NCT00075725

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

Study Contact:

Study Phase:

PHASE3

Recruitment Status:

COMPLETED

NCT ID:

NCT00075725

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

High Risk B-Precursor Acute Lymphoblastic Leukemia (ALL)

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.

Eligibility

Inclusion Criteria:

* Must be eligible for and enrolled on classification study COG-AALL03B1
* 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
* 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

Disease(s) and\or Condition(s)

Acute Lymphoblastic Leukemia

Adult B Acute Lymphoblastic Leukemia

Childhood B Acute Lymphoblastic Leukemia

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: DRUG
- Name: Cyclophosphamide
- Description: Given IV
- Arm Group Labels: Arm I, Arm II, Arm III, Arm IV
- Type: DRUG
- Name: Cytarabine
- Description: Given IT, SC, or IV
- Arm Group Labels: Arm I, Arm II, Arm III, Arm IV
- Type: DRUG
- Name: Daunorubicin Hydrochloride
- Description: Given IV
- Arm Group Labels: Arm I, Arm II, Arm III, Arm IV
- Type: DRUG
- Name: Dexamethasone
- Description: Given PO or IV
- Arm Group Labels: Arm I, Arm II, Arm III, Arm IV
- Type: DRUG
- Name: Doxorubicin Hydrochloride
- Description: Given IV
- Arm Group Labels: Arm I, Arm II, Arm III, Arm IV
- Type: DRUG
- Name: Leucovorin Calcium
- Description: Given IV
- Arm Group Labels: Arm II, Arm IV
- Type: DRUG
- Name: Mercaptopurine
- Description: Given PO
- Arm Group Labels: Arm I, Arm II, Arm III, Arm IV
- Type: DRUG
- Name: Methotrexate
- Description: Given IT or IV
- Arm Group Labels: Arm I, Arm II, Arm III, Arm IV
- Type: DRUG
- Name: Pegaspargase
- Description: Given IM
- Arm Group Labels: Arm I, Arm II, Arm III, Arm IV
- Type: DRUG
- Name: Prednisone
- Description: Given PO or IV
- Arm Group Labels: Arm III, Arm IV
- Type: RADIATION
- Name: Radiation Therapy
- Description: Undergo radiation therapy
- Arm Group Labels: Arm I, Arm II, Arm III, Arm IV
- Type: DRUG
- Name: Thioguanine
- Description: Given PO
- Arm Group Labels: Arm I, Arm II, Arm III, Arm IV
- Type: DRUG
- Name: Vincristine Sulfate
- Description: Given IV
- Arm Group Labels: Arm I, Arm II, Arm III, Arm IV

Sponsor

Children's Oncology Group