18 and older, any sex, with Relapsed Peripheral T-Cell Lymphoma or Refractory Peripheral T-Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Response Rate (ORR) Based on Independent Review Committee (IRC) AssessmentPrimary· 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.
Group
Value
95% CI
Alisertib
33
24 – 43
Pralatrexate, or Romidepsin, or Gemcitabine
45
34 – 55
Progression-Free Survival (PFS) Based on IRC AssessmentPrimary· 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.
Group
Value
95% CI
Alisertib
115
83 – 174
Pralatrexate, or Romidepsin, or Gemcitabine
104
61 – 114
Overall Survival (OS)Secondary· 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.
Group
Value
95% CI
Alisertib
415
263 – 514
Pralatrexate, or Romidepsin, or Gemcitabine
367
258 – 572
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)Secondary· 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
TEAE
Group
Value
95% CI
Alisertib
136
Pralatrexate, or Romidepsin, or Gemcitabine
126
SAE
Group
Value
95% CI
Alisertib
75
Pralatrexate, or Romidepsin, or Gemcitabine
69
Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEsSecondary· 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.
Neutrophil Count Decreased
Group
Value
95% CI
Alisertib
18
Pralatrexate, or Romidepsin, or Gemcitabine
14
White Blood Cell Count Decreased
Group
Value
95% CI
Alisertib
17
Pralatrexate, or Romidepsin, or Gemcitabine
10
Lymphocyte Count Decreased
Group
Value
95% CI
Alisertib
6
Pralatrexate, or Romidepsin, or Gemcitabine
5
Monocyte Count Decreased
Group
Value
95% CI
Alisertib
2
Pralatrexate, or Romidepsin, or Gemcitabine
1
Lymphocyte Count Increased
Group
Value
95% CI
Alisertib
1
Pralatrexate, or Romidepsin, or Gemcitabine
0
Monocyte Count Increased
Group
Value
95% CI
Alisertib
1
Pralatrexate, or Romidepsin, or Gemcitabine
0
White Blood Cell Count Increased
Group
Value
95% CI
Alisertib
1
Pralatrexate, or Romidepsin, or Gemcitabine
0
Platelet Count Decreased
Group
Value
95% CI
Alisertib
15
Pralatrexate, or Romidepsin, or Gemcitabine
22
Number of Participants With Clinically Important Vital Sign Measurements Reported as AEsSecondary· 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.
Heart Rate Increased
Group
Value
95% CI
Alisertib
1
Pralatrexate, or Romidepsin, or Gemcitabine
0
Body Temperature Increased
Group
Value
95% CI
Alisertib
0
Pralatrexate, or Romidepsin, or Gemcitabine
1
Hypotension
Group
Value
95% CI
Alisertib
4
Pralatrexate, or Romidepsin, or Gemcitabine
6
Orthostatic Hypotension
Group
Value
95% CI
Alisertib
2
Pralatrexate, or Romidepsin, or Gemcitabine
1
Hypertension
Group
Value
95% CI
Alisertib
5
Pralatrexate, or Romidepsin, or Gemcitabine
7
Pyrexia
Group
Value
95% CI
Alisertib
48
Pralatrexate, or Romidepsin, or Gemcitabine
40
Complete Response (CR) RateSecondary· 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.
Group
Value
95% CI
Alisertib
18
11 – 26
Pralatrexate, or Romidepsin, or Gemcitabine
27
18 – 37
Time to Disease Progression (TTP)Secondary· 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.
Group
Value
95% CI
Alisertib
162
114 – 231
Pralatrexate, or Romidepsin, or Gemcitabine
116
101 – 227
Duration of Response (DOR)Secondary· 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.
Group
Value
95% CI
Alisertib
225
125 – NA
Pralatrexate, or Romidepsin, or Gemcitabine
172
119 – NA
Time to ResponseSecondary· 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.
Group
Value
95% CI
Alisertib
62
57 – 67
Pralatrexate, or Romidepsin, or Gemcitabine
64
60 – 71
Time to Subsequent Antineoplastic TherapySecondary· From date of last study drug to date of subsequent antineoplastic therapy, if required; approximately 3 years
Time to subsequent antineoplastic therapy was defined as the time from randomization to the first date of subsequent antineoplastic therapy (excluding transplant). Participants without subsequent antineoplastic therapy were censored at the date of death or last known to be alive.
Group
Value
95% CI
Alisertib
336
201 – 490
Pralatrexate, or Romidepsin, or Gemcitabine
233
144 – 429
Change Form Baseline in Reported Symptoms and Quality of Life (QoL) Assessment Per Functional Assessment of Cancer Therapy-Lymphoma (FACT-LYM) for Functioning and SymptomsSecondary· Baseline and End of Treatment (EOT) (Up to 152 Weeks)
The FACT-LYM includes the Functional Assessment of Cancer Therapy General Scale (FACT-G) and a 15-item lymphoma-specific subscale (LYM) over the past week. The FACT-G has 27 items that incorporate 4 scales including physical well-being (PWB; 7 items), social/family well-being (SWB, 7 items), emotional well-being (EWB; 6 items), and functional well-being (FWB; 7 items). The combined FACT-LYM instrument consists of a total of a 42 item questionnaire. Each question is answered on a 5- point scale of 0 (not at all) to 4 (very much) for a total possible score of 168. Higher scores indicate better w
Physical Well-Being, EOT
Group
Value
95% CI
Alisertib
-2.4
± 6.21
Pralatrexate, or Romidepsin, or Gemcitabine
-1.3
± 5.27
Social/Family Well-Being, EOT
Group
Value
95% CI
Alisertib
-0.3
± 4.50
Pralatrexate, or Romidepsin, or Gemcitabine
0.0
± 4.44
Emotional Well-Being, EOT
Group
Value
95% CI
Alisertib
-1.4
± 4.59
Pralatrexate, or Romidepsin, or Gemcitabine
-0.8
± 3.93
Functional Well-Being, EOT
Group
Value
95% CI
Alisertib
-2.4
± 5.40
Pralatrexate, or Romidepsin, or Gemcitabine
-0.3
± 4.79
Adverse events — posted to ClinicalTrials.gov
Time frame: First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a phase 3, randomized, 2-arm, open-label, international trial evaluating alisertib compared with single-agent treatment, as selected by the investigator from the offered options of pralatrexate or gemcitabine or romidepsin, in participants with relapsed or refractory peripheral T-cell lymphoma (PTCL). Note: romidepsin was not used as a single-agent comparator outside the United States of America (USA) as supply was not available.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07465757 — A Study of Alisertib and Paclitaxel in Patients With Small Cell Lung Cancer (SCLC)
· Phase 2
· not yet recruiting
NCT06369285 — A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Meta
· Phase 2
· recruiting
NCT06095505 — A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
· Phase 2
· recruiting
NCT04555837 — Alisertib and Pembrolizumab for the Treatment of Patients With Rb-deficient Head and Neck Squamous Cell Cancer
· Phase 1, PHASE2
· completed
NCT04479306 — Osimertinib in Combination With Alisertib or Sapanisertib for the Treatment of Osimertinib-Resistant EGFR Mutant Stage I
· Phase 1
· completed
Other recruiting trials for Relapsed Peripheral T-Cell Lymphoma
Currently open trials in the same condition.
NCT06508463 — Intravenous Vesicular Stomatitis Virus in Patients With Peripheral T-cell Lymphoma
· Phase 1
· recruiting
NCT06151106 — Chidamide and Duvalisibon for the Treatment of Refractory/Relapsed Peripheral T-cell Lymphoma
· Phase 2
· recruiting
Other Millennium Pharmaceuticals, Inc. trials
Trials by the same sponsor.
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· Phase 1
· withdrawn
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· Phase 1
· completed
NCT04454918 — Study to Assess Absolute Bioavailability (ABA) of TAK-906 and to Characterize Mass Balance, Pharmacokinetics (PK), Metab
· Phase 1
· completed
NCT04056455 — A Study of Mobocertinib Capsules in People With Severe Kidney Problems and People With Healthy Kidneys
· Phase 1
· completed
NCT04091438 — A Study of a Single Intravenous Infusion Dose of TAK-925 in Participants With Idiopathic Hypersomnia
· Phase 1
· completed
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Millennium Pharmaceuticals, Inc.
Last refreshed: 31 July 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01482962.