Trial · NCT00038610
Study of Hyper-CVAD Plus Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia
NCT00038610, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2015-09-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Hyper-CVAD Plus Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia. Trials, record NCT00038610. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00038610
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Hyper-CVAD Plus Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia
- NCT number
- NCT00038610
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 54 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Leukemia
- Interventions
- Imatinib Mesylate, Cyclophosphamide, Doxorubicin, Vincristine, Dexamethasone, Methotrexate, Cytarabine, Mesna, G-CSF
- First posted
- 2002-06-04
- Last updated
- 2015-09-18
- Results first posted
- 2015-09-18
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response To Induction Therapy With Hyper-CVAD Plus Imatinib Mesylate | Baseline to 6 months | Complete Remission (CR): Defined as the presence of 5% or less blasts in the bone marrow, with a granulocyte count of 1.0 × 109/L or higher and a platelet count of 100 × 109/L and no extramedullary disease. Partial Response (PR): As above for CR except for the presence of 6-25% marrow blasts. Molecular CR: Same as for CR with RT-PCR negativity for bcr-abl. Induction Death: Defined as death occurring after start of therapy without meeting the definition of CR or resistant disease. |
| Primary | Disease-Free Survival Rate at 2-year and 5-year. | Baseline to 2-year and 5-year | Disease-Free Survival (DFS) was calculated from the time of complete remission until relapse or death due to any cause. |
| Secondary | Overall Survival Rate at 2-year and 5-year. | Baseline to 2-year and 5-year | Overall survival (OS) was calculated from the date of initiation of therapy until death. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response To Induction Therapy With Hyper-CVAD Plus Imatinib Mesylate | Baseline to 6 months | Of the 54 participants, 39 (72%) presented with de novo disease, 6 (11%) were refractory to standard induction therapy, and 9 (17%) entered the study in complete remission (CR) after one course of standard induction therapy. | participants | NUMBER |
| SECONDARY | Overall Survival Rate at 2-year and 5-year. | Baseline to 2-year and 5-year | percentage of participants | NUMBER | |
| PRIMARY | Disease-Free Survival Rate at 2-year and 5-year. | Baseline to 2-year and 5-year | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response To Induction Therapy With Hyper-CVAD Plus Imatinib Mesylate | Hyper-CVAD + Imatinib | Complete Remission | 42 | participants | |
| Response To Induction Therapy With Hyper-CVAD Plus Imatinib Mesylate | Hyper-CVAD + Imatinib | Partial Remission | 1 | participants | |
| Response To Induction Therapy With Hyper-CVAD Plus Imatinib Mesylate | Hyper-CVAD + Imatinib | Molecular Complete Remission | 17 | participants | |
| Response To Induction Therapy With Hyper-CVAD Plus Imatinib Mesylate | Hyper-CVAD + Imatinib | Induction Death | 1 | participants | |
| Overall Survival Rate at 2-year and 5-year. | Hyper-CVAD + Imatinib | 2-year OS rate | 57 | percentage of participants | |
| Overall Survival Rate at 2-year and 5-year. | Hyper-CVAD + Imatinib | 5-year OS rate | 43 | percentage of participants | |
| Disease-Free Survival Rate at 2-year and 5-year. | Hyper-CVAD + Imatinib | 2-year DFS rate | 49 | percentage of participants | |
| Disease-Free Survival Rate at 2-year and 5-year. | Hyper-CVAD + Imatinib | 5-year DFS rate | 43 | percentage of participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Hyper-CVAD + Imatinib | 54 | |
| Overall Study | COMPLETED | Hyper-CVAD + Imatinib | 54 | |
| Overall Study | NOT COMPLETED | Hyper-CVAD + Imatinib | 0 |
Source ClinicalTrials.gov
Adverse events56
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 | ALBUMIN, SERUM-LOW | Metabolism and nutrition disorders | Hyper-CVAD + Imatinib | 1 | 54 | 1 |
| other | BILIRUBIN INCREASE | Metabolism and nutrition disorders | Hyper-CVAD + Imatinib | 2 | 54 | 3 |
| other | BONE PAIN | Musculoskeletal and connective tissue disorders | Hyper-CVAD + Imatinib | 3 | 54 | 3 |
| other | CONSTIPATION | Gastrointestinal disorders | Hyper-CVAD + Imatinib | 2 | 54 | 3 |
| other | DEHYDRATION | Gastrointestinal disorders | Hyper-CVAD + Imatinib | 1 | 54 | 1 |
| other | DIARRHEA | Gastrointestinal disorders | Hyper-CVAD + Imatinib | 3 | 54 | 4 |
| other | DIZZINESS | Nervous system disorders | Hyper-CVAD + Imatinib | 1 | 54 | 2 |
| other | DYSPNEA | Respiratory, thoracic and mediastinal disorders | Hyper-CVAD + Imatinib | 3 | 54 | 4 |
| other | DYSRHYTHMIA | Cardiac disorders | Hyper-CVAD + Imatinib | 1 | 54 | 1 |
| other | EDEMA | Blood and lymphatic system disorders | Hyper-CVAD + Imatinib | 6 | 54 | 8 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Hyper-CVAD + Imatinib | ||
| Total, other adverse events | Hyper-CVAD + Imatinib | 54 | 54 |
| Total, serious adverse events | Hyper-CVAD + Imatinib | 36 | 54 |
Source ClinicalTrials.gov
Papers2
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.
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/NCT00038610
GET https://conductscience.org/api/trials/v1/NCT00038610/events?page=2