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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 Center Jackson, Mississippi  39216-4505
Medical University of South Carolina Charleston, South Carolina  29425-0721
University of Washington Medical Center Seattle, Washington  98195-6043
Hurley Medical Center Flint, Michigan  48503
Loyola University Medical Center Maywood, Illinois  60153
Akron General Medical Center Akron, Ohio  44302
Via Christi Regional Medical Center Wichita, Kansas  67214
Wesley Medical Center Wichita, Kansas  67214
Group Health Cooperative Seattle, Washington  98112
Great Falls Clinic Great Falls, Montana  59405
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Seattle, Washington  98109
Cancer Center of Kansas - Chanute Chanute, Kansas  66720
Cancer Center of Kansas - Dodge City Dodge City, Kansas  67801
Cancer Center of Kansas - Newton Newton, Kansas  67114
Cancer Center of Kansas - Salina Salina, Kansas  67042
Cancer Center of Kansas - Wellington Wellington, Kansas  67152
Associates in Womens Health Wichita, Kansas  67203
Cancer Center of Kansas - Winfield Winfield, Kansas  67156
Munson Medical Center Traverse City, Michigan  49684
Bozeman Deaconess Hospital Bozeman, Montana  59715
Kalispell Regional Medical Center Kalispell, Montana  59901
Adena Regional Medical Center Chillicothe, Ohio  54601
Grady Memorial Hospital Delaware, Ohio  43015
Fairfield Medical Center Lancaster, Ohio  43130
Harborview Medical Center Seattle, Washington  98104
Cancer Care Northwest - Spokane South Spokane, Washington  99202
Welch Cancer Center Sheridan, Wyoming  82801
University of New Mexico Cancer Center Albuquerque, New Mexico  87131-5636
Salina Regional Health Center Salina, Kansas  67401
Mecosta County Medical Center Big Rapids, Michigan  49307
Grandview Hospital Dayton, Ohio  45405
Providence Milwaukie Hospital Milwaukie, Oregon  97222
Saint Joseph Mercy Hospital Ann Arbor, Michigan  48106
Miami Valley Hospital Dayton, Ohio  45409
Hospital District Sixth of Harper County Anthony, Kansas  67003
Cancer Center of Kansas - Fort Scott Fort Scott, Kansas  66701
Cancer Center of Kansas-Independence Independence, Kansas  67301
Lawrence Memorial Hospital Lawrence, Kansas  66044
Menorah Medical Center Overland Park, Kansas  66209
Shawnee Mission Medical Center Shawnee Mission, Kansas  66204
North Kansas City Hospital Kansas City, Missouri  64116
Research Medical Center Kansas City, Missouri  64132
Saint Luke's East - Lee's Summit Lee's Summit, Missouri  64086
Heartland Regional Medical Center Saint Joseph, Missouri  64506
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
Mary Rutan Hospital Bellefontaine, Ohio  43311
Wayne Hospital Greenville, Ohio  45331
Knox Community Hospital Mount Vernon, Ohio  43050
Wenatchee Valley Medical Center Wenatchee, Washington  98801-2028
Rocky Mountain Oncology Casper, Wyoming  82609
Greene Memorial Hospital Xenia, Ohio  45385
Memorial Medical Center Springfield, Illinois  62781
University of Rochester Rochester, New York  14642
Saint Alphonsus Regional Medical Center Boise, Idaho  83706
Wayne State University Detroit, Michigan  48202
Riverside Methodist Hospital Columbus, Ohio  43214
Licking Memorial Hospital Newark, Ohio  43055-2899
Providence Portland Medical Center Portland, Oregon  97213-3635
Columbus CCOP Columbus, Ohio  43206
University of Kentucky Lexington, Kentucky  40536-0098
Wichita CCOP Wichita, Kansas  67214-3882
Montana Cancer Consortium CCOP Billings, Montana  59101
UC Davis Comprehensive Cancer Center Sacramento, California  95817
Providence Hospital Southfield, Michigan  48075
Decatur Memorial Hospital Decatur, Illinois  62526
Tulane University Health Sciences Center New Orleans, Louisiana  70112
Montana Cancer Specialists Missoula, Montana  59807-7877
Providence Saint Joseph Medical Center Burbank, California  91505-4866
University of Cincinnati Cincinnati, Ohio  45267-0502
Clackamas Radiation Oncology Center Clackamas, Oregon  97015
Providence Newberg Medical Center Newberg, Oregon  97132
Saint Francis Hospital and Medical Center Hartford, Connecticut  06105
Saint Francis Hospital and Health Centers Beech Grove, Indiana  46107
Reid Hospital and Health Care Services Richmond, Indiana  47374
Cancer Center of Kansas-Kingman Kingman, Kansas  67068
Cancer Center of Kansas - Parsons Parsons, Kansas  67357
Cancer Center of Kansas - Pratt Pratt, Kansas  67124
Cancer Center of Kansas-Wichita Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas - Main Office Wichita, Kansas  67214
Michigan Cancer Research Consortium Community Clinical Oncology Program Ann Arbor, Michigan  48106
Oakwood Hospital Dearborn, Michigan  48123
Saint John Hospital and Medical Center Detroit, Michigan  48236
Grand Rapids Clinical Oncology Program Grand Rapids, Michigan  49503
Saint Mary's Health Care Grand Rapids, Michigan  49503
Spectrum Health at Butterworth Campus Grand Rapids, Michigan  49503
Allegiance Health Jackson, Michigan  49201
Sparrow Hospital Lansing, Michigan  48912
Saint Mary Mercy Hospital Livonia, Michigan  48154
Mercy Health Partners-Mercy Campus Muskegon, Michigan  49443
Saint Joseph Mercy Oakland Pontiac, Michigan  48341-2985
Saint Joseph Mercy Port Huron Port Huron, Michigan  48060
Saint Mary's of Michigan Saginaw, Michigan  48601
Saint John Macomb-Oakland Hospital Warren, Michigan  48093
Saint Luke's Hospital of Kansas City Kansas City, Missouri  64111
Saint Joseph Health Center Kansas City, Missouri  64114
Liberty Radiation Oncology Clinic Kansas City, Missouri  64116
Truman Medical Center Kansas City, Missouri  64108
Hematology-Oncology Centers of the Northern Rockies PC Billings, Montana  59101
Saint Vincent Healthcare Billings, Montana  59101
Billings Clinic Billings, Montana  59107-7000
Benefis Healthcare- Sletten Cancer Institute Great Falls, Montana  59405
Saint Peter's Community Hospital Helena, Montana  59601
Glacier Oncology PLLC Kalispell, Montana  59901
Saint Patrick Hospital - Community Hospital Missoula, Montana  59802
Wayne Memorial Hospital Goldsboro, North Carolina  27534
Margaret R Pardee Memorial Hospital Hendersonville, North Carolina  28791
Doctors Hospital Columbus, Ohio  43228
Grant Medical Center Columbus, Ohio  43215
Mount Carmel Health Center West Columbus, Ohio  43222
Good Samaritan Hospital - Dayton Dayton, Ohio  45406
Dayton CCOP Dayton, Ohio  45429
Samaritan North Health Center Dayton, Ohio  45415
Blanchard Valley Hospital Findlay, Ohio  45840
Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio  45005-1066
Kettering Medical Center Kettering, Ohio  45429
Marietta Memorial Hospital Marietta, Ohio  45750
Upper Valley Medical Center Troy, Ohio  45373
Saint Ann's Hospital Westerville, Ohio  43081
Genesis HealthCare System Zanesville, Ohio  43701
Providence Saint Vincent Medical Center Portland, Oregon  97225
Columbia River Oncology Program Portland, Oregon  97225
The Don and Sybil Harrington Cancer Center Amarillo, Texas  79106
Harrison Bremerton Hematology and Oncology Bremerton, Washington  98310
Columbia Basin Hematology and Oncology PLLC Kennewick, Washington  99336
Minor and James Medical PLLC Seattle, Washington  98104
The Polyclinic Seattle, Washington  98122
Swedish Medical Center-First Hill Seattle, Washington  98122-4307
Cancer Center of Kansas-Liberal Liberal, Kansas  67901
University of Michigan University Hospital Ann Arbor, Michigan  48109
Skagit Valley Hospital Mt. Vernon, Washington  98273
Evergreen Hematology and Oncology PS Spokane, Washington  99218
Saint Luke's South Hospital Overland Park, Kansas  66213
Kansas City CCOP Prairie Village, Kansas  66208
Hematology and Oncology Clinic Baton Rouge, Louisiana  70809
Heartland Hematology and Oncology Associates Incorporated Kansas City, Missouri  64118
Southern Ohio Medical Center Portsmouth, Ohio  45662
Cancer Care Center at Island Hospital Anacortes, Washington  98221
Highline Medical Center-Main Campus Burien, Washington  98166
United General Hospital Sedro-Woolley, Washington  98284
Stanford University Hospitals and Clinics Stanford, California  94305
Swedish Cancer Institute-Issaquah Issaquah, Washington  98029
Southwest Oncology Group San Antonio, Texas  78245
Genesys Regional Medical Center-West Flint Campus Flint, Michigan  48532
PeaceHealth Saint Joseph Medical Center Bellingham, Washington  98225
Bronson Battle Creek Battle Creek, Michigan  49017
Springfield Regional Medical Center Springfield, Ohio  45505
Harrison Poulsbo Hematology and Oncology Poulsbo, Washington  98370
PeaceHealth Southwest Medical Center Vancouver, Washington  98664
Providence Willamette Falls Medical Center Oregon City, Oregon  97045