NCTN: 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 (AALL0232)
Study ID: AALL0232
NCT Number: NCT00075725
Children's Oncology Group (COG)
Submitted in collaboration with the NCTN/NCORP Data Archive
Trial Title: NCTN: 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 (AALL0232)
Trial Description: 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.
Clinical data presented in the following publication(s):
- PMID 27114587
Disease type(s): Hematopoietic Neoplasm/Leukemia - Acute Lymphoblastic Leukemia
Clinical Dataset(s) included:
- NCT00075725-D1 (PMID 27114587): There are three datasets associated with this publication (NCT00075725-D1, NCT00075725-D2, and NCT00075725-D3): NCT00075725-D1 includes all patients enrolled on the study. This dataset contains baseline characteristics, BCR-ABL fusion status, MLL rearrangement, bone marrow status at end of induction, and survival data.
- NCT00075725-D2 (PMID 27114587): There are 3 datasets associated with this publication (NCT00075725-D1, NCT00075725-D2, and NCT00075725-D3). NCT00075725-D2 is the subset of patients included in the randomized comparison between Capizzi and High-dose Methotrexate. The dataset includes baseline characteristics, BCR-ABL fusion status, MLL rearrangement, bone marrow status at end of induction, and survival data. Outcomes (EFS time, EFS indicator) in this dataset are different from the outcomes in NCT00075725-D1. The outcome of those assigned to Capizzi who subsequently received High-dose Methotrexate was censored at time of therapy crossover, since in AALL0232, therapy changes were recommended to provide HD-MTX to all participants who had not yet completed maintenance course 1 or received cranial irradiation.
- NCT00075725-D3 (PMID 27114587): There are three datasets associated with this publication (NCT00075725-D1, NCT00075725-D2, and NCT00075725-D3). NCT00075725-D3 is the toxicity data observed in the randomized cohorts (steroid and methotrexate).
Additional whole genome genotyping data for this trial is available under phs001350.
You are encouraged to view the PDF data dictionaries found in the “Documents” tab of the dbGaP study page, which may contain additional information regarding the data or the associated publication(s).
- Type: Interventional
- Archive: The database of Genotypes and Phenotypes (dbGaP)