Acute Myeloid Leukemia Clinical Trial

Azacitidine and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia

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.

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Full Description

PRIMARY OBJECTIVES:

I. To test whether outcomes of patients of age 60 or older with previously untreated non-M3 acute myeloid leukemia treated with azacitidine plus gemtuzumab ozogamicin are sufficient to warrant phase III investigation.

II. To estimate the frequency and severity of toxicities of this regimen in the good- and poor-risk groups of patients.

III. To investigate in a preliminary manner the disease-free survival of patients who achieve complete remission and receive post-remission therapy on this study.

IV. To investigate in a preliminary manner the cytogenetic response rates of patients treated with this regimen.

V. To investigate in a preliminary manner the effects of cytogenetic abnormalities, promoter and global methylation changes, and multidrug resistance on overall survival and response to azacitidine plus gemtuzumab ozogamicin therapy.

OUTLINE: Patients are stratified according to risk status (good [60-69 years of age OR Zubrod performance status [PS] 0-1] vs poor [>= 70 years of age AND Zubrod PS 2-3]).

REMISSION INDUCTION THERAPY: Patients receive azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily (QD) on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. Patients with residual leukemia (blast count >= 5%) receive a second course of induction therapy beginning between days 15-29. Patients achieving complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi) go on to receive consolidation therapy.

CONSOLIDATION THERAPY: Patients receive one course of azacitidine and gemtuzumab ozogamicin as in induction therapy (with azacitidine given SC only).

MAINTENANCE THERAPY: Patients receive azacitidine SC on days 1-7. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsies for cytogenetic studies at baseline, remission, and relapse or progression (and at completion of treatment if it does not correspond to one of these time points). Marrow and blood samples are submitted to correlatives studies and submitted to Southwest Oncology Group (SWOG) acute lymphoblastic leukemia (ALL)/chronic lymphocytic leukemia (CLL)/chronic myelogenous leukemia (CML) Repository in Seattle, WA.

After completion of study therapy, patients are followed every 2 months for 2 years, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months thereafter.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

133

Study ID:

NCT00658814

Recruitment Status:

Active, not recruiting

Sponsor:

National Cancer Institute (NCI)

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There are 157 Locations for this study

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Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank California, 91505, United States
Stanford Cancer Institute Palo Alto
Palo Alto California, 94304, United States
University of California Davis Comprehensive Cancer Center
Sacramento California, 95817, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford Connecticut, 06105, United States
Saint Alphonsus Cancer Care Center-Boise
Boise Idaho, 83706, United States
Saint Anthony's Health
Alton Illinois, 62002, United States
Decatur Memorial Hospital
Decatur Illinois, 62526, United States
Heartland Cancer Research NCORP
Decatur Illinois, 62526, United States
Advocate Sherman Hospital
Elgin Illinois, 60123, United States
Loyola University Medical Center
Maywood Illinois, 60153, United States
Good Samaritan Regional Health Center
Mount Vernon Illinois, 62864, United States
Memorial Medical Center
Springfield Illinois, 62781, United States
Franciscan Saint Francis Health-Beech Grove
Beech Grove Indiana, 46107, United States
Reid Health
Richmond Indiana, 47374, United States
Hospital District Sixth of Harper County
Anthony Kansas, 67003, United States
Cancer Center of Kansas - Chanute
Chanute Kansas, 66720, United States
Cancer Center of Kansas - Dodge City
Dodge City Kansas, 67801, United States
Cancer Center of Kansas - El Dorado
El Dorado Kansas, 67042, United States
Cancer Center of Kansas - Fort Scott
Fort Scott Kansas, 66701, United States
Cancer Center of Kansas-Independence
Independence Kansas, 67301, United States
Cancer Center of Kansas-Kingman
Kingman Kansas, 67068, United States
Lawrence Memorial Hospital
Lawrence Kansas, 66044, United States
Southwest Medical Center
Liberal Kansas, 67901, United States
Cancer Center of Kansas-Liberal
Liberal Kansas, 67905, United States
Cancer Center of Kansas - Newton
Newton Kansas, 67114, United States
Menorah Medical Center
Overland Park Kansas, 66209, United States
Saint Luke's South Hospital
Overland Park Kansas, 66213, United States
Cancer Center of Kansas - Parsons
Parsons Kansas, 67357, United States
Kansas City NCI Community Oncology Research Program
Prairie Village Kansas, 66208, United States
Cancer Center of Kansas - Pratt
Pratt Kansas, 67124, United States
Cancer Center of Kansas - Salina
Salina Kansas, 67401, United States
Salina Regional Health Center
Salina Kansas, 67401, United States
Advent Health - Shawnee Mission Medical Center
Shawnee Mission Kansas, 66204, United States
Cotton O'Neil Cancer Center / Stormont Vail Health
Topeka Kansas, 66606, United States
Cancer Center of Kansas - Wellington
Wellington Kansas, 67152, United States
Associates In Womens Health
Wichita Kansas, 67208, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita Kansas, 67208, United States
Ascension Via Christi Hospitals Wichita
Wichita Kansas, 67214, United States
Cancer Center of Kansas - Wichita
Wichita Kansas, 67214, United States
Wesley Medical Center
Wichita Kansas, 67214, United States
Wichita NCI Community Oncology Research Program
Wichita Kansas, 67214, United States
Cancer Center of Kansas - Winfield
Winfield Kansas, 67156, United States
University of Kentucky/Markey Cancer Center
Lexington Kentucky, 40536, United States
Hematology/Oncology Clinic PLLC
Baton Rouge Louisiana, 70809, United States
Tulane University Health Sciences Center
New Orleans Louisiana, 70112, United States
Michigan Cancer Research Consortium NCORP
Ann Arbor Michigan, 48106, United States
Saint Joseph Mercy Hospital
Ann Arbor Michigan, 48106, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
Bronson Battle Creek
Battle Creek Michigan, 49017, United States
Spectrum Health Big Rapids Hospital
Big Rapids Michigan, 49307, United States
Beaumont Hospital - Dearborn
Dearborn Michigan, 48124, United States
Wayne State University/Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Ascension Saint John Hospital
Detroit Michigan, 48236, United States
Hurley Medical Center
Flint Michigan, 48503, United States
Genesys Regional Medical Center-West Flint Campus
Flint Michigan, 48532, United States
Cancer Research Consortium of West Michigan NCORP
Grand Rapids Michigan, 49503, United States
Mercy Health Saint Mary's
Grand Rapids Michigan, 49503, United States
Spectrum Health at Butterworth Campus
Grand Rapids Michigan, 49503, United States
Allegiance Health
Jackson Michigan, 49201, United States
Sparrow Hospital
Lansing Michigan, 48912, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia Michigan, 48154, United States
Mercy Health Mercy Campus
Muskegon Michigan, 49444, United States
Saint Joseph Mercy Oakland
Pontiac Michigan, 48341, United States
Lake Huron Medical Center
Port Huron Michigan, 48060, United States
Ascension Saint Mary's Hospital
Saginaw Michigan, 48601, United States
Ascension Providence Hospitals - Southfield
Southfield Michigan, 48075, United States
Munson Medical Center
Traverse City Michigan, 49684, United States
Saint John Macomb-Oakland Hospital
Warren Michigan, 48093, United States
Metro Health Hospital
Wyoming Michigan, 49519, United States
University of Mississippi Medical Center
Jackson Mississippi, 39216, United States
Southeast Missouri Hospital
Cape Girardeau Missouri, 63701, United States
Saint Francis Medical Center
Cape Girardeau Missouri, 63703, United States
Truman Medical Centers
Kansas City Missouri, 64108, United States
Saint Luke's Hospital of Kansas City
Kansas City Missouri, 64111, United States
Saint Joseph Health Center
Kansas City Missouri, 64114, United States
North Kansas City Hospital
Kansas City Missouri, 64116, United States
Heartland Hematology and Oncology Associates Incorporated
Kansas City Missouri, 64118, United States
Research Medical Center
Kansas City Missouri, 64132, United States
Saint Luke's East - Lee's Summit
Lee's Summit Missouri, 64086, United States
Liberty Radiation Oncology Center
Liberty Missouri, 64068, United States
Heartland Regional Medical Center
Saint Joseph Missouri, 64506, United States
Saint Joseph Oncology Inc
Saint Joseph Missouri, 64507, United States
Saint Louis Cancer and Breast Institute-South City
Saint Louis Missouri, 63109, United States
Mercy Hospital Saint Louis
Saint Louis Missouri, 63141, United States
Saint Louis-Cape Girardeau CCOP
Saint Louis Missouri, 63141, United States
Billings Clinic Cancer Center
Billings Montana, 59101, United States
Northern Rockies Radiation Oncology Center
Billings Montana, 59101, United States
Saint Vincent Healthcare
Billings Montana, 59101, United States
Montana Cancer Consortium NCORP
Billings Montana, 59102, United States
Saint Vincent Frontier Cancer Center
Billings Montana, 59102, United States
Bozeman Deaconess Hospital
Bozeman Montana, 59715, United States
Saint James Community Hospital and Cancer Treatment Center
Butte Montana, 59701, United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls Montana, 59405, United States
Berdeaux, Donald MD (UIA Investigator)
Great Falls Montana, 59405, United States
Great Falls Clinic
Great Falls Montana, 59405, United States
Northern Montana Hospital
Havre Montana, 59501, United States
Saint Peter's Community Hospital
Helena Montana, 59601, United States
Glacier Oncology PLLC
Kalispell Montana, 59901, United States
Kalispell Medical Oncology
Kalispell Montana, 59901, United States
Kalispell Regional Medical Center
Kalispell Montana, 59901, United States
Montana Cancer Specialists
Missoula Montana, 59802, United States
Saint Patrick Hospital - Community Hospital
Missoula Montana, 59802, United States
Community Medical Hospital
Missoula Montana, 59804, United States
Guardian Oncology and Center for Wellness
Missoula Montana, 59804, United States
University of New Mexico Cancer Center
Albuquerque New Mexico, 87102, United States
University of Rochester
Rochester New York, 14642, United States
Novant Health Presbyterian Medical Center
Charlotte North Carolina, 28204, United States
Wayne Memorial Hospital
Goldsboro North Carolina, 27534, United States
Margaret R Pardee Memorial Hospital
Hendersonville North Carolina, 28791, United States
Rutherford Hospital
Rutherfordton North Carolina, 28139, United States
Southeast Clinical Oncology Research Consortium NCORP
Winston-Salem North Carolina, 27104, United States
Cleveland Clinic Akron General
Akron Ohio, 44307, United States
Mary Rutan Hospital
Bellefontaine Ohio, 43311, United States
Adena Regional Medical Center
Chillicothe Ohio, 45601, United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati Ohio, 45219, United States
Riverside Methodist Hospital
Columbus Ohio, 43214, United States
Columbus NCI Community Oncology Research Program
Columbus Ohio, 43215, United States
Grant Medical Center
Columbus Ohio, 43215, United States
Mount Carmel Health Center West
Columbus Ohio, 43222, United States
Doctors Hospital
Columbus Ohio, 43228, United States
Grandview Hospital
Dayton Ohio, 45405, United States
Good Samaritan Hospital - Dayton
Dayton Ohio, 45406, United States
Miami Valley Hospital
Dayton Ohio, 45409, United States
Miami Valley Hospital North
Dayton Ohio, 45415, United States
Dayton NCI Community Oncology Research Program
Dayton Ohio, 45459, United States
Grady Memorial Hospital
Delaware Ohio, 43015, United States
Blanchard Valley Hospital
Findlay Ohio, 45840, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin Ohio, 45005, United States
Wayne Hospital
Greenville Ohio, 45331, United States
Kettering Medical Center
Kettering Ohio, 45429, United States
Fairfield Medical Center
Lancaster Ohio, 43130, United States
Marietta Memorial Hospital
Marietta Ohio, 45750, United States
Knox Community Hospital
Mount Vernon Ohio, 43050, United States
Licking Memorial Hospital
Newark Ohio, 43055, United States
Southern Ohio Medical Center
Portsmouth Ohio, 45662, United States
Springfield Regional Medical Center
Springfield Ohio, 45505, United States
Upper Valley Medical Center
Troy Ohio, 45373, United States
Saint Ann's Hospital
Westerville Ohio, 43081, United States
Clinton Memorial Hospital
Wilmington Ohio, 45177, United States
Greene Memorial Hospital
Xenia Ohio, 45385, United States
Genesis Healthcare System Cancer Care Center
Zanesville Ohio, 43701, United States
Clackamas Radiation Oncology Center
Clackamas Oregon, 97015, United States
Legacy Mount Hood Medical Center
Gresham Oregon, 97030, United States
Providence Milwaukie Hospital
Milwaukie Oregon, 97222, United States
Providence Newberg Medical Center
Newberg Oregon, 97132, United States
Providence Willamette Falls Medical Center
Oregon City Oregon, 97045, United States
Legacy Good Samaritan Hospital and Medical Center
Portland Oregon, 97210, United States
Providence Portland Medical Center
Portland Oregon, 97213, United States
Adventist Medical Center
Portland Oregon, 97216, United States
Providence Saint Vincent Medical Center
Portland Oregon, 97225, United States
Legacy Emanuel Hospital and Health Center
Portland Oregon, 97227, United States
Salem Hospital
Salem Oregon, 97301, United States
Legacy Meridian Park Hospital
Tualatin Oregon, 97062, United States
AnMed Health Hospital
Anderson South Carolina, 29621, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
Spartanburg Medical Center
Spartanburg South Carolina, 29303, United States
The Don and Sybil Harrington Cancer Center
Amarillo Texas, 79106, United States
Cancer Care Center at Island Hospital
Anacortes Washington, 98221, United States
PeaceHealth Saint Joseph Medical Center
Bellingham Washington, 98225, United States
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton Washington, 98310, United States
Highline Medical Center-Main Campus
Burien Washington, 98166, United States
Swedish Cancer Institute-Issaquah
Issaquah Washington, 98029, United States
Kadlec Clinic Hematology and Oncology
Kennewick Washington, 99336, United States
Skagit Valley Hospital
Mount Vernon Washington, 98274, United States
Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo Washington, 98370, United States
Harborview Medical Center
Seattle Washington, 98104, United States
Minor and James Medical PLLC
Seattle Washington, 98104, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States
Kaiser Permanente Washington
Seattle Washington, 98112, United States
Swedish Medical Center-First Hill
Seattle Washington, 98122, United States
University of Washington Medical Center - Montlake
Seattle Washington, 98195, United States
PeaceHealth United General Medical Center
Sedro-Woolley Washington, 98284, United States
Cancer Care Northwest - Spokane South
Spokane Washington, 99202, United States
Evergreen Hematology and Oncology PS
Spokane Washington, 99218, United States
PeaceHealth Southwest Medical Center
Vancouver Washington, 98664, United States
Wenatchee Valley Hospital and Clinics
Wenatchee Washington, 98801, United States
Rocky Mountain Oncology
Casper Wyoming, 82609, United States
Welch Cancer Center
Sheridan Wyoming, 82801, United States

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

133

Study ID:

NCT00658814

Recruitment Status:

Active, not recruiting

Sponsor:


National Cancer Institute (NCI)

How clear is this clinincal trial information?

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