumab ozogamicin

• No prior systemic chemotherapy for acute leukemia with the exception of hydroxyurea; administration of hydroxyurea to control high white blood cell (WBC) count prior to registration is permitted

• Patients with a history of prior myelodysplastic syndrome (MDS) are eligible according to the following criteria:

• No prior treatment of MDS with AML induction-type chemotherapy or high-dose chemotherapy with hematopoietic stem cell support

• Prior cytarabine allowed if dose < 100 mg/m^2/day

• Prior hematopoietic growth factors, thalidomide, lenalidomide, arsenic trioxide, and signal transduction inhibitors for treatment of MDS allowed

• No prior treatment with azacitidine, decitabine, or gemtuzumab ozogamicin

• At least 30 days since prior therapy for MDS and recovered

• Bilirubin =< 2.0 x institutional upper limit of normal (IULN) within 14 days to registration, unless the elevation is believed to be due to hepatic infiltration by AML

• Hyperbilirubinemia due primarily to elevated unconjugated hyperbilirubinemia secondary to Gilbert syndrome or hemolysis is allowed

• Serum glutamic oxaloacetic transaminase (SGOT) aspartate aminotransferase (AST) =< 2 x IULN, or serum glutamic pyruvate transaminase (SGPT) alanine aminotransferase (ALT) =< 2.0 x IULN , unless the elevation is believed to be due to hepatic infiltration by AML

• Serum creatinine =< 1.5 x IULN

• Left ventricle ejection fraction (LVEF) >= 40% by multi-gated acquisition scan (MUGA) or echocardiogram (ECHO) AND no clinical evidence of congestive heart failure within the past 56 days

• Pretreatment cytogenetics must be performed on all patients; collection of pretreatment specimens must be completed within 14 days prior to registration to S0703; specimens must be submitted to the site's preferred cytogenetics laboratory

• Patients must consent to submit specimens to the Southwest Oncology Group (SWOG) acute lymphoblastic leukemia (ALL)/chronic lymphocytic leukemia (CLL)/chronic myelogenous leukemia (CML) repository for cellular and molecular studies; collection of pretreatment blood and/or marrow specimens must be completed within 14 days prior to registration; if a marrow specimen is available, either from the diagnostic marrow or a repeat pre-registration marrow, then it must be submitted along with a peripheral blood specimen; otherwise peripheral blood alone must be submitted; residual specimens will only be banked if the patient provides separate consent; sites are required to offer patients the opportunity to participate in banking

• No central nervous system (CNS) involvement; if central nervous involvement is clinically suspected, it must be ruled out by a lumbar puncture

• Women of reproductive potential must have a pregnancy test within 28 days prior to registration; patients must not be pregnant or nursing because of the teratogenic potential of the drugs used in this study; women/men of reproductive potential must have agreed to use an effective contraceptive method

• Patients not known to be human immunodeficiency virus positive (HIV+) must be tested for HIV infection within 14 days prior to registration

• HIV-positive patients must meet the following criteria:

• No history of acquired immunodeficiency syndrome (AIDS)-defining events

• CD4 cells >= 500/mm^3

• Viral load of < 50 copies HIV messenger ribonucleic acid (mRNA)/mm^3 if on cART or < 25,000 copies HIV mRNA if not on cART

• No zidovudine or stavudine as part of cART Patients who are HIV+ and do not meet all of these criteria will not be eligible for this study

• No other prior malignancy except for a) adequately treated basal cell or squamous cell skin cancer or b) any diagnosis of malignancy made within the past 2 years earlier, of which there is no clinically evident cancer, and for which the patient has completed all chemotherapy and radiotherapy at least 6 months prior to study registration; prior treatment with AML induction-type chemotherapy is not allowed; concurrent hormonal therapy is allowed

• All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines

• At the time of patient registration, the treating institution's name and identification (ID) number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base

• Patients must have complete remission (CR) or CRi, documented by blood and marrow examinations performed within 42 days before this registration

• Following completion of induction therapy, the blood counts must recover to absolute neutrophil count (ANC) >= 1,000/mcL and platelets >= 90,000/mcL (without transfusion), and must be maintained at these levels during the 7 days prior to registration

• Patients must have serum creatinine =< 1.5 x IULN and SGOT or SGPT =< 1.5 x IULN within 28 days before registration

• Patients must have recovered to =< Grade 2 from any induction cycle non-hematologic toxicities

Where is this trial taking place?
United States
California
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank
Stanford Cancer Institute Palo Alto
Palo Alto
University of California Davis Comprehensive Cancer Center
Sacramento
Connecticut
Smilow Cancer Hospital Care Center at Saint Francis
Hartford
Idaho
Saint Alphonsus Cancer Care Center-Boise
Boise
Illinois
7 locations
Saint Anthony's Health
Alton
Decatur Memorial Hospital
Decatur
Heartland Cancer Research NCORP
Decatur
Advocate Sherman Hospital
Elgin
Loyola University Medical Center
Maywood
Good Samaritan Regional Health Center
Mount Vernon
Memorial Medical Center
Springfield
Indiana
Franciscan Saint Francis Health-Beech Grove
Beech Grove
Reid Health
Richmond
Kansas
28 locations
Hospital District Sixth of Harper County
Anthony
Cancer Center of Kansas - Chanute
Chanute
Cancer Center of Kansas - Dodge City
Dodge City
Cancer Center of Kansas - El Dorado
El Dorado
Cancer Center of Kansas - Fort Scott
Fort Scott
Cancer Center of Kansas-Independence
Independence
Cancer Center of Kansas-Kingman
Kingman
Lawrence Memorial Hospital
Lawrence
Cancer Center of Kansas-Liberal
Liberal
Southwest Medical Center
Liberal
Cancer Center of Kansas - Newton
Newton
Menorah Medical Center
Overland Park
Saint Luke's South Hospital
Overland Park
Cancer Center of Kansas - Parsons
Parsons
Kansas City NCI Community Oncology Research Program
Prairie Village
Cancer Center of Kansas - Pratt
Pratt
Cancer Center of Kansas - Salina
Salina
Salina Regional Health Center
Salina
Advent Health - Shawnee Mission Medical Center
Shawnee Mission
Cotton O'Neil Cancer Center / Stormont Vail Health
Topeka
Cancer Center of Kansas - Wellington
Wellington
Ascension Via Christi Hospitals Wichita
Wichita
Associates In Womens Health
Wichita
Cancer Center of Kansas - Wichita
Wichita
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita
Wesley Medical Center
Wichita
Wichita NCI Community Oncology Research Program
Wichita
Cancer Center of Kansas - Winfield
Winfield
Kentucky
University of Kentucky/Markey Cancer Center
Lexington
Louisiana
Hematology/Oncology Clinic PLLC
Baton Rouge
Tulane University Health Sciences Center
New Orleans
Michigan
24 locations
Michigan Cancer Research Consortium NCORP
Ann Arbor
Saint Joseph Mercy Hospital
Ann Arbor
University of Michigan Comprehensive Cancer Center
Ann Arbor
Bronson Battle Creek
Battle Creek
Spectrum Health Big Rapids Hospital
Big Rapids
Beaumont Hospital - Dearborn
Dearborn
Ascension Saint John Hospital
Detroit
Wayne State University/Karmanos Cancer Institute
Detroit
Genesys Regional Medical Center-West Flint Campus
Flint
Hurley Medical Center
Flint
Cancer Research Consortium of West Michigan NCORP
Grand Rapids
Mercy Health Saint Mary's
Grand Rapids
Spectrum Health at Butterworth Campus
Grand Rapids
Allegiance Health
Jackson
Sparrow Hospital
Lansing
Saint Mary Mercy Hospital
Livonia
Mercy Health Mercy Campus
Muskegon
Saint Joseph Mercy Oakland
Pontiac
Lake Huron Medical Center
Port Huron
Ascension Saint Mary's Hospital
Saginaw
Ascension Providence Hospitals - Southfield
Southfield
Munson Medical Center
Traverse City
Saint John Macomb-Oakland Hospital
Warren
Metro Health Hospital
Wyoming
Missouri
15 locations
Saint Francis Medical Center
Cape Girardeau
Southeast Missouri Hospital
Cape Girardeau
Heartland Hematology and Oncology Associates Incorporated
Kansas City
North Kansas City Hospital
Kansas City
Research Medical Center
Kansas City
Saint Joseph Health Center
Kansas City
Saint Luke's Hospital of Kansas City
Kansas City
Truman Medical Centers
Kansas City
Saint Luke's East - Lee's Summit
Lee's Summit
Liberty Radiation Oncology Center
Liberty
Heartland Regional Medical Center
Saint Joseph
Saint Joseph Oncology Inc
Saint Joseph
Mercy Hospital Saint Louis
Saint Louis
Saint Louis Cancer and Breast Institute-South City
Saint Louis
Saint Louis-Cape Girardeau CCOP
Saint Louis
Mississippi
University of Mississippi Medical Center
Jackson
Montana
19 locations
Billings Clinic Cancer Center
Billings
Montana Cancer Consortium NCORP
Billings
Northern Rockies Radiation Oncology Center
Billings
Saint Vincent Frontier Cancer Center
Billings
Saint Vincent Healthcare
Billings
Bozeman Deaconess Hospital
Bozeman
Saint James Community Hospital and Cancer Treatment Center
Butte
Benefis Healthcare- Sletten Cancer Institute
Great Falls
Berdeaux, Donald MD (UIA Investigator)
Great Falls
Great Falls Clinic
Great Falls
Northern Montana Hospital
Havre
Saint Peter's Community Hospital
Helena
Glacier Oncology PLLC
Kalispell
Kalispell Medical Oncology
Kalispell
Kalispell Regional Medical Center
Kalispell
Community Medical Hospital
Missoula
Guardian Oncology and Center for Wellness
Missoula
Montana Cancer Specialists
Missoula
Saint Patrick Hospital - Community Hospital
Missoula
North Carolina
Novant Health Presbyterian Medical Center
Charlotte
Wayne Memorial Hospital
Goldsboro
Margaret R Pardee Memorial Hospital
Hendersonville
Rutherford Hospital
Rutherfordton
New Mexico
University of New Mexico Cancer Center
Albuquerque
New York
University of Rochester
Rochester
Ohio
30 locations
Cleveland Clinic Akron General
Akron
Mary Rutan Hospital
Bellefontaine
Adena Regional Medical Center
Chillicothe
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati
Columbus NCI Community Oncology Research Program
Columbus
Doctors Hospital
Columbus
Grant Medical Center
Columbus
Mount Carmel Health Center West
Columbus
Riverside Methodist Hospital
Columbus
Dayton NCI Community Oncology Research Program
Dayton
Good Samaritan Hospital - Dayton
Dayton
Grandview Hospital
Dayton
Miami Valley Hospital
Dayton
Miami Valley Hospital North
Dayton
Grady Memorial Hospital
Delaware
Blanchard Valley Hospital
Findlay
Atrium Medical Center-Middletown Regional Hospital
Franklin
Wayne Hospital
Greenville
Kettering Medical Center
Kettering
Fairfield Medical Center
Lancaster
Marietta Memorial Hospital
Marietta
Knox Community Hospital
Mount Vernon
Licking Memorial Hospital
Newark
Southern Ohio Medical Center
Portsmouth
Springfield Regional Medical Center
Springfield
Upper Valley Medical Center
Troy
Saint Ann's Hospital
Westerville
Clinton Memorial Hospital
Wilmington
Greene Memorial Hospital
Xenia
Genesis Healthcare System Cancer Care Center
Zanesville
Oregon
12 locations
Clackamas Radiation Oncology Center
Clackamas
Legacy Mount Hood Medical Center
Gresham
Providence Milwaukie Hospital
Milwaukie
Providence Newberg Medical Center
Newberg
Providence Willamette Falls Medical Center
Oregon City
Adventist Medical Center
Portland
Legacy Emanuel Hospital and Health Center
Portland
Legacy Good Samaritan Hospital and Medical Center
Portland
Providence Portland Medical Center
Portland
Providence Saint Vincent Medical Center
Portland
Salem Hospital
Salem
Legacy Meridian Park Hospital
Tualatin
South Carolina
AnMed Health Hospital
Anderson
Medical University of South Carolina
Charleston
Spartanburg Medical Center
Spartanburg
Texas
The Don and Sybil Harrington Cancer Center
Amarillo
Washington
19 locations
Cancer Care Center at Island Hospital
Anacortes
PeaceHealth Saint Joseph Medical Center
Bellingham
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton
Highline Medical Center-Main Campus
Burien
Swedish Cancer Institute-Issaquah
Issaquah
Kadlec Clinic Hematology and Oncology
Kennewick
Skagit Valley Hospital
Mount Vernon
Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo
Fred Hutchinson Cancer Research Center
Seattle
Harborview Medical Center
Seattle
Kaiser Permanente Washington
Seattle
Minor and James Medical PLLC
Seattle
Swedish Medical Center-First Hill
Seattle
University of Washington Medical Center - Montlake
Seattle
PeaceHealth United General Medical Center
Sedro-woolley
Cancer Care Northwest - Spokane South
Spokane
Evergreen Hematology and Oncology PS
Spokane
PeaceHealth Southwest Medical Center
Vancouver
Wenatchee Valley Hospital and Clinics
Wenatchee
Wyoming
Rocky Mountain Oncology
Casper
Welch Cancer Center
Sheridan
When is this trial taking place?
Start Date: December 1, 2008
Estimated Completion Date: June 1, 2013
How many participants will be in this trial?
Target number of participants: 133
What treatment is being studied in this trial?
Experimental: Treatment (azacitidine, gemtuzumab)
See Detailed Description
Who are the authors of this trial?

This content was sourced from clinicaltrials.gov

Phase II Study of Treatment of Acute Promyelocytic Leukemia (APL) With ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin (GO)
Who is this study for:Child to adult patients with Acute Promyelocytic Leukemia
Status:Recruiting
Start Date:October 5, 2011
Study Type:Drug, Other
Phase: Phase 2
An Open-Label Phase Ib/II Multi-Arm Study of OX40 Agonist Monoclonal Antibody (mAb), Anti-PDL1 mAb, Smoothened Inhibitor, Anti-CD33 mAb, Bcl-2 Inhibitor and Azacitidine as Single-Agents and/or Combinations for the Treatment of Patients With Acute Myeloid Leukemia (AML)
Who is this study for:Adult patients with Acute Myeloid Leukemia
Status:Active, not recruiting
Start Date:December 27, 2017
Study Drug:Anti-OX40 Antibody PF-04518600
Study Type:Drug, Biological
Phase: Phase 1/Phase 2
A Phase Ib Trial With Dose Expansion Evaluating CPX-351 Plus Gemtuzumab Ozogamicin for Relapsed Acute Myelogenous Leukemia
Who is this study for:Patients with relapsed acute myelogenous leukemia
Status:Recruiting
Start Date:July 18, 2019
Study Drug:Gemtuzumab Ozogamicin+CPX-351
Study Type:Drug
Phase: Phase 1