Trial · NCT00458848
Chemotherapy With or Without Imatinib and/or Peripheral Stem Cell Transplant in Acute Lymphoblastic Leukemia
NCT00458848, Phase 2, Completed, Gruppo Italiano Malattie EMatologiche dell'Adulto; results first posted 2019-02-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Chemotherapy With or Without Imatinib and/or Peripheral Stem Cell Transplant in Acute Lymphoblastic Leukemia. Trials, record NCT00458848. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00458848
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Chemotherapy With or Without Imatinib and/or Peripheral Stem Cell Transplant in Acute Lymphoblastic Leukemia
- NCT number
- NCT00458848
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 470 participants, actual
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Conditions
- Leukemia
- Interventions
asparaginase, daunorubicin hydrochloride, etoposide, idarubicin, imatinib mesylate, mercaptopurine, methotrexate, methylprednisolone, mitoxantrone hydrochloride, prednisone, vincristine sulfate, allogeneic hematopoietic stem cell transplantation, autologous hematopoietic stem cell transplantation, peripheral blood stem cell transplantation, radiation therapy
- First posted
- 2007-04-11
- Last updated
- 2019-02-15
- Other registries' IDs
- eudract:2004-001738-11
- Results first posted
- 2019-02-15
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Reaching Disease Free Survival | At 60 months | |
| Secondary | Number of Patients Reaching Complete Hematological Response After Induction Therapy | At the end of induction, day +50 | |
| Secondary | Percentage of Participants Reaching Overall Survival | At 60 months | Overall survival from diagnosis |
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 | Percentage of Participants Reaching Disease Free Survival | At 60 months | percentage of participants | NUMBER | |
| SECONDARY | Number of Patients Reaching Complete Hematological Response After Induction Therapy | At the end of induction, day +50 | participants | NUMBER | |
| SECONDARY | Percentage of Participants Reaching Overall Survival | At 60 months | percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Reaching Disease Free Survival | Philadelphia Positive, Imatinib Only in Induction Therapy | 45.8 | percentage of participants | ||
| Number of Patients Reaching Complete Hematological Response After Induction Therapy | Philadelphia Positive, Imatinib Only in Induction Therapy | 49 | participants | ||
| Percentage of Participants Reaching Overall Survival | Philadelphia Positive, Imatinib Only in Induction Therapy | 48.8 | percentage of patients |
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 | Philadelphia Positive, Imatinib Only in Induction Therapy | 51 | |
| Overall Study | COMPLETED | Philadelphia Positive, Imatinib Only in Induction Therapy | 51 | |
| Overall Study | NOT COMPLETED | Philadelphia Positive, Imatinib Only in Induction Therapy | 0 |
Source ClinicalTrials.gov
Adverse events6
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 |
|---|---|---|---|---|---|---|
| serious | Death | General disorders | Philadelphia Positive, Imatinib Only in Induction Therapy | 2 | 51 | 2 |
| serious | Headache | Nervous system disorders | Philadelphia Positive, Imatinib Only in Induction Therapy | 1 | 51 | 1 |
| serious | Pyrexia | General disorders | Philadelphia Positive, Imatinib Only in Induction Therapy | 1 | 51 | 1 |
| serious | Hypoxia | Respiratory, thoracic and mediastinal disorders | Philadelphia Positive, Imatinib Only in Induction Therapy | 1 | 51 | 1 |
| serious | Abdominal pain | Gastrointestinal disorders | Philadelphia Positive, Imatinib Only in Induction Therapy | 1 | 51 | 1 |
| serious | Intra-abdominal haematoma | Vascular disorders | Philadelphia Positive, Imatinib Only in Induction Therapy | 1 | 51 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Philadelphia Positive, Imatinib Only in Induction Therapy | 2 | 51 |
| Total, other adverse events | Philadelphia Positive, Imatinib Only in Induction Therapy | 0 | 51 |
| Total, serious adverse events | Philadelphia Positive, Imatinib Only in Induction Therapy | 7 | 51 |
Source ClinicalTrials.gov
Papers3
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/NCT00458848
GET https://conductscience.org/api/trials/v1/NCT00458848/registered