Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia
This study is ongoing, but not recruiting participants.
Sponsor:
Children's Oncology Group
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00075725
First received: January 9, 2004
Last updated: May 17, 2013
Last verified: May 2013
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Purpose
RATIONALE: Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and leucovorin calcium, work in different ways to stop cancer cells from dividing so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.
PURPOSE: This randomized phase III trial is studying dexamethasone to see how well it works compared to prednisone during induction therapy. This trial is also studying methotrexate and leucovorin calcium to see how well they work compared to methotrexate alone during maintenance therapy in treating patients with newly diagnosed acute lymphoblastic leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: pegaspargase Drug: prednisone Drug: thioguanine Drug: vincristine sulfate Radiation: radiation therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | High Risk B-Precursor Acute Lymphoblastic Leukemia |
Resource links provided by NLM:
Drug Information available for:
Dexamethasone
Cyclophosphamide
Mercaptopurine
Prednisone
Methotrexate
Folic acid
Cytarabine
Thioguanine
Calcium Gluconate
Dexamethasone acetate
Leucovorin calcium
Vincristine sulfate
Dexamethasone sodium phosphate
Asparaginase
Sulfate ion
Methotrexate sodium
Daunorubicin
Doxorubicin
Daunorubicin hydrochloride
Doxorubicin hydrochloride
Levoleucovorin
Pegaspargase
Daunorubicin citrate
U.S. FDA Resources
Further study details as provided by Children's Oncology Group:
Primary Outcome Measures:
- Comparison of the increase in cure rate of high risk ALL without causing more serious side effects between interventions [ Time Frame: During the first month of treatment ] [ Designated as safety issue: No ]Compared using a two-sided log rank test.
Secondary Outcome Measures:
- Relative safety and efficacy [ Time Frame: Day 29 ] [ Designated as safety issue: Yes ]Relative safety and efficacy of each intervention. Adverse events (AE) are graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Compared using a two-sided log rank test.
- Correlation of minimal residual disease (MRD) with event-free survival and overall survival [ Time Frame: Day 29 ] [ Designated as safety issue: No ]Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells, and negative with < 0.1 detectable leukemia cells.
- Correlation of early marrow response status with MRD [ Time Frame: Day 29 ] [ Designated as safety issue: No ]Bone marrow status is defined as: M1: < 5% lymphoblasts; M2: 5-25% lymphoblasts; M3: > 25% lymphoblasts. Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells, and negative with < 0.1 detectable leukemia cells.
- Additional high-risk patients for treatment with BFM [ Time Frame: Day 29 ] [ Designated as safety issue: No ]Identified using MRD
| Enrollment: | 3154 |
| Study Start Date: | December 2003 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm I
Patients in arm I receive intrathecal cytarabine in week 1; infusions of vincristine sulfate and daunorubicin hydrochloride once a week in weeks 1-4; dexamethasone by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate in weeks 2 and 5 or 2-5; etoposide, cyclophosphamide, methotrexate, leucovorin calcium in weeks 6-10, and an injection of pegaspargase in week 1.
|
Drug: cyclophosphamide
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: cytarabine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: daunorubicin hydrochloride
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: dexamethasone
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: doxorubicin hydrochloride
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: leucovorin calcium
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: mercaptopurine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: methotrexate
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: pegaspargase
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: thioguanine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: vincristine sulfate
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Radiation: radiation therapy
Patients undergo radiation therapy periodically during study treatment
|
|
Active Comparator: Arm II
Patients in arm II will receive intrathecal cytarabine in week 1; infusions of vincristine sulfate and daunorubicin hydrochloride once a week in weeks 1-4; dexamethasone by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate in weeks 2 and 5 or 2-5; and an injection of pegaspargase in week 1.
|
Drug: cyclophosphamide
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: cytarabine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: daunorubicin hydrochloride
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: dexamethasone
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: doxorubicin hydrochloride
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: leucovorin calcium
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: mercaptopurine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: methotrexate
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: pegaspargase
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: thioguanine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: vincristine sulfate
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Radiation: radiation therapy
Patients undergo radiation therapy periodically during study treatment
|
|
Experimental: Arm III
Patients in arm III will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase as in groups one and two. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
|
Drug: cyclophosphamide
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: cytarabine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: daunorubicin hydrochloride
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: dexamethasone
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: doxorubicin hydrochloride
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: leucovorin calcium
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: mercaptopurine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: methotrexate
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: pegaspargase
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: prednisone
Given IV or orally
Other Names:
Drug: thioguanine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: vincristine sulfate
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Radiation: radiation therapy
Patients undergo radiation therapy periodically during study treatment
|
|
Experimental: Arm IV
Patients in arm IV will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase as in groups one and two. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
|
Drug: cyclophosphamide
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: cytarabine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: daunorubicin hydrochloride
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: dexamethasone
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: doxorubicin hydrochloride
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: leucovorin calcium
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: mercaptopurine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: methotrexate
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: pegaspargase
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: prednisone
Given IV or orally
Other Names:
Drug: thioguanine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Drug: vincristine sulfate
Given IV, orally, intrathecally, intramuscularly, or subcutaneously
Other Names:
Radiation: radiation therapy
Patients undergo radiation therapy periodically during study treatment
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 1 Year to 30 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Newly diagnosed B-precursor acute lymphoblastic leukemia
- WBC > 50,000/mm^3 for patients age 1 to 9
- Any WBC for patients age 10 to 30 OR patients who have received prior steroid therapy OR patients with testicular disease
- Must be eligible for and enrolled on classification study COG-AALL03B1
PATIENT CHARACTERISTICS:
Age
- 1 to under 31
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- See Disease Characteristics
Hepatic
- Not specified
Renal
- Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No more than 72 hours since prior intrathecal cytarabine
- No other prior cytotoxic chemotherapy
Endocrine therapy
- Prior steroids allowed
Radiotherapy
- Not specified
Surgery
- Not specified
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075725
Hide Study Locations
Hide Study LocationsLocations
| United States, Alabama | |
| UAB Comprehensive Cancer Center | |
| Birmingham, Alabama, United States, 35294 | |
| University of South Alabama Mitchell Cancer Institute | |
| Mobile, Alabama, United States, 36604 | |
| United States, Arizona | |
| Banner Desert Medical Center | |
| Mesa, Arizona, United States, 85202 | |
| Phoenix Children's Hospital | |
| Phoenix, Arizona, United States, 85016-7710 | |
| Arizona Cancer Center at University of Arizona Health Sciences Center | |
| Tucson, Arizona, United States, 85724-5024 | |
| United States, Arkansas | |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Southern California Permanente Medical Group | |
| Downey, California, United States, 90027 | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010-3000 | |
| Loma Linda University Cancer Institute at Loma Linda University Medical Center | |
| Loma Linda, California, United States, 92354 | |
| Jonathan Jaques Children's Cancer Center at Miller Children's Hospital | |
| Long Beach, California, United States, 90801 | |
| Jonsson Comprehensive Cancer Center at UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center | |
| Los Angeles, California, United States, 90048-1865 | |
| Childrens Hospital Los Angeles | |
| Los Angeles, California, United States, 90027 | |
| Children's Hospital Central California | |
| Madera, California, United States, 93638-8762 | |
| Children's Hospital and Research Center Oakland | |
| Oakland, California, United States, 94609 | |
| Children's Hospital of Orange County | |
| Orange, California, United States, 92868 | |
| Lucile Packard Children's Hospital at Stanford University Medical Center | |
| Palo Alto, California, United States, 95798 | |
| Kaiser Permanente Medical Center - Oakland | |
| Sacramento, California, United States, 95825 | |
| University of California Davis Cancer Center | |
| Sacramento, California, United States, 95817 | |
| Rady Children's Hospital - San Diego | |
| San Diego, California, United States, 92123-4282 | |
| UCSF Helen Diller Family Comprehensive Cancer Center | |
| San Francisco, California, United States, 94115 | |
| Santa Barbara Cottage Children's Hospital | |
| Santa Barbara, California, United States, 93105 | |
| Kaiser Permanente Medical Center - Santa Clara Kiely Campus | |
| Santa Clara, California, United States, 95051-5386 | |
| United States, Colorado | |
| Children's Hospital Center for Cancer and Blood Disorders | |
| Aurora, Colorado, United States, 80045 | |
| Presbyterian - St. Luke's Medical Center | |
| Denver, Colorado, United States, 80218 | |
| United States, Connecticut | |
| Connecticut Children's Medical Center | |
| Hartford, Connecticut, United States, 06106 | |
| Yale Cancer Center | |
| New Haven, Connecticut, United States, 06520-8028 | |
| United States, Delaware | |
| Alfred I. duPont Hospital for Children | |
| Wilmington, Delaware, United States, 19803 | |
| United States, District of Columbia | |
| Children's National Medical Center | |
| Washington, District of Columbia, United States, 20010-2970 | |
| Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | |
| Washington, District of Columbia, United States, 20007 | |
| Walter Reed Army Medical Center | |
| Washington, District of Columbia, United States, 20307-5001 | |
| United States, Florida | |
| Broward General Medical Center Cancer Center | |
| Fort Lauderdale, Florida, United States, 33316 | |
| Lee Cancer Care of Lee Memorial Health System | |
| Fort Myers, Florida, United States, 33901 | |
| University of Florida Shands Cancer Center | |
| Gainesville, Florida, United States, 32610-0232 | |
| Memorial Cancer Institute at Memorial Regional Hospital | |
| Hollywood, Florida, United States, 33021 | |
| Nemours Children's Clinic | |
| Jacksonville, Florida, United States, 32207 | |
| University of Miami Sylvester Comprehensive Cancer Center - Miami | |
| Miami, Florida, United States, 33136 | |
| Baptist-South Miami Regional Cancer Program | |
| Miami, Florida, United States, 33176 | |
| Miami Children's Hospital | |
| Miami, Florida, United States, 33155 | |
| Florida Hospital Cancer Institute at Florida Hospital Orlando | |
| Orlando, Florida, United States, 32803-1273 | |
| Nemours Children's Clinic - Orlando | |
| Orlando, Florida, United States, 32806 | |
| M.D. Anderson Cancer Center at Orlando | |
| Orlando, Florida, United States, 32806 | |
| Sacred Heart Cancer Center at Sacred Heart Hospital | |
| Pensacola, Florida, United States, 32504 | |
| All Children's Hospital | |
| Saint Petersburg, Florida, United States, 33701 | |
| St. Joseph's Cancer Institute at St. Joseph's Hospital | |
| Tampa, Florida, United States, 33607 | |
| Kaplan Cancer Center at St. Mary's Medical Center | |
| West Palm Beach, Florida, United States, 33407 | |
| United States, Georgia | |
| AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus | |
| Atlanta, Georgia, United States, 30322 | |
| MBCCOP - Medical College of Georgia Cancer Center | |
| Augusta, Georgia, United States, 30912-3730 | |
| Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | |
| Savannah, Georgia, United States, 31403-3089 | |
| United States, Hawaii | |
| Cancer Research Center of Hawaii | |
| Honolulu, Hawaii, United States, 96813 | |
| Tripler Army Medical Center | |
| Tripler AMC, Hawaii, United States, 96859-5000 | |
| United States, Idaho | |
| Mountain States Tumor Institute at St. Luke's Regional Medical Center | |
| Boise, Idaho, United States, 83712-6297 | |
| United States, Illinois | |
| University of Illinois Cancer Center | |
| Chicago, Illinois, United States, 60612-7243 | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| Children's Memorial Hospital - Chicago | |
| Chicago, Illinois, United States, 60614 | |
| Rush University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153 | |
| Keyser Family Cancer Center at Advocate Hope Children's Hospital | |
| Oak Lawn, Illinois, United States, 60453 | |
| Advocate Lutheran General Cancer Care Center | |
| Park Ridge, Illinois, United States, 60068-1174 | |
| Simmons Cooper Cancer Institute | |
| Springfield, Illinois, United States, 62794-9677 | |
| United States, Indiana | |
| Indiana University Melvin and Bren Simon Cancer Center | |
| Indianapolis, Indiana, United States, 46202-5289 | |
| St. Vincent Indianapolis Hospital | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Iowa | |
| Blank Children's Hospital | |
| Des Moines, Iowa, United States, 50309 | |
| Holden Comprehensive Cancer Center at University of Iowa | |
| Iowa City, Iowa, United States, 52242-1002 | |
| United States, Kansas | |
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160-7357 | |
| United States, Kentucky | |
| Lucille P. Markey Cancer Center at University of Kentucky | |
| Lexington, Kentucky, United States, 40536-0093 | |
| Kosair Children's Hospital | |
| Louisville, Kentucky, United States, 40232 | |
| United States, Louisiana | |
| Tulane Cancer Center Office of Clinical Research | |
| Alexandria, Louisiana, United States, 71315-3198 | |
| Children's Hospital of New Orleans | |
| New Orleans, Louisiana, United States, 70118 | |
| United States, Maine | |
| CancerCare of Maine at Eastern Maine Medical Center | |
| Bangor, Maine, United States, 04401 | |
| Maine Children's Cancer Program at Barbara Bush Children's Hospital | |
| Scarborough, Maine, United States, 04074-9308 | |
| United States, Maryland | |
| Alvin and Lois Lapidus Cancer Institute at Sinai Hospital | |
| Baltimore, Maryland, United States, 21215 | |
| Greenebaum Cancer Center at University of Maryland Medical Center | |
| Baltimore, Maryland, United States, 21201 | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
| United States, Massachusetts | |
| Floating Hospital for Children at Tufts - New England Medical Center | |
| Boston, Massachusetts, United States, 02111 | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Baystate Regional Cancer Program at D'Amour Center for Cancer Care | |
| Springfield, Massachusetts, United States, 01199-0001 | |
| UMASS Memorial Cancer Center - University Campus | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Michigan | |
| C.S. Mott Children's Hospital at University of Michigan Medical Center | |
| Ann Arbor, Michigan, United States, 48109-0286 | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
| Hurley Medical Center | |
| Flint, Michigan, United States, 48503 | |
| Butterworth Hospital at Spectrum Health | |
| Grand Rapids, Michigan, United States, 49503-2560 | |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | |
| Grosse Pointe Woods, Michigan, United States, 48236 | |
| CCOP - Kalamazoo | |
| Kalamazoo, Michigan, United States, 49007-5381 | |
| Breslin Cancer Center at Ingham Regional Medical Center | |
| Lansing, Michigan, United States, 48910 | |
| William Beaumont Hospital - Royal Oak Campus | |
| Royal Oak, Michigan, United States, 48073 | |
| United States, Minnesota | |
| Masonic Cancer Center at University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| Children's Hospitals and Clinics of Minnesota - Minneapolis | |
| Minneapolis, Minnesota, United States, 55404 | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| Children's Hospitals and Clinics of Minnesota - St. Paul | |
| St. Paul, Minnesota, United States, 55102-2392 | |
| United States, Mississippi | |
| University of Mississippi Cancer Clinic | |
| Jackson, Mississippi, United States, 39216-4505 | |
| United States, Missouri | |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | |
| Columbia, Missouri, United States, 65203 | |
| Children's Mercy Hospital | |
| Kansas City, Missouri, United States, 64108 | |
| Cardinal Glennon Children's Hospital | |
| St. Louis, Missouri, United States, 63104 | |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Nebraska | |
| Children's Hospital | |
| Omaha, Nebraska, United States, 68114-4113 | |
| UNMC Eppley Cancer Center at the University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198-6805 | |
| United States, Nevada | |
| CCOP - Nevada Cancer Research Foundation | |
| Las Vegas, Nevada, United States, 89109-2306 | |
| United States, New Hampshire | |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756-0002 | |
| United States, New Jersey | |
| Hackensack University Medical Center Cancer Center | |
| Hackensack, New Jersey, United States, 07601 | |
| St. Barnabas Medical Center Cancer Center | |
| Livingston, New Jersey, United States, 07039 | |
| Overlook Hospital | |
| Morristown, New Jersey, United States, 07962 | |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | |
| New Brunswick, New Jersey, United States, 08903 | |
| Saint Peter's University Hospital | |
| New Brunswick, New Jersey, United States, 08901 | |
| Newark Beth Israel Medical Center | |
| Newark, New Jersey, United States, 07112 | |
| St. Joseph's Hospital and Medical Center | |
| Paterson, New Jersey, United States, 07503 | |
| United States, New Mexico | |
| University of New Mexico Cancer Center | |
| Albuquerque, New Mexico, United States, 87131-5636 | |
| United States, New York | |
| Albany Medical Center Hospital | |
| Albany, New York, United States, 12208-3419 | |
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | |
| Bronx, New York, United States, 10461 | |
| Brookdale University Hospital and Medical Center | |
| Brooklyn, New York, United States, 11212 | |
| Brooklyn Hospital Center | |
| Brooklyn, New York, United States, 11201-5493 | |
| Maimonides Cancer Center at Maimonides Medical Center | |
| Brooklyn, New York, United States, 11219 | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| Winthrop University Hospital | |
| Mineola, New York, United States, 11501 | |
| Schneider Children's Hospital | |
| New Hyde Park, New York, United States, 11040 | |
| New York Weill Cornell Cancer Center at Cornell University | |
| New York, New York, United States, 10021 | |
| NYU Cancer Institute at New York University Medical Center | |
| New York, New York, United States, 10016 | |
| Mount Sinai Medical Center | |
| New York, New York, United States, 10029 | |
| Stony Brook University Cancer Center | |
| Stony Brook, New York, United States, 11794-9446 | |
| SUNY Upstate Medical University Hospital | |
| Syracuse, New York, United States, 13210 | |
| New York Medical College | |
| Valhalla, New York, United States, 10595 | |
| United States, North Carolina | |
| Mission Hospitals - Memorial Campus | |
| Asheville, North Carolina, United States, 28801 | |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| Blumenthal Cancer Center at Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28232-2861 | |
| Presbyterian Cancer Center at Presbyterian Hospital | |
| Charlotte, North Carolina, United States, 28233-3549 | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| Leo W. Jenkins Cancer Center at ECU Medical School | |
| Greenville, North Carolina, United States, 27834 | |
| Wake Forest University Comprehensive Cancer Center | |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
| United States, North Dakota | |
| CCOP - MeritCare Hospital | |
| Fargo, North Dakota, United States, 58122 | |
| United States, Ohio | |
| Akron Children's Hospital | |
| Akron, Ohio, United States, 44308-1062 | |
| Cincinnati Children's Hospital Medical Center | |
| Cincinnati, Ohio, United States, 45229-3039 | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| Rainbow Babies and Children's Hospital | |
| Cleveland, Ohio, United States, 44106-5000 | |
| Nationwide Children's Hospital | |
| Columbus, Ohio, United States, 43205-2696 | |
| Dayton Children's - Dayton | |
| Dayton, Ohio, United States, 45404-1815 | |
| Medical University of Ohio Cancer Center | |
| Toledo, Ohio, United States, 43614 | |
| Toledo Hospital | |
| Toledo, Ohio, United States, 43606 | |
| Tod Children's Hospital | |
| Youngstown, Ohio, United States, 44501 | |
| United States, Oklahoma | |
| Oklahoma University Cancer Institute | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Natalie Warren Bryant Cancer Center at St. Francis Hospital | |
| Tulsa, Oklahoma, United States, 74136 | |
| United States, Oregon | |
| Knight Cancer Institute at Oregon Health and Science University | |
| Portland, Oregon, United States, 97239-3098 | |
| Legacy Emanuel Hospital and Health Center and Children's Hospital | |
| Portland, Oregon, United States, 97227 | |
| United States, Pennsylvania | |
| Lehigh Valley Hospital - Muhlenberg | |
| Bethlehem, Pennsylvania, United States, 18017 | |
| Geisinger Cancer Institute at Geisinger Health | |
| Danville, Pennsylvania, United States, 17822-0001 | |
| Penn State Children's Hospital | |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| St. Christopher's Hospital for Children | |
| Philadelphia, Pennsylvania, United States, 19134-1095 | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104-9786 | |
| Children's Hospital of Pittsburgh of UPMC | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Rhode Island | |
| Rhode Island Hospital Comprehensive Cancer Center | |
| Providence, Rhode Island, United States, 02903 | |
| United States, South Carolina | |
| Hollings Cancer Center at Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| Palmetto Health South Carolina Cancer Center | |
| Columbia, South Carolina, United States, 29203 | |
| Greenville Hospital Cancer Center | |
| Greenville, South Carolina, United States, 29605 | |
| United States, South Dakota | |
| Avera Cancer Institute | |
| Sioux Falls, South Dakota, United States, 57105 | |
| Sanford Cancer Center at Sanford USD Medical Center | |
| Sioux Falls, South Dakota, United States, 57117-5039 | |
| United States, Tennessee | |
| T.C. Thompson Children's Hospital | |
| Chattanooga, Tennessee, United States, 37403 | |
| East Tennessee Children's Hospital | |
| Knoxville, Tennessee, United States, 37901 | |
| Vanderbilt-Ingram Cancer Center | |
| Nashville, Tennessee, United States, 37232-6838 | |
| United States, Texas | |
| Texas Tech University Health Sciences Center School of Medicine - Amarillo | |
| Amarillo, Texas, United States, 79106 | |
| Dell Children's Medical Center of Central Texas | |
| Austin, Texas, United States, 78723 | |
| Driscoll Children's Hospital | |
| Corpus Christi, Texas, United States, 78411 | |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | |
| Dallas, Texas, United States, 75390 | |
| Medical City Dallas Hospital | |
| Dallas, Texas, United States, 75230 | |
| Cook Children's Medical Center - Fort Worth | |
| Fort Worth, Texas, United States, 76104 | |
| University of Texas Medical Branch | |
| Galveston, Texas, United States, 77555-0361 | |
| Baylor University Medical Center - Houston | |
| Houston, Texas, United States, 77030-2399 | |
| M. D. Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030-4009 | |
| Covenant Children's Hospital | |
| Lubbock, Texas, United States, 79410 | |
| Methodist Children's Hospital of South Texas | |
| San Antonio, Texas, United States, 78229-3993 | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78207 | |
| CCOP - Scott and White Hospital | |
| Temple, Texas, United States, 76508 | |
| United States, Utah | |
| Primary Children's Medical Center | |
| Salt Lake City, Utah, United States, 84113-1100 | |
| United States, Vermont | |
| Fletcher Allen Health Care - University Health Center Campus | |
| Burlington, Vermont, United States, 05401 | |
| United States, Virginia | |
| University of Virginia Cancer Center | |
| Charlottesville, Virginia, United States, 22908 | |
| Inova Fairfax Hospital | |
| Falls Church, Virginia, United States, 22042-3300 | |
| Children's Hospital of The King's Daughters | |
| Norfolk, Virginia, United States, 23507-1971 | |
| Naval Medical Center - Portsmouth | |
| Portsmouth, Virginia, United States, 23708-2197 | |
| Virginia Commonwealth University Massey Cancer Center | |
| Richmond, Virginia, United States, 23298-0037 | |
| Carilion Medical Center for Children at Roanoke Community Hospital | |
| Roanoke, Virginia, United States, 24014 | |
| United States, Washington | |
| Children's Hospital and Regional Medical Center - Seattle | |
| Seattle, Washington, United States, 98105 | |
| Deaconess Medical Center | |
| Spokane, Washington, United States, 99210-0248 | |
| Providence Cancer Center at Sacred Heart Medical Center | |
| Spokane, Washington, United States, 99220-2555 | |
| Mary Bridge Children's Hospital and Health Center - Tacoma | |
| Tacoma, Washington, United States, 98405 | |
| Madigan Army Medical Center - Tacoma | |
| Tacoma, Washington, United States, 98431 | |
| United States, West Virginia | |
| West Virginia University Health Sciences Center - Charleston | |
| Charleston, West Virginia, United States, 25302 | |
| Edwards Comprehensive Cancer Center at Cabell Huntington Hospital | |
| Huntington, West Virginia, United States, 25701 | |
| Mary Babb Randolph Cancer Center at West Virginia University Hospitals | |
| Morgantown, West Virginia, United States, 26506 | |
| United States, Wisconsin | |
| St. Vincent Hospital Regional Cancer Center | |
| Green Bay, Wisconsin, United States, 54307-3508 | |
| Gundersen Lutheran Center for Cancer and Blood | |
| La Crosse, Wisconsin, United States, 54601 | |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792-6164 | |
| Marshfield Clinic - Marshfield Center | |
| Marshfield, Wisconsin, United States, 54449 | |
| Midwest Children's Cancer Center at Children's Hospital of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Australia, Queensland | |
| Royal Children's Hospital | |
| Brisbane, Queensland, Australia, 4029 | |
| Australia, South Australia | |
| Women's and Children's Hospital | |
| North Adelaide, South Australia, Australia, 5006 | |
| Australia, Victoria | |
| Royal Children's Hospital | |
| Parkville, Victoria, Australia, 3052 | |
| Australia, Western Australia | |
| Princess Margaret Hospital for Children | |
| Perth, Western Australia, Australia, 6001 | |
| Canada, Alberta | |
| Alberta Children's Hospital | |
| Calgary, Alberta, Canada, T3B 6A8 | |
| University of Alberta Hospital | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Canada, British Columbia | |
| Children's & Women's Hospital of British Columbia | |
| Vancouver, British Columbia, Canada, V6H 3V4 | |
| Canada, Manitoba | |
| CancerCare Manitoba | |
| Winnipeg, Manitoba, Canada, R3E 0V9 | |
| Canada, Newfoundland and Labrador | |
| Janeway Children's Health and Rehabilitation Centre | |
| St. John's, Newfoundland and Labrador, Canada, A1B 3V6 | |
| Canada, Nova Scotia | |
| IWK Health Centre | |
| Halifax, Nova Scotia, Canada, B3J 3G9 | |
| Canada, Ontario | |
| Cancer Centre of Southeastern Ontario at Kingston General Hospital | |
| Kingston, Ontario, Canada, K7L 2V7 | |
| Children's Hospital of Western Ontario | |
| London, Ontario, Canada, N6A 5W9 | |
| Children's Hospital of Eastern Ontario | |
| Ottawa, Ontario, Canada, K1H 8L1 | |
| Hospital for Sick Children | |
| Toronto, Ontario, Canada, M5G 1X8 | |
| Canada, Saskatchewan | |
| Allan Blair Cancer Centre at Pasqua Hospital | |
| Regina, Saskatchewan, Canada, S4T 7T1 | |
| Saskatoon Cancer Centre at the University of Saskatchewan | |
| Saskatoon, Saskatchewan, Canada, S7N 4H4 | |
| New Zealand | |
| Starship Children's Health | |
| Auckland, New Zealand, 1 | |
| Christchurch Hospital | |
| Christchurch, New Zealand, 8140 | |
| Wellington Children's Hospital | |
| Wellington, New Zealand, 6002 | |
| Switzerland | |
| Swiss Pediatric Oncology Group Bern | |
| Bern, Switzerland, 3010 | |
| Swiss Pediatric Oncology Group Geneva | |
| Geneva, Switzerland, 1205 | |
| Swiss Pediatric Oncology Group Lausanne | |
| Lausanne, Switzerland, 1011 | |
Sponsors and Collaborators
Children's Oncology Group
Investigators
| Study Chair: | Eric C. Larsen, MD | Maine Children's Cancer Program at Barbara Bush Children's Hospital |
More Information
Additional Information:
Publications:
Raetz EA, Devidas M, Carroll AJ, et al.: Cytogenetic and early-response characteristics of adolescents and young adults with acute lymphoblastic leukemia (ALL): A Children's Oncology Group (COG) study. [Abstract] J Clin Oncol 28 (Suppl 15): A-9509, 2010.
Mattano LA Jr, Nachman JB, Devidas M, et al.: Increased incidence of osteonecrosis (ON) with a dexamethasone (DEX) induction for high risk acute lymphoblastic leukemia (HR-ALL): a report from the Children's Oncology Group (COG). [Abstract] Blood 112 (11): A-898, 2008.
Bleyer A: Older adolescents and young adults with acute lymphoblastic leukemia (ALL) in the United States: from the lowest to highest death rate and number of deaths--more rationale for the CALBG-SWOG-ECOG C10403 trial based on COG AALL0232. [Abstract] J Clin Oncol 26 (Suppl 15): A-18034, 2008.
Harvey RC, Chen IM, Ar K, et al.: Identification of novel cluster groups in high-risk pediatric B-precursor acute lymphoblastic leukemia (HR-ALL) by gene expression profiling: correlation with clinical and outcome variables a Children's Oncology Group (COG) study. [Abstract] Blood 112 (11): A-2256, 2008.
Maloney KW, Larsen E, Mattano LA, et al.: Increased infection-related mortality for children with Down syndrome (DS) in contemporary Childrens Oncology Group (COG) acute lymphoblastic leukemia (ALL) clinical trials. [Abstract] Blood 108 (11): A-1865, 2006.
| Responsible Party: | Children's Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00075725 History of Changes |
| Other Study ID Numbers: | AALL0232, COG-AALL0232, CDR0000349182 |
| Study First Received: | January 9, 2004 |
| Last Updated: | May 17, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Children's Oncology Group:
|
untreated childhood acute lymphoblastic leukemia B-cell childhood acute lymphoblastic leukemia untreated adult acute lymphoblastic leukemia B-cell adult acute lymphoblastic leukemia |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases 6-Mercaptopurine Cytarabine Methotrexate Thioguanine Cyclophosphamide Pegaspargase |
Asparaginase Daunorubicin Dexamethasone Doxorubicin Prednisone Vincristine BB 1101 Dexamethasone acetate Dexamethasone 21-phosphate Leucovorin Levoleucovorin Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic |
ClinicalTrials.gov processed this record on May 19, 2013