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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003545-18 | EudraCT Number | ||
| DRKS00004503 | Registry Identifier | Germany (DRKS) | |
| NL39566.068.12 | Registry Identifier | Netherlands (CCMO) | |
| U1111-1181-8218 | Registry Identifier | WHO |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alisertib | Drug | Alisertib enteric coated tablets |
| |
| Pralatrexate |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Takeda Oncology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30707661 | Derived | 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. |
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Participants with a diagnosis of Relapsed or Refractory Peripheral T-Cell Lymphoma were randomized 1:1 to either alisertib or comparator (investigator's choice of pralatrexate, romidepsin [USA only], or gemcitabine).
Participants took part in the study at 105 investigative sites in the United States including Puerto Rico, Canada, European Union, Russian Federation, Turkey, Israel, Australia, New Zealand and Latin America from 11 June 2012 to the end of study on 18 December 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Alisertib | 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). |
| FG001 | Pralatrexate, or Romidepsin, or Gemcitabine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
Pralatrexate IV infusion |
|
| Gemcitabine | Drug | Gemcitabine IV infusion |
|
| Romidepsin | Drug | Romidepsin IV infusion |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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. | Baseline and End of Treatment (EOT) (Up to 152 Weeks) |
| La Jolla |
| California |
| United States |
| Orlando | Florida | United States |
| Tampa | Florida | United States |
| Indianapolis | Indiana | United States |
| Iowa City | Iowa | United States |
| Boston | Massachusetts | United States |
| Detroit | Michigan | United States |
| Rochester | Minnesota | United States |
| Jefferson City | Missouri | United States |
| St Louis | Missouri | United States |
| Lebanon | New Hampshire | United States |
| Hackensack | New Jersey | United States |
| Buffalo | New York | United States |
| New York | New York | United States |
| Syracuse | New York | United States |
| Durham | North Carolina | United States |
| Columbus | Ohio | United States |
| Toledo | Ohio | United States |
| Charleston | South Carolina | United States |
| Houston | Texas | United States |
| Burlington | Vermont | United States |
| Seattle | Washington | United States |
| Morgantown | West Virginia | United States |
| Adelaide | Australia |
| Concord | Australia |
| Gosford | Australia |
| Hobart | Australia |
| St Leonards | Australia |
| Graz | Austria |
| Innsbruck | Austria |
| Salzburg | Austria |
| Vienna | Austria |
| Minsk Didtrict | Belarus |
| Vitebsk | Belarus |
| Bruges | Belgium |
| Brussels | Belgium |
| Ghent | Belgium |
| Kortrijk | Belgium |
| Turnhout | Belgium |
| Yvoir | Belgium |
| Belo Horizonte | Brazil |
| Campianas | Brazil |
| Caxias do Sul | Brazil |
| Curitiba | Brazil |
| Goiânia | Brazil |
| Porto Alegre | Brazil |
| Porto Alegre/rs | Brazil |
| Rio de Janeiro | Brazil |
| Salvador | Brazil |
| SAO Paulo - SP | Brazil |
| São Paulo | Brazil |
| Pleven | Bulgaria |
| Sofia | Bulgaria |
| Varna | Bulgaria |
| Ottawa | Ontario | Canada |
| Toronto | Ontario | Canada |
| Concepción | Chile |
| Santiago | Chile |
| Prague | Czechia |
| Arhus C | Denmark |
| København Ø | Denmark |
| Alexandria | Egypt |
| BENI SWEF | Egypt |
| Cairo | Egypt |
| Dakahlia | Egypt |
| Bordeaux | France |
| Marseille | France |
| Paris | France |
| Pessac | France |
| Pierre-Bénite | France |
| Tours | France |
| Berlin | Germany |
| Essen | Germany |
| Freiburg im Breisgau | Germany |
| Göttingen | Germany |
| Homburg/saar | Germany |
| Mainz | Germany |
| München | Germany |
| Ulm | Germany |
| Budapest | Hungary |
| Debrecen | Hungary |
| Kaposvár | Hungary |
| Pécs | Hungary |
| Beersheba | Israel |
| Haifa | Israel |
| Jerusalem | Israel |
| Petah Tikva | Israel |
| Ramat Gan | Israel |
| Tel Aviv | Israel |
| Bari | Italy |
| Bologna | Italy |
| Cagliari | Italy |
| Florence | Italy |
| Meldola | Italy |
| Modena | Italy |
| Ravenna | Italy |
| Rimini | Italy |
| Roma | Italy |
| Torino | Italy |
| Durango Durango | Mexico |
| México | Mexico |
| Monterrey | Mexico |
| Monterrey Nuevo LEON | Mexico |
| San Luis Potosí City | Mexico |
| Maastricht | Netherlands |
| Nieuwegein | Netherlands |
| Auckland | New Zealand |
| Christchurch | New Zealand |
| Takapuna | New Zealand |
| Arequipa | Peru |
| Lima | Peru |
| Bydgoszcz | Poland |
| Chorzów | Poland |
| Krakow | Poland |
| Lodz | Poland |
| Warsaw | Poland |
| Wroclaw | Poland |
| Braga | Portugal |
| Coimbra | Portugal |
| Porto | Portugal |
| San Juan | PR | Puerto Rico |
| Bucharest | Romania |
| Chelyabinsk | Russia |
| Moscow | Russia |
| Petrozavodsk | Russia |
| Saint Petersburg | Russia |
| Bratislava | Slovakia |
| Martin | Slovakia |
| Barcelona | Spain |
| Girona | Spain |
| Madrid | Spain |
| Pamplona | Spain |
| Salamanca | Spain |
| Seville | Spain |
| Valencia | Spain |
| Linköping | Sweden |
| Lund | Sweden |
| Solna | Sweden |
| Ankara | Turkey (Türkiye) |
| Denizli | Turkey (Türkiye) |
| Istanbul | Turkey (Türkiye) |
| Kayseri | Turkey (Türkiye) |
| Samsun | Turkey (Türkiye) |
| Birmingham | United Kingdom |
| Cardiff | United Kingdom |
| Liverpool | United Kingdom |
| Manchester | United Kingdom |
| Newcastle upon Tyne | United Kingdom |
| Southampton | United Kingdom |
| Truro | United Kingdom |
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).
| Safety Population: Received Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Alisertib | 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). |
| BG001 | Pralatrexate, or Romidepsin, or Gemcitabine | 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). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Height | Mean | Standard Deviation | cm |
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| Weight | Mean | Standard Deviation | kg |
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| Body Surface Area (BSA) | Body surface area (m^2)=square root [height (cm)*weight (kg)/3600]. | Mean | Standard Deviation | m^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 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 |
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| Primary | 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. | 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. | Posted | Median | 95% Confidence Interval | days | 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 |
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| Secondary | 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. | 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. | Posted | Median | 95% Confidence Interval | days | 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) |
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| Secondary | 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. | 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. | Posted | Number | participants | First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) |
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| Secondary | 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. | 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. | Posted | Number | participants | First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) |
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| Secondary | 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. | 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. | Posted | Number | participants | First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) |
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| Secondary | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 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) |
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| Secondary | 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. | 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. | Posted | Median | 95% Confidence Interval | days | 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 |
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| Secondary | 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. | 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. | Posted | Median | 95% Confidence Interval | days | 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 |
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| Secondary | 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. | 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. | Posted | Median | 95% Confidence Interval | days | 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 |
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| Secondary | 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. | 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. | Posted | Median | 95% Confidence Interval | days | From date of last study drug to date of subsequent antineoplastic therapy, if required; approximately 3 years |
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| Secondary | Plasma Concentration-time Data to Contribute to Future Population Pharmacokinetics (PK) Analysis | This Outcome Measure was registered in error and is not a Primary or Secondary Outcome Measure. | Posted | Cycle 1, Days 1 and 7; Cycle 2, Day 8; Cycle 3, Day 8; Cycle 4, Day 8. Duration is approximately 4 months. |
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| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and End of Treatment (EOT) (Up to 152 Weeks) |
|
First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Alisertib | 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). | 11 | 137 | 75 | 137 | 134 | 137 |
| EG001 | Gemcitabine | 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). | 5 | 29 | 18 | 29 | 29 | 29 |
| EG002 | Pralatrexate | 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). | 8 | 76 | 46 | 76 | 72 | 76 |
| EG003 | Romidepsin | 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). | 2 | 22 | 6 | 22 | 21 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA version 15.0 | Systematic Assessment | One treatment-emergent death occurred during treatment with alisertib and is related. |
|
| Lung infection | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA version 15.0 | Systematic Assessment | One treatment-emergent death occurred during treatment with alisertib and is not related. |
|
| Septic shock | Infections and infestations | MedDRA version 15.0 | Systematic Assessment | Four treatment-emergent deaths occurred during treatment with alisertib, two related and two not related. |
|
| Skin infection | Infections and infestations | MedDRA version 15.0 | Systematic Assessment | One treatment-emergent death occurred during treatment with pralatrexate and is not related. |
|
| Dermatitis infected | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| Epiglottitis | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| Cytomegalovirus chorioretinitis | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| Pseudomonal sepsis | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| Meningitis aseptic | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| Oral infection | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| Pneumonia haemophilus | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| Eczema herpeticum | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Microcytic anaemia | Blood and lymphatic system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA version 15.0 | Systematic Assessment | Three treatment-emergent deaths occurred during treatment with pralatrexate and are not related. |
|
| Multiple organ dysfunction syndrome | General disorders | MedDRA version 15.0 | Systematic Assessment | Two treatment-emergent deaths occurred during treatment, one with alisertib, not related and one with pralatrexate, related. |
|
| Influenza like illness | General disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Hypothermia | General disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Catheter site phlebitis | General disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA version 15.0 | Systematic Assessment | One treatment-emergent death occurred during treatment with gemcitabine and is related. |
|
| Stomatitis | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment | One treatment-emergent death occurred during treatment with gemcitabine and is not related. |
|
| Jejunal perforation | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment | One treatment-emergent death occurred during treatment with pralatrexate and is not related. |
|
| Haematemesis | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment | Two treatment-emergent deaths occurred during treatment, one with alisertib and one with pralatrexate and are not related. |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment | One treatment-emergent death occurred during treatment with gemcitabine and is not related. |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment | One treatment-emergent death occurred during treatment with pralatrexate and is not related. |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Peripheral T-cell lymphoma unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment | Five treatment-emergent deaths occurred during treatment and are not related, two with alisertib, one with gemcitabine, and two with romidepsin. |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment | One treatment-emergent death occurred during treatment with alisertib and is not related. |
|
| Anaplastic large cell lymphoma T- and null-cell types | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment | One treatment-emergent death occurred during treatment with gemcitabine and is not related. |
|
| Atrial fibrillation | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Atrioventricular block second degree | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Cardiomegaly | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Hypophagia | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Carotid artery aneurysm | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Acute prerenal failure | Renal and urinary disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Cystitis haemorrhagic | Renal and urinary disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Cholangitis acute | Hepatobiliary disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Venoocclusive liver disease | Hepatobiliary disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Dermatitis bullous | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Toxic epidermal necrolysis | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Acute generalised exanthematous pustulosis | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Compartment syndrome | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Shock haemorrhagic | Vascular disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Anaphylactoid reaction | Immune system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA version 15.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA version 15.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA version 15.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Staphylococcal skin infection | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
| |
| Adult T-cell lymphoma/leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Lymph node pain | Blood and lymphatic system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA version 15.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA version 15.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA version 15.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 15.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA version 15.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version 15.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA version 15.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA version 15.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA version 15.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| Mucosal infection | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
|
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C550258 | MLN 8237 |
| C418863 | 10-propargyl-10-deazaaminopterin |
| D000093542 | Gemcitabine |
| C087123 | romidepsin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| Asian |
|
| Other |
|
| Not Reported |
|
| Austria |
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| Belgium |
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| Brazil |
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| Bulgaria |
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| Canada |
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| Czech Republic |
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| Denmark |
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| France |
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| Germany |
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| Hungary |
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| Israel |
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| Italy |
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| Mexico |
|
| Netherlands |
|
| New Zealand |
|
| Peru |
|
| Poland |
|
| Portugal |
|
| Puerto Rico |
|
| Romania |
|
| Russia |
|
| Spain |
|
| Sweden |
|
| Turkey |
|
| United Kingdom |
|
| United States |
|
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