Relapsed Peripheral T-Cell LymphomaPhase 3NCT01482962
Alisertib (MLN8237) or Investigator's Choice in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma
A Phase 3 study testing Alisertib, Pralatrexate and Gemcitabine in people with Relapsed Peripheral T-Cell Lymphoma and Refractory Peripheral T-Cell Lymphoma, run by Millennium Pharmaceuticals, Inc. at 151 sites in 31 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed Peripheral T-Cell Lymphoma, Refractory Peripheral T-Cell Lymphoma
- What is being tested?
- Alisertib, Pralatrexate and Gemcitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 271 participants
- Where
- 151 sitesin 31 countries
- Study dates
- 11 Jun 2012to 18 Dec 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants age 18 or older
- Participants with Peripheral T cell lymphoma (PTCL) (selected subtypes) according to World Health Organization (WHO) criteria and have relapsed or are refractory to at least 1 prior systemic, cytotoxic therapy for PTCL. Participants must have received conventional therapy as a prior therapy. Cutaneous-only disease is not permitted. Participants must have documented evidence of progressive and measurable disease.
- Tumor biopsy available for central hematopathologic review
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Female participants who are post menopausal for at least 1 year, surgically sterile, or agree to practice 2 effective methods of contraception through 30 days after the last dose of study drug or agree to abstain from heterosexual intercourse.
- Male participants who agree to practice effective barrier contraception through 6 months after the last dose of alisertib or agree to abstain from heterosexual intercourse
- Suitable venous access
- Voluntary written consent
Who cannot join
- Known central nervous system lymphoma
- Systemic antineoplastic therapy, immunotherapy, investigational agent or radiation therapy within 4 weeks of first dose of study treatment or concomitant use during study
- Prior administration of an Aurora A kinase-targeted agent, including alisertib; or all of the 3 comparator drugs (pralatrexate, or romidepsin or gemcitabine; or known hypersensitivity)
- History of uncontrolled sleep apnea syndrome or other conditions that could result in excessive daytime sleepiness
- Cardiac condition as specified in study protocol, including left ventricular ejection fraction (LVEF) <40%
- Concomitant use of other medicines as specified in study protocol
Show all 16Show fewer
- Participants with abnormal gastric or bowel function who require continuous treatment with H2-receptor antagonists or proton pump inhibitors
- Known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C
- Autologous stem cell transplant less than 3 months prior to enrollment
- Participants who have undergone allogeneic stem cell or organ transplantation any time
- Inadequate blood levels, bone marrow or other organ function as specified in study protocol
- The participant must have recovered to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade ≤ 1 toxicity, to participant's baseline status (except alopecia), or deemed irreversible from the effects of prior cancer therapy
- Major surgery, serious infection, or infection requiring systemic antibiotic therapy within 14 days prior to the first dose of study treatment
- Female participants who are breastfeeding or pregnant
- Coexistent second malignancy or history of prior solid organ malignancy within previous 3 years
- Serious medical or psychiatric illness or laboratory abnormality that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol
Trial locations and contacts
151 sites in 31 countries.
151 sites in 31 countries
United States24 sites
Study site
Birmingham, Alabama
Study site
Boston, Massachusetts
Study site
Buffalo, New York
Study site
Burlington, Vermont
Study site
Charleston, South Carolina
Study site
Columbus, Ohio
Study site
Detroit, Michigan
Study site
Durham, North Carolina
Study site
Hackensack, New Jersey
Study site
Houston, Texas
Study site
Indianapolis, Indiana
Study site
Iowa City, Iowa
Study site
Jefferson City, Missouri
Study site
La Jolla, California
Study site
Lebanon, New Hampshire
Study site
Morgantown, West Virginia
Study site
New York, New York
Study site
Orlando, Florida
Study site
Rochester, Minnesota
Study site
Seattle, Washington
Study site
St Louis, Missouri
Study site
Syracuse, New York
Study site
Tampa, Florida
Study site
Toledo, Ohio
Brazil11 sites
Study site
Belo Horizonte
Study site
Campianas
Study site
Caxias do Sul
Study site
Curitiba
Study site
Goiânia
Study site
Porto Alegre
Study site
Porto Alegre/rs
Study site
Rio de Janeiro
Study site
Salvador
Study site
São Paulo
Study site
SAO Paulo - SP
Italy10 sites
Study site
Bari
Study site
Bologna
Study site
Cagliari
Study site
Florence
Study site
Meldola
Study site
Modena
Study site
Ravenna
Study site
Rimini
Study site
Roma
Study site
Torino
Germany8 sites
Study site
Berlin
Study site
Essen
Study site
Freiburg im Breisgau
Study site
Göttingen
Study site
Homburg/saar
Study site
Mainz
Study site
München
Study site
Ulm
Spain7 sites
Study site
Barcelona
Study site
Girona
Study site
Madrid
Study site
Pamplona
Study site
Salamanca
Study site
Seville
Study site
Valencia
United Kingdom7 sites
Study site
Birmingham
Study site
Cardiff
Study site
Liverpool
Study site
Manchester
Study site
Newcastle upon Tyne
Study site
Southampton
Study site
Truro
Belgium6 sites
Study site
Bruges
Study site
Brussels
Study site
Ghent
Study site
Kortrijk
Study site
Turnhout
Study site
Yvoir
France6 sites
Study site
Bordeaux
Study site
Marseille
Study site
Paris
Study site
Pessac
Study site
Pierre-Bénite
Study site
Tours
Israel6 sites
Study site
Beersheba
Study site
Haifa
Study site
Jerusalem
Study site
Petah Tikva
Study site
Ramat Gan
Study site
Tel Aviv
Poland6 sites
Study site
Bydgoszcz
Study site
Chorzów
Study site
Krakow
Study site
Lodz
Study site
Warsaw
Study site
Wroclaw
Australia5 sites
Study site
Adelaide
Study site
Concord
Study site
Gosford
Study site
Hobart
Study site
St Leonards
Mexico5 sites
Study site
Durango Durango
Study site
México
Study site
Monterrey
Study site
Monterrey Nuevo LEON
Study site
San Luis Potosí City
Turkey (Türkiye)5 sites
Study site
Ankara
Study site
Denizli
Study site
Istanbul
Study site
Kayseri
Study site
Samsun
Austria4 sites
Study site
Graz
Study site
Innsbruck
Study site
Salzburg
Study site
Vienna
Egypt4 sites
Study site
Alexandria
Study site
BENI SWEF
Study site
Cairo
Study site
Dakahlia
Hungary4 sites
Study site
Budapest
Study site
Debrecen
Study site
Kaposvár
Study site
Pécs
Russia4 sites
Study site
Chelyabinsk
Study site
Moscow
Study site
Petrozavodsk
Study site
Saint Petersburg
New Zealand3 sites
Study site
Auckland
Study site
Christchurch
Study site
Takapuna
About this study
Official title: A Phase 3, Randomized, Two-Arm, Open-Label, Multicenter, International Trial of Alisertib (MLN8237) or Investigator's Choice (Selected Single Agent) in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma
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.
Read the detailed description
The drug being tested in this study was Alisertib. Alisertib was tested to treat people who have relapsed/refractory peripheral T-cell lymphoma (PTCL).
This study evaluated alisertib for the improvement in overall response rate (ORR) compared with single-agent treatment, as selected by the investigator from the offered options of pralatrexate, romidepsin (US only), or gemcitabine, in participants with relapsed or refractory PTCL.
The study enrolled 271 patients. Participants were randomized (1:1) to one of 2 treatment arms:
- Alisertib
- Investigator's choice (Pralatrexate, Romidepsin, or Gemcitabine)
This multi-center trial was conducted worldwide. The overall time to participate in this study was approximately 5 years. Participants made multiple visits to the clinic, and then were contacted by telephone up to 42-months after the last participant was randomized, or until death, for follow-up assessment.
- Being tested
- Alisertib, Pralatrexate, Gemcitabine, Romidepsin
- Keywords
- Drug Therapy
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlisertibDrug
Alisertib enteric coated tablets
PralatrexateDrug
Pralatrexate IV infusion
GemcitabineDrug
Gemcitabine IV infusion
RomidepsinDrug
Romidepsin IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Alisertib | Experimental | Alisertib 50 mg, enteric-coated tablet formulation, orally, twice daily for 7 consecutive days (Cycle Days 1-7) in a 21-day cycle (Up to 148 Weeks). Receives: Drug: Alisertib |
| Pralatrexate, or Romidepsin, or Gemcitabine | Active comparator | Pralatrexate 30 mg/m^2, intravenous (IV) push over 3 to 5 minutes, once weekly, for 6 weeks in 7-week cycles with concurrent vitamin B12 and folic acid supplementation. Cycles were repeated every 7-weeks provided the participant continued to benefit from and tolerate the therapy (Up to 115 Weeks), or Gemcitabine 1,000 mg/m^2 over 30 minutes, intravenously, on Days 1, 8, and 15 of a 28-day cycle until the absence of disease progression or unacceptable toxicity (Up to 32 Weeks), or Romidepsin 14 mg/m^2, intravenously over a 4-hour period, on Days 1, 8, and 15 of a 28-cycle. Cycles were repeated every 28 days provided the patient continued to benefit from and tolerate the therapy (Up to 30 Weeks). Receives: Drug: Pralatrexate; Drug: Gemcitabine; Drug: Romidepsin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR) Based on Independent Review Committee (IRC) Assessment
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.
Measured: 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
Progression-Free Survival (PFS) Based on IRC Assessment
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.
Measured: 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
Secondary outcomes (11)
Overall Survival (OS)
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.
Measured: 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)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
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.
Measured: First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks)
Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs
Clinical laboratory tests included chemistry, hematology and urinalysis test. Clinically significant treatment-emergent laboratory abnormalities were reported by the investigator as TEAEs.
Measured: First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks)
Number of Participants With Clinically Important Vital Sign Measurements Reported as AEs
Vital signs included blood pressure, heart rate and temperature. Individual clinically significant changes in vital signs were reported by the investigator as TEAEs.
Measured: First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks)
Complete Response (CR) Rate
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.
Measured: 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)
Time to Disease Progression (TTP)
Time to Progression (TTP) was defined as the time from the date of randomization to the date of first documentation of PD/relapse.
Measured: 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
Duration of Response (DOR)
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.
Measured: 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
Time to Response is defined as the time from the date of randomization to the date of first documentation of PR or better.
Measured: 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 Subsequent Antineoplastic Therapy
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.
Measured: From date of last study drug to date of subsequent antineoplastic therapy, if required; approximately 3 years
Plasma Concentration-time Data to Contribute to Future Population Pharmacokinetics (PK) Analysis
Measured: Cycle 1, Days 1 and 7; Cycle 2, Day 8; Cycle 3, Day 8; Cycle 4, Day 8. Duration is approximately 4 months.
Change Form Baseline in Reported Symptoms and Quality of Life (QoL) Assessment Per Functional Assessment of Cancer Therapy-Lymphoma (FACT-LYM) for Functioning and Symptoms
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 well-being and a positive change from Baseline indicates improvement.
Measured: Baseline and End of Treatment (EOT) (Up to 152 Weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study start11 Jun 2012
- Primary completion30 Jun 2015
- Study completion18 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsed Peripheral T-Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Takeda Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01482962
- Sponsor's protocol ID
- C14012
- Other IDs
- 2011-003545-18, DRKS00004503, NL39566.068.12, U1111-1181-8218
- Status last verified
- Jul 2018
- First submitted
- 28 Nov 2011
- Last updated
- 31 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
O'Connor OA, Ozcan M, Jacobsen ED, Roncero JM, Trotman J, Demeter J, Masszi T, Pereira J, Ramchandren R, Beaven A, Caballero D, Horwitz SM, Lennard A, Turgut M, Hamerschlak N, d'Amore FA, Foss F, Kim WS, Leonard JP, Zinzani PL, Chiattone CS, Hsi ED, Trumper L, Liu H, Sheldon-Waniga E, Ullmann CD, Venkatakrishnan K, Leonard EJ, Shustov AR; Lumiere Study Investigators. Randomized Phase III Study of Alisertib or Investigator's Choice (Selected Single Agent) in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma. J Clin Oncol. 2019 Mar 10;37(8):613-623. doi: 10.1200/JCO.18.00899. Epub 2019 Feb 1.
PubMed 30707661
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Two-Arm, Open-Label, Multicenter, International Trial of Alisertib (MLN8237) or Investigator's Choice (Selected Single Agent) in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT01482962
- Acronym / sponsor ID
- C14012
- Keywords
- Drug Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Jun 2012 (actual)
- Primary completion
- 30 Jun 2015 (actual)
- Study completion
- 18 Dec 2017 (actual)
- First posted
- 1 Dec 2011 (estimated)
- Results
- Posted 31 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The drug being tested in this study was Alisertib. Alisertib was tested to treat people who have relapsed/refractory peripheral T-cell lymphoma (PTCL).
This study evaluated alisertib for the improvement in overall response rate (ORR) compared with single-agent treatment, as selected by the investigator from the offered options of pralatrexate, romidepsin (US only), or gemcitabine, in participants with relapsed or refractory PTCL.
The study enrolled 271 patients. Participants were randomized (1:1) to one of 2 treatment arms:
- Alisertib
- Investigator's choice (Pralatrexate, Romidepsin, or Gemcitabine)
This multi-center trial was conducted worldwide. The overall time to participate in this study was approximately 5 years. Participants made multiple visits to the clinic, and then were contacted by telephone up to 42-months after the last participant was randomized, or until death, for follow-up assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alisertib | Experimental | Drug: AlisertibAlisertib 50 mg, enteric-coated tablet formulation, orally, twice daily for 7 consecutive days (Cycle Days 1-7) in a 21-day cycle (Up to 148 Weeks). |
| Pralatrexate, or Romidepsin, or Gemcitabine | Active comparator | Drug: Pralatrexate, Drug: Gemcitabine, Drug: RomidepsinPralatrexate 30 mg/m^2, intravenous (IV) push over 3 to 5 minutes, once weekly, for 6 weeks in 7-week cycles with concurrent vitamin B12 and folic acid supplementation. Cycles were repeated every 7-weeks provided the participant continued to benefit from and tolerate the therapy (Up to 115 Weeks), or Gemcitabine 1,000 mg/m^2 over 30 minutes, intravenously, on Days 1, 8, and 15 of a 28-day cycle until the absence of disease progression or unacceptable toxicity (Up to 32 Weeks), or Romidepsin 14 mg/m^2, intravenously over a 4-hour period, on Days 1, 8, and 15 of a 28-cycle. Cycles were repeated every 28 days provided the patient continued to benefit from and tolerate the therapy (Up to 30 Weeks). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female participants age 18 or older
- Participants with Peripheral T cell lymphoma (PTCL) (selected subtypes) according to World Health Organization (WHO) criteria and have relapsed or are refractory to at least 1 prior systemic, cytotoxic therapy for PTCL. Participants must have received conventional therapy as a prior therapy. Cutaneous-only disease is not permitted. Participants must have documented evidence of progressive and measurable disease.
- Tumor biopsy available for central hematopathologic review
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Female participants who are post menopausal for at least 1 year, surgically sterile, or agree to practice 2 effective methods of contraception through 30 days after the last dose of study drug or agree to abstain from heterosexual intercourse.
Key exclusion criteria (16 listed)
- Known central nervous system lymphoma
- Systemic antineoplastic therapy, immunotherapy, investigational agent or radiation therapy within 4 weeks of first dose of study treatment or concomitant use during study
- Prior administration of an Aurora A kinase-targeted agent, including alisertib; or all of the 3 comparator drugs (pralatrexate, or romidepsin or gemcitabine; or known hypersensitivity)
- History of uncontrolled sleep apnea syndrome or other conditions that could result in excessive daytime sleepiness
- Cardiac condition as specified in study protocol, including left ventricular ejection fraction (LVEF) <40%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlisertibAlisertib enteric coated tablets | Drug | Alisertib |
| PralatrexatePralatrexate IV infusion | Drug | Pralatrexate, or Romidepsin, or Gemcitabine |
| GemcitabineGemcitabine IV infusion | Drug | Pralatrexate, or Romidepsin, or Gemcitabine |
| RomidepsinRomidepsin IV infusion | Drug | Pralatrexate, or Romidepsin, or Gemcitabine |
Primary outcome
Overall Response Rate (ORR) Based on Independent Review Committee (IRC) Assessment
Time frame: 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.
Progression-Free Survival (PFS) Based on IRC Assessment
Time frame: 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.
11 secondary outcomes
Overall Survival (OS)
Time frame: 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)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks)
Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs
Time frame: First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks)
Number of Participants With Clinically Important Vital Sign Measurements Reported as AEs
Time frame: First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks)
Complete Response (CR) Rate
Time frame: 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)
Time to Disease Progression (TTP)
Time frame: 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
Duration of Response (DOR)
Time frame: 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
Time frame: 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 Subsequent Antineoplastic Therapy
Time frame: From date of last study drug to date of subsequent antineoplastic therapy, if required; approximately 3 years
Plasma Concentration-time Data to Contribute to Future Population Pharmacokinetics (PK) Analysis
Time frame: Cycle 1, Days 1 and 7; Cycle 2, Day 8; Cycle 3, Day 8; Cycle 4, Day 8. Duration is approximately 4 months.
Change Form Baseline in Reported Symptoms and Quality of Life (QoL) Assessment Per Functional Assessment of Cancer Therapy-Lymphoma (FACT-LYM) for Functioning and Symptoms
Time frame: Baseline and End of Treatment (EOT) (Up to 152 Weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30707661O'Connor OA, Ozcan M, Jacobsen ED, Roncero JM, Trotman J, Demeter J, Masszi T, Pereira J, Ramchandren R, Beaven A, Caballero D, Horwitz SM, Lennard A, Turgut M, Hamerschlak N, d'Amore FA, Foss F, Kim WS, Leonard JP, Zinzani PL, Chiattone CS, Hsi ED, Trumper L, Liu H, Sheldon-Waniga E, Ullmann CD, Venkatakrishnan K, Leonard EJ, Shustov AR; Lumiere Study Investigators. Randomized Phase III Study of Alisertib or Investigator's Choice (Selected Single Agent) in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma. J Clin Oncol. 2019 Mar 10;37(8):613-623. doi: 10.1200/JCO.18.00899. Epub 2019 Feb 1.
Related trials for Relapsed Peripheral T-Cell Lymphoma
Active, not recruitingObservational study
Multi-omics Profiling of Relapsed Extranodal Natural Killer (NK)/T-cell Lymphoma
Extranodal NK/T-cell Lymphoma, Nasal Type
RecruitingPhase 1/2
A Platform Trial Evaluating New Drugs or Combination in R/R Peripheral T-cell Lymphomas
Peripheral T Cells Lymphoma (PTCL), Follicular Helper T-Cell Lymphoma
Active, not recruitingPhase 2
Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)
Relapsed/Refractory Peripheral T-Cell Lymphoma, Adult T Cell Leukemia/Lymphoma
Not yet recruitingPhase 2
Zilovertamab Vedotin and Lenalidomide (ZiVLen) Therapy for Relapsed/Refractory Peripheral T-Cell Lymphoma
Peripheral T-Cell Lymphoma Refractory
RecruitingPhase 1
Belinostat in Combination With Azacitidine or Pralatrexate for the Treatment of Relapse or Refractory T-cell Lymphoma
Recurrent Anaplastic Large Cell Lymphoma, Recurrent Enteropathy-Associated T-Cell Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Takeda Oncology
151 sites in 31 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alisertib, Pralatrexate and Gemcitabine in people with Relapsed Peripheral T-Cell Lymphoma and Refractory Peripheral T-Cell Lymphoma, run by Millennium Pharmaceuticals, Inc. at 151 sites in 31 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 151 sites in United States, Brazil, Italy, Germany, Spain and 26 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) Based on Independent Review Committee (IRC) Assessment (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01482962, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2018.