Trial · NCT00390793
Combination Chemotherapy and Dasatinib in Treating Participants With Philadelphia Positive or BCR-ABL Positive Acute Lymphoblastic Leukemia.
NCT00390793, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2025-02-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Combination Chemotherapy and Dasatinib in Treating Participants With Philadelphia Positive or BCR-ABL Positive Acute Lymphoblastic Leukemia. Trials, record NCT00390793. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00390793
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Chemotherapy and Dasatinib in Treating Participants With Philadelphia Positive or BCR-ABL Positive Acute Lymphoblastic Leukemia.
- NCT number
- NCT00390793
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 107 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
Acute Lymphoblastic Leukemia, BCR-ABL1 Fusion Protein Expression, Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Philadelphia Chromosome Positive, Recurrent Acute Lymphoblastic Leukemia, t(9;22)
- Interventions
- Cyclophosphamide, Cytarabine, Dasatinib, Dexamethasone, Doxorubicin, Methotrexate, Prednisone, Vincristine
- First posted
- 2006-10-20
- Last updated
- 2025-02-17
- Results first posted
- 2025-02-17
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-free Survival Rate (EFS) | Up to 17 years, 4 months, 2 days | Time from date of treatment start until the date of failure or death from any cause. |
| Primary | Disease-free Survival | Up to 17 years, 4 months, 2 days | Time from date of treatment start until the date of first objective documentation of disease-relapse. |
| Secondary | Participants With a Response | Up to 17 years, 4 months, 2 days | Participants achieving complete remission (CR) + partial remission (PR) - Complete Remission (CR): Normalization of the peripheral blood and bone marrow with 5% or less blasts in normocellular or hypercellular marrow with a granulocyte count of 1 x 10\^9/L or above, and platelet count of 100 x 10\^9/L. Complete resolution of all sites of extramedullary disease is required for CR. |
| Secondary | Overall Survival | Up to 17 years, 4 months, 2 days | Time from date of treatment start until date of death due to any cause or last Follow-up. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Event-free Survival Rate (EFS) | Up to 17 years, 4 months, 2 days | Of the 107 participants registered on study, 106 were evaluable for Event Free Survival. | Months | MEDIAN |
| PRIMARY | Disease-free Survival | Up to 17 years, 4 months, 2 days | Of the 107 participants registered on study, 95 were evaluable for Disease Free Survival. | Months | MEDIAN |
| SECONDARY | Participants With a Response | Up to 17 years, 4 months, 2 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Survival | Up to 17 years, 4 months, 2 days | Of the 107 participants registered on study, 106 were evaluable for Overall Survival. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Event-free Survival Rate (EFS) | Treatment (Chemotherapy, Dasatinib) | 21.3 | Full Range 0.2 to 208 | Months | |
| Disease-free Survival | Treatment (Chemotherapy, Dasatinib) | 25.3 | Full Range 0.3 to 208 | Months | |
| Participants With a Response | Treatment (Chemotherapy, Dasatinib) | 95 | Participants | ||
| Overall Survival | Treatment (Chemotherapy, Dasatinib) | 42.9 | Full Range 0.2 to 208 | Months |
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 | Treatment (Chemotherapy, Dasatinib) | 107 | |
| Overall Study | COMPLETED | Treatment (Chemotherapy, Dasatinib) | 107 | |
| Overall Study | NOT COMPLETED | Treatment (Chemotherapy, Dasatinib) | 0 |
Source ClinicalTrials.gov
Adverse events43
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 | abdominal Pain | Gastrointestinal disorders | Treatment (Chemotherapy, Dasatinib) | 2 | 107 | 2 |
| serious | Bilateral Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Treatment (Chemotherapy, Dasatinib) | 2 | 107 | 2 |
| serious | Bone Pain | Musculoskeletal and connective tissue disorders | Treatment (Chemotherapy, Dasatinib) | 1 | 107 | 1 |
| serious | Cellulitis | Infections and infestations | Treatment (Chemotherapy, Dasatinib) | 1 | 107 | 1 |
| serious | Cellulitis buttocks | Infections and infestations | Treatment (Chemotherapy, Dasatinib) | 1 | 107 | 1 |
| serious | Colitis | Gastrointestinal disorders | Treatment (Chemotherapy, Dasatinib) | 1 | 107 | 2 |
| serious | Death | General disorders | Treatment (Chemotherapy, Dasatinib) | 2 | 107 | 2 |
| serious | Dehydration | Metabolism and nutrition disorders | Treatment (Chemotherapy, Dasatinib) | 1 | 107 | 1 |
| serious | Diarrhea | Gastrointestinal disorders | Treatment (Chemotherapy, Dasatinib) | 4 | 107 | 4 |
| serious | Diverticulitis | Gastrointestinal disorders | Treatment (Chemotherapy, Dasatinib) | 1 | 107 | 1 |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Chemotherapy, Dasatinib) | 4 | 107 |
| Total, other adverse events | Treatment (Chemotherapy, Dasatinib) | 0 | 107 |
| Total, serious adverse events | Treatment (Chemotherapy, Dasatinib) | 38 | 107 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20466853 | DERIVED |
Source PubMed
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 |
|---|---|---|---|---|---|
| P30CA016672 | The University of Texas MD Anderson Cancer Center Support Grant (CCSG) | KOONG, ALBERT | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 1985 to 2026 |
Source NIH RePORTER
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/NCT00390793
GET https://conductscience.org/api/trials/v1/NCT00390793/events?page=2