Trial · NCT01482962
Alisertib (MLN8237) or Investigator's Choice in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma
NCT01482962, Phase 3, Completed, Millennium Pharmaceuticals, Inc.; results first posted 2018-07-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Alisertib (MLN8237) or Investigator's Choice in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma. Trials, record NCT01482962. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01482962
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Alisertib (MLN8237) or Investigator's Choice in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma
- NCT number
- NCT01482962
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 271 participants, actual
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Conditions
- Relapsed Peripheral T-Cell Lymphoma, Refractory Peripheral T-Cell Lymphoma
- Interventions
- Alisertib, Pralatrexate, Gemcitabine, Romidepsin
- First posted
- 2011-12-01
- Last updated
- 2018-07-31
- Other registries' IDs
- eudract:2011-003545-18
- Results first posted
- 2018-07-31
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) Based on Independent Review Committee (IRC) Assessment | Every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until progressive disease. Duration is approximately 3 years | ORR was defined as the percentage of participants who achieve Complete Response (CR) or Partial Response (PR) as assessed by the IRC using International Working Group (IWG) criteria. CR=Disappearance of all evidence of disease and PR=Regression of measurable disease and no new sites. |
| Primary | Progression-Free Survival (PFS) Based on IRC Assessment | Every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until progressive disease. Duration is approximately 3 years | PFS was defined as the time from the date of randomization to the date of first documentation of progressive disease (PD) or death due to any cause, whichever occurred first. |
| Secondary | Overall Survival (OS) | Participants were followed for survival for 2 years from date of last participant off study treatment, or death, whichever occurs first. Contacts were every 4 months (Median follow-up 519 days in the alisertib arm and 586 days in the comparative arm) | OS was defined as the time from the date of randomization to the date of death. Participants without documentation of death were censored at the date last known to be alive. |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) | 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 TEAE is defined as an adverse event with an onset that occurs after receiving study drug. A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/ birth defect or is a medically important event. |
| Secondary | Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs | First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) | Clinical laboratory tests included chemistry, hematology and urinalysis test. Clinically significant treatment-emergent laboratory abnormalities were reported by the investigator as TEAEs. |
| Secondary | Number of Participants With Clinically Important Vital Sign Measurements Reported as AEs | First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) | Vital signs included blood pressure, heart rate and temperature. Individual clinically significant changes in vital signs were reported by the investigator as TEAEs. |
| Secondary | Complete Response (CR) Rate | At the end of every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until PD (approximately 3 years) | Complete Response (CR) rate is defined as the percentage of participants with CR as assessed by the IRC using IWG criteria (2007 Cheson). CR= Disappearance of all evidence of disease. |
| Secondary | Time to Disease Progression (TTP) | At the end of every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until progressive disease. Duration is approximately 3 years | Time to Progression (TTP) was defined as the time from the date of randomization to the date of first documentation of PD/relapse. |
| Secondary | Duration of Response (DOR) | At the end of every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until progressive disease. Duration is approximately 3 years | DOR was defined as the time from the date of first documentation of a PR or better to the date of first documentation of progressive disease (PD)/relapse for responders as assessed by the IRC using IWG criteria. Responders without documentation of PD/relapse were censored at the date of last response assessment that was stable disease (SD) or better. |
| Secondary | Time to Response | At the end of every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until progressive disease. Duration is approximately 3 years | Time to Response is defined as the time from the date of randomization to the date of first documentation of PR or better. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) Based on Independent Review Committee (IRC) Assessment | Every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until progressive disease. Duration is approximately 3 years | Response-evaluable population, participants with peripheral T-cell lymphoma confirmed by an independent hematopathology central review, with measurable disease at Baseline, who received at least 1 dose of alisertib or comparator and had postbaseline response assessment of CR, PR, stable disease (SD) or progressive disease (PD) by the IRC. | percentage of participants | NUMBER |
| PRIMARY | Progression-Free Survival (PFS) Based on IRC Assessment | Every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until progressive disease. Duration is approximately 3 years | Intent-to-treat (ITT) population was defined as all participants who were randomized. The participants were analyzed according to the treatment they were randomized to receive, regardless of any errors of dosing. | days | MEDIAN |
| SECONDARY | Overall Survival (OS) | Participants were followed for survival for 2 years from date of last participant off study treatment, or death, whichever occurs first. Contacts were every 4 months (Median follow-up 519 days in the alisertib arm and 586 days in the comparative arm) | ITT population was defined as all participants who were randomized. The participants were analyzed according to the treatment they were randomized to receive, regardless of any errors of dosing. | days | MEDIAN |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) | Safety population was defined as all participants who received at least 1 dose of alisertib, or one of the comparator drugs. Participants were analyzed according to the treatment actually received. | participants | NUMBER |
| SECONDARY | Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs | First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) | Safety population was defined as all participants who received at least 1 dose of alisertib, or one of the comparator drugs. Participants were analyzed according to the treatment actually received. | participants | NUMBER |
| SECONDARY | Number of Participants With Clinically Important Vital Sign Measurements Reported as AEs | First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) | Safety population was defined as all participants who received at least 1 dose of alisertib, or one of the comparator drugs. Participants were analyzed according to the treatment actually received. | participants | NUMBER |
| SECONDARY | Complete Response (CR) Rate | At the end of every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until PD (approximately 3 years) | Response-evaluable population was defined as participants with peripheral T-cell lymphoma confirmed by an independent hematopathology central review, with measurable disease at baseline, who receive at least 1 dose of alisertib or the comparator drug, and 1 postbaseline response assessment of CR, PR, SD or PD by the independent radiology committee. | percentage of participants | NUMBER |
| SECONDARY | Time to Disease Progression (TTP) | At the end of every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until progressive disease. Duration is approximately 3 years | ITT population was defined as all participants who were randomized. The participants were analyzed according to the treatment they were randomized to receive, regardless of any errors of dosing. | days | MEDIAN |
| SECONDARY | Duration of Response (DOR) | At the end of every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until progressive disease. Duration is approximately 3 years | All responders in response-evaluable population defined as participants with peripheral T-cell lymphoma confirmed by independent hematopathology central review with measurable disease at baseline who receive at least 1 dose of alisertib or comparator drug and 1 postbaseline response assessment of CR, PR, SD or PD by independent radiology committee. | days | MEDIAN |
| SECONDARY | Time to Response | At the end of every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until progressive disease. Duration is approximately 3 years | All responders in response-evaluable population defined as participants with peripheral T-cell lymphoma confirmed by independent hematopathology central review with measurable disease at baseline who receive at least 1 dose of alisertib or comparator drug and 1 postbaseline response assessment of CR, PR, SD or PD by independent radiology committee. | days | MEDIAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group118
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) Based on Independent Review Committee (IRC) Assessment | Alisertib | 33 | 95% Confidence Interval 24 to 43 | percentage of participants | |
| Overall Response Rate (ORR) Based on Independent Review Committee (IRC) Assessment | Pralatrexate, or Romidepsin, or Gemcitabine | 45 | 95% Confidence Interval 34 to 55 | percentage of participants | |
| Progression-Free Survival (PFS) Based on IRC Assessment | Alisertib | 115 | 95% Confidence Interval 83 to 174 | days | |
| Progression-Free Survival (PFS) Based on IRC Assessment | Pralatrexate, or Romidepsin, or Gemcitabine | 104 | 95% Confidence Interval 61 to 114 | days | |
| Overall Survival (OS) | Alisertib | 415 | 95% Confidence Interval 263 to 514 | days | |
| Overall Survival (OS) | Pralatrexate, or Romidepsin, or Gemcitabine | 367 | 95% Confidence Interval 258 to 572 | days | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Alisertib | TEAE | 136 | participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Pralatrexate, or Romidepsin, or Gemcitabine | TEAE | 126 | participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Alisertib | SAE | 75 | participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Pralatrexate, or Romidepsin, or Gemcitabine | SAE | 69 | participants |
1 to 10 of 118Source ClinicalTrials.gov
See all 118 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Alisertib | 138 | |
| Overall Study | STARTED | Pralatrexate, or Romidepsin, or Gemcitabine | 133 | |
| Overall Study | Safety Population: Received Study Drug | Alisertib | 137 | |
| Overall Study | Safety Population: Received Study Drug | Pralatrexate, or Romidepsin, or Gemcitabine | 127 | |
| Overall Study | COMPLETED | Alisertib | 0 | |
| Overall Study | COMPLETED | Pralatrexate, or Romidepsin, or Gemcitabine | 0 | |
| Overall Study | NOT COMPLETED | Alisertib | 138 | |
| Overall Study | NOT COMPLETED | Pralatrexate, or Romidepsin, or Gemcitabine | 133 |
Source ClinicalTrials.gov
Adverse events864
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 | Diarrhoea | Gastrointestinal disorders | Alisertib | 61 | 137 | |
| other | Diarrhoea | Gastrointestinal disorders | Gemcitabine | 5 | 29 | |
| other | Diarrhoea | Gastrointestinal disorders | Pralatrexate | 18 | 76 | |
| other | Diarrhoea | Gastrointestinal disorders | Romidepsin | 10 | 22 | |
| other | Stomatitis | Gastrointestinal disorders | Alisertib | 42 | 137 | |
| other | Stomatitis | Gastrointestinal disorders | Gemcitabine | 0 | 29 | |
| other | Stomatitis | Gastrointestinal disorders | Pralatrexate | 48 | 76 | |
| other | Stomatitis | Gastrointestinal disorders | Romidepsin | 2 | 22 | |
| other | Nausea | Gastrointestinal disorders | Alisertib | 35 | 137 | |
| other | Nausea | Gastrointestinal disorders | Gemcitabine | 7 | 29 |
1 to 10 of 864Source ClinicalTrials.gov
See all 864 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Alisertib | 11 | 137 |
| Total, all-cause mortality | Gemcitabine | 5 | 29 |
| Total, all-cause mortality | Pralatrexate | 8 | 76 |
| Total, all-cause mortality | Romidepsin | 2 | 22 |
| Total, other adverse events | Alisertib | 134 | 137 |
| Total, other adverse events | Gemcitabine | 29 | 29 |
| Total, other adverse events | Pralatrexate | 72 | 76 |
| Total, other adverse events | Romidepsin | 21 | 22 |
| Total, serious adverse events | Alisertib | 75 | 137 |
| Total, serious adverse events | Gemcitabine | 18 | 29 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30707661 | DERIVED |
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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