Trial · NCT00792948
Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia
NCT00792948, Phase 2, Active not recruiting, National Cancer Institute (NCI); results first posted 2017-04-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia. Trials, record NCT00792948. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00792948
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia
- NCT number
- NCT00792948
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 97 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Acute Lymphoblastic Leukemia, Adult B Acute Lymphoblastic Leukemia, Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1, Adult L1 Acute Lymphoblastic Leukemia, Adult L2 Acute Lymphoblastic Leukemia, Adult T Acute Lymphoblastic Leukemia, Recurrent Adult Acute Lymphoblastic Leukemia
- Interventions
Allogeneic Hematopoietic Stem Cell Transplantation, Cyclophosphamide, Cytarabine, Dasatinib, Dexamethasone, Doxorubicin Hydrochloride, Etoposide, Filgrastim, Laboratory Biomarker Analysis, Leucovorin Calcium, Methotrexate, Methylprednisolone, Peripheral Blood Stem Cell Transplantation, Prednisone, Sirolimus, Tacrolimus, Total-Body Irradiation, Vincristine Sulfate
- First posted
- 2008-11-18
- Last updated
- 2026-10-22
- Results first posted
- 2017-04-26
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Relapse-free Survival (RFS) After Allogeneic Stem Cell Transplantation | 12 months | Will be estimated using the method of Kaplan-Meier. |
| Secondary | Continuous Complete Remission (CCR) Rate | 18 months | Will be testing using an exact binomial test |
| Other | Overall Survival (OS) | From the date of initial registration on the study until death from any cause, assessed up to 5 years | OS will be estimated using the method of Kaplan-Meier. |
| Other | MRD as Assessed Using Real-time Quantitative Polymerase Chain Reaction and Flow Cytometry | Up to 5 years | Correlation between the two measures of MRD measured on the same remission specimens will be examined using scatterplots and correlation analysis. The prognostic effect for relapse of each measure will be illustrated using cumulative incidence plots, and estimated using Cox regression models. This outcome will be reported as funding allows. |
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 | Relapse-free Survival (RFS) After Allogeneic Stem Cell Transplantation | 12 months | Patients who received allogeneic stem cell transplant | Probability of 12-month RFS | NUMBER |
| SECONDARY | Continuous Complete Remission (CCR) Rate | 18 months | Patients who had not received prior ALL therapy | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Overall Survival (OS) | From the date of initial registration on the study until death from any cause, assessed up to 5 years | Analysis includes eligible patients who received treatment. | Probability of surviving 12 months | NUMBER |
| OTHER_PRE_SPECIFIED | MRD as Assessed Using Real-time Quantitative Polymerase Chain Reaction and Flow Cytometry | Up to 5 years |
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 |
|---|---|---|---|---|---|
| Relapse-free Survival (RFS) After Allogeneic Stem Cell Transplantation | Treatment | 0.83 | 95% Confidence Interval 0.67 to 0.91 | Probability of 12-month RFS | |
| Continuous Complete Remission (CCR) Rate | Treatment | 57 | 95% Confidence Interval 43 to 69 | percentage of participants | |
| Overall Survival (OS) | Treatment | 0.88 | 95% Confidence Interval 0.80 to 0.93 | Probability of surviving 12 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 | 97 | |
| Overall Study | COMPLETED | Treatment | 69 | |
| Overall Study | NOT COMPLETED | Treatment | 28 |
Source ClinicalTrials.gov
Adverse events968
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 | Blood/Bone Marrow-Other | Blood and lymphatic system disorders | Induction/Consolidation | 5 | 93 | |
| other | Blood/Bone Marrow-Other | Blood and lymphatic system disorders | Vincristine/Prednisone/Dasatinib | 1 | 22 | |
| other | Blood/Bone Marrow-Other | Blood and lymphatic system disorders | Allogeneic Stem Cell Transplant | 0 | 4 | |
| other | Blood/Bone Marrow-Other | Blood and lymphatic system disorders | Dasatinib | 1 | 39 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Induction/Consolidation | 28 | 93 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Vincristine/Prednisone/Dasatinib | 1 | 22 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Allogeneic Stem Cell Transplant | 0 | 4 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Dasatinib | 1 | 39 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Induction/Consolidation | 69 | 93 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Vincristine/Prednisone/Dasatinib | 14 | 22 |
1 to 10 of 968Source ClinicalTrials.gov
See all 968 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Induction/Consolidation | ||
| Total, all-cause mortality | Vincristine/Prednisone/Dasatinib | ||
| Total, all-cause mortality | Allogeneic Stem Cell Transplant | ||
| Total, all-cause mortality | Dasatinib | ||
| Total, other adverse events | Induction/Consolidation | 89 | 93 |
| Total, other adverse events | Vincristine/Prednisone/Dasatinib | 22 | 22 |
| Total, other adverse events | Allogeneic Stem Cell Transplant | 0 | 4 |
| Total, other adverse events | Dasatinib | 36 | 39 |
| Total, serious adverse events | Induction/Consolidation | 43 | 93 |
| Total, serious adverse events | Vincristine/Prednisone/Dasatinib | 5 | 22 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29618479 | DERIVED |
Source PubMed
Grants2
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 | Source |
|---|---|---|---|---|---|---|
| U10CA180888 | SWOG Network Group Operations Center of the NCTN | LARA, PRIMO N.; HERSHMAN, DAWN | UNIVERSITY OF CALIFORNIA AT DAVIS | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA032102 | Southwest Oncology Group Treatment Grant | BLANKE, CHARLES D. | OREGON HEALTH & SCIENCE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2013 | 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/NCT00792948
GET https://conductscience.org/api/trials/v1/NCT00792948/events?page=2