ID

24032

Description

Responsible Party: Millennium Pharmaceuticals, Inc. ClinicalTrials.gov Identifier: NCT01482962 History of Changes Other Study ID Numbers: C14012 2011-003545-18 ( EudraCT Number ) DRKS00004503 ( Registry Identifier: Germany (DRKS) ) NL39566.068.12 ( Registry Identifier: Netherlands (CCMO) ) U1111-1181-8218 ( Registry Identifier: WHO ) Study First Received: November 28, 2011 Last Updated: March 30, 2017 Alisertib (MLN8237) or Investigator's Choice in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma ODM derived from: https://clinicaltrials.gov/ct2/show/NCT01482962

Link

https://clinicaltrials.gov/ct2/show/NCT01482962

Keywords

Versions (1)
  1. 7/23/17 7/23/17 -
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July 23, 2017

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Creative Commons BY 4.0
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Eligibility Peripheral T-Cell Lymphoma NCT01482962 DRKS00004503

English

Eligibility Peripheral T-Cell Lymphoma NCT01482962 DRKS00004503

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Male or female patients age 18 or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Patients with PTCL according to World Health Organization (WHO) criteria and have relapsed or are refractory to at least 1 prior systemic, cytoxic therapy for PTCL. Patients must have received conventional therapy as a prior therapy. Cutaneous-only disease is no permitted. Patients must have documented evidence of progressive disease.
Description

Peripheral T-Cell Lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0079774
Tumor biopsy available for central hematopathologic review
Description

Tumor biopsy

Data type

boolean

Alias
UMLS CUI [1]
C0677862
Measurable disease according to the IWG criteria
Description

Measurable disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Description

ECOG Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Female patients 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.
Description

Contraceptive Methods

Data type

boolean

Alias
UMLS CUI [1]
C0700589
Male patients who agree to practice effective barrier contraception through 6 months after the last dose of alisertib or agree to abstain from heterosexual intercourse
Description

Barrier contraception

Data type

boolean

Alias
UMLS CUI [1]
C0004764
Suitable venous access
Description

Venous access

Data type

boolean

Alias
UMLS CUI [1]
C0750164
Voluntary written consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Known central nervous system lymphoma
Description

CNS lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0280803
Systemic antineoplastic therapy, immunotherapy, investigational agent or radiation therapy within 4 weeks of first dose of study treatment or concomitant use during study
Description

Antineoplastic Therapy

Data type

boolean

Alias
UMLS CUI [1]
C2346834
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)
Description

Aurora A kinase-targeted agent

Data type

boolean

Alias
UMLS CUI [1,1]
C0971285
UMLS CUI [1,2]
C2985566
History of uncontrolled sleep apnea syndrome or other conditions that could result in excessive daytime sleepiness
Description

Sleep apnea syndromes

Data type

boolean

Alias
UMLS CUI [1]
C0037315
Cardiac condition as specified in study protocol, including left ventricular ejection fraction (LVEF) <40%
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
Concomitant use of other medicines as specified in study protocol
Description

Concomitant Therapy

Data type

boolean

Alias
UMLS CUI [1]
C1707479
Patients with abnormal gastric or bowel function who require continuous treatment with H2-receptor antagonists or proton pump inhibitors
Description

Gastrointestinal function

Data type

boolean

Alias
UMLS CUI [1]
C0516983
Known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C
Description

HIV, HBV, HCV

Data type

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0149709
UMLS CUI [3]
C1112419
Autologous stem cell transplant less than 3 months prior to enrollment
Description

Autologous stem cell transplant

Data type

boolean

Alias
UMLS CUI [1]
C1831743
Patients who have undergone allogeneic stem cell or organ transplantation any time
Description

Allogeneic stem cell or organ transplantation

Data type

boolean

Alias
UMLS CUI [1]
C2242529
UMLS CUI [2]
C0029216
Inadequate blood levels, bone marrow or other organ function as specified in study protocol
Description

Organ Function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
The patient must have recovered to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade ≤ 1 toxicity, to patients's baseline status (except alopecia), or deemed irreversible from the effects of prior cancer therapy
Description

Adverse Event

Data type

boolean

Alias
UMLS CUI [1]
C0877248
Major surgery, serious infection, or infection requiring systemic antibiotic therapy within 14 days prior to the first dose of study treatment
Description

Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
Female patients who are breastfeeding or pregnant
Description

Gynaecological Status

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Coexistent second malignancy or history of prior solid organ malignancy within previous 3 years
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
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
Description

Study Completion

Data type

boolean

Alias
UMLS CUI [1]
C2826674
Healthy Volunteers
Description

Control Group

Data type

boolean

Alias
UMLS CUI [1]
C0009932
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Similar models

Eligibility Peripheral T-Cell Lymphoma NCT01482962 DRKS00004503

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Age
Item
Male or female patients age 18 or older
boolean
C0001779 (UMLS CUI [1])
Peripheral T-Cell Lymphoma
Item
Patients with PTCL according to World Health Organization (WHO) criteria and have relapsed or are refractory to at least 1 prior systemic, cytoxic therapy for PTCL. Patients must have received conventional therapy as a prior therapy. Cutaneous-only disease is no permitted. Patients must have documented evidence of progressive disease.
boolean
C0079774 (UMLS CUI [1])
Tumor biopsy
Item
Tumor biopsy available for central hematopathologic review
boolean
C0677862 (UMLS CUI [1])
Measurable disease
Item
Measurable disease according to the IWG criteria
boolean
C1513041 (UMLS CUI [1])
ECOG Performance Status
Item
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
boolean
C1520224 (UMLS CUI [1])
Contraceptive Methods
Item
Female patients 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.
boolean
C0700589 (UMLS CUI [1])
Barrier contraception
Item
Male patients who agree to practice effective barrier contraception through 6 months after the last dose of alisertib or agree to abstain from heterosexual intercourse
boolean
C0004764 (UMLS CUI [1])
Venous access
Item
Suitable venous access
boolean
C0750164 (UMLS CUI [1])
Informed Consent
Item
Voluntary written consent
boolean
C0021430 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
CNS lymphoma
Item
Known central nervous system lymphoma
boolean
C0280803 (UMLS CUI [1])
Antineoplastic Therapy
Item
Systemic antineoplastic therapy, immunotherapy, investigational agent or radiation therapy within 4 weeks of first dose of study treatment or concomitant use during study
boolean
C2346834 (UMLS CUI [1])
Aurora A kinase-targeted agent
Item
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)
boolean
C0971285 (UMLS CUI [1,1])
C2985566 (UMLS CUI [1,2])
Sleep apnea syndromes
Item
History of uncontrolled sleep apnea syndrome or other conditions that could result in excessive daytime sleepiness
boolean
C0037315 (UMLS CUI [1])
Left ventricular ejection fraction
Item
Cardiac condition as specified in study protocol, including left ventricular ejection fraction (LVEF) <40%
boolean
C0428772 (UMLS CUI [1])
Concomitant Therapy
Item
Concomitant use of other medicines as specified in study protocol
boolean
C1707479 (UMLS CUI [1])
Gastrointestinal function
Item
Patients with abnormal gastric or bowel function who require continuous treatment with H2-receptor antagonists or proton pump inhibitors
boolean
C0516983 (UMLS CUI [1])
HIV, HBV, HCV
Item
Known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C
boolean
C0019699 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C1112419 (UMLS CUI [3])
Autologous stem cell transplant
Item
Autologous stem cell transplant less than 3 months prior to enrollment
boolean
C1831743 (UMLS CUI [1])
Allogeneic stem cell or organ transplantation
Item
Patients who have undergone allogeneic stem cell or organ transplantation any time
boolean
C2242529 (UMLS CUI [1])
C0029216 (UMLS CUI [2])
Organ Function
Item
Inadequate blood levels, bone marrow or other organ function as specified in study protocol
boolean
C0678852 (UMLS CUI [1])
Adverse Event
Item
The patient must have recovered to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade ≤ 1 toxicity, to patients's baseline status (except alopecia), or deemed irreversible from the effects of prior cancer therapy
boolean
C0877248 (UMLS CUI [1])
Comorbidity
Item
Major surgery, serious infection, or infection requiring systemic antibiotic therapy within 14 days prior to the first dose of study treatment
boolean
C0009488 (UMLS CUI [1])
Gynaecological Status
Item
Female patients who are breastfeeding or pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Malignant Neoplasms
Item
Coexistent second malignancy or history of prior solid organ malignancy within previous 3 years
boolean
C0006826 (UMLS CUI [1])
Study Completion
Item
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
boolean
C2826674 (UMLS CUI [1])
Control Group
Item
Healthy Volunteers
boolean
C0009932 (UMLS CUI [1])
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