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Alisertib (MLN8237) or Investigator's Choice in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma

Primary Purpose

Relapsed Peripheral T-Cell Lymphoma, Refractory Peripheral T-Cell Lymphoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Alisertib
Pralatrexate
Gemcitabine
Romidepsin
Sponsored by
Millennium Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed Peripheral T-Cell Lymphoma focused on measuring Drug Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria

  • 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
  • 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Alisertib

Pralatrexate, or Romidepsin, or Gemcitabine

Arm Description

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 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).

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
Plasma Concentration-time Data to Contribute to Future Population Pharmacokinetics (PK) Analysis
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.

Full Information

First Posted
November 28, 2011
Last Updated
July 6, 2018
Sponsor
Millennium Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01482962
Brief Title
Alisertib (MLN8237) or Investigator's Choice in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
June 11, 2012 (Actual)
Primary Completion Date
June 30, 2015 (Actual)
Study Completion Date
December 18, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Millennium Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed Peripheral T-Cell Lymphoma, Refractory Peripheral T-Cell Lymphoma
Keywords
Drug Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
271 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alisertib
Arm Type
Experimental
Arm Description
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).
Arm Title
Pralatrexate, or Romidepsin, or Gemcitabine
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Alisertib
Intervention Description
Alisertib enteric coated tablets
Intervention Type
Drug
Intervention Name(s)
Pralatrexate
Intervention Description
Pralatrexate IV infusion
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Gemcitabine IV infusion
Intervention Type
Drug
Intervention Name(s)
Romidepsin
Intervention Description
Romidepsin IV infusion
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR) Based on Independent Review Committee (IRC) Assessment
Description
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.
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
Title
Progression-Free Survival (PFS) Based on IRC Assessment
Description
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.
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
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
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.
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)
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Description
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.
Time Frame
First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks)
Title
Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs
Description
Clinical laboratory tests included chemistry, hematology and urinalysis test. Clinically significant treatment-emergent laboratory abnormalities were reported by the investigator as TEAEs.
Time Frame
First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks)
Title
Number of Participants With Clinically Important Vital Sign Measurements Reported as AEs
Description
Vital signs included blood pressure, heart rate and temperature. Individual clinically significant changes in vital signs were reported by the investigator as TEAEs.
Time Frame
First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks)
Title
Complete Response (CR) Rate
Description
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.
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)
Title
Time to Disease Progression (TTP)
Description
Time to Progression (TTP) was defined as the time from the date of randomization to the date of first documentation of PD/relapse.
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
Title
Duration of Response (DOR)
Description
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.
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
Title
Time to Response
Description
Time to Response is defined as the time from the date of randomization to the date of first documentation of PR or better.
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
Title
Time to Subsequent Antineoplastic Therapy
Description
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.
Time Frame
From date of last study drug to date of subsequent antineoplastic therapy, if required; approximately 3 years
Title
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.
Title
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
Description
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.
Time Frame
Baseline and End of Treatment (EOT) (Up to 152 Weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Takeda Oncology
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
La Jolla
State/Province
California
Country
United States
City
Orlando
State/Province
Florida
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Iowa City
State/Province
Iowa
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Detroit
State/Province
Michigan
Country
United States
City
Rochester
State/Province
Minnesota
Country
United States
City
Jefferson City
State/Province
Missouri
Country
United States
City
Saint Louis
State/Province
Missouri
Country
United States
City
Lebanon
State/Province
New Hampshire
Country
United States
City
Hackensack
State/Province
New Jersey
Country
United States
City
Buffalo
State/Province
New York
Country
United States
City
New York
State/Province
New York
Country
United States
City
Syracuse
State/Province
New York
Country
United States
City
Durham
State/Province
North Carolina
Country
United States
City
Columbus
State/Province
Ohio
Country
United States
City
Toledo
State/Province
Ohio
Country
United States
City
Charleston
State/Province
South Carolina
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Burlington
State/Province
Vermont
Country
United States
City
Seattle
State/Province
Washington
Country
United States
City
Morgantown
State/Province
West Virginia
Country
United States
City
Adelaide
Country
Australia
City
Concord
Country
Australia
City
Gosford
Country
Australia
City
Hobart
Country
Australia
City
St Leonards
Country
Australia
City
Graz
Country
Austria
City
Innsbruck
Country
Austria
City
Salzburg
Country
Austria
City
Wien
Country
Austria
City
Minsk Didtrict
Country
Belarus
City
Vitebsk
Country
Belarus
City
Brugge
Country
Belgium
City
Brussels
Country
Belgium
City
Gent
Country
Belgium
City
Kortrijk
Country
Belgium
City
Turnhout
Country
Belgium
City
Yvoir
Country
Belgium
City
Belo Horizonte
Country
Brazil
City
Campianas
Country
Brazil
City
Caxias Do Sul
Country
Brazil
City
Curitiba
Country
Brazil
City
Goiania
Country
Brazil
City
Porto Alegre/rs
Country
Brazil
City
Porto Alegre
Country
Brazil
City
Rio de Janeiro
Country
Brazil
City
Salvador
Country
Brazil
City
SAO Paulo - SP
Country
Brazil
City
Sao Paulo
Country
Brazil
City
Pleven
Country
Bulgaria
City
Sofia
Country
Bulgaria
City
Varna
Country
Bulgaria
City
Ottawa
State/Province
Ontario
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada
City
Concepcion
Country
Chile
City
Santiago
Country
Chile
City
Praha 2
Country
Czechia
City
Arhus C
Country
Denmark
City
Kobenhavn O
Country
Denmark
City
Alexandria
Country
Egypt
City
Beni Swef
Country
Egypt
City
Cairo
Country
Egypt
City
Dakahlia
Country
Egypt
City
Bordeaux
Country
France
City
Marseille
Country
France
City
Paris
Country
France
City
Pessac
Country
France
City
Pierre Benite
Country
France
City
Tours
Country
France
City
Berlin
Country
Germany
City
Essen
Country
Germany
City
Freiburg
Country
Germany
City
Goettingen
Country
Germany
City
Homburg/saar
Country
Germany
City
Mainz
Country
Germany
City
Muenchen
Country
Germany
City
Munchen
Country
Germany
City
ULM
Country
Germany
City
Budapest
Country
Hungary
City
Debrecen
Country
Hungary
City
Kaposvar
Country
Hungary
City
Pecs
Country
Hungary
City
Beer-sheva
Country
Israel
City
Haifa
Country
Israel
City
Jerusalem
Country
Israel
City
Petach Tikva
Country
Israel
City
Ramat-gan
Country
Israel
City
Tel Aviv
Country
Israel
City
Bari
Country
Italy
City
Bologna
Country
Italy
City
Cagliari
Country
Italy
City
Firenze
Country
Italy
City
Meldola
Country
Italy
City
Modena
Country
Italy
City
Ravenna
Country
Italy
City
Rimini
Country
Italy
City
Roma
Country
Italy
City
Torino
Country
Italy
City
Durango Durango
Country
Mexico
City
Mexico
Country
Mexico
City
Monterrey Nuevo LEON
Country
Mexico
City
Monterrey
Country
Mexico
City
San Luis Potosi
Country
Mexico
City
Maastricht
Country
Netherlands
City
Nieuwegein
Country
Netherlands
City
Auckland
Country
New Zealand
City
Christchurch
Country
New Zealand
City
Takapuna
Country
New Zealand
City
Arequipa
Country
Peru
City
Lima
Country
Peru
City
Bydgoszcz
Country
Poland
City
Chorzow
Country
Poland
City
Krakow
Country
Poland
City
Lodz
Country
Poland
City
Warszawa
Country
Poland
City
Wroclaw
Country
Poland
City
Braga
Country
Portugal
City
Coimbra
Country
Portugal
City
Porto
Country
Portugal
City
San Juan
Country
Puerto Rico
City
Bucuresti
Country
Romania
City
Chelyabinsk
Country
Russian Federation
City
Moscow
Country
Russian Federation
City
Petrozavodsk
Country
Russian Federation
City
St Petersburg
Country
Russian Federation
City
Bratislava
Country
Slovakia
City
Martin
Country
Slovakia
City
Barcelona
Country
Spain
City
Girona
Country
Spain
City
Madrid
Country
Spain
City
Pamplona
Country
Spain
City
Salamanca
Country
Spain
City
Sevilla
Country
Spain
City
Valencia
Country
Spain
City
Linkoping
Country
Sweden
City
Lund
Country
Sweden
City
Solna
Country
Sweden
City
Ankara
Country
Turkey
City
Denizli
Country
Turkey
City
Istanbul
Country
Turkey
City
Kayseri
Country
Turkey
City
Samsun
Country
Turkey
City
Birmingham
Country
United Kingdom
City
Cardiff
Country
United Kingdom
City
Liverpool
Country
United Kingdom
City
Manchester
Country
United Kingdom
City
Newcastle Upon Tyne
Country
United Kingdom
City
Southampton
Country
United Kingdom
City
Truro
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
30707661
Citation
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.
Results Reference
derived

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Alisertib (MLN8237) or Investigator's Choice in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma

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