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
NCT00075725, Phase 3, Completed, Children's Oncology Group; results first posted 2015-08-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT00075725. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00075725
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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
- NCT number
- NCT00075725
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,154 participants, actual
- Lead sponsor
- Children's Oncology Group
- Conditions
- Acute Lymphoblastic Leukemia, Adult B Acute Lymphoblastic Leukemia, Childhood B Acute Lymphoblastic Leukemia
- Interventions
Cyclophosphamide, Cytarabine, Daunorubicin Hydrochloride, Dexamethasone, Doxorubicin Hydrochloride, Leucovorin Calcium, Mercaptopurine, Methotrexate, Pegaspargase, Prednisone, Radiation Therapy, Thioguanine, Vincristine Sulfate
- First posted
- 2004-01-13
- Last updated
- 2021-04-27
- Results first posted
- 2015-08-06
- Limitations and caveats
The COG SDC reviewed the NLM notification related to ct.gov AE/SAE reporting. The information in 'Additional Description' is accurate with respect to data supplied to ct.gov.COG plans to submit data AE/SAE data consistent with the text in this field.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Comparison of the Increase in Cure Rate of High Risk ALL Without Causing More Serious Side Effects Between Interventions | 5 years | Event Free Probability. |
| Secondary | Correlation of Minimal Residual Disease (MRD) Positive With Overall Survival (OS) | 5 Years | Bone marrow MRD status is defined as positive with \>= 0.1 detectable leukemia cells, and negative with \< 0.1 detectable leukemia cells. |
| Secondary | Correlation of Minimal Residual Disease (MRD) Negative With Overall Survival (OS). | 5 years | Bone marrow MRD status is defined as negative with \< .01 detectable leukemia cells. |
| Secondary | Correlation of Early Marrow Response Status With MRD Positive. | 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. |
| Secondary | Correlation of Early Marrow Response Status With MRD Negative. | 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. |
| Secondary | Correlation of Minimal Residual Disease (MRD) Positive With Event Free Survival (EFS) | 5 years | Bone marrow MRD status is defined as positive with \>= 0.1 detectable leukemia cells. |
| Secondary | Correlation of Minimal Residual Disease (MRD) Negative With Event Free Survival (EFS). | 5 years | Bone marrow MRD status is defined as negative with \< 0.1 detectable leukemia cells. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Comparison of the Increase in Cure Rate of High Risk ALL Without Causing More Serious Side Effects Between Interventions | 5 years | Group Prednisone and High Dose MTX (non-random) who either had EFS events occur before 5 years or did not have minimum 5 years of follow-up. | percentage of participants | NUMBER |
| SECONDARY | Correlation of Minimal Residual Disease (MRD) Positive With Overall Survival (OS) | 5 Years | Groups Prednisone Capizzi MTX (Down's Syndrome), Dexamethasone, Capizzi MTX (non-random) \& Prednisone and High Dose MTX (non-random) are not included in this OM as no patients survived the 5 year window for analysis. Cohort of MRD Positive patients who either had EFS/OS events occur before 5 years or did not have minimum 5 years of follow-up. | percentage of participants | NUMBER |
| SECONDARY | Correlation of Minimal Residual Disease (MRD) Negative With Overall Survival (OS). | 5 years | Patients on Arm/Group Prednisone and High Dose Methotrexate (non randomly assigned) are not included in the OM as there were no survivors for the 5 year duration. Cohort of MRD Negative patients some of whom have had EFS/OS events after 5 years or have minimum 5 years of follow-up. | percentage of participants | NUMBER |
| SECONDARY | Correlation of Early Marrow Response Status With MRD Positive. | Day 29 | participants | NUMBER | |
| SECONDARY | Correlation of Early Marrow Response Status With MRD Negative. | Day 29 | participants | NUMBER | |
| SECONDARY | Correlation of Minimal Residual Disease (MRD) Positive With Event Free Survival (EFS) | 5 years | Groups Prednisone Capizzi MTX (Down's Syndrome), Dexamethasone, Capizzi MTX (non-random) \& Prednisone and High Dose MTX (non-random) are not included in this OM as no patients survived the 5 year window for analysis. Cohort of MRD Positive patients who either had EFS/OS events occur before 5 years or did not have minimum 5 years of follow-up. | percentage of participants | NUMBER |
| SECONDARY | Correlation of Minimal Residual Disease (MRD) Negative With Event Free Survival (EFS). | 5 years | Group Prednisone and High Dose MTX (non-random) who either had EFS/OS events occur before 5 years or did not have minimum 5 years of follow-up. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group75
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Comparison of the Increase in Cure Rate of High Risk ALL Without Causing More Serious Side Effects Between Interventions | Dexamethasone and Capizzi Methotrexate Patients < 10 Years | 83.2 | 95% Confidence Interval 76.6 to 89.9 | percentage of participants | |
| Comparison of the Increase in Cure Rate of High Risk ALL Without Causing More Serious Side Effects Between Interventions | Dexamethasone, High Dose Methotrexate (Non Randomly Assigned) | 81.6 | 95% Confidence Interval 71.2 to 91.9 | percentage of participants | |
| Comparison of the Increase in Cure Rate of High Risk ALL Without Causing More Serious Side Effects Between Interventions | Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old | 69.1 | 95% Confidence Interval 63.1 to 75.2 | percentage of participants | |
| Comparison of the Increase in Cure Rate of High Risk ALL Without Causing More Serious Side Effects Between Interventions | Dexamethasone, High Dose Methotrexate (IM) < 10 Years | 91.2 | 95% Confidence Interval 85.7 to 96.7 | percentage of participants | |
| Comparison of the Increase in Cure Rate of High Risk ALL Without Causing More Serious Side Effects Between Interventions | Prednisone, Capizzi Methotrexate <10 Years | 82.1 | 95% Confidence Interval 75.3 to 89.0 | percentage of participants | |
| Comparison of the Increase in Cure Rate of High Risk ALL Without Causing More Serious Side Effects Between Interventions | Prednisone, Capezzi Methotrexate >= 10 Years | 73.5 | 95% Confidence Interval 67.4 to 79.7 | percentage of participants | |
| Comparison of the Increase in Cure Rate of High Risk ALL Without Causing More Serious Side Effects Between Interventions | Predisone and High Dose Methotrexate < 10 Yrs Old | 80.8 | 95% Confidence Interval 73.6 to 88.0 | percentage of participants | |
| Comparison of the Increase in Cure Rate of High Risk ALL Without Causing More Serious Side Effects Between Interventions | Prenisone and High Dose Methotrexate >=10 Years | 75.8 | 95% Confidence Interval 70.0 to 81.6 | percentage of participants | |
| Comparison of the Increase in Cure Rate of High Risk ALL Without Causing More Serious Side Effects Between Interventions | Dexamethasone, High Dose Methotrexate (IM) >= 10 Years | 77.0 | 95% Confidence Interval 71.5 to 82.6 | percentage of participants | |
| Comparison of the Increase in Cure Rate of High Risk ALL Without Causing More Serious Side Effects Between Interventions | Prenisone, Capezzi Methotrexate (Down's Syndrome) | 61.8 | 95% Confidence Interval 43.1 to 80.5 | percentage of participants |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dexamethasone and Capizzi Methotrexate Patients < 10 Years | 246 | |
| Overall Study | STARTED | Dexamethasone, High Dose Methotrexate (Non Randomly Assigned) | 106 | |
| Overall Study | STARTED | Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old | 296 | |
| Overall Study | STARTED | Dexamethasone, High Dose Methotrexate (IM) < 10 Years | 246 | |
| Overall Study | STARTED | Prednisone, Capizzi Methotrexate <10 Years | 232 | |
| Overall Study | STARTED | Prednisone, Capezzi Methotrexate >= 10 Years | 710 | |
| Overall Study | STARTED | Prednisone and High Dose Methotrexate < 10 Yrs Old | 246 | |
| Overall Study | STARTED | Prednisone and High Dose Methotrexate >=10 Years | 696 | |
| Overall Study | STARTED | Dexamethasone, High Dose Methotrexate (IM) >= 10 Years | 302 | |
| Overall Study | STARTED | Prednisone, Capezzi Methotrexate (Down's Syndrome) | 34 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events6,708
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal distension | Gastrointestinal disorders | Dexamethasone and Capizzi Methotrexate Patients < 10 Years | 2 | 218 | 2 |
| other | Abdominal distension | Gastrointestinal disorders | Dexamethasone, High Dose Methotrexate (Non Randomly Assigned) | 3 | 90 | 3 |
| other | Abdominal distension | Gastrointestinal disorders | Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old | 1 | 261 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Dexamethasone, High Dose Methotrexate (IM) < 10 Years | 0 | 206 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Prednisone, Capizzi Methotrexate <10 Years | 0 | 214 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Prednisone, Capezzi Methotrexate >= 10 Years | 0 | 598 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Prednisone and High Dose Methotrexate < 10 Yrs Old | 2 | 213 | 3 |
| other | Abdominal distension | Gastrointestinal disorders | Prednisone and High Dose Methotrexate >=10 Years | 1 | 601 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Dexamethasone, High Dose Methotrexate (IM) >= 10 Years | 1 | 262 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Prednisone, Capezzi Methotrexate (Down's Syndrome) | 0 | 30 | 0 |
1 to 10 of 6,708Source ClinicalTrials.gov
See all 6,708 adverse eventsAdverse event totals36
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dexamethasone and Capizzi Methotrexate Patients < 10 Years | ||
| Total, all-cause mortality | Dexamethasone, High Dose Methotrexate (Non Randomly Assigned) | ||
| Total, all-cause mortality | Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old | ||
| Total, all-cause mortality | Dexamethasone, High Dose Methotrexate (IM) < 10 Years | ||
| Total, all-cause mortality | Prednisone, Capizzi Methotrexate <10 Years | ||
| Total, all-cause mortality | Prednisone, Capezzi Methotrexate >= 10 Years | ||
| Total, all-cause mortality | Prednisone and High Dose Methotrexate < 10 Yrs Old | ||
| Total, all-cause mortality | Prednisone and High Dose Methotrexate >=10 Years | ||
| Total, all-cause mortality | Dexamethasone, High Dose Methotrexate (IM) >= 10 Years | ||
| Total, all-cause mortality | Prednisone, Capezzi Methotrexate (Down's Syndrome) |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse event totalsPapers10
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA098543 | Children's Oncology Group Chair's Grant | ADAMSON, PETER C. | CHILDREN'S HOSP OF PHILADELPHIA | NATIONAL CANCER INSTITUTE | 2003 to 2013 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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