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
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| ClinicalTrials.gov Identifier: NCT00075725 |
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Recruitment Status :
Completed
First Posted : January 13, 2004
Results First Posted : August 6, 2015
Last Update Posted : April 27, 2021
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Sponsor:
Children's Oncology Group
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
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Brief Summary:
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 (ALL). 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute Lymphoblastic Leukemia Adult B Acute Lymphoblastic Leukemia Childhood B Acute Lymphoblastic Leukemia | Drug: Cyclophosphamide Drug: Cytarabine Drug: Daunorubicin Hydrochloride Drug: Dexamethasone Drug: Doxorubicin Hydrochloride Drug: Leucovorin Calcium Drug: Mercaptopurine Drug: Methotrexate Drug: Pegaspargase Drug: Prednisone Radiation: Radiation Therapy Drug: Thioguanine Drug: Vincristine Sulfate | Phase 3 |
Show detailed description
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 3154 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | High Risk B-Precursor Acute Lymphoblastic Leukemia (ALL) |
| Actual Study Start Date : | December 29, 2003 |
| Actual Primary Completion Date : | December 31, 2010 |
| Actual Study Completion Date : | March 31, 2021 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Arm I
Patients in arm I receive intrathecal cytarabine in week 1; infusions of vincristine and daunorubicin 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.
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Drug: Cyclophosphamide
Given IV
Other Names:
Drug: Cytarabine Given IT, SC, or IV
Other Names:
Drug: Daunorubicin Hydrochloride Given IV
Other Names:
Drug: Dexamethasone Given PO or IV
Other Names:
Drug: Doxorubicin Hydrochloride Given IV
Other Names:
Drug: Mercaptopurine Given PO
Other Names:
Drug: Methotrexate Given IT or IV
Other Names:
Drug: Pegaspargase Given IM
Other Names:
Radiation: Radiation Therapy Undergo radiation therapy
Other Names:
Drug: Thioguanine Given PO
Other Names:
Drug: Vincristine Sulfate Given IV
Other Names:
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Active Comparator: Arm II
Patients in arm II will receive intrathecal cytarabine in week 1; infusions of vincristine and daunorubicin 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.
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Drug: Cyclophosphamide
Given IV
Other Names:
Drug: Cytarabine Given IT, SC, or IV
Other Names:
Drug: Daunorubicin Hydrochloride Given IV
Other Names:
Drug: Dexamethasone Given PO or IV
Other Names:
Drug: Doxorubicin Hydrochloride Given IV
Other Names:
Drug: Leucovorin Calcium Given IV
Other Names:
Drug: Mercaptopurine Given PO
Other Names:
Drug: Methotrexate Given IT or IV
Other Names:
Drug: Pegaspargase Given IM
Other Names:
Radiation: Radiation Therapy Undergo radiation therapy
Other Names:
Drug: Thioguanine Given PO
Other Names:
Drug: Vincristine Sulfate Given IV
Other Names:
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Experimental: Arm III
Patients in arm III will receive cytarabine, vincristine, daunorubicin, 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 by infusion, injection, intrathecally, and by mouth for up to 8 weeks. |
Drug: Cyclophosphamide
Given IV
Other Names:
Drug: Cytarabine Given IT, SC, or IV
Other Names:
Drug: Daunorubicin Hydrochloride Given IV
Other Names:
Drug: Dexamethasone Given PO or IV
Other Names:
Drug: Doxorubicin Hydrochloride Given IV
Other Names:
Drug: Mercaptopurine Given PO
Other Names:
Drug: Methotrexate Given IT or IV
Other Names:
Drug: Pegaspargase Given IM
Other Names:
Drug: Prednisone Given PO or IV
Other Names:
Radiation: Radiation Therapy Undergo radiation therapy
Other Names:
Drug: Thioguanine Given PO
Other Names:
Drug: Vincristine Sulfate Given IV
Other Names:
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Experimental: Arm IV
Patients in arm IV will receive cytarabine, vincristine, daunorubicin, 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 by infusion, injection, intrathecally, and by mouth for up to 8 weeks. |
Drug: Cyclophosphamide
Given IV
Other Names:
Drug: Cytarabine Given IT, SC, or IV
Other Names:
Drug: Daunorubicin Hydrochloride Given IV
Other Names:
Drug: Dexamethasone Given PO or IV
Other Names:
Drug: Doxorubicin Hydrochloride Given IV
Other Names:
Drug: Leucovorin Calcium Given IV
Other Names:
Drug: Mercaptopurine Given PO
Other Names:
Drug: Methotrexate Given IT or IV
Other Names:
Drug: Pegaspargase Given IM
Other Names:
Drug: Prednisone Given PO or IV
Other Names:
Radiation: Radiation Therapy Undergo radiation therapy
Other Names:
Drug: Thioguanine Given PO
Other Names:
Drug: Vincristine Sulfate Given IV
Other Names:
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Primary Outcome Measures :
- Comparison of the Increase in Cure Rate of High Risk ALL Without Causing More Serious Side Effects Between Interventions [ Time Frame: 5 years ]Event Free Probability.
Secondary Outcome Measures :
- Correlation of Minimal Residual Disease (MRD) Positive With Overall Survival (OS) [ Time Frame: 5 Years ]Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells, and negative with < 0.1 detectable leukemia cells.
- Correlation of Minimal Residual Disease (MRD) Negative With Overall Survival (OS). [ Time Frame: 5 years ]Bone marrow MRD status is defined as negative with < .01 detectable leukemia cells.
- Correlation of Early Marrow Response Status With MRD Positive. [ Time Frame: Day 29 ]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.
- Correlation of Early Marrow Response Status With MRD Negative. [ Time Frame: Day 29 ]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.
- Correlation of Minimal Residual Disease (MRD) Positive With Event Free Survival (EFS) [ Time Frame: 5 years ]Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells.
- Correlation of Minimal Residual Disease (MRD) Negative With Event Free Survival (EFS). [ Time Frame: 5 years ]Bone marrow MRD status is defined as negative with < 0.1 detectable leukemia cells.
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| Ages Eligible for Study: | 1 Year to 30 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Must be eligible for and enrolled on classification study COG-AALL03B1
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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
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Whit blood cell (WBC) criteria:
- Age 1 - 9 years: WBC >= 50,000/uL
- Age 10 - 30 years: any WBC
- Prior steroid therapy: any WBC
- Testicular disease: any WBC
- Patients shall have had no other prior cytotoxic chemotherapy with the exception of steroids and intrathecal cytarabine
- Patients receiving prior steroid therapy (as described in AALL03B1) are eligible for study; the dose and duration of previous steroid therapy should be carefully documented
- All patients and/or their parents or legal guardians must sign a written informed consent
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:
- Patients with Down syndrome are ineligible to enroll onto this study
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00075725
Locations
Show 234 study locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Eric C Larsen | Children's Oncology Group |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Children's Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00075725 |
| Other Study ID Numbers: |
AALL0232 NCI-2009-00301 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) COG-AALL0232 CDR0000349182 11723 AALL0232 ( Other Identifier: Children's Oncology Group ) AALL0232 ( Other Identifier: CTEP ) U10CA098543 ( U.S. NIH Grant/Contract ) |
| First Posted: | January 13, 2004 Key Record Dates |
| Results First Posted: | August 6, 2015 |
| Last Update Posted: | April 27, 2021 |
| Last Verified: | April 2021 |
Additional relevant MeSH terms:
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Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Calcium, Dietary Leucovorin Folic Acid Cytarabine Dexamethasone Dexamethasone acetate |
Prednisone Cortisone Cyclophosphamide Doxorubicin Liposomal doxorubicin Methotrexate Vincristine Daunorubicin Asparaginase Mercaptopurine Thioguanine Pegaspargase BB 1101 Calcium 2-Aminopurine |