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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 CenterSeattle, Washington  98109
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
University of Chicago Cancer Research CenterChicago, Illinois  60637
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
Hurley Medical CenterFlint, Michigan  48503
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - North Shore University HospitalManhasset, New York  11030
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
St. John Macomb HospitalWarren, Michigan  48093
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Duluth Clinic Cancer Center - DuluthDuluth, Minnesota  55805-1983
CCOP - DuluthDuluth, Minnesota  55805
Miller - Dwan Medical CenterDuluth, Minnesota  55805
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Hutchinson Area Health CareHutchinson, Minnesota  55350
HealthEast Cancer Care at St. John's HospitalMaplewood, Minnesota  55109
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
St. Francis Cancer Center at St. Francis Medical CenterShakopee, Minnesota  55379
Park Nicollet Cancer CenterSt. Louis Park, Minnesota  55416
Regions Hospital Cancer Care CenterSt. Paul, Minnesota  55101
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
St. Rita's Medical CenterLima, Ohio  45801
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
Geisinger Medical Group - Scenery ParkState College, Pennsylvania  16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical CenterWilkes-Barre, Pennsylvania  18711
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
LDS HospitalSalt Lake City, Utah  84143
CCOP - Grand RapidsGrand Rapids, Michigan  49503
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Sutter Cancer CenterSacramento, California  95816
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Wesley Medical CenterWichita, Kansas  67214
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Mary Babb Randolph Cancer Center at West Virginia University HospitalsMorgantown, West Virginia  26506
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
Green Bay Oncology, Limited - EscanabaEscanaba, Michigan  49431
Dickinson County Healthcare SystemIron Mountain, Michigan  49801
St. Mary's Hospital Medical Center - Green BayGreen Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54301-3526
Green Bay Oncology, Limited at St. Mary's HospitalGreen Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical CenterMarinette, Wisconsin  54143
Green Bay Oncology, Limited - Oconto FallsOconto Falls, Wisconsin  54154
Green Bay Oncology, Limited - Sturgeon BaySturgeon Bay, Wisconsin  54235
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
Munson Medical CenterTraverse City, Michigan  49684
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
American Fork HospitalAmerican Fork, Utah  84003
Logan Regional HospitalLogan, Utah  84321
Utah Cancer Specialists at UCS Cancer CenterSalt Lake City, Utah  84106
Olympic Hematology and OncologyBremerton, Washington  98310
Skagit Valley Hospital Cancer Care CenterMt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Harborview Medical CenterSeattle, Washington  98104
Group Health Central HospitalSeattle, Washington  98104
North Puget Oncology at United General HospitalSedro-Wooley, Washington  98284
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
UNMC Eppley Cancer Center at the University of Nebraska Medical CenterOmaha, Nebraska  68198-7680
M.D. Anderson Cancer Center at OrlandoOrlando, Florida  32806
Swedish-American Regional Cancer CenterRockford, Illinois  61104-2315
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Butterworth Hospital at Spectrum HealthGrand Rapids, Michigan  49503-2560
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
Don Monti Comprehensive Cancer Center at North Shore University HospitalManhasset, New York  11030
Geisinger Cancer Institute at Geisinger HealthDanville, Pennsylvania  17822-0001
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
Hematology Oncology Associates - SkokieSkokie, Illinois  60076
Sutter Cancer Center at Roseville Medical CenterRoseville, California  95661
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical CenterBoise, Idaho  83706
Hematology and Oncology AssociatesChicago, Illinois  60611
North Shore Oncology and Hematology Associates, Limited - LibertyvilleLibertyville, Illinois  60048
Fort Wayne Medical Oncology and HematologyFort Wayne, Indiana  46815
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Mecosta County Medical CenterBig Rapids, Michigan  49307
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Bon Secours St. Francis Health SystemGreenville, South Carolina  29601
Dixie Regional Medical Center - East CampusSaint George, Utah  84770
Minor and James Medical, PLLCSeattle, Washington  98104
Polyclinic First HillSeattle, Washington  98122
Holy Family Memorial Medical Center Cancer Care CenterManitowoc, Wisconsin  54221-1450
Massachusetts General HospitalBoston, Massachusetts  02114-2617
H. Lee Moffitt Cancer Center and Research Institute at University of South FloridaTampa, Florida  33612
Stanford Cancer CenterStanford, California  94305-5824
Tunnell Cancer Center at Beebe Medical CenterLewes, Delaware  19958
Kellogg Cancer Care CenterHighland Park, Illinois  60035
Cancer Care and Hematology Specialists of Chicagoland - NilesNiles, Illinois  60714
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas - Fort ScottFort Scott, Kansas  66701
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Lawrence Memorial HospitalLawrence, Kansas  66044
Cancer Center of Kansas, PA - LiberalLiberal, Kansas  67905
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Menorah Medical CenterOverland Park, Kansas  66209
Saint Luke's Hospital - SouthOverland Park, Kansas  66213
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Foote Memorial HospitalJackson, Michigan  49201
St. Mary Mercy HospitalLivonia, Michigan  48154
St. Joseph Mercy OaklandPontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy HospitalPort Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - SaginawSaginaw, Michigan  48601
Willmar Cancer Center at Rice Memorial HospitalWillmar, Minnesota  56201
Heartland Hematology Oncology Associates, IncorporatedKansas City, Missouri  64118
North Kansas City HospitalKansas City, Missouri  64116
Saint Luke's Cancer Institute at Saint Luke's HospitalKansas City, Missouri  64111
Research Medical CenterKansas City, Missouri  64132
Saint Luke's East - Lee's SummitLee's Summit, Missouri  64086
Heartland Regional Medical CenterSaint Joseph, Missouri  64506
Saint Joseph Oncology, IncorporatedSaint Joseph, Missouri  64507
Billings Clinic - DowntownBillings, Montana  59107-7000
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
St. James Healthcare Cancer CareButte, Montana  59701
Great Falls Clinic - Main FacilityGreat Falls, Montana  59405
Sletten Cancer Institute at Benefis HealthcareGreat Falls, Montana  59405
Kalispell Medical Oncology at KRMCKalispell, Montana  59901
Monter Cancer Center of the North Shore-LIJ Health SystemLake Success, New York  11042
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer CenterColumbus, Ohio  43210-1240
Geisinger Hazleton Cancer CenterHazleton, Pennsylvania  18201
Sandra L. Maxwell Cancer CenterCedar City, Utah  84720
Jon and Karen Huntsman Cancer Center at Intermountain Medical CenterMurray, Utah  84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital CenterOgden, Utah  84403
St. Joseph Cancer CenterBellingham, Washington  98225
Columbia Basin HematologyKennewick, Washington  99336
Harrison Poulsbo Hematology and OnocologyPoulsbo, Washington  98370
Evergreen Hematology and Oncology, PSSpokane, Washington  99218
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Rocky Mountain OncologyCasper, Wyoming  82609
Saint Louis University Cancer CenterSaint Louis, Missouri  63110
Rutherford HospitalRutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Union Hospital of Cecil CountyElkton MD, Maryland  21921
Dana-Farber/Brigham and Women's Cancer CenterBoston, Massachusetts  02115
Kinston Medical SpecialistsKinston, North Carolina  28501
Lacks Cancer Center at Saint Mary's Health CareGrand Rapids, Michigan  49503
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101
Providence Medical CenterKansas City, Kansas  66112
Parvin Radiation OncologyKansas City, Missouri  64116
Mercy General Health PartnersMuskegon, Michigan  49443
AnMed Cancer CenterAnderson, South Carolina  29621
Provena St. Mary's Regional Cancer Center - KankakeeKankakee, Illinois  60901
Minnesota Oncology - MaplewoodMaplewood, Minnesota  55109
Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdale, Minnesota  55422-2900
Lakeview HospitalStillwater, Minnesota  55082
Minnesota Oncology - WoodburyWoodbury, Minnesota  55125
CCOP - Kansas CityPrairie Village, Kansas  66208
Island Hospital Cancer Care Center at Island HospitalAnacortes, Washington  98221
Highline Medical Center Cancer CenterBurien, Washington  98166
New Ulm Medical CenterNew Ulm, Minnesota  56073
St. Nicholas HospitalSheboygan, Wisconsin  53081
Spectrum Health Reed City HospitalReed City, Michigan  49677
Cancer Center of Kansas, PA - McPhersonMcPherson, Kansas  67460
Swedish Medical Center - Issaquah CampusIssaquah, Washington  98029