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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 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