Trial · NCT00807495
Study of Alisertib (MLN8237) in Adults With Aggressive Non-Hodgkin's Lymphoma
NCT00807495, Phase 2, Completed, Millennium Pharmaceuticals, Inc.; results first posted 2018-03-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Alisertib (MLN8237) in Adults With Aggressive Non-Hodgkin's Lymphoma. Trials, record NCT00807495. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00807495
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Alisertib (MLN8237) in Adults With Aggressive Non-Hodgkin's Lymphoma
- NCT number
- NCT00807495
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 48 participants, actual
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Conditions
Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, Burkitt's Lymphoma, T-cell Lymphoma, Excluding Primary Cutaneous T-cell Lymphoma, Transformed Follicular Lymphoma With ≥ 50% Diffuse Large Cell Component
- Interventions
- Alisertib
- First posted
- 2008-12-12
- Last updated
- 2018-03-27
- Results first posted
- 2018-03-27
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Best Overall Response Rate Based on Investigator's Assessment (Applying the IWG 2007 Response Criteria) | Baseline and every 2 cycles up to Month 12 (approximately 16 cycles), from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months from last dose (Up to 4 years) | Best overall response rate is defined as the percentage of participants with complete response (CR) or partial response (PR) as assessed by the Investigator using International Working Group (IWG) Criteria. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites (as specified in the Cheson 2007, IWG response criteria). |
| Secondary | Time to Progression (TTP) | Baseline and every 2 cycles up to Month 12, from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Up to 4 years) | Time to progression (TTP) is defined as the time in days from the date of first study drug administration to the date of first documentation of Progressive Disease (PD) according to IWG criteria (Cheson 2007). PD is defined as any new lesion or increase by \>50% of previously involved sites from nadir. |
| Secondary | Progression Free Survival (PFS) | Baseline and every 2 cycles up to Month 12, from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Up to 4 years) | PFS is defined as the time in days from the date of first study drug administration to the date of first documentation of progressive disease (PD) or death. |
| Secondary | Duration of Response (DOR) | Baseline and every 2 cycles up to Month 12, from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Up to 4 years) | DOR is defined as the time from the date of first documentation of a CR, or partial response (PR) to the date of first documentation of PD according to IWG criteria. CR definition includes the complete disappearance of all evidence of disease, the definition of PR includes at least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses, and PD is defined as any new lesion or increase by \>50% of previously involved sites from nadir, as described in the IWG response criteria (Cheson 2007). |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events | First dose of study drug to 30 days after last dose (Up to 25 months) | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and includes all-causality (ie, treatment-related and not treatment-related as assessed by the investigator). |
| Secondary | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events | First dose of study drug to 30 days after last dose (Up to 25 months) | Vital signs (blood pressure, heart rate, and oral temperature) measurements were obtained throughout the study. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. |
| Secondary | Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events | First dose of study drug to 30 days after last dose (Up to 25 months) | Abnormal laboratory values for chemistry or hematology tests that were assessed by the investigator using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE V4). A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. |
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 | Best Overall Response Rate Based on Investigator's Assessment (Applying the IWG 2007 Response Criteria) | Baseline and every 2 cycles up to Month 12 (approximately 16 cycles), from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months from last dose (Up to 4 years) | Safety population was defined as all participants who received any amount of alisertib. Efficacy analysis for the response-evaluable population is a subset of the safety population, with participants having a minimum of baseline imaging and one on-study imaging. | percentage of participants | NUMBER |
| SECONDARY | Time to Progression (TTP) | Baseline and every 2 cycles up to Month 12, from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Up to 4 years) | Response-evaluable population is subset of safety population, defined as all participants who received any amount of alisertib, having minimum of baseline imaging and one on-study imaging. Here number of participants analyzed were participants with PD. TTP was censored at the last response assessment that was SD or better. | days | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) | Baseline and every 2 cycles up to Month 12, from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Up to 4 years) | Response-evaluable population is subset of safety population, defined as all participants who received any amount of alisertib, having minimum of baseline imaging and one on-study imaging. For a participant who had not progressed and had not died, PFS was censored at the last response assessment that was SD or better. | days | MEDIAN |
| SECONDARY | Duration of Response (DOR) | Baseline and every 2 cycles up to Month 12, from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Up to 4 years) | Response-evaluable population is subset of safety population, defined as all participants who received any amount of alisertib, having minimum of baseline imaging and one on-study imaging. All responders were evaluated in this outcome measure. Participants who had not progressed, DOR was censored at last response assessment that was SD or better. | days | MEDIAN |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events | First dose of study drug to 30 days after last dose (Up to 25 months) | Safety population was defined as all participants who received any amount of alisertib. | participants | NUMBER |
| SECONDARY | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events | First dose of study drug to 30 days after last dose (Up to 25 months) | Safety population was defined as all participants who received any amount of alisertib. | participants | NUMBER |
| SECONDARY | Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events | First dose of study drug to 30 days after last dose (Up to 25 months) | Safety population was defined as all participants who received any amount of alisertib. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group140
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Best Overall Response Rate Based on Investigator's Assessment (Applying the IWG 2007 Response Criteria) | Alisertib 50 mg BID Starting Dose (DLBL) | 25 | percentage of participants | ||
| Best Overall Response Rate Based on Investigator's Assessment (Applying the IWG 2007 Response Criteria) | Alisertib 50 mg BID Starting Dose (MCL) | 23 | percentage of participants | ||
| Best Overall Response Rate Based on Investigator's Assessment (Applying the IWG 2007 Response Criteria) | Alisertib 50 mg BID Starting Dose (TFL) | 40 | percentage of participants | ||
| Best Overall Response Rate Based on Investigator's Assessment (Applying the IWG 2007 Response Criteria) | Alisertib 50 mg BID Starting Dose (BL) | 100 | percentage of participants | ||
| Best Overall Response Rate Based on Investigator's Assessment (Applying the IWG 2007 Response Criteria) | Alisertib 50 mg BID Starting Dose (ATL) | 50 | percentage of participants | ||
| Time to Progression (TTP) | Alisertib 50 mg BID Starting Dose (DLBL) | 84.0 | 95% Confidence Interval 48.0 to 430.0 | days | |
| Time to Progression (TTP) | Alisertib 50 mg BID Starting Dose (MCL) | 139.0 | 95% Confidence Interval 48.0 to 809.0 | days | |
| Time to Progression (TTP) | Alisertib 50 mg BID Starting Dose (TFL) | NA | 95% Confidence Interval NA to NA | days | |
| Time to Progression (TTP) | Alisertib 50 mg BID Starting Dose (BL) | NA | 95% Confidence Interval NA to NA | days | |
| Time to Progression (TTP) | Alisertib 50 mg BID Starting Dose (ATL) | 237.0 | 95% Confidence Interval 46.0 to 631.0 | days |
1 to 10 of 140Source ClinicalTrials.gov
See all 140 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Alisertib 50 mg BID Starting Dose (DLBL) | 22 | |
| Overall Study | STARTED | Alisertib 50 mg BID Starting Dose (MCL) | 13 | |
| Overall Study | STARTED | Alisertib 50 mg BID Starting Dose (TFL) | 5 | |
| Overall Study | STARTED | Alisertib 50 mg BID Starting Dose (BL) | 1 | |
| Overall Study | STARTED | Alisertib 50 mg BID Starting Dose (ATL) | 7 | |
| Overall Study | COMPLETED | Alisertib 50 mg BID Starting Dose (DLBL) | 14 | |
| Overall Study | COMPLETED | Alisertib 50 mg BID Starting Dose (MCL) | 7 | |
| Overall Study | COMPLETED | Alisertib 50 mg BID Starting Dose (TFL) | 1 | |
| Overall Study | COMPLETED | Alisertib 50 mg BID Starting Dose (BL) | 0 | |
| Overall Study | COMPLETED | Alisertib 50 mg BID Starting Dose (ATL) | 2 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events1,025
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 | Neutropenia | Blood and lymphatic system disorders | Alisertib 50 mg BID Starting Dose (DLBL) | 16 | 22 | |
| other | Neutropenia | Blood and lymphatic system disorders | Alisertib 50 mg BID Starting Dose (MCL) | 9 | 13 | |
| other | Neutropenia | Blood and lymphatic system disorders | Alisertib 50 mg BID Starting Dose (TFL) | 4 | 5 | |
| other | Neutropenia | Blood and lymphatic system disorders | Alisertib 50 mg BID Starting Dose (BL) | 1 | 1 | |
| other | Neutropenia | Blood and lymphatic system disorders | Alisertib 50 mg BID Starting Dose (ATL) | 4 | 7 | |
| other | Anaemia | Blood and lymphatic system disorders | Alisertib 50 mg BID Starting Dose (DLBL) | 15 | 22 | |
| other | Anaemia | Blood and lymphatic system disorders | Alisertib 50 mg BID Starting Dose (MCL) | 7 | 13 | |
| other | Anaemia | Blood and lymphatic system disorders | Alisertib 50 mg BID Starting Dose (TFL) | 3 | 5 | |
| other | Anaemia | Blood and lymphatic system disorders | Alisertib 50 mg BID Starting Dose (BL) | 1 | 1 | |
| other | Anaemia | Blood and lymphatic system disorders | Alisertib 50 mg BID Starting Dose (ATL) | 5 | 7 |
1 to 10 of 1,025Source ClinicalTrials.gov
See all 1,025 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Alisertib 50 mg BID Starting Dose (DLBL) | ||
| Total, all-cause mortality | Alisertib 50 mg BID Starting Dose (MCL) | ||
| Total, all-cause mortality | Alisertib 50 mg BID Starting Dose (TFL) | ||
| Total, all-cause mortality | Alisertib 50 mg BID Starting Dose (BL) | ||
| Total, all-cause mortality | Alisertib 50 mg BID Starting Dose (ATL) | ||
| Total, other adverse events | Alisertib 50 mg BID Starting Dose (DLBL) | 22 | 22 |
| Total, other adverse events | Alisertib 50 mg BID Starting Dose (MCL) | 13 | 13 |
| Total, other adverse events | Alisertib 50 mg BID Starting Dose (TFL) | 5 | 5 |
| Total, other adverse events | Alisertib 50 mg BID Starting Dose (BL) | 1 | 1 |
| Total, other adverse events | Alisertib 50 mg BID Starting Dose (ATL) | 7 | 7 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 17242396 | RESULT |
Source PubMed
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 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.
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