Trial · NCT00137111
Therapy for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia
NCT00137111, Phase 3, Completed, St. Jude Children's Research Hospital; results first posted 2011-04-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Therapy for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia. Trials, record NCT00137111. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00137111
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Therapy for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia
- NCT number
- NCT00137111
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 501 participants, actual
- Lead sponsor
- St. Jude Children's Research Hospital
- Conditions
- Lymphoblastic Leukemia, Acute
- Interventions
Prednisone, Dexamethasone, Vincristine, Daunorubicin, Doxorubicin, L-asparaginase, PEG-L-asparaginase, Erwinia asparaginase, Methotrexate, Cyclophosphamide, Cytarabine, Etoposide, Mercaptopurine, Imatinib, chemotherapy, intrathecal chemotherapy, steroid therapy, hematopoietic stem cell transplantation
- First posted
- 2005-08-29
- Last updated
- 2020-09-11
- Results first posted
- 2011-04-26
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Event-free Survival (EFS) | Median follow-up time (range) 5.6 (1.3 to 8.9) years | EFS was measured from the start of on-study to the date of first treatment failure of any kind (relapse, death, lineage switch, or second malignancy) or to the last date of follow-up. Failure to enter remission was considered an event at time zero. Measurement was determined by Kaplan-Meyer estimate. |
| Primary | Continuous Complete Remission Since Week 56 Therapy. | Median follow up time (range) 4.5 (1 to 7.8) years | CCR was measured from end of week 56 therapy to the date of first treatment failure of any kind (relapse, death, lineage switch, or second malignancy) or to the last date of follow-up. Measurement was determined by Kaplan-Meyer estimate. |
| Secondary | Minimal Residual Disease (MRD) | End of Induction (Day 46 MRD measurement) | Detection of MRD at end of induction where positive MRD was defined as one or more leukemic cell per 10,000 mononuclear bone-marrow cells (\>=0.01%). |
| Secondary | Mean Difference of Active Methotrexate Polyglutamates (MTXPG) in Leukemia Cells Between Two Arms (4 Hours vs. 24 Hours). | 42 hours after start of high dose methotrexate infusion (HDMTX) | Children were randomly assigned to receive initial single-agent treatment with HDMTX (1g/m\^2) as either a 24-hour infusion or a 4-hour infusion and the outcome measure was the accumulation of MTXPG in leukemia cells. |
| Secondary | Circulating Leukemia Cells in Peripheral Blood Change From Prior to the Methotrexate Infusion to Three Days After Between Two Arms (4 Hours vs. 24 Hours) | Immediately before the methotrexate infusion and three days after subsequent infusion | White blood cell (leukocytes) counts in peripheral blood by Complete Blood Count Measurement: Percentage change of leukemia cells from baseline |
| Other | Median Difference in CASP1 Gene Expression in Primary Leukemia Cells of Patients in Glucocorticoid-resistant Cells vs Glucocorticoid-sensitive Cells | Pre-treatment | Prednisolone sensitivity was measured in primary leukemia cells from bone marrow collected at diagnosis. Expression of CASP1 was determined by HG-U133A microarray. Values given are gene expression values, and the unit is arbitrary units (AU) defined as scaled fluorescence measured on microarray. |
| Other | Median Difference in NLRP3 Gene Expression in Primary Leukemia Cells of Patients in Glucocorticoid-resistant Cells vs. Glucocorticoid-sensitive Cells | Pre-treatment | Prednisolone sensitivity was measured in primary leukemia cells from bone marrow collected at diagnosis. Expression of NLRP3 was determined by HG-U133A microarray. Values given are gene expression values, and the unit is arbitrary units (AU) defined as scaled fluorescence measured on microarray. |
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 | Overall Event-free Survival (EFS) | Median follow-up time (range) 5.6 (1.3 to 8.9) years | 498 enrolled patients were eligible for analysis to estimate the overall event-free survival of children at least one year of age at diagnosis who are treated with risk-directed therapy. | Percentage of Participants | NUMBER |
| PRIMARY | Continuous Complete Remission Since Week 56 Therapy. | Median follow up time (range) 4.5 (1 to 7.8) years | Patients meeting the following high risk CNS Relapse criteria: white cell blood cell count at diagnosis more than 100,000; Philadelphia Chromosome Positive; CNS 3 at diagnosis; T-Lineage with white blood cell count more than 50,000. | Percentage of participants | NUMBER |
| SECONDARY | Minimal Residual Disease (MRD) | End of Induction (Day 46 MRD measurement) | Patients who completed induction and had successful MRD studies on day 46. | participants | NUMBER |
| SECONDARY | Mean Difference of Active Methotrexate Polyglutamates (MTXPG) in Leukemia Cells Between Two Arms (4 Hours vs. 24 Hours). | 42 hours after start of high dose methotrexate infusion (HDMTX) | The 286 patients randomized to treatment with high-dose methotrexate (HDMTX) who had methotrexate polyglutamate (MTXPG) concentration measured in bone marrow ALL cells . | pmol/1,000,000,000 cells | MEAN |
| SECONDARY | Circulating Leukemia Cells in Peripheral Blood Change From Prior to the Methotrexate Infusion to Three Days After Between Two Arms (4 Hours vs. 24 Hours) | Immediately before the methotrexate infusion and three days after subsequent infusion | Three hundred twenty (320) patients were evaluable to assess the influence of infusion duration on methotrexate's antileukemic effects. | Percent change | MEAN |
| OTHER_PRE_SPECIFIED | Median Difference in CASP1 Gene Expression in Primary Leukemia Cells of Patients in Glucocorticoid-resistant Cells vs Glucocorticoid-sensitive Cells | Pre-treatment | One hundred forty-four (144) patients were evaluable to assess prednisolone sensitivity measured in bone marrow ALL cells and CASP1 expression in RNA by MTT assay. | arbitrary units | MEDIAN |
| OTHER_PRE_SPECIFIED | Median Difference in NLRP3 Gene Expression in Primary Leukemia Cells of Patients in Glucocorticoid-resistant Cells vs. Glucocorticoid-sensitive Cells | Pre-treatment | One hundred forty-four (144) patients were evaluable to assess prednisolone sensitivity measured in bone marrow ALL cells and NLRP3 expression in RNA by MTT assay | arbitrary units | MEDIAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Event-free Survival (EFS) | Total Therapy | 87.3 | .831 to .901 | Percentage of Participants | |
| Continuous Complete Remission Since Week 56 Therapy. | Patients With High Risk of CNS Relapse | 92.2 | 82 to 100 | Percentage of participants | |
| Minimal Residual Disease (MRD) | Total Therapy | Negative <0.01% | 390 | participants | |
| Minimal Residual Disease (MRD) | Total Therapy | Positive >= 0.01% | 102 | participants | |
| Mean Difference of Active Methotrexate Polyglutamates (MTXPG) in Leukemia Cells Between Two Arms (4 Hours vs. 24 Hours). | 4 hr | 1688 | Standard Deviation 2015 | pmol/1,000,000,000 cells | |
| Mean Difference of Active Methotrexate Polyglutamates (MTXPG) in Leukemia Cells Between Two Arms (4 Hours vs. 24 Hours). | 24 hr | 2521 | Standard Deviation 2950 | pmol/1,000,000,000 cells | |
| Circulating Leukemia Cells in Peripheral Blood Change From Prior to the Methotrexate Infusion to Three Days After Between Two Arms (4 Hours vs. 24 Hours) | 4 hr | -44 | Standard Deviation 42.2 | Percent change | |
| Circulating Leukemia Cells in Peripheral Blood Change From Prior to the Methotrexate Infusion to Three Days After Between Two Arms (4 Hours vs. 24 Hours) | 24 hr | -50 | Standard Deviation 35.5 | Percent change | |
| Median Difference in CASP1 Gene Expression in Primary Leukemia Cells of Patients in Glucocorticoid-resistant Cells vs Glucocorticoid-sensitive Cells | Total Therapy | Prednisolone-sensitive cells | 341.3 | Inter-Quartile Range 202.1 to 430.2 | arbitrary units |
| Median Difference in CASP1 Gene Expression in Primary Leukemia Cells of Patients in Glucocorticoid-resistant Cells vs Glucocorticoid-sensitive Cells | Total Therapy | Prednisolone-resistant cells | 447.9 | Inter-Quartile Range 332.2 to 544.9 | arbitrary units |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Window Therapy | STARTED | Total Therapy | 0 | |
| Window Therapy | STARTED | 4 hr | 176 | |
| Window Therapy | STARTED | 24 hr | 180 | |
| Window Therapy | STARTED | Non Randomized | 142 | |
| Window Therapy | COMPLETED | Total Therapy | 0 | |
| Window Therapy | COMPLETED | 4 hr | 176 | |
| Window Therapy | COMPLETED | 24 hr | 180 | |
| Window Therapy | COMPLETED | Non Randomized | 142 | |
| Window Therapy | NOT COMPLETED | Total Therapy | 0 | |
| Window Therapy | NOT COMPLETED | 4 hr | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events69
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 pain or cramping | General disorders | Total Therapy | 47 | 498 | 69 |
| other | Allergic Reaction to Asparaginase | Immune system disorders | Total Therapy | 41 | 498 | 45 |
| other | Anorexia | Gastrointestinal disorders | Total Therapy | 26 | 498 | 31 |
| other | Catheter-related infection | Infections and infestations | Total Therapy | 86 | 498 | 131 |
| other | Dehydration | Gastrointestinal disorders | Total Therapy | 29 | 498 | 36 |
| other | Diarrhea patients without colostomy | Gastrointestinal disorders | Total Therapy | 53 | 498 | 62 |
| other | Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe | Infections and infestations | Total Therapy | 436 | 498 | 1,407 |
| other | Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L) | General disorders | Total Therapy | 208 | 498 | 403 |
| other | Headache | General disorders | Total Therapy | 26 | 498 | 38 |
| other | Hyperglycemia | Metabolism and nutrition disorders | Total Therapy | 43 | 498 | 62 |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Total Therapy | ||
| Total, other adverse events | Total Therapy | 468 | 498 |
| Total, serious adverse events | Total Therapy | 74 | 498 |
Source ClinicalTrials.gov
Papers208
The papers the trial lists on ClinicalTrials.gov.
Grants3
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 | Source |
|---|---|---|---|---|---|---|
| P30CA021765 | Cancer Center Support Grant (CCSG) | ROBERTS, CHARLES | ST. JUDE CHILDREN'S RESEARCH HOSPITAL | NATIONAL CANCER INSTITUTE | 1985 to 2026 | NIH RePORTER |
| R37CA036401 | PHARMACOGENOMICS OF CHILDHOOD LEUKEMIA (ALL) | EVANS, WILLIAM E | ST. JUDE CHILDREN'S RESEARCH HOSPITAL | NATIONAL CANCER INSTITUTE | 1987 to 2014 | NIH RePORTER |
| F32CA141762 | MicroRNA pharmacogenomics: implications for childhood leukemia (ALL) | PAUGH, STEVEN WILLIAM | ST. JUDE CHILDREN'S RESEARCH HOSPITAL | NATIONAL CANCER INSTITUTE | 2009 to 2011 | 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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