Acute Myeloid Leukemia Clinical Trial
Official title:
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
Verified date | January 2024 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 133 |
Est. completion date | March 7, 2025 |
Est. primary completion date | June 1, 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility | Inclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic Akron General | Akron | Ohio |
United States | University of New Mexico Cancer Center | Albuquerque | New Mexico |
United States | Saint Anthony's Health | Alton | Illinois |
United States | The Don and Sybil Harrington Cancer Center | Amarillo | Texas |
United States | Cancer Care Center at Island Hospital | Anacortes | Washington |
United States | AnMed Health Hospital | Anderson | South Carolina |
United States | Michigan Cancer Research Consortium NCORP | Ann Arbor | Michigan |
United States | Trinity Health Saint Joseph Mercy Hospital Ann Arbor | Ann Arbor | Michigan |
United States | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan |
United States | Hospital District Sixth of Harper County | Anthony | Kansas |
United States | Hematology/Oncology Clinic PLLC | Baton Rouge | Louisiana |
United States | Bronson Battle Creek | Battle Creek | Michigan |
United States | Franciscan Saint Francis Health-Beech Grove | Beech Grove | Indiana |
United States | Mary Rutan Hospital | Bellefontaine | Ohio |
United States | PeaceHealth Saint Joseph Medical Center | Bellingham | Washington |
United States | Spectrum Health Big Rapids Hospital | Big Rapids | Michigan |
United States | Billings Clinic Cancer Center | Billings | Montana |
United States | Montana Cancer Consortium NCORP | Billings | Montana |
United States | Northern Rockies Radiation Oncology Center | Billings | Montana |
United States | Saint Vincent Frontier Cancer Center | Billings | Montana |
United States | Saint Vincent Healthcare | Billings | Montana |
United States | Saint Alphonsus Cancer Care Center-Boise | Boise | Idaho |
United States | Bozeman Health Deaconess Hospital | Bozeman | Montana |
United States | Harrison HealthPartners Hematology and Oncology-Bremerton | Bremerton | Washington |
United States | Providence Saint Joseph Medical Center/Disney Family Cancer Center | Burbank | California |
United States | Highline Medical Center-Main Campus | Burien | Washington |
United States | Saint James Community Hospital and Cancer Treatment Center | Butte | Montana |
United States | Saint Francis Medical Center | Cape Girardeau | Missouri |
United States | Southeast Missouri Hospital | Cape Girardeau | Missouri |
United States | Rocky Mountain Oncology | Casper | Wyoming |
United States | Cancer Center of Kansas - Chanute | Chanute | Kansas |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Novant Health Presbyterian Medical Center | Charlotte | North Carolina |
United States | Adena Regional Medical Center | Chillicothe | Ohio |
United States | University of Cincinnati Cancer Center-UC Medical Center | Cincinnati | Ohio |
United States | Clackamas Radiation Oncology Center | Clackamas | Oregon |
United States | Columbus NCI Community Oncology Research Program | Columbus | Ohio |
United States | Doctors Hospital | Columbus | Ohio |
United States | Grant Medical Center | Columbus | Ohio |
United States | Mount Carmel Health Center West | Columbus | Ohio |
United States | Riverside Methodist Hospital | Columbus | Ohio |
United States | Dayton NCI Community Oncology Research Program | Dayton | Ohio |
United States | Good Samaritan Hospital - Dayton | Dayton | Ohio |
United States | Grandview Hospital | Dayton | Ohio |
United States | Miami Valley Hospital | Dayton | Ohio |
United States | Miami Valley Hospital North | Dayton | Ohio |
United States | Beaumont Hospital - Dearborn | Dearborn | Michigan |
United States | Decatur Memorial Hospital | Decatur | Illinois |
United States | Heartland Cancer Research NCORP | Decatur | Illinois |
United States | Grady Memorial Hospital | Delaware | Ohio |
United States | Ascension Saint John Hospital | Detroit | Michigan |
United States | Wayne State University/Karmanos Cancer Institute | Detroit | Michigan |
United States | Cancer Center of Kansas - Dodge City | Dodge City | Kansas |
United States | Cancer Center of Kansas - El Dorado | El Dorado | Kansas |
United States | Advocate Sherman Hospital | Elgin | Illinois |
United States | Blanchard Valley Hospital | Findlay | Ohio |
United States | Genesys Regional Medical Center-West Flint Campus | Flint | Michigan |
United States | Hurley Medical Center | Flint | Michigan |
United States | Cancer Center of Kansas - Fort Scott | Fort Scott | Kansas |
United States | Atrium Medical Center-Middletown Regional Hospital | Franklin | Ohio |
United States | Wayne Memorial Hospital | Goldsboro | North Carolina |
United States | Cancer Research Consortium of West Michigan NCORP | Grand Rapids | Michigan |
United States | Corewell Health Grand Rapids Hospitals - Butterworth Hospital | Grand Rapids | Michigan |
United States | Trinity Health Grand Rapids Hospital | Grand Rapids | Michigan |
United States | Benefis Sletten Cancer Institute | Great Falls | Montana |
United States | Berdeaux, Donald MD (UIA Investigator) | Great Falls | Montana |
United States | Great Falls Clinic | Great Falls | Montana |
United States | Wayne Hospital | Greenville | Ohio |
United States | Legacy Mount Hood Medical Center | Gresham | Oregon |
United States | Smilow Cancer Hospital Care Center at Saint Francis | Hartford | Connecticut |
United States | Northern Montana Hospital | Havre | Montana |
United States | Saint Peter's Community Hospital | Helena | Montana |
United States | Margaret R Pardee Memorial Hospital | Hendersonville | North Carolina |
United States | Cancer Center of Kansas-Independence | Independence | Kansas |
United States | Swedish Cancer Institute-Issaquah | Issaquah | Washington |
United States | Allegiance Health | Jackson | Michigan |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | Glacier Oncology PLLC | Kalispell | Montana |
United States | Kalispell Medical Oncology | Kalispell | Montana |
United States | Kalispell Regional Medical Center | Kalispell | Montana |
United States | Heartland Hematology and Oncology Associates Incorporated | Kansas City | Missouri |
United States | North Kansas City Hospital | Kansas City | Missouri |
United States | Research Medical Center | Kansas City | Missouri |
United States | Saint Joseph Health Center | Kansas City | Missouri |
United States | Saint Luke's Hospital of Kansas City | Kansas City | Missouri |
United States | University Health Truman Medical Center | Kansas City | Missouri |
United States | Kadlec Clinic Hematology and Oncology | Kennewick | Washington |
United States | Kettering Medical Center | Kettering | Ohio |
United States | Cancer Center of Kansas-Kingman | Kingman | Kansas |
United States | Fairfield Medical Center | Lancaster | Ohio |
United States | University of Michigan Health - Sparrow Lansing | Lansing | Michigan |
United States | Lawrence Memorial Hospital | Lawrence | Kansas |
United States | Saint Luke's East - Lee's Summit | Lee's Summit | Missouri |
United States | University of Kentucky/Markey Cancer Center | Lexington | Kentucky |
United States | Cancer Center of Kansas-Liberal | Liberal | Kansas |
United States | Southwest Medical Center | Liberal | Kansas |
United States | Liberty Radiation Oncology Center | Liberty | Missouri |
United States | Trinity Health Saint Mary Mercy Livonia Hospital | Livonia | Michigan |
United States | Marietta Memorial Hospital | Marietta | Ohio |
United States | Loyola University Medical Center | Maywood | Illinois |
United States | Providence Milwaukie Hospital | Milwaukie | Oregon |
United States | Community Medical Center | Missoula | Montana |
United States | Guardian Oncology and Center for Wellness | Missoula | Montana |
United States | Montana Cancer Specialists | Missoula | Montana |
United States | Saint Patrick Hospital - Community Hospital | Missoula | Montana |
United States | Good Samaritan Regional Health Center | Mount Vernon | Illinois |
United States | Knox Community Hospital | Mount Vernon | Ohio |
United States | Skagit Valley Hospital | Mount Vernon | Washington |
United States | Trinity Health Muskegon Hospital | Muskegon | Michigan |
United States | Tulane University School of Medicine | New Orleans | Louisiana |
United States | Licking Memorial Hospital | Newark | Ohio |
United States | Providence Newberg Medical Center | Newberg | Oregon |
United States | Cancer Center of Kansas - Newton | Newton | Kansas |
United States | Providence Willamette Falls Medical Center | Oregon City | Oregon |
United States | Menorah Medical Center | Overland Park | Kansas |
United States | Saint Luke's South Hospital | Overland Park | Kansas |
United States | Stanford Cancer Institute Palo Alto | Palo Alto | California |
United States | Cancer Center of Kansas - Parsons | Parsons | Kansas |
United States | Trinity Health Saint Joseph Mercy Oakland Hospital | Pontiac | Michigan |
United States | Lake Huron Medical Center | Port Huron | Michigan |
United States | Adventist Medical Center | Portland | Oregon |
United States | Legacy Emanuel Hospital and Health Center | Portland | Oregon |
United States | Legacy Good Samaritan Hospital and Medical Center | Portland | Oregon |
United States | Providence Portland Medical Center | Portland | Oregon |
United States | Providence Saint Vincent Medical Center | Portland | Oregon |
United States | Southern Ohio Medical Center | Portsmouth | Ohio |
United States | Harrison HealthPartners Hematology and Oncology-Poulsbo | Poulsbo | Washington |
United States | Kansas City NCI Community Oncology Research Program | Prairie Village | Kansas |
United States | Cancer Center of Kansas - Pratt | Pratt | Kansas |
United States | Reid Health | Richmond | Indiana |
United States | University of Rochester | Rochester | New York |
United States | Rutherford Hospital | Rutherfordton | North Carolina |
United States | University of California Davis Comprehensive Cancer Center | Sacramento | California |
United States | Ascension Saint Mary's Hospital | Saginaw | Michigan |
United States | Heartland Regional Medical Center | Saint Joseph | Missouri |
United States | Saint Joseph Oncology Inc | Saint Joseph | Missouri |
United States | Mercy Hospital Saint Louis | Saint Louis | Missouri |
United States | Saint Louis Cancer and Breast Institute-South City | Saint Louis | Missouri |
United States | Saint Louis-Cape Girardeau CCOP | Saint Louis | Missouri |
United States | Salem Hospital | Salem | Oregon |
United States | Cancer Center of Kansas - Salina | Salina | Kansas |
United States | Salina Regional Health Center | Salina | Kansas |
United States | Fred Hutchinson Cancer Center | Seattle | Washington |
United States | Harborview Medical Center | Seattle | Washington |
United States | Kaiser Permanente Washington | Seattle | Washington |
United States | Minor and James Medical PLLC | Seattle | Washington |
United States | Swedish Medical Center-First Hill | Seattle | Washington |
United States | University of Washington Medical Center - Montlake | Seattle | Washington |
United States | PeaceHealth United General Medical Center | Sedro-Woolley | Washington |
United States | Advent Health - Shawnee Mission Medical Center | Shawnee Mission | Kansas |
United States | Welch Cancer Center | Sheridan | Wyoming |
United States | Ascension Providence Hospitals - Southfield | Southfield | Michigan |
United States | Spartanburg Medical Center | Spartanburg | South Carolina |
United States | Cancer Care Northwest - Spokane South | Spokane | Washington |
United States | Evergreen Hematology and Oncology PS | Spokane | Washington |
United States | Memorial Medical Center | Springfield | Illinois |
United States | Springfield Regional Medical Center | Springfield | Ohio |
United States | Cotton O'Neil Cancer Center / Stormont Vail Health | Topeka | Kansas |
United States | Munson Medical Center | Traverse City | Michigan |
United States | Upper Valley Medical Center | Troy | Ohio |
United States | Legacy Meridian Park Hospital | Tualatin | Oregon |
United States | PeaceHealth Southwest Medical Center | Vancouver | Washington |
United States | Saint John Macomb-Oakland Hospital | Warren | Michigan |
United States | Cancer Center of Kansas - Wellington | Wellington | Kansas |
United States | Wenatchee Valley Hospital and Clinics | Wenatchee | Washington |
United States | Saint Ann's Hospital | Westerville | Ohio |
United States | Ascension Via Christi Hospitals Wichita | Wichita | Kansas |
United States | Associates In Womens Health | Wichita | Kansas |
United States | Cancer Center of Kansas - Wichita | Wichita | Kansas |
United States | Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita | Kansas |
United States | Wesley Medical Center | Wichita | Kansas |
United States | Wichita NCI Community Oncology Research Program | Wichita | Kansas |
United States | Clinton Memorial Hospital/Foster J Boyd Regional Cancer Center | Wilmington | Ohio |
United States | Cancer Center of Kansas - Winfield | Winfield | Kansas |
United States | Southeast Clinical Oncology Research Consortium NCORP | Winston-Salem | North Carolina |
United States | University of Michigan Health - West | Wyoming | Michigan |
United States | Greene Memorial Hospital | Xenia | Ohio |
United States | Genesis Healthcare System Cancer Care Center | Zanesville | Ohio |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete Response | Morphologic complete remission (CR): ANC >=1,000/mcL, platelet count >=100,000/mcL, <5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be <1,000/mcL and/or platelet count <100,000/mcL. | Up to 60 days | |
Primary | 30-Day Survival | Patients surviving more than 30 days after study registration | 30 days | |
Secondary | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Only adverse events that are possibly, probably or definitely related to study drug are reported. | Up to 5 years | |
Secondary | Relapse-free Survival | Relapse-free survival (RFS) is defined for all patients who achieve CR or CRi. RFS is measured from the date CR or CRi is first achieved until relapse or death form any cause, with observation censored on the date of last contact for patients last known to be alive without report of relapse. Relapse from CR/CRi is defined as reappearance of leukemic blasts in the peripheral blood; or > 5% blasts in the bone marrow not attributable to another cause; or appearance or reappearance of extramedullary disease. | Up to 5 years |
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