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ALINC #17 Treatment for Patients With Low Risk Acute Lymphoblastic Leukemia: A Pediatric Oncology Group Phase III Study


Phase 3
1 Year
9 Years
Not Enrolling
Both
Leukemia

Thank you

Trial Information

ALINC #17 Treatment for Patients With Low Risk Acute Lymphoblastic Leukemia: A Pediatric Oncology Group Phase III Study


OBJECTIVES:

- Compare the efficacy and toxicity of short methotrexate infusion vs longer infusion in
patients with low-risk acute lymphoblastic leukemia.

- Compare the efficacy of these regimens of methotrexate, with or without multidrug
intensification, in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
genetics (stratum 1: trisomy 4/10 but not TEL/AML1 vs stratum 2: TEL/AML1 with or without
trisomy 4/10).

All patients receive induction therapy (weeks 1-4) on another protocol (POG-9900).

Stratum 1

- Consolidation therapy begins on week 5. Patients are randomized to arm I or II.

- Arm I: Patients receive methotrexate (MTX) IV over 24 hours on day 1 and oral
leucovorin calcium (CF) every 6 hours for 3 doses beginning 42 hours after
initiation of MTX infusion during weeks 7, 10, 13, 16, and 19.

- Arm II: Patients receive MTX IV over 4 hours on day 1 and oral CF as in arm I
during weeks 7, 10, 13, 16, and 19.

- Patients in arms I and II also receive MTX intrathecally (IT) on weeks 7, 10, 13, 16,
19, and 22; oral mercaptopurine (6-MP) daily on weeks 5-24; oral dexamethasone (DM)
twice daily on days 1-7 of weeks 8 and 17; and vincristine (VCR) IV on day 1 of weeks
8, 9, 17, and 18.

Stratum 2

- Consolidation therapy begins on week 5 and delayed intensification therapy begins on
week 16. Patients are randomized to delayed intensification or no delayed
intensification. Patients randomized to no delayed intensification are then randomized
to consolidation therapy on arm I or II. Patients randomized to delayed intensification
are then randomized to arm III or IV. Patients with trisomy 4/10 are not randomized to
arms III and IV.

- Arm III: Patients receive MTX IV and CF as in arm I on weeks 7, 10, 13, 24, 27,
and 30.

- Arm IV: Patients receive MTX IV and CF as in arm II on weeks 7, 10, 13, 24, 27,
and 30.

- Patients in arms III and IV also receive oral 6-MP daily on weeks 5-13 and then
beginning on week 24 and continuing until the end of consolidation; MTX IT on weeks 7,
10, 13, 16, 20, 21, and 30; oral DM twice daily on days 1-7 of weeks 8, 16-18, and 28;
VCR IV on day 1 of weeks 8, 9, 16-18, 28, and 29; pegaspargase intramuscularly on week
16; daunorubicin IV on day 1 of weeks 16-18; cyclophosphamide IV on day 1 of week 20;
cytarabine IV or subcutaneously on days 2-5 of weeks 20 and 21; and oral thioguanine
daily on days 1-14 of weeks 20 and 21.

All patients then receive continuation therapy beginning on week 25 for arms I and II and
week 33 for arms III and IV and continuing until week 130 for all arms.

Continuation

- Arms I and II: Patients receive oral 6-MP daily on weeks 25-130; oral DM twice a day on
days 1-7 and VCR IV on days 1 and 8 during weeks 25, 41, 57, 73, 89, and 105; oral MTX
weekly on weeks 25-130 (except during weeks of IT MTX); and MTX IT on weeks 25, 37, 49,
61, 73, 85, 97, and 109.

- Arms III and IV: Patients receive oral 6-MP daily on weeks 33-130; oral DM twice a day
on days 1-7 and VCR IV on days 1 and 8 during weeks 41, 57, 73, 89, and 105; oral MTX
weekly on weeks 33-130 (except during weeks of IT MTX); and MTX IT on weeks 37, 49, 61,
73, 85, 97, and 109.

Patients are followed every 2 months for 2 years, every 3 months for 1 year, every 6 months
for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total 902 patients will be accrued for this study within 3.22 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of B-cell precursor acute lymphoblastic leukemia

- Registered on POG-9900 Classification Study

- Registered within 7 days of documenting complete response (CR) after induction
therapy on day 29 or, if 2 more weeks of induction are required, within 7 days of CR
determination

- Classified as low-risk:

- WBC less than 50,000/mm^3

- Age 1 to 9

- No adverse translocations [E2A-PBX1, t(1;19) or BCR/ABL, t(9;22); and MLL
rearrangements]

- No CNS 3 disease (CSF WBC at least 5/mm^3 with blasts present)

- No testicular disease

- At least one of the following present:

- TEL/AML1, t(12;21)

- Simultaneous trisomy of chromosomes 4 and 10

PATIENT CHARACTERISTICS:

Age:

- 1 to 9

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- See Disease Characteristics

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: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Event-free survival

Outcome Description:

The test statistic will compare Kaplan-Meier curves with sample size derived from a modification of the Makuch-Simon method for historical controls

Outcome Time Frame:

4 years

Safety Issue:

No

Principal Investigator

Paul L. Martin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke Cancer Institute

Authority:

United States: Federal Government

Study ID:

9904

NCT ID:

NCT00005585

Start Date:

April 2000

Completion Date:

Related Keywords:

  • Leukemia
  • childhood acute lymphoblastic leukemia in remission
  • B-cell 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
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
Hackensack University Medical CenterHackensack, New Jersey  07601
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
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
Simmons Cancer Center at University of Texas Southwestern Medical Center at DallasDallas, Texas  75390
Stanford Cancer Center at Stanford University Medical CenterStanford, California  94305
Comprehensive Cancer Center at University of Alabama at BirminghamBirmingham, Alabama  35294
Children's Hospital and Health Center - San DiegoSan Diego, California  92123-4282
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
Kaiser Permanente Medical Center - Santa Clara Kiely CampusSanta Clara, California  95051-5386
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
MBCCOP-Medical College of Georgia Cancer CenterAugusta, Georgia  30912-4000
East Tennessee State University Cancer Center at Johnson City Medical CenterJohnson City, Tennessee  37604
MBCCOP - South Texas PediatricsSan Antonio, Texas  78229-3900
Center for Cancer Prevention and Care at Scott and White ClinicTemple, Texas  76508
St. Joseph's Children's Hospital of TampaTampa, Florida  33677-4227
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
University of Virginia Cancer CenterCharlottesville, Virginia  22908
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