Trial · NCT00136084
Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplasia
NCT00136084, Phase 3, Completed, St. Jude Children's Research Hospital; results first posted 2010-03-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplasia. Trials, record NCT00136084. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00136084
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplasia
- NCT number
- NCT00136084
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 238 participants, actual
- Lead sponsor
- St. Jude Children's Research Hospital
- Conditions
- Leukemia, Myelocytic, Acute
- Interventions
- Cladribine, Cyclophosphamide, Cytarabine, Daunorubicin, Dexamethasone, Etoposide, Cytarabine, Gemtuzumab, L-asparaginase, Mercaptopurine, methotrexate, Mitoxantrone, Prednisone, Vincristine
- First posted
- 2005-08-26
- Last updated
- 2012-12-05
- Results first posted
- 2010-03-26
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Minimal Residual Disease (MRD). | Day 22 MRD measurement | Detection of Minimal Residual Disease following one course of chemotherapy where positive MRD was defined as one or more leukemic cell per 1000 mononuclear bone-marrow cells (\>=0.1%). |
| Secondary | Proportion of Minimal Residual Disease (MRD)+ Patients Who Become MRD- After One Course of Gemtuzumab Ozogamicin (GO) | Consolidation I | To estimate the proportion of minimal residual disease (MRD)+ patients who become MRD- after one course of gemtuzumab ozogamicin (GO) |
| Secondary | Proportion of MRD Reduction After One Course of Cytarabine + Daunomycin + Etoposide (ADE) + GO | Induction II | To estimate proportion of patients with MRD reduction after one course of Induction II (cytarabine + daunomycin + etoposide (ADE) + GO), who had no response to first course of induction therapy. |
| Secondary | Proportion of Patients Experienced Toxicity of Cytarabine + Daunomycin + Etoposide (ADE) + GO. | Induction II | To estimate proportion of patients experiencing CTC Grade 3 or 4 toxicity during Induction II (Cytarabine + Daunomycin + Etoposide (ADE) + GO), who had no response to first course of induction therapy |
| Secondary | To Estimate the Overall Event-free Survival (EFS) of AML Patients Who Undergo Risk-adapted and Genotype-directed Therapy | Five Year | Overall event-free survival (EFS) was defined as the time from study enrollment to induction failure, relapse, secondary malignancy, death, or study withdrawal for any reason, with event-free patients censored on the date of the last follow-up |
| Secondary | To Assess Whether Inhibition of DNA Synthesis is Greater After High-dose Ara-C (HDAC) Than After Low-dose Ara-C (LDAC) Therapy | Measurements were assessed in Induction I chemotherapy | Inhibition of DNA synthesis is defined as the percentage of DNA synthesis rate at 24-hour post-araC treatment over DNA synthesis rate pre-araC treatment. |
| Secondary | Relationship of Inhibition of DNA Synthesis and Clinical Response | Measurements were assessed in Induction I chemotherapy | Clinical response is defined as MRD (minimal residual disease) measured by flow cytometry at day 22. The MRD at day 22 is classified as positive (with MRD) or negative (no detectable MRD). The relation between inhibition of DNA synthesis and MRD was performed by logistic regression. In the model, logit of probability of MRD positive was regressed on inhibition of DNA synthesis. |
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 | Minimal Residual Disease (MRD). | Day 22 MRD measurement | Of the 223 randomized patients, 205 patients were included in the day 22 MRD analysis. 18 patients were not included in the day 22 MRD analysis. 5 patients had inadequate sample for MRD, 11 patients had no suitable phenotype to determine MRD, 1 patient was not done on MRD, and 1 patient was lost for follow-up. | participants | NUMBER |
| SECONDARY | Proportion of Minimal Residual Disease (MRD)+ Patients Who Become MRD- After One Course of Gemtuzumab Ozogamicin (GO) | Consolidation I | Sixteen patients received GO treatment during consolidation I. One patient with negative MRD received GO treatment, which was not consistent with the protocol definition. 15 patients were analyzed. Out of the 15 patients, 7 patients were treated on HDAC arm and 8 patients were treated on LDAC arm. | Participants | NUMBER |
| SECONDARY | Proportion of MRD Reduction After One Course of Cytarabine + Daunomycin + Etoposide (ADE) + GO | Induction II | Out of the 30 patients received ADE + GO treatment, one patient had inevaluable MRD prior to and after the treatment. 29 patients were analyzed. Out of the 29 patients, 10 patients were treated on HDAC arm and 19 patients were treated on LDAC arm. | Participants | NUMBER |
| SECONDARY | Proportion of Patients Experienced Toxicity of Cytarabine + Daunomycin + Etoposide (ADE) + GO. | Induction II | 30 patients received ADE + GO during induction II and were analyzed. Out of the 30 patients, 11 patients were treated on HDAC arm, and 19 patients were treated on LDAC arm. | Participants | NUMBER |
| SECONDARY | To Estimate the Overall Event-free Survival (EFS) of AML Patients Who Undergo Risk-adapted and Genotype-directed Therapy | Five Year | 238 patients were enrolled on the study. Out of 238, 6 were determined to be ineligible and 2 were not randomized. Of the 230 patients, 14 bi-phenotypic leukemia patients were excluded. 216 AML patients were included to estimate EFS. | Percentage of Participants | NUMBER |
| SECONDARY | To Assess Whether Inhibition of DNA Synthesis is Greater After High-dose Ara-C (HDAC) Than After Low-dose Ara-C (LDAC) Therapy | Measurements were assessed in Induction I chemotherapy | Of 232 eligible patients, 49 had DNA synthesis rate performed prior to araC treatment. Of the 49 patients, 23 had no 24-hr samples and 3 did not have enough cells in 24-hr samples. 21 patients with both pre and post araC samples were included in the DNA inhibition study. Of the 21 patients, 9 were treated on HDAC and 12 were treated on LDAC. | Percent Inhibition of DNA Synthesis | MEAN |
| SECONDARY | Relationship of Inhibition of DNA Synthesis and Clinical Response | Measurements were assessed in Induction I chemotherapy | Of 232 eligible patients, 49 had DNA synthesis rate performed prior to araC treatment. Of the 49 patients, 23 had no 24-hr samples and 3 did not have enough cells in 24-hr samples. 21 patients with both pre and post araC samples were included in the DNA inhibition study. 17 of the 21 patients had evaluable day 22 MRD. | Percent inhibition of DNA Synthesis | MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Minimal Residual Disease (MRD). | Arm 1: (HDAC) | MRD Positive | 31 | participants | |
| Minimal Residual Disease (MRD). | Arm 2:(LDAC) | MRD Positive | 43 | participants | |
| Minimal Residual Disease (MRD). | Arm 1: (HDAC) | MRD Negative | 68 | participants | |
| Minimal Residual Disease (MRD). | Arm 2:(LDAC) | MRD Negative | 63 | participants | |
| Proportion of Minimal Residual Disease (MRD)+ Patients Who Become MRD- After One Course of Gemtuzumab Ozogamicin (GO) | Overall | Negative | 11 | Participants | |
| Proportion of Minimal Residual Disease (MRD)+ Patients Who Become MRD- After One Course of Gemtuzumab Ozogamicin (GO) | Overall | Positive | 4 | Participants | |
| Proportion of MRD Reduction After One Course of Cytarabine + Daunomycin + Etoposide (ADE) + GO | Overall | Decrease | 27 | Participants | |
| Proportion of MRD Reduction After One Course of Cytarabine + Daunomycin + Etoposide (ADE) + GO | Overall | Increase or no change | 2 | Participants | |
| Proportion of Patients Experienced Toxicity of Cytarabine + Daunomycin + Etoposide (ADE) + GO. | Overall | Experienced Grade 3 or 4 toxicities | 27 | Participants | |
| Proportion of Patients Experienced Toxicity of Cytarabine + Daunomycin + Etoposide (ADE) + GO. | Overall | Did not experience Grade 3 or 4 toxicities | 3 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1: (HDAC) | 109 | |
| Overall Study | STARTED | Arm 2:(LDAC) | 114 | |
| Overall Study | COMPLETED | Arm 1: (HDAC) | 61 | |
| Overall Study | COMPLETED | Arm 2:(LDAC) | 72 | |
| Overall Study | NOT COMPLETED | Arm 1: (HDAC) | 48 | |
| Overall Study | NOT COMPLETED | Arm 2:(LDAC) | 42 |
Source ClinicalTrials.gov
Adverse events184
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 | Arm 1: (HDAC) | 11 | 109 | 12 |
| other | Abdominal pain or cramping | General disorders | Arm 2:(LDAC) | 0 | 114 | 0 |
| other | Acidosis (metabolic or respiratory) | Metabolism and nutrition disorders | Arm 1: (HDAC) | 6 | 109 | 8 |
| other | Acidosis (metabolic or respiratory) | Metabolism and nutrition disorders | Arm 2:(LDAC) | 0 | 114 | 0 |
| other | Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | Arm 1: (HDAC) | 17 | 109 | 19 |
| other | Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | Arm 2:(LDAC) | 16 | 114 | 19 |
| other | Anorexia | Gastrointestinal disorders | Arm 1: (HDAC) | 23 | 109 | 28 |
| other | Anorexia | Gastrointestinal disorders | Arm 2:(LDAC) | 16 | 114 | 26 |
| other | Bilirubin | Hepatobiliary disorders | Arm 1: (HDAC) | 7 | 109 | 8 |
| other | Bilirubin | Hepatobiliary disorders | Arm 2:(LDAC) | 0 | 114 | 0 |
1 to 10 of 184Source ClinicalTrials.gov
See all 184 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1: (HDAC) | ||
| Total, all-cause mortality | Arm 2:(LDAC) | ||
| Total, other adverse events | Arm 1: (HDAC) | 107 | 109 |
| Total, other adverse events | Arm 2:(LDAC) | 112 | 114 |
| Total, serious adverse events | Arm 1: (HDAC) | 23 | 109 |
| Total, serious adverse events | Arm 2:(LDAC) | 19 | 114 |
Source ClinicalTrials.gov
Papers3
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 |
|---|---|---|---|---|---|
| R01CA113482 | Cell Therapy of Refractory Leukemia | CAMPANA, DARIO | ST. JUDE CHILDREN'S RESEARCH HOSPITAL | NATIONAL CANCER INSTITUTE | 2006 to 2010 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm 1: (HDAC) vs Arm 2:(LDAC): serious adverse events |
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/NCT00136084
GET https://conductscience.org/api/trials/v1/NCT00136084/events?page=2