Trial · NCT02530619
Alisertib in Treating Patients With Myelofibrosis or Relapsed or Refractory Acute Megakaryoblastic Leukemia
NCT02530619, Not applicable, Unknown, Northwestern University; results first posted 2020-12-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Alisertib in Treating Patients With Myelofibrosis or Relapsed or Refractory Acute Megakaryoblastic Leukemia. Trials, record NCT02530619. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02530619
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Alisertib in Treating Patients With Myelofibrosis or Relapsed or Refractory Acute Megakaryoblastic Leukemia
- NCT number
- NCT02530619
- Status
- Unknown
- Phases
- Not applicable
- Enrollment
- 26 participants, actual
- Lead sponsor
- Northwestern University
- Conditions
- Acute Megakaryoblastic Leukemia, Myelofibrosis, Primary Myelofibrosis
- Interventions
- Alisertib, Laboratory Biomarker Analysis, Pharmacological Study
- First posted
- 2015-08-21
- Last updated
- 2021-05-26
- Results first posted
- 2020-12-19
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety Profile of Alisertib Per NCI's Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. | From time of treatment to 6 months post discontinuation (range of cycles attempted 1 to 29, median 7.5 cycles, 1 Cycle = 21 days) | Adverse events will be defined as those included in CTCAE v 4.0. The AEs that were determined to be at least possibly related to study drug and graded 3, 4, 5 are included here. Grade 1 (mild): the event causes discomfort without disruption of normal daily activities. Grade 2 (moderate): the event causes discomfort that affects normal daily activities. Grade 3 (severe): the event makes the patient unable to perform normal daily activities or significantly affects his/her clinical status. Grade 4 (Life-threatening): the patient was at risk of death at the time of the event. Grade 5 (fatal): the event caused death. All patients who received at least 1 dose of alisertib were considered evaluable for this endpoint. |
| Secondary | Response to Treatment | Baseline to up to 6 months after the last dose of treatment | Serial blood and/or bone marrow samples will be collected at specific timepoints for each disease to determine response to alisertib treatment. |
| Other | Changes in Biomarker Expression Levels | Baseline to up to 6 months after the last dose of treatment | To evaluate the relationship between biomarker expression levels and response. Biomarkers will include a) genes encoding key enzymes in Aurora kinase signaling, b) markers of cellular aneuploidy and apoptosis, and c) markers of megakaryocytic differentiation. |
| Other | Changes in MF Symptoms Assessed by the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) Score (MF Patients) | Once per cycle (1 cycle=21 days) | To evaluate improvement in MF symptoms in the MF arm, changes in symptom scores over time will be calculated. |
| Other | Changes in Pharmacodynamic Effects of Alisertib | Baseline to up to 6 months after the last dose of treatment | Serial blood and/or bone marrow samples will be collected at specific timepoints. Flow cytometry, colony forming assays, AURKA autophosphorylation assays, and in vitro cultures of patient specimens to assess the effect of MLN8237 on megakaryocytes and other hematopoietic cells will be measured. |
| Other | Changes in Splenomegaly by Palpation (MF Patients) | Baseline to up to 6 months after the last dose of treatment | To evaluate reduction in splenomegaly by palpation in the MF arm. Patients will be examined for splenomegaly by palpation once per cycle and change from baseline will be calculated over time. |
| Other | Change in Bone Marrow Fibrosis (MF Patients) | Screening and up to 54 weeks | Assess change in bone marrow fibrosis in patients in the MF arm. Bone marrow will be assessed at screening and after cycle 6 in this population. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Safety Profile of Alisertib Per NCI's Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. | From time of treatment to 6 months post discontinuation (range of cycles attempted 1 to 29, median 7.5 cycles, 1 Cycle = 21 days) | Data was collected from all patients for the primary endpoint until May 2018 when it was determined there was sufficient data collected for primary endpoint analysis and primary endpoint was determined to be met. At the time of data cut off, 7 patients remained on active treatment and range of cycles completed by patients was 1-29 (median 7.5 cycles). No further data was collected after May 2018 for primary outcome measure purposes. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Response to Treatment | Baseline to up to 6 months after the last dose of treatment | |||
| OTHER_PRE_SPECIFIED | Changes in Biomarker Expression Levels | Baseline to up to 6 months after the last dose of treatment | |||
| OTHER_PRE_SPECIFIED | Changes in MF Symptoms Assessed by the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) Score (MF Patients) | Once per cycle (1 cycle=21 days) | |||
| OTHER_PRE_SPECIFIED | Changes in Pharmacodynamic Effects of Alisertib | Baseline to up to 6 months after the last dose of treatment | |||
| OTHER_PRE_SPECIFIED | Changes in Splenomegaly by Palpation (MF Patients) | Baseline to up to 6 months after the last dose of treatment | |||
| OTHER_PRE_SPECIFIED | Change in Bone Marrow Fibrosis (MF Patients) | Screening and up to 54 weeks |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety Profile of Alisertib Per NCI's Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. | Alisertib 50 mg BID | Neutropenia Grade 3 | 5 | Participants | |
| Safety Profile of Alisertib Per NCI's Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. | Alisertib 50 mg BID | Neutropenia Grade 4 | 5 | Participants | |
| Safety Profile of Alisertib Per NCI's Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. | Alisertib 50 mg BID | Febrile Neutropenia Grade 3 | 1 | Participants | |
| Safety Profile of Alisertib Per NCI's Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. | Alisertib 50 mg BID | Lymphocytopenia Grade 3 | 9 | Participants | |
| Safety Profile of Alisertib Per NCI's Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. | Alisertib 50 mg BID | Thrombocytopenia Grade 3 | 5 | Participants | |
| Safety Profile of Alisertib Per NCI's Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. | Alisertib 50 mg BID | Thrombocytopenia Grade 4 | 2 | Participants | |
| Safety Profile of Alisertib Per NCI's Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. | Alisertib 50 mg BID | Anemia Grade 3 | 5 | Participants | |
| Safety Profile of Alisertib Per NCI's Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. | Alisertib 50 mg BID | Vertigo Grade 3 | 1 | Participants | |
| Safety Profile of Alisertib Per NCI's Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. | Alisertib 50 mg BID | Diarrhea Grade 3 | 1 | Participants | |
| Safety Profile of Alisertib Per NCI's Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. | Alisertib 50 mg BID | Alanine aminotransferase increased Grade 3 | 1 | Participants |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow17
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Registered for Study | STARTED | Alisertib 50 mg BID | 26 | |
| Registered for Study | Registered | Alisertib 50 mg BID | 26 | |
| Registered for Study | Received 1st Dose of Alisertib | Alisertib 50 mg BID | 24 | |
| Registered for Study | COMPLETED | Alisertib 50 mg BID | 24 | |
| Registered for Study | NOT COMPLETED | Alisertib 50 mg BID | 2 | |
| Completed 1st Cycle of Treatment | STARTED | Alisertib 50 mg BID | 24 | |
| Completed 1st Cycle of Treatment | COMPLETED | Alisertib 50 mg BID | 24 | |
| Completed 1st Cycle of Treatment | NOT COMPLETED | Alisertib 50 mg BID | 0 | |
| Continued Treatment Cycles 2 Through 6 | STARTED | Alisertib 50 mg BID | 24 | |
| Continued Treatment Cycles 2 Through 6 | COMPLETED | Alisertib 50 mg BID | 14 |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 participant flowAdverse events162
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 | Alisertib 50 mg BID | 11 | 24 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Alisertib 50 mg BID | 2 | 24 | |
| other | Atrial fibrillation | Cardiac disorders | Alisertib 50 mg BID | 1 | 24 | |
| other | Chest pain - cardiac | Cardiac disorders | Alisertib 50 mg BID | 1 | 24 | |
| other | Myocardial infarction | Cardiac disorders | Alisertib 50 mg BID | 1 | 24 | |
| other | Palpitations | Cardiac disorders | Alisertib 50 mg BID | 1 | 24 | |
| other | Sinus bradycardia | Cardiac disorders | Alisertib 50 mg BID | 2 | 24 | |
| other | Sinus tachycardia | Cardiac disorders | Alisertib 50 mg BID | 1 | 24 | |
| other | Ventricular arrhythmia | Cardiac disorders | Alisertib 50 mg BID | 1 | 24 | |
| other | Ear pain | Ear and labyrinth disorders | Alisertib 50 mg BID | 1 | 24 |
1 to 10 of 162Source ClinicalTrials.gov
See all 162 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Alisertib 50 mg BID | 5 | 24 |
| Total, other adverse events | Alisertib 50 mg BID | 24 | 24 |
| Total, serious adverse events | Alisertib 50 mg BID | 8 | 24 |
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 |
|---|---|---|---|---|---|
| P30CA060553 | The Robert H. Lurie Comprehensive Cancer Center | PLATANIAS, LEONIDAS C. | NORTHWESTERN UNIVERSITY | NATIONAL CANCER INSTITUTE | 1993 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/NCT02530619
GET https://conductscience.org/api/trials/v1/NCT02530619/events?page=2