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: August 6, 2014
Last verified: August 2014
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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
Cytarabine
Thioguanine
Leucovorin calcium
Vincristine sulfate
Dexamethasone sodium phosphate
Asparaginase
Methotrexate sodium
Daunorubicin
Doxorubicin
Daunorubicin hydrochloride
Doxorubicin hydrochloride
Dexamethasone acetate
Levoleucovorin
Pegaspargase
Daunorubicin citrate
Asparaginase erwinia chrysanthemi
Genetic and Rare Diseases Information Center resources:
Acute Lymphoblastic Leukemia
Acute Lymphoblastic Leukemia, Childhood
Acute Monoblastic Leukemia
Acute Myeloblastic Leukemia Type 5
Lymphosarcoma
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: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Dexamethasone and Capizzi Methotrexate patients < 10 years
Patients receive intrathecal 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 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (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).
|
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: Dexamethasone, High Dose Methotrexate (non randomly assigned)
Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal 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 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (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).
|
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: Dexamethasone & Capizzi Methotrexate patients => 10 years old
Patients receive intrathecal 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 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (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).
|
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: Dexamethasone during Induction, High Dose Methotrexate (IM)
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 intrathecal 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 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (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).
|
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: Prednisone, Capizzi methotrexate (<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 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: 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: Prednisone, Capezzi methotrexate (>= 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 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: 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: Predisone and High Dose Methotrexate (< 10 yrs old)
Patients randomly assigned to the PH regimen receive intrathecal 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 and 22. 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: 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:
|
|
Experimental: Prenisone and High Dose Methotrexate (>=10 yrs old)
Patients randomly assigned to the PH regimen receive intrathecal 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 and 22. 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: 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:
|
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075725
Show 213 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075725
Show 213 Study Locations
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.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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: | August 6, 2014 |
| 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 Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type 6-Mercaptopurine Asparaginase BB 1101 Cyclophosphamide Daunorubicin Dexamethasone |
Dexamethasone 21-phosphate Dexamethasone acetate Doxorubicin Liposomal doxorubicin Methotrexate Pegaspargase Prednisone Thioguanine Vincristine Abortifacient Agents Abortifacient Agents, Nonsteroidal Alkylating Agents Anti-Inflammatory Agents Antibiotics, Antineoplastic Antiemetics |
ClinicalTrials.gov processed this record on March 03, 2015