Trial · NCT01256398
Dasatinib Followed by Stem Cell Transplant in Treating Older Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
NCT01256398, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2019-05-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dasatinib Followed by Stem Cell Transplant in Treating Older Patients With Newly Diagnosed Acute Lymphoblastic Leukemia. Trials, record NCT01256398. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01256398
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dasatinib Followed by Stem Cell Transplant in Treating Older Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
- NCT number
- NCT01256398
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 66 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Acute Lymphoblastic Leukemia, Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
- Interventions
Alemtuzumab, Allogeneic Hematopoietic Stem Cell Transplantation, Autologous Hematopoietic Stem Cell Transplantation, Cyclophosphamide, Cytarabine, Dasatinib, Daunorubicin Hydrochloride, Dexamethasone, Etoposide Phosphate, Filgrastim, Fludarabine Phosphate, In Vitro-Treated Peripheral Blood Stem Cell Transplantation, Laboratory Biomarker Analysis, Leucovorin Calcium, Melphalan, Mercaptopurine, Methotrexate, Pegfilgrastim, Pharmacological Study, Tacrolimus, Vincristine Sulfate
- First posted
- 2010-12-08
- Last updated
- 2023-04-04
- Results first posted
- 2019-05-21
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease Free Survival Defined From the Date of First Induction Complete Response (CR) to Relapse or Death Due to Any Cause | At 3 years after CR | Estimated using the Kaplan-Meier estimator. Proportions will be estimated using point as well as interval estimators. All interval estimators will be constructed using the finite sample size sampling distribution at the unadjusted two-sided level of 0.05. |
| Secondary | Probability of Being BCR-ABL Negative in the Bone Marrow and Peripheral Blood at the Completion of the CNS Prophylaxis Course (Restricted to Those Patients Achieving a CR) | 10 years | Proportions will be estimated based on the combined and individual cohorts. |
| Secondary | Feasibility of Maintenance Therapy in This Patient Population (Restricted to Those Patients Achieving a CR). Feasibility Will be Defined as the Number of Deaths Ocuring. | 10 years | Proportions will be estimated based on the combined and individual cohorts. |
| Secondary | Overall Survival (OS) | 10 years | Estimated using the Kaplan-Meier estimator. Proportions will be estimated using point as well as interval estimators. All interval estimators will be constructed using the finite sample size sampling distribution at the unadjusted two-sided level of 0.05. |
| Secondary | Disease Free Survival (DFS) | 10 years | Estimated using the Kaplan-Meier estimator. Proportions will be estimated using point as well as interval estimators. All interval estimators will be constructed using the finite sample size sampling distribution at the unadjusted two-sided level of 0.05. |
| Secondary | Response | 10 years | Proportion of patients reaching a CR. A CR requires the following: an absolute neutrophil count (segs and bands) \>1000/μL, no circulating blasts, platelets \>100,000/μL; adequate bone marrow cellularity with trilineage hematopoiesis, and \<5% marrow leukemia blast cells. All previous extramedullary manifestations of disease must be absent (e.g., lymphadenopathy, splenomegaly, skin or gum infiltration, testicular masses, or CNS involvement). |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Disease Free Survival Defined From the Date of First Induction Complete Response (CR) to Relapse or Death Due to Any Cause | At 3 years after CR | All patients that reached CR and chose to continue with the study. | percentage of patients | NUMBER |
| SECONDARY | Probability of Being BCR-ABL Negative in the Bone Marrow and Peripheral Blood at the Completion of the CNS Prophylaxis Course (Restricted to Those Patients Achieving a CR) | 10 years | proportion of participants | NUMBER | |
| SECONDARY | Feasibility of Maintenance Therapy in This Patient Population (Restricted to Those Patients Achieving a CR). Feasibility Will be Defined as the Number of Deaths Ocuring. | 10 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Survival (OS) | 10 years | Months | MEDIAN | |
| SECONDARY | Disease Free Survival (DFS) | 10 years | All CR patients | Months | MEDIAN |
| SECONDARY | Response | 10 years | proportion of participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease Free Survival Defined From the Date of First Induction Complete Response (CR) to Relapse or Death Due to Any Cause | Treatment (Chemotherapy, Transplant) | 52.6 | 95% Confidence Interval 36.8 to 68.5 | percentage of patients | |
| Probability of Being BCR-ABL Negative in the Bone Marrow and Peripheral Blood at the Completion of the CNS Prophylaxis Course (Restricted to Those Patients Achieving a CR) | Treatment (Chemotherapy, Transplant) | 0.667 | proportion of participants | ||
| Feasibility of Maintenance Therapy in This Patient Population (Restricted to Those Patients Achieving a CR). Feasibility Will be Defined as the Number of Deaths Ocuring. | Treatment (Chemotherapy, Transplant) | 5 | Participants | ||
| Overall Survival (OS) | Treatment (Chemotherapy, Transplant) | 55.9 | 95% Confidence Interval 31.8 to NA | Months | |
| Disease Free Survival (DFS) | Treatment (Chemotherapy, Transplant) | 29.7 | 95% Confidence Interval 21.5 to 43.0 | Months | |
| Response | Treatment (Chemotherapy, Transplant) | .9846 | proportion 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 | Treatment (Chemotherapy, Transplant) | 66 | |
| Overall Study | COMPLETED | Treatment (Chemotherapy, Transplant) | 65 | |
| Overall Study | NOT COMPLETED | Treatment (Chemotherapy, Transplant) | 1 |
Source ClinicalTrials.gov
Adverse events295
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 | Anemia | Blood and lymphatic system disorders | Treatment (Chemotherapy, Transplant) | 59 | 65 | 535 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Treatment (Chemotherapy, Transplant) | 4 | 65 | 5 |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Treatment (Chemotherapy, Transplant) | 10 | 65 | 18 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Treatment (Chemotherapy, Transplant) | 27 | 65 | 41 |
| other | Hemolysis | Blood and lymphatic system disorders | Treatment (Chemotherapy, Transplant) | 1 | 65 | 1 |
| other | Leukocytosis | Blood and lymphatic system disorders | Treatment (Chemotherapy, Transplant) | 6 | 65 | 6 |
| other | Lymph node pain | Blood and lymphatic system disorders | Treatment (Chemotherapy, Transplant) | 1 | 65 | 1 |
| other | Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | Treatment (Chemotherapy, Transplant) | 1 | 65 | 1 |
| other | Atrial fibrillation | Cardiac disorders | Treatment (Chemotherapy, Transplant) | 4 | 65 | 4 |
| other | Cardiac disorders - Other, specify | Cardiac disorders | Treatment (Chemotherapy, Transplant) | 6 | 65 | 9 |
1 to 10 of 295Source ClinicalTrials.gov
See all 295 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Chemotherapy, Transplant) | 5 | 65 |
| Total, other adverse events | Treatment (Chemotherapy, Transplant) | 65 | 65 |
| Total, serious adverse events | Treatment (Chemotherapy, Transplant) | 5 | 65 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34492682 | 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 |
|---|---|---|---|---|---|---|
| U10CA180821 | Alliance for Clinical Trials in Oncology Operations Center | Galanis, Evanthia; Hahn, Olwen; Kozono, David | ALLIANCE NCTN FOUNDATION | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA031946 | Cancer and Leukemia Group B | BERTAGNOLLI, MONICA M | BRIGHAM AND WOMEN'S HOSPITAL | 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/NCT01256398
GET https://conductscience.org/api/trials/v1/NCT01256398/events?page=2