Trial · NCT00391989
Treatment of Adult Ph+ LAL With BMS-354825
NCT00391989, Phase 2, Completed, Gruppo Italiano Malattie EMatologiche dell'Adulto; results first posted 2015-01-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treatment of Adult Ph+ LAL With BMS-354825. Trials, record NCT00391989. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00391989
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Adult Ph+ LAL With BMS-354825
- NCT number
- NCT00391989
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 53 participants, actual
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Conditions
- Lymphoblastic Leukemia, Acute
- Interventions
- Dasatinib
- First posted
- 2006-10-25
- Last updated
- 2017-01-04
- Results first posted
- 2015-01-26
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of Hematological Complete Remission (HCR) Obtained During the BMS Induction Treatment Within Day +85 From the Start of BMS (i.e., Whenever Achieved From the Start of the Experimental Drug). | End of the study, up to day 85 | |
| Secondary | The Incidence of Grade >2 CTC-NCI Side Effects and Toxicities; | End of study | |
| Secondary | The Best Cytogenetic Response Obtained During BMS Treatment Within Day +85, Whenever Achieved From the Start of the Experimental Drug; | End of study | |
| Secondary | the Best Molecular Response Obtained During BMS Treatment Within Day +85, Whenever Achieved From the Start of the Experimental Drug; | End of study | |
| Secondary | DFS, Defined as the Time Interval Between the Evaluation of HCR and Hematological Relapse of the Disease or Death in First HCR; | End of study | |
| Secondary | the Cumulative Incidence of Relapse; | End of study | |
| Secondary | OS, Defined as the Time Interval Between Inclusion and Death for Any Cause. | End of study |
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 | Rate of Hematological Complete Remission (HCR) Obtained During the BMS Induction Treatment Within Day +85 From the Start of BMS (i.e., Whenever Achieved From the Start of the Experimental Drug). | End of the study, up to day 85 | Patients | NUMBER | |
| SECONDARY | The Incidence of Grade >2 CTC-NCI Side Effects and Toxicities; | End of study | |||
| SECONDARY | The Best Cytogenetic Response Obtained During BMS Treatment Within Day +85, Whenever Achieved From the Start of the Experimental Drug; | End of study | |||
| SECONDARY | the Best Molecular Response Obtained During BMS Treatment Within Day +85, Whenever Achieved From the Start of the Experimental Drug; | End of study | |||
| SECONDARY | DFS, Defined as the Time Interval Between the Evaluation of HCR and Hematological Relapse of the Disease or Death in First HCR; | End of study | |||
| SECONDARY | the Cumulative Incidence of Relapse; | End of study | |||
| SECONDARY | OS, Defined as the Time Interval Between Inclusion and Death for Any Cause. | End of study |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Rate of Hematological Complete Remission (HCR) Obtained During the BMS Induction Treatment Within Day +85 From the Start of BMS (i.e., Whenever Achieved From the Start of the Experimental Drug). | Study Group | 53 | 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 | Study Group | 55 | |
| Overall Study | COMPLETED | Study Group | 53 | |
| Overall Study | NOT COMPLETED | Study Group | 2 |
Source ClinicalTrials.gov
Adverse events24
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 | Fever | General disorders | Dasatinib | 1 | 53 | |
| other | Weight gain | General disorders | Dasatinib | 1 | 53 | |
| other | proteinuria | General disorders | Dasatinib | 1 | 53 | |
| other | Mild increase of liver function | General disorders | Dasatinib | 2 | 53 | |
| other | Gastrointestinal | Gastrointestinal disorders | Dasatinib | 1 | 53 | |
| other | Infection | General disorders | Dasatinib | 1 | 53 | |
| other | Mood alteration | General disorders | Dasatinib | 1 | 53 | |
| other | Hyperkalemia | General disorders | Dasatinib | 1 | 53 | |
| other | Acute pulmonary edema | General disorders | Dasatinib | 1 | 53 | |
| other | Diarrhea | General disorders | Dasatinib | 1 | 53 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dasatinib | ||
| Total, other adverse events | Dasatinib | 12 | 53 |
| Total, serious adverse events | Dasatinib | 13 | 53 |
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/NCT00391989
GET https://conductscience.org/api/trials/v1/NCT00391989/events?page=2