Trial · NCT01441882
Dasatinib in Treating Patients With Chronic Lymphocytic Leukemia
NCT01441882, Phase 2, Completed, OHSU Knight Cancer Institute; results first posted 2018-02-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dasatinib in Treating Patients With Chronic Lymphocytic Leukemia. Trials, record NCT01441882. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01441882
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dasatinib in Treating Patients With Chronic Lymphocytic Leukemia
- NCT number
- NCT01441882
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 19 participants, actual
- Lead sponsor
- OHSU Knight Cancer Institute
- Conditions
- Refractory Chronic Lymphocytic Leukemia, Stage I Chronic Lymphocytic Leukemia, Stage II Chronic Lymphocytic Leukemia, Stage III Chronic Lymphocytic Leukemia, Stage IV Chronic Lymphocytic Leukemia
- Interventions
- Dasatinib, Laboratory Biomarker Analysis, Pharmacological Study
- First posted
- 2011-09-28
- Last updated
- 2021-04-08
- Results first posted
- 2018-02-15
- Limitations and caveats
- No limitations or caveats are noted at this time.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Number of Participants With In Vitro Dasatinib Sensitivity in Predicting Clinical Activity | 8 weeks | Defined by a decrease in absolute lymphocyte count, as determined by peripheral blood complete blood count (CBC) with differential or by bone marrow examination of 50 % and/or a decrease of detectable total lymph node size or spleen size by 50% (either by clinical examination contrast enhanced computed tomography \[CT\]). |
| Secondary | Objective Response | Up to 2 years | Proportion of patients achieving the endpoint along with its 95% exact binomial confidence interval will be presented. Complete Response (CR): present \>=2 mos: no symptoms of CLL, normal findings on exam, ALC \< 4.000/mm3, ANC \>1.500/ mm3, platelet (PLT) count (ct) \>100.000/ mm3, hemoglobin (Hgb) concentration \>11 g/dL (untransfused), bone marrow (BM) lymphocytosis \<30%, and no nodules (lymphoid aggregates) on BM biopsy. Partial Response (PR): present \>=2 months: a reduction in prev. enlarged nodes, spleen, \& liver by at least 50%. ANC \>= 1.500/ mm3 or PLT ct \>= 100.000/ mm3 or Hgb concentration \>=11 g/dL or 50% improvement over pre-therapy reductions in Hgb concentration and/or PLT ct. Nodular PR: persistent BM nodules or infiltrates seen on BM biopsy those achieving a CR or PR. Stable Disease (SD): Does not meet CR or PR, but also not progressive disease (PD). PD: 50% size increase of lymph node, spleen, liver; or histologic (e.g. Richter's) transformation (per NCI and iwCLL). |
| Secondary | Overall Survival | Up to 2 years | Kaplan-Meier method will be used to estimate the survival curve. |
| Secondary | Progression-free Survival | Up to 2 years | Kaplan-Meier method will be used to estimate the survival curve. |
| Secondary | Incidence of Adverse Events (Number of Participants Affected) | Up to 4 years | Assessed According to the NCI Common Terminology Criteria for Adverse Events Version 4.0. Adverse events will be tabulated and summarized according to key reporting criteria (i.e., grade or seriousness, unanticipated, treatment attribution). Refer to the Adverse Event tables below for specific details. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Number of Participants With In Vitro Dasatinib Sensitivity in Predicting Clinical Activity | 8 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Objective Response | Up to 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Survival | Up to 2 years | Given the significant evolution of the treatment landscape, overall survival was no longer deemed to be a worthwhile/meaningful endpoint. Patients were lost to follow up and data was not collected. | ||
| SECONDARY | Progression-free Survival | Up to 2 years | Given the significant evolution of the treatment landscape, overall survival was no longer deemed to be a worthwhile/meaningful endpoint. Patients were lost to follow up and data was not collected. | ||
| SECONDARY | Incidence of Adverse Events (Number of Participants Affected) | Up to 4 years | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Number of Participants With In Vitro Dasatinib Sensitivity in Predicting Clinical Activity | Treatment (Dasatinib) | In vitro dasatinib sensitivity in predicting clini | 5 | Participants | |
| The Number of Participants With In Vitro Dasatinib Sensitivity in Predicting Clinical Activity | Treatment (Dasatinib) | ABS lymph ct decrease > 50% | 4 | Participants | |
| The Number of Participants With In Vitro Dasatinib Sensitivity in Predicting Clinical Activity | Treatment (Dasatinib) | Total lymph size decrease > 50% | 4 | Participants | |
| The Number of Participants With In Vitro Dasatinib Sensitivity in Predicting Clinical Activity | Treatment (Dasatinib) | Spleen decrease by > 50% | 0 | Participants | |
| Objective Response | Treatment (Dasatinib) | Complete Response (CR) | 0 | Participants | |
| Objective Response | Treatment (Dasatinib) | Partial Response (PR) | 2 | Participants | |
| Objective Response | Treatment (Dasatinib) | Partial Response with Lymphocytosis (PR-L) | 2 | Participants | |
| Objective Response | Treatment (Dasatinib) | Stable Disease (SD) | 8 | Participants | |
| Objective Response | Treatment (Dasatinib) | Progression | 1 | Participants | |
| Incidence of Adverse Events (Number of Participants Affected) | Treatment (Dasatinib) | 8 | 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 (Dasatinib) | 19 | |
| Overall Study | COMPLETED | Treatment (Dasatinib) | 13 | |
| Overall Study | NOT COMPLETED | Treatment (Dasatinib) | 6 |
Source ClinicalTrials.gov
Adverse events15
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 | Facial Swelling | Skin and subcutaneous tissue disorders | Treatment (Dasatinib) | 1 | 13 | 1 |
| serious | Colitis | Gastrointestinal disorders | Treatment (Dasatinib) | 1 | 13 | 1 |
| serious | Fatigue | General disorders | Treatment (Dasatinib) | 2 | 13 | 2 |
| serious | Hypocalcemia | Metabolism and nutrition disorders | Treatment (Dasatinib) | 1 | 13 | 1 |
| serious | Edema | Blood and lymphatic system disorders | Treatment (Dasatinib) | 1 | 13 | 1 |
| serious | Bilateral leg edema | Blood and lymphatic system disorders | Treatment (Dasatinib) | 1 | 13 | 1 |
| serious | Leukocytosis | Blood and lymphatic system disorders | Treatment (Dasatinib) | 1 | 13 | 1 |
| serious | Thrombocytopenia | Blood and lymphatic system disorders | Treatment (Dasatinib) | 2 | 13 | 2 |
| serious | Neutropenia | Blood and lymphatic system disorders | Treatment (Dasatinib) | 1 | 13 | 1 |
| serious | Anemia | Blood and lymphatic system disorders | Treatment (Dasatinib) | 2 | 13 | 2 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Dasatinib) | 0 | 13 |
| Total, other adverse events | Treatment (Dasatinib) | 0 | 13 |
| Total, serious adverse events | Treatment (Dasatinib) | 8 | 13 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|---|---|---|---|
| P30CA069533 | OHSU Knight Cancer Institute | KUMMAR, SHIVAANI | OREGON HEALTH & SCIENCE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1997 to 2025 |
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/NCT01441882
GET https://conductscience.org/api/trials/v1/NCT01441882/registered