Know Cancer

or
forgot password

ALinC 17: Protocol for Patients With Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia (ALL): A Phase III Study


Phase 3
1 Year
21 Years
Not Enrolling
Both
Leukemia

Thank you

Trial Information

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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Confirmed diagnosis of newly diagnosed B-precursor acute lymphocytic leukemia

- Standard risk (not low, high, or very high risk)

- Prior registration and treatment on POG 9900 Classification Study

PATIENT CHARACTERISTICS:

Age:

- 1 to 21 at diagnosis

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Improvement in outcome in children receiving multidrug delayed-intensification therapy

Outcome Description:

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

Outcome Time Frame:

Up to 4 years

Safety Issue:

No

Principal Investigator

Naomi J. Winick, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Simmons Cancer Center

Authority:

United States: Federal Government

Study ID:

9905

NCT ID:

NCT00005596

Start Date:

April 2000

Completion Date:

Related Keywords:

  • Leukemia
  • untreated childhood acute lymphoblastic leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Tripler Army Medical CenterHonolulu, Hawaii  96859-5000
CCOP - WichitaWichita, Kansas  67214-3882
Children's Hospital of MichiganDetroit, Michigan  48201
Hurley Medical CenterFlint, Michigan  48503
Rhode Island HospitalProvidence, Rhode Island  02903
Medical City Dallas HospitalDallas, Texas  75230
San Antonio Military Pediatric Cancer and Blood Disorders CenterLackland Air Force Base, Texas  78236-5300
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Midwest Children's Cancer CenterMilwaukee, Wisconsin  53226
Yale Comprehensive Cancer CenterNew Haven, Connecticut  06520-8028
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Natalie Warren Bryant Cancer Center at St. Francis HospitalTulsa, Oklahoma  74136
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Cancer Center at the University of VirginiaCharlottesville, Virginia  22908
University of Texas Medical BranchGalveston, Texas  77555-1329
St. Vincent HospitalGreen Bay, Wisconsin  54307-3508
University of Miami Sylvester Comprehensive Cancer CenterMiami, Florida  33136
Rush University Medical CenterChicago, Illinois  60612-3824
UMASS Memorial Cancer Center - University CampusWorcester, Massachusetts  01605-2982
Keesler Medical Center - Keesler Air Force BaseKeesler AFB, Mississippi  39534-2576
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Long Island Cancer Center at Stony Brook University HospitalStony Brook, New York  11790-7775
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
CCOP - Scott and White HospitalTemple, Texas  76508
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Madigan Army Medical CenterTacoma, Washington  98431-5048
Sutter Cancer CenterSacramento, California  95816
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
University of California Davis Cancer CenterSacramento, California  95817
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San DiegoSan Diego, California  92120
Kaiser Permanente Medical Center - Santa ClaraSanta Clara, California  95051-5386
Broward General Medical CenterFort Lauderdale, Florida  33316
Children's Hospital of Southwest FloridaFort Myers, Florida  33908
Joe DiMaggio Children's Hospital at MemorialHollywood, Florida  33021
Nemours Children's ClinicJacksonville, Florida  32207
Miami Children's HospitalMiami, Florida  33155-4069
Florida Hospital Cancer InstituteOrlando, Florida  32804
Nemours Children's Clinic-OrlandoOrlando, Florida  32806
Sacred Heart Children's HospitalPensacola, Florida  32504
All Children's HospitalSt. Petersburg, Florida  33701
Children's Memorial Hospital - ChicagoChicago, Illinois  60614
Advocate Hope Children's HospitalOak Lawn, Illinois  60453
Saint Jude Midwest AffiliatePeoria, Illinois  61637
Wesley Medical CenterWichita, Kansas  67214
Children's Hospital of New OrleansNew Orleans, Louisiana  70118
Maine Children's Cancer ProgramScarborough, Maine  04074-9308
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
Floating Hospital for ChildrenBoston, Massachusetts  02111
Cardinal Glennon Children's HospitalSaint Louis, Missouri  63104
University of New Mexico Cancer Research and Treatment CenterAlbuquerque, New Mexico  87131
Schneider Children's HospitalNew Hyde Park, New York  11042
St. Christopher's Hospital for ChildrenPhiladelphia, Pennsylvania  19134-1095
Children's Hospital of Greenville Hospital SystemGreenville, South Carolina  29605
St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794
Driscoll Children's HospitalCorpus Christi, Texas  78466
Cook Children's Medical Center - Fort WorthFort Worth, Texas  76104
Inova Fairfax HospitalFalls Church, Virginia  22042-3300
St. Louis Children's HospitalSaint Louis, Missouri  63110
Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona  85724
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Tulane Cancer Center at Tulane University Hospital and ClinicNew Orleans, Louisiana  70112
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Oklahoma University Medical CenterOklahoma City, Oklahoma  73104
Stanford Cancer Center at Stanford University Medical CenterStanford, California  94305
Comprehensive Cancer Center at University of Alabama at BirminghamBirmingham, Alabama  35294
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Baptist-South Miami Regional Cancer ProgramMiami, Florida  33176
Kaplan Cancer Center at St. Mary's Medical CenterWest Palm Beach, Florida  33407
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Ochsner Cancer Institute at Ochsner Clinic FoundationNew Orleans, Louisiana  70121
Mount Sinai Medical CenterNew York, New York  10029
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Mission Hospitals - Memorial CampusAsheville, North Carolina  28801
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Legacy Emanuel Hospital and Health Center & Children's HospitalPortland, Oregon  97227
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Naval Medical Center - PortsmouthPortsmouth, Virginia  23708-2197
Massey Cancer Center at Virginia Commonwealth UniversityRichmond, Virginia  23298-0037
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston DivisionCharleston, West Virginia  25302
Mary Babb Randolph Cancer Center at West Virginia University HospitalsMorgantown, West Virginia  26506
CCOP - Marshfield Clinic Research FoundationMarshfield, Wisconsin  54449
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Vermont Cancer Center at University of VermontBurlington, Vermont  05405-0075
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite CampusAtlanta, Georgia  30342
Carilion Medical Center for Children at Roanoke Community HospitalRoanoke, Virginia  24014
University of South Alabama Cancer Research InstituteMobile, Alabama  36604
Children's Hospital and Health Center, San DiegoSan Diego, California  92123-4282
St. Joseph's Children's HospitalTampa, Florida  33677-4227
MBCCOP-Medical College of Georgia Cancer CenterAugusta, Georgia  30912-4000
Cancer Center at Hackensack University Medical CenterHackensack, New Jersey  07601
East Tennessee State University Cancer Center at Johnson City Medical CenterJohnson City, Tennessee  37604
Simmons Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390-9063
MBCCOP - South Texas PediatricsSan Antonio, Texas  78229-3900
Center for Cancer Prevention and Care at Scott and White ClinicTemple, Texas  76508
Pediatric Specialty Clinic at Eastern Maine Medical CenterBangor, Maine  04401
Walter Reed Army Medical CenterSilver Spring, Maryland  20910
University of Missouri - ColumbiaColumbia, Missouri  65203
Leo W. Jenkins Cancer Center at Pitt County Memorial HospitalGreenville, North Carolina  27858-4354
Beth Israel Medical Center - Singer DivisionNew York, New York  10128
Texas Children's Cancer Center and Hematology Service at Texas Children's HospitalHouston, Texas  77030-2399