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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.


Phase 2
60 Years
N/A
Open (Enrolling)
Both
Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloblastic Leukemia With Maturation (M2), Adult Acute Myeloblastic Leukemia Without Maturation (M1), Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Acute Myelomonocytic Leukemia (M4), Adult Erythroleukemia (M6a), Adult Pure Erythroid Leukemia (M6b), Secondary Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia

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Trial Information

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.


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 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.

MAINTENANCE THERAPY: Patients receive azacitidine IV over 10-40 minutes or subcutaneously 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. Marrow and blood samples are
submitted to correlatives studies and submitted to SWOG ALL/CLL/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.


Inclusion Criteria:



- Morphologically confirmed diagnosis of acute myeloidleukemia (AML)

- No acute promyelocytic leukemia (FAB M3)

- No blastic transformation of chronic myelogenous leukemia

- 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

- Must be registered on SWOG-S9910

- No CNS involvement

- Zubrod performance status 0-3

- Total bilirubin ≤ 2.0 times upper limit of normal (ULN) (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 allowed

- AST or ALT ≤ 2.0 times ULN (unless the elevation is believed to be due to hepatic
infiltration by AML)

- Serum creatinine ≤ 1.5 times ULN

- LVEF ≥ 40% by MUGA or ECHO AND no clinical evidence of congestive heart failure
within the past 56 days

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

- Negative pregnancy test

- Not pregnant or nursing

- Fertile patients must use effective contraception

- HIV-positive patients must meet the following criteria:

- No history of AIDS-defining events

- CD4 cells ≥ 500/mm^3

- Viral load of < 50 copies HIV mRNA/mm^3 if on cART or < 25,000 copiesHIV mRNA if
not on cART

- No zidovudine or stavudine as part of cART

- No other prior malignancy except for adequately treated basal cell or squamous cell
skin cancer or any diagnosis of malignancy made within the past 2 years 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

- Concurrent hormonal therapy allowed

- At least 6 months since prior chemotherapy or radiotherapy

- No prior systemic chemotherapy for acute leukemiaexcept hydroxyurea

- Prior hydroxyurea to control high WBC count allowed

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Probability of achieving CR or CRp

Outcome Time Frame:

30 days

Safety Issue:

No

Principal Investigator

Sucha Nand

Investigator Role:

Principal Investigator

Investigator Affiliation:

Southwest Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00790

NCT ID:

NCT00658814

Start Date:

December 2008

Completion Date:

Related Keywords:

  • Adult Acute Megakaryoblastic Leukemia (M7)
  • Adult Acute Monoblastic Leukemia (M5a)
  • Adult Acute Monocytic Leukemia (M5b)
  • Adult Acute Myeloblastic Leukemia With Maturation (M2)
  • Adult Acute Myeloblastic Leukemia Without Maturation (M1)
  • Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
  • Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
  • Adult Acute Myelomonocytic Leukemia (M4)
  • Adult Erythroleukemia (M6a)
  • Adult Pure Erythroid Leukemia (M6b)
  • Secondary Acute Myeloid Leukemia
  • Untreated Adult Acute Myeloid Leukemia
  • Congenital Abnormalities
  • Leukemia
  • Leukemia, Erythroblastic, Acute
  • Leukemia, Megakaryoblastic, Acute
  • Leukemia, Monocytic, Acute
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelomonocytic, Acute
  • Leukemia, Myelomonocytic, Chronic

Name

Location

University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Medical University of South CarolinaCharleston, South Carolina  29425-0721
University of Washington Medical CenterSeattle, Washington  98195-6043
Hurley Medical CenterFlint, Michigan  48503
Loyola University Medical CenterMaywood, Illinois  60153
Akron General Medical CenterAkron, Ohio  44302
Via Christi Regional Medical CenterWichita, Kansas  67214
Wesley Medical CenterWichita, Kansas  67214
Group Health CooperativeSeattle, Washington  98112
Great Falls ClinicGreat Falls, Montana  59405
Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109
Cancer Center of Kansas - ChanuteChanute, Kansas  66720
Cancer Center of Kansas - Dodge CityDodge City, Kansas  67801
Cancer Center of Kansas - NewtonNewton, Kansas  67114
Cancer Center of Kansas - SalinaSalina, Kansas  67042
Cancer Center of Kansas - WellingtonWellington, Kansas  67152
Associates in Womens HealthWichita, Kansas  67203
Cancer Center of Kansas - WinfieldWinfield, Kansas  67156
Munson Medical CenterTraverse City, Michigan  49684
Bozeman Deaconess HospitalBozeman, Montana  59715
Kalispell Regional Medical CenterKalispell, Montana  59901
Adena Regional Medical CenterChillicothe, Ohio  54601
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Harborview Medical CenterSeattle, Washington  98104
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Welch Cancer CenterSheridan, Wyoming  82801
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Salina Regional Health CenterSalina, Kansas  67401
Mecosta County Medical CenterBig Rapids, Michigan  49307
Grandview HospitalDayton, Ohio  45405
Providence Milwaukie HospitalMilwaukie, Oregon  97222
Saint Joseph Mercy HospitalAnn Arbor, Michigan  48106
Miami Valley HospitalDayton, Ohio  45409
Hospital District Sixth of Harper CountyAnthony, Kansas  67003
Cancer Center of Kansas - Fort ScottFort Scott, Kansas  66701
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Lawrence Memorial HospitalLawrence, Kansas  66044
Menorah Medical CenterOverland Park, Kansas  66209
Shawnee Mission Medical CenterShawnee Mission, Kansas  66204
North Kansas City HospitalKansas City, Missouri  64116
Research Medical CenterKansas City, Missouri  64132
Saint Luke's East - Lee's SummitLee's Summit, Missouri  64086
Heartland Regional Medical CenterSaint Joseph, Missouri  64506
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
Mary Rutan HospitalBellefontaine, Ohio  43311
Wayne HospitalGreenville, Ohio  45331
Knox Community HospitalMount Vernon, Ohio  43050
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Rocky Mountain OncologyCasper, Wyoming  82609
Greene Memorial HospitalXenia, Ohio  45385
Memorial Medical CenterSpringfield, Illinois  62781
University of RochesterRochester, New York  14642
Saint Alphonsus Regional Medical CenterBoise, Idaho  83706
Wayne State UniversityDetroit, Michigan  48202
Riverside Methodist HospitalColumbus, Ohio  43214
Licking Memorial HospitalNewark, Ohio  43055-2899
Providence Portland Medical CenterPortland, Oregon  97213-3635
Columbus CCOPColumbus, Ohio  43206
University of KentuckyLexington, Kentucky  40536-0098
Wichita CCOPWichita, Kansas  67214-3882
Montana Cancer Consortium CCOPBillings, Montana  59101
UC Davis Comprehensive Cancer CenterSacramento, California  95817
Providence HospitalSouthfield, Michigan  48075
Decatur Memorial HospitalDecatur, Illinois  62526
Tulane University Health Sciences CenterNew Orleans, Louisiana  70112
Montana Cancer SpecialistsMissoula, Montana  59807-7877
Providence Saint Joseph Medical CenterBurbank, California  91505-4866
University of CincinnatiCincinnati, Ohio  45267-0502
Clackamas Radiation Oncology CenterClackamas, Oregon  97015
Providence Newberg Medical CenterNewberg, Oregon  97132
Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
Saint Francis Hospital and Health CentersBeech Grove, Indiana  46107
Reid Hospital and Health Care ServicesRichmond, Indiana  47374
Cancer Center of Kansas-KingmanKingman, Kansas  67068
Cancer Center of Kansas - ParsonsParsons, Kansas  67357
Cancer Center of Kansas - PrattPratt, Kansas  67124
Cancer Center of Kansas-Wichita Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas - Main OfficeWichita, Kansas  67214
Michigan Cancer Research Consortium Community Clinical Oncology ProgramAnn Arbor, Michigan  48106
Oakwood HospitalDearborn, Michigan  48123
Saint John Hospital and Medical CenterDetroit, Michigan  48236
Grand Rapids Clinical Oncology ProgramGrand Rapids, Michigan  49503
Saint Mary's Health CareGrand Rapids, Michigan  49503
Spectrum Health at Butterworth CampusGrand Rapids, Michigan  49503
Allegiance HealthJackson, Michigan  49201
Sparrow HospitalLansing, Michigan  48912
Saint Mary Mercy HospitalLivonia, Michigan  48154
Mercy Health Partners-Mercy CampusMuskegon, Michigan  49443
Saint Joseph Mercy OaklandPontiac, Michigan  48341-2985
Saint Joseph Mercy Port HuronPort Huron, Michigan  48060
Saint Mary's of MichiganSaginaw, Michigan  48601
Saint John Macomb-Oakland HospitalWarren, Michigan  48093
Saint Luke's Hospital of Kansas CityKansas City, Missouri  64111
Saint Joseph Health CenterKansas City, Missouri  64114
Liberty Radiation Oncology ClinicKansas City, Missouri  64116
Truman Medical CenterKansas City, Missouri  64108
Hematology-Oncology Centers of the Northern Rockies PCBillings, Montana  59101
Saint Vincent HealthcareBillings, Montana  59101
Billings ClinicBillings, Montana  59107-7000
Benefis Healthcare- Sletten Cancer InstituteGreat Falls, Montana  59405
Saint Peter's Community HospitalHelena, Montana  59601
Glacier Oncology PLLCKalispell, Montana  59901
Saint Patrick Hospital - Community HospitalMissoula, Montana  59802
Wayne Memorial HospitalGoldsboro, North Carolina  27534
Margaret R Pardee Memorial HospitalHendersonville, North Carolina  28791
Doctors HospitalColumbus, Ohio  43228
Grant Medical CenterColumbus, Ohio  43215
Mount Carmel Health Center WestColumbus, Ohio  43222
Good Samaritan Hospital - DaytonDayton, Ohio  45406
Dayton CCOPDayton, Ohio  45429
Samaritan North Health CenterDayton, Ohio  45415
Blanchard Valley HospitalFindlay, Ohio  45840
Atrium Medical Center-Middletown Regional HospitalFranklin, Ohio  45005-1066
Kettering Medical CenterKettering, Ohio  45429
Marietta Memorial HospitalMarietta, Ohio  45750
Upper Valley Medical CenterTroy, Ohio  45373
Saint Ann's HospitalWesterville, Ohio  43081
Genesis HealthCare SystemZanesville, Ohio  43701
Providence Saint Vincent Medical CenterPortland, Oregon  97225
Columbia River Oncology ProgramPortland, Oregon  97225
The Don and Sybil Harrington Cancer CenterAmarillo, Texas  79106
Harrison Bremerton Hematology and OncologyBremerton, Washington  98310
Columbia Basin Hematology and Oncology PLLCKennewick, Washington  99336
Minor and James Medical PLLCSeattle, Washington  98104
The PolyclinicSeattle, Washington  98122
Swedish Medical Center-First HillSeattle, Washington  98122-4307
Cancer Center of Kansas-LiberalLiberal, Kansas  67901
University of Michigan University HospitalAnn Arbor, Michigan  48109
Skagit Valley HospitalMt. Vernon, Washington  98273
Evergreen Hematology and Oncology PSSpokane, Washington  99218
Saint Luke's South HospitalOverland Park, Kansas  66213
Kansas City CCOPPrairie Village, Kansas  66208
Hematology and Oncology ClinicBaton Rouge, Louisiana  70809
Heartland Hematology and Oncology Associates IncorporatedKansas City, Missouri  64118
Southern Ohio Medical CenterPortsmouth, Ohio  45662
Cancer Care Center at Island HospitalAnacortes, Washington  98221
Highline Medical Center-Main CampusBurien, Washington  98166
United General HospitalSedro-Woolley, Washington  98284
Stanford University Hospitals and ClinicsStanford, California  94305
Swedish Cancer Institute-IssaquahIssaquah, Washington  98029
Southwest Oncology GroupSan Antonio, Texas  78245
Genesys Regional Medical Center-West Flint CampusFlint, Michigan  48532
PeaceHealth Saint Joseph Medical CenterBellingham, Washington  98225
Bronson Battle CreekBattle Creek, Michigan  49017
Springfield Regional Medical CenterSpringfield, Ohio  45505
Harrison Poulsbo Hematology and OncologyPoulsbo, Washington  98370
PeaceHealth Southwest Medical CenterVancouver, Washington  98664
Providence Willamette Falls Medical CenterOregon City, Oregon  97045