Clinical Trial: 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
Status:
COMPLETEDPhase:
Phase 3| Lead Sponsor: | Children's Oncology Group |
| Information Provided By: | Children's Oncology Group |
| Last Update Posted: | 2021-04-27 |
Study Overview
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.
Official Title
Conditions
Intervention / Treatment
- 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
Other Study ID Numbers
- AALL0232
- NCI-2009-00301
- COG-AALL0232
- CDR0000349182
- 11723
- AALL0232
- AALL0232
- U10CA098543
Start Date (Actual)
Primary Completion Date (Actual)
Study Completion Date (Actual)
Enrollment (Actual)
Study Type
Phase
| Lead Sponsor: | Children's Oncology Group |
| Information Provided By: | Children's Oncology Group |
| Last Update Posted: | 2021-04-27 |
Study Overview
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.
Official Title
Conditions
Intervention / Treatment
- 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
Other Study ID Numbers
- AALL0232
- NCI-2009-00301
- COG-AALL0232
- CDR0000349182
- 11723
- AALL0232
- AALL0232
- U10CA098543