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S0535, A Phase II Study of ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin in Patients With Previously Untreated High-Risk Acute Promyelocytic Leukemia


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Leukemia

Thank you

Trial Information

S0535, A Phase II Study of ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin in Patients With Previously Untreated High-Risk Acute Promyelocytic Leukemia


OBJECTIVES:

- To assess the event-free survival and death during the first six weeks in patients with
previously untreated, high-risk acute promyelocytic leukemia treated with a combined
regimen of tretinoin, arsenic trioxide, and gemtuzumab ozogamicin.

- To estimate the frequency and severity of toxicities of this regimen in this group of
patients.

- To investigate the molecular response rate utilizing this regimen in high-risk
patients.

OUTLINE:

- Induction chemotherapy: Patients receive oral tretinoin twice daily beginning on day 1
until CR (up to 90 days), gemtuzumab ozogamicin IV over 2 hours on day 1, and arsenic
trioxide IV over 2 hours 5 days a week beginning on day 10 until CR (up to 60 days) in
the absence of disease progression or unacceptable toxicity. Patients achieving A1 bone
marrow, B1 peripheral blood, and C1 extramedullary disease status proceed to
consolidation therapy after maintaining B1 peripheral blood status for ≥ 7 days.

- Consolidation therapy: Beginning between 2-8 weeks after documentation of complete
response (CR), patients receive consolidation therapy.

- Consolidation courses 1 and 2: Patients receive arsenic trioxide IV over 2 hours 5
days a week for 5 weeks. Treatment repeats every 7 weeks for up to 2 courses.
Patients remaining in A1 bone marrow, B1 peripheral blood, and C1 extramedullary
disease status continue with consolidation courses 3 and 4.

- Consolidation courses 3 and 4: Within 4 weeks of completing consolidation course
2, patients receive oral tretinoin twice daily on days 1-7 and daunomycin IV bolus
or over 1 hour on days 1-3. Within 2-8 weeks after recovery to B1 peripheral blood
status, patients receive consolidation course 4 as in course 3. Patients who
remain in B1 peripheral blood and C1 extramedullary disease status continue on
consolidation courses 5 and 6.

- Consolidation courses 5 and 6: Beginning between 2-8 weeks after recovery to B1
peripheral blood status, patients receive gemtuzumab IV over 2 hours on day 1.
Between 2-8 weeks after recovery to B1 peripheral blood status, patients receive
consolidation course 6 as in course 5. Patients who remain in A1 bone marrow, B1
peripheral blood, and C1 extramedullary disease status proceed to maintenance
therapy.

- Maintenance therapy: Beginning 2-8 weeks after recovery of blood counts, patients
receive oral tretinoin twice daily on days 1-7 every other week for 1 year, oral
mercaptopurine once daily for 1 year, and oral methotrexate once weekly for 1 year.

Patients undergo bone marrow aspirates and biopsies periodically during study. Samples are
analyzed for cytogenetics by fluorescence in situ hybridization (FISH) and for PML-RARα by
polymerase chain reaction (PCR).

After completion of study treatment, patients are evaluated at 3, 6, 9, 12, 18, 24, and 36
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Morphologically confirmed acute promyelocytic leukemia (APL) based on bone marrow
examination

- APL-RARα-negative by RT-PCR are not eligible

- High-risk disease, defined as WBC > 100,000/mm^3

- Bone marrow specimens must be made available for cytogenetic studies

PATIENT CHARACTERISTICS:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No prolonged QTc > 0.47 sec

- No other malignancy within the past 5 years, except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
stage I or stage II cancer from which the patients is currently in complete remission

PRIOR CONCURRENT THERAPY:

- No prior systemic chemotherapy for acute leukemia

- At least 3 days since prior tretinoin (ATRA) allowed

- Prior hydroxyurea, corticosteroids, or leukapheresis to control high cell counts
allowed

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Continuous complete remission at 3 years

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Jeffrey E. Lancet, MD

Investigator Role:

Study Chair

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000572619

NCT ID:

NCT00551460

Start Date:

November 2007

Completion Date:

Related Keywords:

  • Leukemia
  • adult acute promyelocytic leukemia (M3)
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • untreated adult acute myeloid leukemia
  • Leukemia
  • Leukemia, Promyelocytic, Acute

Name

Location

Fred Hutchinson Cancer Research Center Seattle, Washington  98109
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Mayo Clinic Cancer Center Rochester, Minnesota  55905
Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood, Illinois  60153-5500
University of Chicago Cancer Research Center Chicago, Illinois  60637
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
CCOP - Wichita Wichita, Kansas  67214-3882
Hurley Medical Center Flint, Michigan  48503
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - North Shore University Hospital Manhasset, New York  11030
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
Mercy Medical Center - Sioux City Sioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLP Sioux City, Iowa  51101
St. Luke's Regional Medical Center Sioux City, Iowa  51104
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
Saint Joseph Mercy Cancer Center Ann Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn, Michigan  48123-2500
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
Bronson Methodist Hospital Kalamazoo, Michigan  49007
West Michigan Cancer Center Kalamazoo, Michigan  49007-3731
Borgess Medical Center Kalamazooaa, Michigan  49001
Sparrow Regional Cancer Center Lansing, Michigan  48912-1811
St. John Macomb Hospital Warren, Michigan  48093
Fairview Ridges Hospital Burnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids, Minnesota  55433
Duluth Clinic Cancer Center - Duluth Duluth, Minnesota  55805-1983
CCOP - Duluth Duluth, Minnesota  55805
Miller - Dwan Medical Center Duluth, Minnesota  55805
Fairview Southdale Hospital Edina, Minnesota  55435
Mercy and Unity Cancer Center at Unity Hospital Fridley, Minnesota  55432
Hutchinson Area Health Care Hutchinson, Minnesota  55350
HealthEast Cancer Care at St. John's Hospital Maplewood, Minnesota  55109
Hennepin County Medical Center - Minneapolis Minneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Minneapolis, Minnesota  55407
St. Francis Cancer Center at St. Francis Medical Center Shakopee, Minnesota  55379
Park Nicollet Cancer Center St. Louis Park, Minnesota  55416
Regions Hospital Cancer Care Center St. Paul, Minnesota  55101
United Hospital St. Paul, Minnesota  55102
Ridgeview Medical Center Waconia, Minnesota  55387
St. Rita's Medical Center Lima, Ohio  45801
Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283
Geisinger Medical Group - Scenery Park State College, Pennsylvania  16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center Wilkes-Barre, Pennsylvania  18711
CCOP - Montana Cancer Consortium Billings, Montana  59101
LDS Hospital Salt Lake City, Utah  84143
CCOP - Grand Rapids Grand Rapids, Michigan  49503
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
Sutter Cancer Center Sacramento, California  95816
Utah Valley Regional Medical Center - Provo Provo, Utah  84604
Wesley Medical Center Wichita, Kansas  67214
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle, Washington  98104
Long Island Jewish Medical Center New Hyde Park, New York  11040
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita, Kansas  67214
SUNY Upstate Medical University Hospital Syracuse, New York  13210
Hollings Cancer Center at Medical University of South Carolina Charleston, South Carolina  29425
Mary Babb Randolph Cancer Center at West Virginia University Hospitals Morgantown, West Virginia  26506
St. Vincent Hospital Regional Cancer Center Green Bay, Wisconsin  54307-3508
Green Bay Oncology, Limited - Escanaba Escanaba, Michigan  49431
Dickinson County Healthcare System Iron Mountain, Michigan  49801
St. Mary's Hospital Medical Center - Green Bay Green Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center Green Bay, Wisconsin  54301-3526
Green Bay Oncology, Limited at St. Mary's Hospital Green Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical Center Marinette, Wisconsin  54143
Green Bay Oncology, Limited - Oconto Falls Oconto Falls, Wisconsin  54154
Green Bay Oncology, Limited - Sturgeon Bay Sturgeon Bay, Wisconsin  54235
Battle Creek Health System Cancer Care Center Battle Creek, Michigan  49017
Munson Medical Center Traverse City, Michigan  49684
Hematology-Oncology Centers of the Northern Rockies - Billings Billings, Montana  59101
St. Peter's Hospital Helena, Montana  59601
Kalispell Regional Medical Center Kalispell, Montana  59901
Glacier Oncology, PLLC Kalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula, Montana  59802
Montana Cancer Specialists at Montana Cancer Center Missoula, Montana  59802
Wayne Memorial Hospital, Incorporated Goldsboro, North Carolina  27534
American Fork Hospital American Fork, Utah  84003
Logan Regional Hospital Logan, Utah  84321
Utah Cancer Specialists at UCS Cancer Center Salt Lake City, Utah  84106
Olympic Hematology and Oncology Bremerton, Washington  98310
Skagit Valley Hospital Cancer Care Center Mt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical Center Seattle, Washington  98195
Harborview Medical Center Seattle, Washington  98104
Group Health Central Hospital Seattle, Washington  98104
North Puget Oncology at United General Hospital Sedro-Wooley, Washington  98284
Cancer Care Northwest - Spokane South Spokane, Washington  99202
Greenebaum Cancer Center at University of Maryland Medical Center Baltimore, Maryland  21201
UNMC Eppley Cancer Center at the University of Nebraska Medical Center Omaha, Nebraska  68198-7680
M.D. Anderson Cancer Center at Orlando Orlando, Florida  32806
Swedish-American Regional Cancer Center Rockford, Illinois  61104-2315
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute Boston, Massachusetts  02115
Butterworth Hospital at Spectrum Health Grand Rapids, Michigan  49503-2560
University of Mississippi Cancer Clinic Jackson, Mississippi  39216-4505
Don Monti Comprehensive Cancer Center at North Shore University Hospital Manhasset, New York  11030
Geisinger Cancer Institute at Geisinger Health Danville, Pennsylvania  17822-0001
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center Hartford, Connecticut  06105
Hematology Oncology Associates - Skokie Skokie, Illinois  60076
Sutter Cancer Center at Roseville Medical Center Roseville, California  95661
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center Boise, Idaho  83706
Hematology and Oncology Associates Chicago, Illinois  60611
North Shore Oncology and Hematology Associates, Limited - Libertyville Libertyville, Illinois  60048
Fort Wayne Medical Oncology and Hematology Fort Wayne, Indiana  46815
Cancer Center of Kansas, PA - Dodge City Dodge City, Kansas  67801
Mecosta County Medical Center Big Rapids, Michigan  49307
Cancer Institute of New Jersey at Cooper - Voorhees Voorhees, New Jersey  08043
Bon Secours St. Francis Health System Greenville, South Carolina  29601
Dixie Regional Medical Center - East Campus Saint George, Utah  84770
Minor and James Medical, PLLC Seattle, Washington  98104
Polyclinic First Hill Seattle, Washington  98122
Holy Family Memorial Medical Center Cancer Care Center Manitowoc, Wisconsin  54221-1450
Massachusetts General Hospital Boston, Massachusetts  02114-2617
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida Tampa, Florida  33612
Stanford Cancer Center Stanford, California  94305-5824
Tunnell Cancer Center at Beebe Medical Center Lewes, Delaware  19958
Kellogg Cancer Care Center Highland Park, Illinois  60035
Cancer Care and Hematology Specialists of Chicagoland - Niles Niles, Illinois  60714
Cancer Center of Kansas, PA - Chanute Chanute, Kansas  66720
Cancer Center of Kansas, PA - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas - Fort Scott Fort Scott, Kansas  66701
Cancer Center of Kansas-Independence Independence, Kansas  67301
Cancer Center of Kansas, PA - Kingman Kingman, Kansas  67068
Lawrence Memorial Hospital Lawrence, Kansas  66044
Cancer Center of Kansas, PA - Liberal Liberal, Kansas  67905
Cancer Center of Kansas, PA - Newton Newton, Kansas  67114
Menorah Medical Center Overland Park, Kansas  66209
Saint Luke's Hospital - South Overland Park, Kansas  66213
Cancer Center of Kansas, PA - Parsons Parsons, Kansas  67357
Cancer Center of Kansas, PA - Pratt Pratt, Kansas  67124
Cancer Center of Kansas, PA - Salina Salina, Kansas  67401
Cancer Center of Kansas, PA - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, PA - Wichita Wichita, Kansas  67214
Associates in Womens Health, PA - North Review Wichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas, PA - Winfield Winfield, Kansas  67156
Foote Memorial Hospital Jackson, Michigan  49201
St. Mary Mercy Hospital Livonia, Michigan  48154
St. Joseph Mercy Oakland Pontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy Hospital Port Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - Saginaw Saginaw, Michigan  48601
Willmar Cancer Center at Rice Memorial Hospital Willmar, Minnesota  56201
Heartland Hematology Oncology Associates, Incorporated Kansas City, Missouri  64118
North Kansas City Hospital Kansas City, Missouri  64116
Saint Luke's Cancer Institute at Saint Luke's Hospital Kansas City, Missouri  64111
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
Saint Joseph Oncology, Incorporated Saint Joseph, Missouri  64507
Billings Clinic - Downtown Billings, Montana  59107-7000
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
St. James Healthcare Cancer Care Butte, Montana  59701
Great Falls Clinic - Main Facility Great Falls, Montana  59405
Sletten Cancer Institute at Benefis Healthcare Great Falls, Montana  59405
Kalispell Medical Oncology at KRMC Kalispell, Montana  59901
Monter Cancer Center of the North Shore-LIJ Health System Lake Success, New York  11042
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Columbus, Ohio  43210-1240
Geisinger Hazleton Cancer Center Hazleton, Pennsylvania  18201
Sandra L. Maxwell Cancer Center Cedar City, Utah  84720
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center Murray, Utah  84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center Ogden, Utah  84403
St. Joseph Cancer Center Bellingham, Washington  98225
Columbia Basin Hematology Kennewick, Washington  99336
Harrison Poulsbo Hematology and Onocology Poulsbo, Washington  98370
Evergreen Hematology and Oncology, PS Spokane, Washington  99218
Wenatchee Valley Medical Center Wenatchee, Washington  98801-2028
Rocky Mountain Oncology Casper, Wyoming  82609
Saint Louis University Cancer Center Saint Louis, Missouri  63110
Rutherford Hospital Rutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Union Hospital of Cecil County Elkton MD, Maryland  21921
Dana-Farber/Brigham and Women's Cancer Center Boston, Massachusetts  02115
Kinston Medical Specialists Kinston, North Carolina  28501
Lacks Cancer Center at Saint Mary's Health Care Grand Rapids, Michigan  49503
St. Vincent Healthcare Cancer Care Services Billings, Montana  59101
Providence Medical Center Kansas City, Kansas  66112
Parvin Radiation Oncology Kansas City, Missouri  64116
Mercy General Health Partners Muskegon, Michigan  49443
AnMed Cancer Center Anderson, South Carolina  29621
Provena St. Mary's Regional Cancer Center - Kankakee Kankakee, Illinois  60901
Minnesota Oncology - Maplewood Maplewood, Minnesota  55109
Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale, Minnesota  55422-2900
Lakeview Hospital Stillwater, Minnesota  55082
Minnesota Oncology - Woodbury Woodbury, Minnesota  55125
CCOP - Kansas City Prairie Village, Kansas  66208
Island Hospital Cancer Care Center at Island Hospital Anacortes, Washington  98221
Highline Medical Center Cancer Center Burien, Washington  98166
New Ulm Medical Center New Ulm, Minnesota  56073
St. Nicholas Hospital Sheboygan, Wisconsin  53081
Spectrum Health Reed City Hospital Reed City, Michigan  49677
Cancer Center of Kansas, PA - McPherson McPherson, Kansas  67460
Swedish Medical Center - Issaquah Campus Issaquah, Washington  98029