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Leukemia

High Risk B-Precursor Acute Lymphoblastic Leukemia

Unique Dataset IDnci-data-351ClinicalTrial.gov IDNCT00075725
DownloadableNo
SponsorChildren's Oncology GroupData ProviderNational Cancer InstituteTotal Study Enrolled Patients3154RandomizationYesPubMed (PMID)27114587.0
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataN/AIntervention TypeRadiation, DrugDataset TypeOther

Clinical Trial Title

High Risk B-Precursor Acute Lymphoblastic Leukemia

Trial Summary and Conditions

RATIONALE: Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and leucovorin calcium (LCV), 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.

Data Summary

See data dictionary for more details.

Study Objectives

OBJECTIVES: Compare the outcome of patients with high-risk acute lymphoblastic leukemia treated with 2 different chemotherapy regimens. Compare the relative safety and efficacy of dexamethasone vs prednisone during induction therapy in patients treated with these regimens. Compare the relative safety and efficacy of high-dose methotrexate with leucovorin rescue vs escalating methotrexate without leucovorin rescue during interim maintenance I in patients treated with these regimens. Correlate minimal residual disease (MRD) at day 29 with event-free survival and overall survival of patients treated with these regimens. Correlate early marrow response status with day-29 MRD in patients treated with these regimens. Identify additional high-risk patients for treatment with the fully augmented Berlin-Frankfurt-Munster regimen by using day-29 MRD. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to early response (slow early response (SER) vs rapid early response (RER).

Outcome Measures

Primary: 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: Correlation of Minimal Residual Disease (MRD) Positive With Overall Survival (OS) [ Time Frame: 5 Years ] Correlation of Minimal Residual Disease (MRD) Negative With Overall Survival (OS). [ Time Frame: 5 years ] Correlation of Early Marrow Response Status With MRD Positive. [ Time Frame: Day 29 ] Correlation of Early Marrow Response Status With MRD Negative. [ Time Frame: Day 29 ] Correlation of Minimal Residual Disease (MRD) Positive With Event Free Survival (EFS) [ Time Frame: 5 years ] Correlation of Minimal Residual Disease (MRD) Negative With Event Free Survival (EFS). [ Time Frame: 5 years ]

ClinicalTrial.gov

Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):

NCI Description

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).

Available Downloads: NCT00075725-D3

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00075725-D3-Data-Dictionary.pdf

DATA: NCT00075725-D3-Dataset.csv

OTHER: README.pdf

Available Downloads: NCT00075725-D2

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00075725-D2-Data-Dictionary.pdf

DATA: NCT00075725-D2-Dataset.csv

OTHER: README.pdf

Available Downloads: NCT00075725-D1

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00075725-D1-Data-Dictionary.pdf

DATA: NCT00075725-D1-Dataset.csv

OTHER: README.pdf