The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00075725




Registration number
NCT00075725
Ethics application status
Date submitted
9/01/2004
Date registered
13/01/2004
Date last updated
24/03/2020

Titles & IDs
Public title
Dexamethasone Compared With Prednisone During Induction Therapy and MTX With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia
Scientific title
High Risk B-Precursor Acute Lymphoblastic Leukemia
Secondary ID [1] 0 0
COG-AALL0232
Secondary ID [2] 0 0
AALL0232
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - cyclophosphamide
Treatment: Drugs - cytarabine
Treatment: Drugs - daunorubicin hydrochloride
Treatment: Drugs - dexamethasone
Treatment: Drugs - doxorubicin hydrochloride
Treatment: Drugs - leucovorin calcium
Treatment: Drugs - mercaptopurine
Treatment: Drugs - methotrexate
Treatment: Drugs - pegaspargase
Treatment: Drugs - prednisone
Treatment: Drugs - thioguanine
Treatment: Drugs - vincristine sulfate
Treatment: Other - radiation therapy

Experimental: Dexamethasone & Capizzi MTX patients<10 yrs - Patients receive IT cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg = 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 & 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 & 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 & 2; IT MTX (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg = 9 15 mg) on days 8 & 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).

Experimental: Dexamethasone, High Dose (DH) MTX (non random) - Patients non-randomly assigned to the DH regimen based on one (or more) of the following: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive IT cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg = 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 & 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 & 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 & 2; IT MTX (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg = 9 15 mg) on days 8 & 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).

Experimental: Dexamethasone & Capizzi MTX patients =>10 yrs - Patients receive IT cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg = 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 & 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 & 2; IT MTX (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg = 9 15 mg) on days 8 & 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).

Experimental: Dexamethasone during Induction, High Dose MTX (IM)<10 - Patients randomly assigned to the DH regimen based on one (or more) of the following: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive IT cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg = 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 & 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 & 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 & 2; IT MTX (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg = 9 15 mg) on days 8 & 29 (CNS3 also on days 15 & 22) and injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).

Experimental: Prednisone, Capizzi (PC) MTX (<10 yrs old) - Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and IT MTX in weeks 2 & 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.

Experimental: Prednisone, Capizzi MTX (>= 10 yrs) - Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and IT MTX in weeks 2 & 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.

Experimental: Prednisone and High Dose (PH) MTX (< 10 yrs) - Patients randomly assigned to the PH regimen receive IT cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg = 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 & 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 & 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and IT MTX 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.

Experimental: Prednisone and High Dose MTX (>=10 yrs) - Patients randomly assigned to the PH regimen receive IT cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg = 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 & 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 & 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and IT MTX in weeks 2 & 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning 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.

Experimental: Dexamethasone, High Dose MTX (IM) >=10 yrs - Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive IT cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg = 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 & 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 & 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 & 2; IT MTX (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg = 9 15 mg) on days 8 & 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).

Experimental: Prednisone, Capizzi MTX Down Syndrome (DS) (non random) - Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and IT MTX in weeks 2 & 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.

Experimental: Dexamethasone, Capizzi MTX DS (non random) - Patients receive IT cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg = 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 & 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 & 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 & 2; IT MTX (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg = 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).

Experimental: Prednisone & High Dose MTX (non random) - Patients non-randomly assigned to the PH regimen based on one (or more) of the following: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry or (3) extensive pre-treatment with steroids prior to entry. Patients receive IT cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg = 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15, & 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15, & 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and IT MTX in weeks 2 & 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning 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.


Treatment: Drugs: cyclophosphamide
Given IV, orally, intrathecally, intramuscularly, or subcutaneously

Treatment: Drugs: cytarabine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously

Treatment: Drugs: daunorubicin hydrochloride
Given IV, orally, intrathecally, intramuscularly, or subcutaneously

Treatment: Drugs: dexamethasone
Given IV, orally, intrathecally, intramuscularly, or subcutaneously

Treatment: Drugs: doxorubicin hydrochloride
Given IV, orally, intrathecally, intramuscularly, or subcutaneously

Treatment: Drugs: leucovorin calcium
Given IV, orally, intrathecally, intramuscularly, or subcutaneously

Treatment: Drugs: mercaptopurine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously

Treatment: Drugs: methotrexate
Given IV, orally, intrathecally, intramuscularly, or subcutaneously

Treatment: Drugs: pegaspargase
Given IV, orally, intrathecally, intramuscularly, or subcutaneously

Treatment: Drugs: prednisone
Given IV or orally

Treatment: Drugs: thioguanine
Given IV, orally, intrathecally, intramuscularly, or subcutaneously

Treatment: Drugs: vincristine sulfate
Given IV, orally, intrathecally, intramuscularly, or subcutaneously

Treatment: Other: radiation therapy
Patients undergo radiation therapy periodically during study treatment

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Comparison of the Increase in Cure Rate of High Risk ALL Without Causing More Serious Side Effects Between Interventions - Event Free Probability.
Timepoint [1] 0 0
5 years
Secondary outcome [1] 0 0
Correlation of Minimal Residual Disease (MRD) Positive With Overall Survival (OS) - Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells, and negative with < 0.1 detectable leukemia cells.
Timepoint [1] 0 0
5 Years
Secondary outcome [2] 0 0
Correlation of Minimal Residual Disease (MRD) Negative With Overall Survival (OS). - Bone marrow MRD status is defined as negative with < .01 detectable leukemia cells.
Timepoint [2] 0 0
5 years
Secondary outcome [3] 0 0
Correlation of Early Marrow Response Status With MRD Positive. - 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.
Timepoint [3] 0 0
Day 29
Secondary outcome [4] 0 0
Correlation of Early Marrow Response Status With MRD Negative. - 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.
Timepoint [4] 0 0
Day 29
Secondary outcome [5] 0 0
Correlation of Minimal Residual Disease (MRD) Positive With Event Free Survival (EFS) - Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells.
Timepoint [5] 0 0
5 years
Secondary outcome [6] 0 0
Correlation of Minimal Residual Disease (MRD) Negative With Event Free Survival (EFS). - Bone marrow MRD status is defined as negative with < 0.1 detectable leukemia cells.
Timepoint [6] 0 0
5 years

Eligibility
Key inclusion 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
Minimum age
1 Year
Maximum age
30 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Royal Children's Hospital - Brisbane
Recruitment hospital [2] 0 0
Women's and Children's Hospital - North Adelaide
Recruitment hospital [3] 0 0
Royal Children's Hospital - Parkville
Recruitment hospital [4] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
4029 - Brisbane
Recruitment postcode(s) [2] 0 0
5006 - North Adelaide
Recruitment postcode(s) [3] 0 0
3052 - Parkville
Recruitment postcode(s) [4] 0 0
6001 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Delaware
Country [8] 0 0
United States of America
State/province [8] 0 0
District of Columbia
Country [9] 0 0
United States of America
State/province [9] 0 0
Florida
Country [10] 0 0
United States of America
State/province [10] 0 0
Georgia
Country [11] 0 0
United States of America
State/province [11] 0 0
Hawaii
Country [12] 0 0
United States of America
State/province [12] 0 0
Idaho
Country [13] 0 0
United States of America
State/province [13] 0 0
Illinois
Country [14] 0 0
United States of America
State/province [14] 0 0
Indiana
Country [15] 0 0
United States of America
State/province [15] 0 0
Iowa
Country [16] 0 0
United States of America
State/province [16] 0 0
Kansas
Country [17] 0 0
United States of America
State/province [17] 0 0
Kentucky
Country [18] 0 0
United States of America
State/province [18] 0 0
Louisiana
Country [19] 0 0
United States of America
State/province [19] 0 0
Maine
Country [20] 0 0
United States of America
State/province [20] 0 0
Maryland
Country [21] 0 0
United States of America
State/province [21] 0 0
Massachusetts
Country [22] 0 0
United States of America
State/province [22] 0 0
Michigan
Country [23] 0 0
United States of America
State/province [23] 0 0
Minnesota
Country [24] 0 0
United States of America
State/province [24] 0 0
Mississippi
Country [25] 0 0
United States of America
State/province [25] 0 0
Missouri
Country [26] 0 0
United States of America
State/province [26] 0 0
Nebraska
Country [27] 0 0
United States of America
State/province [27] 0 0
Nevada
Country [28] 0 0
United States of America
State/province [28] 0 0
New Hampshire
Country [29] 0 0
United States of America
State/province [29] 0 0
New Jersey
Country [30] 0 0
United States of America
State/province [30] 0 0
New Mexico
Country [31] 0 0
United States of America
State/province [31] 0 0
New York
Country [32] 0 0
United States of America
State/province [32] 0 0
North Carolina
Country [33] 0 0
United States of America
State/province [33] 0 0
North Dakota
Country [34] 0 0
United States of America
State/province [34] 0 0
Ohio
Country [35] 0 0
United States of America
State/province [35] 0 0
Oklahoma
Country [36] 0 0
United States of America
State/province [36] 0 0
Oregon
Country [37] 0 0
United States of America
State/province [37] 0 0
Pennsylvania
Country [38] 0 0
United States of America
State/province [38] 0 0
Rhode Island
Country [39] 0 0
United States of America
State/province [39] 0 0
South Carolina
Country [40] 0 0
United States of America
State/province [40] 0 0
South Dakota
Country [41] 0 0
United States of America
State/province [41] 0 0
Tennessee
Country [42] 0 0
United States of America
State/province [42] 0 0
Texas
Country [43] 0 0
United States of America
State/province [43] 0 0
Utah
Country [44] 0 0
United States of America
State/province [44] 0 0
Vermont
Country [45] 0 0
United States of America
State/province [45] 0 0
Virginia
Country [46] 0 0
United States of America
State/province [46] 0 0
Washington
Country [47] 0 0
United States of America
State/province [47] 0 0
West Virginia
Country [48] 0 0
United States of America
State/province [48] 0 0
Wisconsin
Country [49] 0 0
Canada
State/province [49] 0 0
Alberta
Country [50] 0 0
Canada
State/province [50] 0 0
British Columbia
Country [51] 0 0
Canada
State/province [51] 0 0
Manitoba
Country [52] 0 0
Canada
State/province [52] 0 0
Newfoundland and Labrador
Country [53] 0 0
Canada
State/province [53] 0 0
Nova Scotia
Country [54] 0 0
Canada
State/province [54] 0 0
Ontario
Country [55] 0 0
Canada
State/province [55] 0 0
Saskatchewan
Country [56] 0 0
New Zealand
State/province [56] 0 0
Auckland
Country [57] 0 0
New Zealand
State/province [57] 0 0
Christchurch
Country [58] 0 0
New Zealand
State/province [58] 0 0
Wellington
Country [59] 0 0
Switzerland
State/province [59] 0 0
Bern
Country [60] 0 0
Switzerland
State/province [60] 0 0
Geneva
Country [61] 0 0
Switzerland
State/province [61] 0 0
Lausanne

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE: Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and
leucovorin calcium (LCV), 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.
Trial website
https://clinicaltrials.gov/show/NCT00075725
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Eric C. Larsen, MD
Address 0 0
Maine Children's Cancer Program at Barbara Bush Children's Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00075725