Trial · NCT00103285
Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
NCT00103285, Phase 3, Completed, Children's Oncology Group; results first posted 2018-07-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia. Trials, record NCT00103285. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00103285
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
- NCT number
- NCT00103285
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 5,377 participants, actual
- Lead sponsor
- Children's Oncology Group
- Conditions
- Acute Lymphoblastic Leukemia, Childhood B Acute Lymphoblastic Leukemia
- Interventions
3-Dimensional Conformal Radiation Therapy, Cyclophosphamide, Cytarabine, Dexamethasone, Doxorubicin Hydrochloride, Leucovorin Calcium, Mercaptopurine, Methotrexate, Pegaspargase, Thioguanine, Vincristine Sulfate
- First posted
- 2005-02-08
- Last updated
- 2021-06-14
- Results first posted
- 2018-07-11
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-free Survival (EFS) for SR-Average ALL Patients | 6 years | EFS for SR-Average with standard and Intensified Consolidation. Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. |
| Primary | Event-free Survival (EFS) for SR-Low Patients | 6 years | Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. |
| Secondary | Health-related Quality of Life Relative to Physical, Social and Emotional Impairment | At 1, 6 and 12 months after diagnosis and, 3 months post-therapy | To identify potentially modifiable factors associated with impaired health related quality of life (HRQOL) at different periods of therapy in the patients who are SR-average enrolled on the standard risk ALL study.Standardized scores will be computed for child function using the gender and age-adjusted scores available from normative data from a healthy population of about 10,000 children. The various domains of family functioning will be assessed using well-validated instruments and analyzed as a dichotomous variable (impaired vs. non-impaired family functioning). Multiple regression analysis will be used to test the effect of family functioning (adjusted for therapy given, age at diagnosis, gender, socioeconomic status and other factors) on child function. |
| Secondary | Event-Free Survival Probability According to MRD Status End Induction (Day 29) | MRD at Day 29 of therapy | Event-Free survival by Day 29 MRD status (negative vs positive), Event Free Probability (time from study entry to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. |
| Secondary | Overall Survival Probability (OS) According to Induction Day 29 MRD Status | Overall Survival Probability of 6 years | Overall survival by Day 29 MRD status (negative vs positive), Overall survival defined as time from study entry to death or date of last contact for patients who are alive. |
| Secondary | Early Marrow Status (EMS) by MRD Status End Induction (Day 29) | Early Marrow Status at Day 15, MRD Status at Day 29 of therapy. | Early Marrow Status defined as M1 versus M2/M3 marrow is correlated with MRD (Positive vs. Negative) |
| Secondary | Optimal Time Point for Advance Health Related Quality of Life Intervention | At 1 month after diagnosis and 3 months post-therapy. | Percentage of patients with elevated Anxiety. |
| Secondary | Event-free Survival (EFS) for SR-High Patients. | 6 years | Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. |
| Secondary | Event-Free Survival (EFS) for Low MRD (Negative) Subjects by Genetic Subset (TEL/Trisomy Positive vs Negative) | 6 years | Event-free probability where EFS is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Event-free Survival (EFS) for SR-Average ALL Patients | 6 years | Only eligible patients are included in this population. Populations are based on enrollments for all four arms initially, and then only for Arms I and II (standard therapy) once Arms III and IV (intensified therapy) were closed to accrual. | percent probability | NUMBER |
| PRIMARY | Event-free Survival (EFS) for SR-Low Patients | 6 years | Only eligible patients are included in the analysis. | Percent probability | NUMBER |
| SECONDARY | Health-related Quality of Life Relative to Physical, Social and Emotional Impairment | At 1, 6 and 12 months after diagnosis and, 3 months post-therapy | This analysis is restricted to the 160 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites, who consented to and completed the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales (physical, emotional and social functioning). | Percentage of participants | NUMBER |
| SECONDARY | Event-Free Survival Probability According to MRD Status End Induction (Day 29) | MRD at Day 29 of therapy | 4981 eligible evaluable patients enrolled on AALL0331 had MRD data at Day 29 | Percent Probability | NUMBER |
| SECONDARY | Overall Survival Probability (OS) According to Induction Day 29 MRD Status | Overall Survival Probability of 6 years | 4981 eligible evaluable patients enrolled on AALL0331 had MRD data at Day 29. | percent probability | NUMBER |
| SECONDARY | Early Marrow Status (EMS) by MRD Status End Induction (Day 29) | Early Marrow Status at Day 15, MRD Status at Day 29 of therapy. | Patients who had MRD day 29 data but their Bone Marrow (BM) days 8/15 data were missing are excluded. This analysis was done with patients who had both MRD and BM data. There were 5 patients excluded in both MRD Negative and MRD Positive groups due to missing days 8/15 BM. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Optimal Time Point for Advance Health Related Quality of Life Intervention | At 1 month after diagnosis and 3 months post-therapy. | Parents of 159 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the BASC-2 Anxiety Scale at 1 month after diagnosis, and 3 months post-therapy. Of these, 159 patients had data at 1 month after diagnosis and 96 patients had data at 3 months post therapy. | Percentage of participants | NUMBER |
| SECONDARY | Event-free Survival (EFS) for SR-High Patients. | 6 years | CCR: Complete Continuous Remission, where time to event is defined as the time from start of consolidation therapy to first event or date of last follow up for those who did not experience an event. All patients enrolled on the SR-High were used in this analysis regardless of completion of therapy. | percent probability | NUMBER |
| SECONDARY | Event-Free Survival (EFS) for Low MRD (Negative) Subjects by Genetic Subset (TEL/Trisomy Positive vs Negative) | 6 years | Patients on the two arms being compared got similar therapy. All patients included in this analysis are MRD negative. SR-Average patients who were CNS2 at diagnosis were excluded in order to have comparable patient cohorts. SR-Low patients are TEL/Trisomy positive while SR-Average patients are TEL/Trisomy negative. | Percent probability | NUMBER |
Source ClinicalTrials.gov
Results by group31
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Event-free Survival (EFS) for SR-Average ALL Patients | Group 2-SR-avg ALL, Arm I-combination Chemotherapy | Standard and Intensified therapy | 83.82 | 95% Confidence Interval 78.86 to 88.78 | percent probability |
| Event-free Survival (EFS) for SR-Average ALL Patients | Group 2-SR-avg ALL, Arm II-combination Chemotherapy | Standard and Intensified therapy | 88.89 | 95% Confidence Interval 84.79 to 92.99 | percent probability |
| Event-free Survival (EFS) for SR-Average ALL Patients | Group 2-SR-avg ALL, Arm III-combination Chemotherapy | Standard and Intensified therapy | 88.34 | 95% Confidence Interval 83.99 to 92.69 | percent probability |
| Event-free Survival (EFS) for SR-Average ALL Patients | Group 2-SR-avg ALL, Arm IV-combination Chemotherapy | Standard and Intensified therapy | 90.51 | 95% Confidence Interval 86.55 to 94.47 | percent probability |
| Event-free Survival (EFS) for SR-Average ALL Patients | Group 2-SR-avg ALL, Arm I-combination Chemotherapy | Standard therapy | 87.41 | 95% Confidence Interval 83.63 to 91.19 | percent probability |
| Event-free Survival (EFS) for SR-Average ALL Patients | Group 2-SR-avg ALL, Arm II-combination Chemotherapy | Standard therapy | 88.29 | 95% Confidence Interval 84.76 to 91.82 | percent probability |
| Event-free Survival (EFS) for SR-Low Patients | SR-low ALL, Arm I-combination Chemotherapy | 95.22 | 95% Confidence Interval 93.6 to 96.9 | Percent probability | |
| Event-free Survival (EFS) for SR-Low Patients | SR-low ALL, Arm II-combination Chemotherapy | 93.96 | 95% Confidence Interval 92.1 to 95.8 | Percent probability | |
| Health-related Quality of Life Relative to Physical, Social and Emotional Impairment | Induction Therapy | Physical Impairment 1 mth after diagnosis | 76.39 | 95% Confidence Interval 68.6 to 83.1 | Percentage of participants |
| Health-related Quality of Life Relative to Physical, Social and Emotional Impairment | Induction Therapy | Physical Impairment 6 mths after diagnosis | 42.75 | 95% Confidence Interval 34.2 to 51.7 | Percentage of participants |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 results by groupParticipant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction | STARTED | Group 0 Induction Therapy | 5,377 | |
| Induction | STARTED | Group 1-SR-low ALL, Arm I-combination Chemotherapy | 0 | |
| Induction | STARTED | Group 1-SR-low ALL, Arm II-combination Chemotherapy | 0 | |
| Induction | STARTED | Group 2-SR-avg ALL, Arm I-combination Chemotherapy | 0 | |
| Induction | STARTED | Group 2-SR-avg ALL, Arm II-combination Chemotherapy | 0 | |
| Induction | STARTED | Group 2-SR-avg ALL, Arm III-combination Chemotherapy | 0 | |
| Induction | STARTED | Group 2-SR-avg ALL, Arm IV-combination Chemotherapy | 0 | |
| Induction | STARTED | Group 3-SR-high ALL, Combination Chemotherapy | 0 | |
| Induction | COMPLETED | Group 0 Induction Therapy | 4,028 | |
| Induction | COMPLETED | Group 1-SR-low ALL, Arm I-combination Chemotherapy | 0 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events3,680
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 | Anemia | Blood and lymphatic system disorders | Group 0 Induction Therapy | 86 | 1,306 | 88 |
| other | Anemia | Blood and lymphatic system disorders | Group 1-SR-low ALL, Arm I-combination Chemotherapy | 258 | 931 | 438 |
| other | Anemia | Blood and lymphatic system disorders | Group 1-SR-low ALL, Arm II-combination Chemotherapy | 232 | 931 | 356 |
| other | Anemia | Blood and lymphatic system disorders | Group 2-SR-avg ALL, Arm I-combination Chemotherapy | 119 | 501 | 183 |
| other | Anemia | Blood and lymphatic system disorders | Group 2-SR-avg ALL, Arm II-combination Chemotherapy | 127 | 509 | 213 |
| other | Anemia | Blood and lymphatic system disorders | Group 2-SR-avg ALL, Arm III-combination Chemotherapy | 55 | 246 | 113 |
| other | Anemia | Blood and lymphatic system disorders | Group 2-SR-avg ALL, Arm IV-combination Chemotherapy | 90 | 247 | 150 |
| other | Anemia | Blood and lymphatic system disorders | Group 3-SR-high ALL, Combination Chemotherapy | 213 | 638 | 466 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Group 0 Induction Therapy | 2 | 1,306 | 2 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Group 1-SR-low ALL, Arm I-combination Chemotherapy | 8 | 931 | 16 |
1 to 10 of 3,680Source ClinicalTrials.gov
See all 3,680 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 0 Induction Therapy | ||
| Total, all-cause mortality | Group 1-SR-low ALL, Arm I-combination Chemotherapy | ||
| Total, all-cause mortality | Group 1-SR-low ALL, Arm II-combination Chemotherapy | ||
| Total, all-cause mortality | Group 2-SR-avg ALL, Arm I-combination Chemotherapy | ||
| Total, all-cause mortality | Group 2-SR-avg ALL, Arm II-combination Chemotherapy | ||
| Total, all-cause mortality | Group 2-SR-avg ALL, Arm III-combination Chemotherapy | ||
| Total, all-cause mortality | Group 2-SR-avg ALL, Arm IV-combination Chemotherapy | ||
| Total, all-cause mortality | Group 3-SR-high ALL, Combination Chemotherapy | ||
| Total, other adverse events | Group 0 Induction Therapy | 790 | 1,306 |
| Total, other adverse events | Group 1-SR-low ALL, Arm I-combination Chemotherapy | 901 | 931 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers7
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| All Patients for Induction, MRD Negative vs All Patients for Induction, MRD Positive: Early Marrow Status (EMS) by MRD Status End Induction (Day 29) |
Source Trial comparisons
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.
GET https://conductscience.org/api/trials/v1/NCT00103285
GET https://conductscience.org/api/trials/v1/NCT00103285/results?page=2