Ireland
--:--IST
Active, not recruiting Phase 2

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

NCT00658814 · tracked via the Priya Life Science Mexico tracker
Phase
Phase 2
Started
2008-12-01
Last updated
2026-07-01

Condition(s) studied

Acute Myeloid LeukemiaAdult Acute Megakaryoblastic LeukemiaAdult Acute Monoblastic LeukemiaAdult Acute Monocytic LeukemiaAdult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11Adult Acute Myeloid Leukemia With MaturationAdult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11Adult Acute Myeloid Leukemia With t(8;21)(q22;q22.1); RUNX1-RUNX1T1Adult Acute Myeloid Leukemia With t(9;11)(p21.3;q23.3); MLLT3-KMT2AAdult Acute Myeloid Leukemia Without MaturationAdult Acute Myelomonocytic LeukemiaAdult ErythroleukemiaAdult Pure Erythroid LeukemiaSecondary Acute Myeloid Leukemia

Investigational drug(s) / intervention(s)

Azacitidine →Gemtuzumab Ozogamicin →

Azacitidine: Given IV or SC during induction; given SC during consolidation and maintenance

Gemtuzumab Ozogamicin: Given IV

Study 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.

Eligibility

Sex
ALL
Min age
60 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Complete Response — Up to 60 days
    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.
  • 30-Day Survival — 30 days
    Patients surviving more than 30 days after study registration

Trial sites (177)

FacilityCityRegionStatus
Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California
Stanford Cancer Institute Palo Alto Palo Alto California
University of California Davis Comprehensive Cancer Center Sacramento California
Smilow Cancer Hospital Care Center at Saint Francis Hartford Connecticut
Saint Alphonsus Cancer Care Center-Boise Boise Idaho
OSF Saint Anthony's Health Center Alton Illinois
Decatur Memorial Hospital Decatur Illinois
Heartland Cancer Research NCORP Decatur Illinois
Advocate Sherman Hospital Elgin Illinois
Loyola University Medical Center Maywood Illinois
SSM Health Good Samaritan Mount Vernon Illinois
Springfield Memorial Hospital Springfield Illinois
Franciscan Saint Francis Health-Beech Grove Beech Grove Indiana
Reid Health Richmond Indiana
Hospital District Sixth of Harper County Anthony Kansas
Cancer Center of Kansas - Chanute Chanute Kansas
Cancer Center of Kansas - Dodge City Dodge City Kansas
Cancer Center of Kansas - El Dorado El Dorado Kansas
Cancer Center of Kansas - Fort Scott Fort Scott Kansas
Cancer Center of Kansas-Independence Independence Kansas
Cancer Center of Kansas-Kingman Kingman Kansas
Lawrence Memorial Hospital Lawrence Kansas
Southwest Medical Center Liberal Kansas
Cancer Center of Kansas-Liberal Liberal Kansas
Cancer Center of Kansas - Newton Newton Kansas
Menorah Medical Center Overland Park Kansas
Saint Luke's South Hospital Overland Park Kansas
Cancer Center of Kansas - Parsons Parsons Kansas
Kansas City NCI Community Oncology Research Program Prairie Village Kansas
Cancer Center of Kansas - Pratt Pratt Kansas
Cancer Center of Kansas - Salina Salina Kansas
Salina Regional Health Center Salina Kansas
AdventHealth Shawnee Mission Shawnee Mission Kansas
Cotton O'Neil Cancer Center / Stormont Vail Health Topeka Kansas
Cancer Center of Kansas - Wellington Wellington Kansas
Associates In Womens Health Wichita Kansas
Cancer Center of Kansas-Wichita Medical Arts Tower Wichita Kansas
Ascension Via Christi Hospitals Wichita Wichita Kansas
Cancer Center of Kansas - Wichita Wichita Kansas
Wesley Medical Center Wichita Kansas

+ 137 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT00658814 on ClinicalTrials.gov ↗ ← All trials in Mexico