Trial · NCT00372593
Combination Chemotherapy With or Without Gemtuzumab in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia
NCT00372593, Phase 3, Completed, Children's Oncology Group; results first posted 2015-01-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Combination Chemotherapy With or Without Gemtuzumab in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia. Trials, record NCT00372593. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00372593
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Chemotherapy With or Without Gemtuzumab in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia
- NCT number
- NCT00372593
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,070 participants, actual
- Lead sponsor
- Children's Oncology Group
- Conditions
- Leukemia
- Interventions
- asparaginase, cytarabine, daunorubicin hydrochloride, etoposide, gemtuzumab ozogamicin, mitoxantrone hydrochloride
- First posted
- 2006-09-07
- Last updated
- 2021-03-24
- Results first posted
- 2015-01-13
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-free Survival at 3 Years | Time from study entry to time of induction failure, relapse, or death, assessed at 3 years | The Kaplan-Meier method will be used to calculate estimates of Event Free Survival (EFS). The log-rank test will be used to compare survival between treatment groups. Analysis of EFS of Down syndrome patients will be performed separately. Monitoring for efficacy of GMTZ with respect to Overall Survival (OS) and EFS will utilize monitoring based on the Lan-DeMets criterion with α-spending function αt\^2 (truncated at 3 standard deviations) and 2.5% type I error. |
| Primary | Overall Survival at 3 Years | Time from study entry, assessed at 3 years | The Kaplan-Meier method will be used to calculate estimates of OS. Analysis of OS of Down syndrome patients will be performed separately. Monitoring for efficacy of GMTZ with respect to OS and EFS will utilize monitoring based on the Lan-DeMets criterion with α-spending function αt\^2 (truncated at 3 standard deviations) and 2.5% type I error. |
| Secondary | Remission Induction Rate After 2 Courses of Induction Therapy | After 2 courses of induction (I and II) therapy, assessed for up to 10 years | Patients without an evaluable bone marrow at the end of Induction I will be excluded from the calculation of remission rate after 2 courses of therapy because their responses are not evaluable. The following patients will be considered to not be in complete remission (CR) after 2 courses of therapy: (1) patients who die during Induction I and II; (2) patients with ≥ 5% blasts or extramedullary disease at the end of Induction II. |
| Secondary | Disease-free Survival (DFS) | At 3 years from end of Intensification I | Time from end of Intensification I to relapse, death or last contact |
| Secondary | Mortality | During the first three courses of therapy | Number of participants who died during the first three courses of therapy. |
| Secondary | Time to Marrow Recovery | At 25 days after treatment with Induction I, Induction II, and Intensification I | Mean time to ANC recovery - defined as ANC greater than 500/MicroLiter for 3 consecutive days. |
| Secondary | Toxicities, Including Infectious Complications | From the time therapy is initiated, assessed up to 10 years | Number of participants with at least one grade 3 or higher adverse event during therapy. |
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 | Event-free Survival at 3 Years | Time from study entry to time of induction failure, relapse, or death, assessed at 3 years | Ineligible patients are excluded from analyses of Overall Survival and Event Free Survival. | percentage of participants | NUMBER |
| PRIMARY | Overall Survival at 3 Years | Time from study entry, assessed at 3 years | Ineligible patients are excluded from analyses of Overall Survival and Event Free Survival. | percentage of participants | NUMBER |
| SECONDARY | Remission Induction Rate After 2 Courses of Induction Therapy | After 2 courses of induction (I and II) therapy, assessed for up to 10 years | Ineligible (n=42) patients are excluded. Patients without an evaluable bone marrow at the end of Induction I or at the end of Induction II are excluded from the calculation of remission rate after 2 courses of therapy because their responses are not evaluable (n=45). | Proportion of participants | NUMBER |
| SECONDARY | Disease-free Survival (DFS) | At 3 years from end of Intensification I | Ineligible (n=42) patients are excluded. Patients who did not continue on therapy at end of Intensification I are also excluded (n=247). | Percentage participants DFS at 3 years | NUMBER |
| SECONDARY | Mortality | During the first three courses of therapy | Ineligible (n=42) patients are excluded. | Number of participants | NUMBER |
| SECONDARY | Time to Marrow Recovery | At 25 days after treatment with Induction I, Induction II, and Intensification I | Excluded: Ineligible patients (pts) (n=42) for overall number of pts analyzed. For Induction I: Pts who did not have ANC recovery (n=237) or w/unknown (w/unk) status (n=14). For Induction II: Pts who did not have ANC recovery (n=142) or w/unk status (n=82). For Intensification I: Pts who did not have ANC recovery (n=104) or w/unk status (n=182) | Mean days | MEAN |
| SECONDARY | Toxicities, Including Infectious Complications | From the time therapy is initiated, assessed up to 10 years | Ineligible (n=42) patients are excluded. | Number of participants | NUMBER |
Source ClinicalTrials.gov
Results by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Event-free Survival at 3 Years | Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome | 46.9 | 95% Confidence Interval 42.5 to 51.3 | percentage of participants | |
| Event-free Survival at 3 Years | Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome | 53.1 | 95% Confidence Interval 48.6 to 57.4 | percentage of participants | |
| Event-free Survival at 3 Years | Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome | 50.0 | 95% Confidence Interval 11.1 to 80.4 | percentage of participants | |
| Overall Survival at 3 Years | Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome | 65.4 | 95% Confidence Interval 61.0 to 69.4 | percentage of participants | |
| Overall Survival at 3 Years | Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome | 69.4 | 95% Confidence Interval 65.1 to 73.3 | percentage of participants | |
| Overall Survival at 3 Years | Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome | 50.0 | 95% Confidence Interval 11.1 to 80.4 | percentage of participants | |
| Remission Induction Rate After 2 Courses of Induction Therapy | Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome | 0.851324 | Proportion of participants | ||
| Remission Induction Rate After 2 Courses of Induction Therapy | Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome | 0.882716 | Proportion of participants | ||
| Remission Induction Rate After 2 Courses of Induction Therapy | Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome | 0.666667 | Proportion of participants | ||
| Disease-free Survival (DFS) | Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome | 56.6 | 95% Confidence Interval 51.3 to 61.5 | Percentage participants DFS at 3 years |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome | 531 | |
| Overall Study | STARTED | Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome | 532 | |
| Overall Study | STARTED | Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome | 7 | |
| Overall Study | COMPLETED | Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome | 327 | |
| Overall Study | COMPLETED | Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome | 334 | |
| Overall Study | COMPLETED | Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome | 3 | |
| Overall Study | NOT COMPLETED | Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome | 204 | |
| Overall Study | NOT COMPLETED | Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome | 198 | |
| Overall Study | NOT COMPLETED | Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome | 4 |
Source ClinicalTrials.gov
Adverse events1,035
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 | Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome | 3 | 511 | |
| other | Abdominal distension | Gastrointestinal disorders | Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome | 4 | 511 | |
| other | Abdominal distension | Gastrointestinal disorders | Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome | 0 | 6 | |
| other | Abdominal infection | Infections and infestations | Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome | 2 | 511 | |
| other | Abdominal infection | Infections and infestations | Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome | 1 | 511 | |
| other | Abdominal infection | Infections and infestations | Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome | 0 | 6 | |
| other | Abdominal pain | Gastrointestinal disorders | Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome | 38 | 511 | |
| other | Abdominal pain | Gastrointestinal disorders | Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome | 44 | 511 | |
| other | Abdominal pain | Gastrointestinal disorders | Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome | 0 | 6 | |
| other | Abducens nerve disorder | Nervous system disorders | Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome | 0 | 511 |
1 to 10 of 1,035Source ClinicalTrials.gov
See all 1,035 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome | ||
| Total, all-cause mortality | Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome | ||
| Total, all-cause mortality | Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome | ||
| Total, other adverse events | Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome | 482 | 511 |
| Total, other adverse events | Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome | 479 | 511 |
| Total, other adverse events | Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome | 5 | 6 |
| Total, serious adverse events | Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome | 26 | 511 |
| Total, serious adverse events | Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome | 32 | 511 |
| Total, serious adverse events | Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome | 2 | 6 |
Source ClinicalTrials.gov
Papers12
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
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.
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The record and each of its lists are JSON, twenty rows a page. No key.
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