Trial · NCT00550615
Dasatinib in Relapsed or Refractory Non-Hodgkin's Lymphoma
NCT00550615, Phase 1, Phase 2, Completed, University of Nebraska; results first posted 2019-02-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dasatinib in Relapsed or Refractory Non-Hodgkin's Lymphoma. Trials, record NCT00550615. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00550615
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dasatinib in Relapsed or Refractory Non-Hodgkin's Lymphoma
- NCT number
- NCT00550615
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 38 participants, actual
- Lead sponsor
- University of Nebraska
- Conditions
- Non-Hodgkin's Lymphoma
- Interventions
- Dasatinib, Dasatinib Maximum Tolerated Dose
- First posted
- 2007-10-30
- Last updated
- 2023-09-26
- Results first posted
- 2019-02-01
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose | after 1-28 day cycle of therapy | |
| Secondary | Number of Participants With Clinical Response Rates | after 2-28 day cycles of therapy | The Objective response rate (CR+PR) and the Clinical Benefit Rate (CR+PR+SD) were calculated according to revised response criteria for malignant lymphoma (Cheson) CR - Complete response is defined as: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy. PR - Partial response is defined as: ≥ 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. SD - Stable Disease is define as: Failing to attain the criteria needed for a PR, but not fulfilling those for progressive disease. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose | after 1-28 day cycle of therapy | Two subjects enrolled in Phase 1 of the study were never treated and not included in the analysis. | milligrams PO daily | NUMBER |
| SECONDARY | Number of Participants With Clinical Response Rates | after 2-28 day cycles of therapy | Of the 38 participants consented only 24 for were evaluable. See the participant flow section. | Participants | COUNT_OF_PARTICIPANTS |
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 |
|---|---|---|---|---|---|
| Maximum Tolerated Dose | All Phase I Participants | 200 | milligrams PO daily | ||
| Number of Participants With Clinical Response Rates | Evauable Participants From Both Phases of the Trial | Objective response rate | 7 | Participants | |
| Number of Participants With Clinical Response Rates | Evauable Participants From Both Phases of the Trial | Clinical Benefit Rate | 17 | Participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase I Dose Cohort # 1 (100 mg Per Day) | 3 | |
| Overall Study | STARTED | Phase I Dose Cohort # 2 (150 mg Per Day) | 3 | |
| Overall Study | STARTED | Phase I Dose Cohort # 3 (200 mg Per Day) | 10 | |
| Overall Study | STARTED | Phase II Participants | 22 | |
| Overall Study | COMPLETED | Phase I Dose Cohort # 1 (100 mg Per Day) | 3 | |
| Overall Study | COMPLETED | Phase I Dose Cohort # 2 (150 mg Per Day) | 3 | |
| Overall Study | COMPLETED | Phase I Dose Cohort # 3 (200 mg Per Day) | 6 | |
| Overall Study | COMPLETED | Phase II Participants | 12 | |
| Overall Study | NOT COMPLETED | Phase I Dose Cohort # 1 (100 mg Per Day) | 0 | |
| Overall Study | NOT COMPLETED | Phase I Dose Cohort # 2 (150 mg Per Day) | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events260
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 | Pleural effusion | Respiratory, thoracic and mediastinal disorders | Phase I Participants | 11 | 14 | 15 |
| other | Pleural effusion | Respiratory, thoracic and mediastinal disorders | Phase II Participants | 6 | 19 | 7 |
| other | platelet count decreased | Investigations | Phase I Participants | 6 | 14 | 6 |
| other | platelet count decreased | Investigations | Phase II Participants | 11 | 19 | 17 |
| other | anemia | Blood and lymphatic system disorders | Phase I Participants | 9 | 14 | 10 |
| other | anemia | Blood and lymphatic system disorders | Phase II Participants | 7 | 19 | 13 |
| other | Fatigue | General disorders | Phase I Participants | 6 | 14 | 7 |
| other | Fatigue | General disorders | Phase II Participants | 8 | 19 | 8 |
| other | diarrhea | Gastrointestinal disorders | Phase I Participants | 3 | 14 | 4 |
| other | diarrhea | Gastrointestinal disorders | Phase II Participants | 9 | 19 | 9 |
1 to 10 of 260Source ClinicalTrials.gov
See all 260 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase I Participants | 1 | 14 |
| Total, all-cause mortality | Phase II Participants | 4 | 19 |
| Total, other adverse events | Phase I Participants | 14 | 14 |
| Total, other adverse events | Phase II Participants | 18 | 19 |
| Total, serious adverse events | Phase I Participants | 7 | 14 |
| Total, serious adverse events | Phase II Participants | 9 | 19 |
Source ClinicalTrials.gov
Papers7
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Phase I Participants vs Phase II Participants: deaths from any cause | Trial comparisons |
| Phase I Participants vs Phase II Participants: serious adverse events | Trial comparisons |
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/NCT00550615
GET https://conductscience.org/api/trials/v1/NCT00550615/events?page=2