ALinC 17: Protocol for Patients With Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia (ALL): A Phase III Study
OBJECTIVES:
- Determine if multidrug delayed-intensification therapy improves outcome in children
with newly diagnosed standard-risk acute lymphocytic leukemia.
- Compare the efficacy and toxicity of methotrexate administered over 4 hours vs
methotrexate administered over 24 hours in this patient population.
- Determine the correlation between event-free survival, minimal residual disease, and
early response in this patient population treated with this multiple drug regimen.
OUTLINE: This is a randomized, multicenter study.
- Induction (weeks 1-4): Patients receive induction therapy on POG 9900.
- Consolidation (weeks 5-32): Patients are randomized to one of four treatment arms.
Patients with t(1;19) are randomized to either arm III or arm IV.
- Arm I (weeks 5-24): Patients receive IT methotrexate (MTX) on day 1 followed by
MTX IV over 20 minutes followed by MTX continuously over 23.6 hours on weeks 7,
10, 13, 16,19, and 22. At 42 hours after the beginning of the MTX infusion,
patients receive oral leucovorin calcium every 6 hours for a total of 3 doses.
Patients also receive oral mercaptopurine daily beginning on week 5 and continuing
until the completion of consolidation therapy; oral dexamethasone twice daily on
days 1-7 of weeks 8 and 17; and vincristine IV on day 1 of weeks 8, 9, 17, and 18.
- Arm II (weeks 5-24): Patients receive MTX IV over 4 hours on weeks 7, 10, 13, 16,
19, and 22. At 42 hours after the beginning of the MTX infusion, patients receive
oral leucovorin calcium as in arm I. Patients also receive mercaptopurine,
dexamethasone, vincristine, and IT MTX as in arm I.
- Arm III (weeks 5-32): Patients receive MTX IV as in arm I on weeks 7, 10, 13, 24,
27, and 30; leucovorin calcium as in arm I; pegaspargase IM on day 2, 3, OR 4 of
week 16; and oral mercaptopurine daily on weeks 5-13, and from week 24 until the
completion of consolidation therapy. Patients also receive IT MTX as in arm I on
weeks 7, 10, 13, 16, 20, 21, and 30; oral dexamethasone twice daily on weeks 8,
16-18, and 28 for a total of 35 days; vincristine IV on day 1 of weeks 8, 9, 16,
17, 18, 28, and 29; daunorubicin IV on day 1 of weeks 16-18; cyclophosphamide IV
over 30 minutes on day 1 of week 20; cytarabine IV or subcutaneously daily on days
2-5 of weeks 20 and 21; and oral thioguanine daily on weeks 20-21.
- Arm IV (weeks 5-32): Patients receive MTX IV as in arm II on weeks 7, 10, 13, 24,
27, and 30; leucovorin calcium as in arm I; and pegaspargase, mercaptopurine, IT
MTX, dexamethasone, vincristine, daunorubicin, cyclophosphamide, cytarabine, and
thioguanine as in arm III.
- Intensive continuation (weeks 25-80): At weeks 25-72 for arms I and II, and at weeks
33-80 for arms III and IV, patients receive oral MTX every 6 hours for 4 doses on weeks
1, 3, 5, 7, 9, and 11; oral mercaptopurine daily; oral leucovorin calcium every 12
hours for 2 doses beginning 48 hours after the start of MTX; IT MTX and vincristine IV
on day 1 of week 12; and oral dexamethasone twice daily on days 1-7, beginning with the
administration of vincristine. Treatment repeats every 12 weeks for 4 courses.
- Additional continuation (weeks 73-130): At weeks 73-130 for arms I and II, and at weeks
81-130 for arms III and IV, patients receive oral MTX weekly; oral mercaptopurine
daily; vincristine IV on day 1 every 12 weeks; oral dexamethasone as during intensive
continuation therapy; and IT MTX on day 1 every 12 weeks, beginning with the last week
of the first course (in place of oral MTX).
Patients are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1
year, every 6 months for 1 year, and then every 6-12 months for 1 year.
PROJECTED ACCRUAL: A total of 1,014 patients will be accrued for this study within 3.22
years.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Improvement in outcome in children receiving multidrug delayed-intensification therapy
The overall plan is to accrue for 3.1 years or until all accrual goals have been met, whichever occurs first. Since power is determined by event-rates, lower or higher than expected event rates could lead to an amendment to alter the accrual goal. This consideration will be made independent of arm-specific outcome, in order to eliminate bias
Up to 4 years
No
Naomi J. Winick, MD
Study Chair
Simmons Cancer Center
United States: Federal Government
9905
NCT00005596
April 2000
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Tripler Army Medical Center | Honolulu, Hawaii 96859-5000 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
Children's Hospital of Michigan | Detroit, Michigan 48201 |
Hurley Medical Center | Flint, Michigan 48503 |
Rhode Island Hospital | Providence, Rhode Island 02903 |
Medical City Dallas Hospital | Dallas, Texas 75230 |
San Antonio Military Pediatric Cancer and Blood Disorders Center | Lackland Air Force Base, Texas 78236-5300 |
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
Midwest Children's Cancer Center | Milwaukee, Wisconsin 53226 |
Yale Comprehensive Cancer Center | New Haven, Connecticut 06520-8028 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa, Oklahoma 74136 |
Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
Cancer Center at the University of Virginia | Charlottesville, Virginia 22908 |
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
St. Vincent Hospital | Green Bay, Wisconsin 54307-3508 |
University of Miami Sylvester Comprehensive Cancer Center | Miami, Florida 33136 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
UMASS Memorial Cancer Center - University Campus | Worcester, Massachusetts 01605-2982 |
Keesler Medical Center - Keesler Air Force Base | Keesler AFB, Mississippi 39534-2576 |
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
Long Island Cancer Center at Stony Brook University Hospital | Stony Brook, New York 11790-7775 |
CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
CCOP - Scott and White Hospital | Temple, Texas 76508 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
Madigan Army Medical Center | Tacoma, Washington 98431-5048 |
Sutter Cancer Center | Sacramento, California 95816 |
Rebecca and John Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
University of California Davis Cancer Center | Sacramento, California 95817 |
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego | San Diego, California 92120 |
Kaiser Permanente Medical Center - Santa Clara | Santa Clara, California 95051-5386 |
Broward General Medical Center | Fort Lauderdale, Florida 33316 |
Children's Hospital of Southwest Florida | Fort Myers, Florida 33908 |
Joe DiMaggio Children's Hospital at Memorial | Hollywood, Florida 33021 |
Nemours Children's Clinic | Jacksonville, Florida 32207 |
Miami Children's Hospital | Miami, Florida 33155-4069 |
Florida Hospital Cancer Institute | Orlando, Florida 32804 |
Nemours Children's Clinic-Orlando | Orlando, Florida 32806 |
Sacred Heart Children's Hospital | Pensacola, Florida 32504 |
All Children's Hospital | St. Petersburg, Florida 33701 |
Children's Memorial Hospital - Chicago | Chicago, Illinois 60614 |
Advocate Hope Children's Hospital | Oak Lawn, Illinois 60453 |
Saint Jude Midwest Affiliate | Peoria, Illinois 61637 |
Wesley Medical Center | Wichita, Kansas 67214 |
Children's Hospital of New Orleans | New Orleans, Louisiana 70118 |
Maine Children's Cancer Program | Scarborough, Maine 04074-9308 |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
Floating Hospital for Children | Boston, Massachusetts 02111 |
Cardinal Glennon Children's Hospital | Saint Louis, Missouri 63104 |
University of New Mexico Cancer Research and Treatment Center | Albuquerque, New Mexico 87131 |
Schneider Children's Hospital | New Hyde Park, New York 11042 |
St. Christopher's Hospital for Children | Philadelphia, Pennsylvania 19134-1095 |
Children's Hospital of Greenville Hospital System | Greenville, South Carolina 29605 |
St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
Driscoll Children's Hospital | Corpus Christi, Texas 78466 |
Cook Children's Medical Center - Fort Worth | Fort Worth, Texas 76104 |
Inova Fairfax Hospital | Falls Church, Virginia 22042-3300 |
St. Louis Children's Hospital | Saint Louis, Missouri 63110 |
Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson, Arizona 85724 |
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Tulane Cancer Center at Tulane University Hospital and Clinic | New Orleans, Louisiana 70112 |
Blumenthal Cancer Center at Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
Oklahoma University Medical Center | Oklahoma City, Oklahoma 73104 |
Stanford Cancer Center at Stanford University Medical Center | Stanford, California 94305 |
Comprehensive Cancer Center at University of Alabama at Birmingham | Birmingham, Alabama 35294 |
University of Florida Shands Cancer Center | Gainesville, Florida 32610-0232 |
Baptist-South Miami Regional Cancer Program | Miami, Florida 33176 |
Kaplan Cancer Center at St. Mary's Medical Center | West Palm Beach, Florida 33407 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Ochsner Cancer Institute at Ochsner Clinic Foundation | New Orleans, Louisiana 70121 |
Mount Sinai Medical Center | New York, New York 10029 |
SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
Mission Hospitals - Memorial Campus | Asheville, North Carolina 28801 |
Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Legacy Emanuel Hospital and Health Center & Children's Hospital | Portland, Oregon 97227 |
Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
Naval Medical Center - Portsmouth | Portsmouth, Virginia 23708-2197 |
Massey Cancer Center at Virginia Commonwealth University | Richmond, Virginia 23298-0037 |
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division | Charleston, West Virginia 25302 |
Mary Babb Randolph Cancer Center at West Virginia University Hospitals | Morgantown, West Virginia 26506 |
CCOP - Marshfield Clinic Research Foundation | Marshfield, Wisconsin 54449 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
Vermont Cancer Center at University of Vermont | Burlington, Vermont 05405-0075 |
Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus | Atlanta, Georgia 30342 |
Carilion Medical Center for Children at Roanoke Community Hospital | Roanoke, Virginia 24014 |
University of South Alabama Cancer Research Institute | Mobile, Alabama 36604 |
Children's Hospital and Health Center, San Diego | San Diego, California 92123-4282 |
St. Joseph's Children's Hospital | Tampa, Florida 33677-4227 |
MBCCOP-Medical College of Georgia Cancer Center | Augusta, Georgia 30912-4000 |
Cancer Center at Hackensack University Medical Center | Hackensack, New Jersey 07601 |
East Tennessee State University Cancer Center at Johnson City Medical Center | Johnson City, Tennessee 37604 |
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390-9063 |
MBCCOP - South Texas Pediatrics | San Antonio, Texas 78229-3900 |
Center for Cancer Prevention and Care at Scott and White Clinic | Temple, Texas 76508 |
Pediatric Specialty Clinic at Eastern Maine Medical Center | Bangor, Maine 04401 |
Walter Reed Army Medical Center | Silver Spring, Maryland 20910 |
University of Missouri - Columbia | Columbia, Missouri 65203 |
Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital | Greenville, North Carolina 27858-4354 |
Beth Israel Medical Center - Singer Division | New York, New York 10128 |
Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital | Houston, Texas 77030-2399 |