ID

37009

Beskrivning

Study of Tipifarnib in Subjects With Relapsed or Refractory Peripheral T-Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT02464228

Länk

https://clinicaltrials.gov/show/NCT02464228

Nyckelord

Versioner (1)
  1. 2019-06-29 2019-06-29 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

29 juni 2019

DOI

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Creative Commons BY 4.0
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Eligibility Relapsed Peripheral T-Cell Lymphoma NCT02464228

Engelsk

Eligibility Relapsed Peripheral T-Cell Lymphoma NCT02464228

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of ptcl according to the most recent edition of the world health organization (who) classification of tumors of hematopoietic or lymphoid tissues, as follows:
Beskrivning

Peripheral T-Cell Lymphoma WHO tumor classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079774
UMLS CUI [1,2]
C1301142
1. anaplastic large cell lymphoma (alcl), alk positive
Beskrivning

ALK-positive anaplastic large cell lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C1332079
2. alcl, alk negative
Beskrivning

Anaplastic large cell lymphoma, ALK negative

Datatyp

boolean

Alias
UMLS CUI [1]
C1332078
3. angioimmunoblastic t-cell lymphoma (aitl)
Beskrivning

Angioimmunoblastic T-cell lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0020981
4. enteropathy-associated t-cell lymphoma
Beskrivning

Enteropathy-Associated T-Cell Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0456889
5. extranodal natural killer (nk) t-cell lymphoma, nasal type
Beskrivning

Nasal Type Extranodal NK/T-Cell Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0392788
6. hepatosplenic t-cell lymphoma
Beskrivning

Hepatosplenic T-cell lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C1333984
7. peripheral t-cell lymphoma, no otherwise specified (nos)
Beskrivning

Peripheral T-Cell Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0079774
8. subcutaneous panniculitis-like t-cell lymphoma
Beskrivning

Subcutaneous panniculitis-like T-cell lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0522624
relapsed or are refractory to at least 1 prior systemic cytotoxic therapy. -subjects must have received conventional therapy as a prior therapy.
Beskrivning

Cytotoxic Chemotherapy Systemic Quantity | Disease recurrence | Refractory Disease | Conventional Treatment Previous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C0679254
UMLS CUI [3]
C1514815
UMLS CUI [4,1]
C2945704
UMLS CUI [4,2]
C0205156
ecog performance status of 0-2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
acceptable liver and renal function
Beskrivning

Liver function | Renal function

Datatyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
acceptable hematologic status
Beskrivning

Hematologic function

Datatyp

boolean

Alias
UMLS CUI [1]
C0221130
female subjects must be either:
Beskrivning

Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
1. of non-child-bearing potential (surgically sterilized or at least 2 years post-menopausal); or
Beskrivning

Childbearing Potential Absent | Female Sterilization | Postmenopausal state

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0015787
UMLS CUI [3]
C0232970
2. if of child-bearing potential, subject must use an adequate method of contraception consisting of two-barrier method or one barrier method with a spermicide or intrauterine device. both females and male subjects with female partners of child-bearing potential must agree to use an adequate method of contraception for 2 weeks prior to screening, during, and at least 4 weeks after last dose of trial medication. female subjects must have a negative serum or urine pregnancy test within 72 hours prior to start of trial medication.
Beskrivning

Childbearing Potential Contraceptive methods | Barrier Contraception Double | Contraception, Barrier | Spermatocidal Agents | Intrauterine Devices | Gender Partner Childbearing Potential | Gender Contraceptive methods | Gender Serum pregnancy test negative | Gender Urine pregnancy test negative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0004764
UMLS CUI [2,2]
C0205173
UMLS CUI [3]
C0004764
UMLS CUI [4]
C0037862
UMLS CUI [5]
C0021900
UMLS CUI [6,1]
C0079399
UMLS CUI [6,2]
C0682323
UMLS CUI [6,3]
C3831118
UMLS CUI [7,1]
C0079399
UMLS CUI [7,2]
C0700589
UMLS CUI [8,1]
C0079399
UMLS CUI [8,2]
C0430061
UMLS CUI [9,1]
C0079399
UMLS CUI [9,2]
C0430057
3. not breast feeding at any time during the study.
Beskrivning

Breast Feeding Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006147
UMLS CUI [1,2]
C0332197
written and voluntary informed consent.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
diagnosis of any of the following:
Beskrivning

Diagnosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0011900
1. precursor t-cell lymphoma or leukemia
Beskrivning

Precursor T-cell lymphoblastic lymphoma | Precursor T-Cell Lymphoblastic Leukemia

Datatyp

boolean

Alias
UMLS CUI [1]
C1292758
UMLS CUI [2]
C1961099
2. adult t-cell lymphoma/leukemia (atll)
Beskrivning

Adult T-Cell Lymphoma/Leukemia

Datatyp

boolean

Alias
UMLS CUI [1]
C0023493
3. t-cell prolymphocytic leukemia
Beskrivning

T-Cell Prolymphocytic Leukemia

Datatyp

boolean

Alias
UMLS CUI [1]
C2363142
4. t-cell large granular lymphocytic leukemia
Beskrivning

T-Cell Large Granular Lymphocyte Leukemia

Datatyp

boolean

Alias
UMLS CUI [1]
C1955861
5. primary cutaneous type anaplastic large cell lymphoma
Beskrivning

Primary Cutaneous Anaplastic Large Cell Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C1301362
6. mycosis fungoide/sezary syndrome
Beskrivning

Mycosis Fungoides | Sezary Syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C0026948
UMLS CUI [2]
C0036920
ongoing treatment with an anticancer agent not contemplated in this protocol.
Beskrivning

Antineoplastic Agents | Exception Study Protocol

Datatyp

boolean

Alias
UMLS CUI [1]
C0003392
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2348563
any history of clinically relevant coronary artery disease or myocardial infarction within the last 3 years.
Beskrivning

Coronary Artery Disease | Myocardial Infarction

Datatyp

boolean

Alias
UMLS CUI [1]
C1956346
UMLS CUI [2]
C0027051
known central nervous system lymphoma.
Beskrivning

Central nervous system lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0742472
stem cell transplant less than 3 months prior to enrolment.
Beskrivning

Stem cell transplant

Datatyp

boolean

Alias
UMLS CUI [1]
C1504389
non-tolerable > grade 2 neuropathy or evidence of unstable neurological symptoms within 4 weeks of cycle 1 day 1.
Beskrivning

Neuropathy CTCAE Grades | Neurologic Symptoms Unstable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C0235031
UMLS CUI [2,2]
C0443343
major surgery, other than diagnostic surgery, within 2 weeks prior to cycle 1 day 1, without complete recovery.
Beskrivning

Major surgery | Exception Diagnostic surgical procedure | Complete Recovery Lacking

Datatyp

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0522769
UMLS CUI [3,1]
C2826210
UMLS CUI [3,2]
C0332268
other active malignancy requiring therapy such as radiation, chemotherapy, or immunotherapy.
Beskrivning

Cancer Other Treatment required for | Therapeutic radiology procedure | Chemotherapy | Immunotherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0332121
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0392920
UMLS CUI [4]
C0021083
active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy. known infection with hiv, or an active infection with hepatitis b or hepatitis c.
Beskrivning

Bacterial Infections Uncontrolled | Virus Diseases Uncontrolled | Mycoses Uncontrolled | Requirement Systemic therapy | HIV Infection | Hepatitis B | Hepatitis C

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004623
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0042769
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0026946
UMLS CUI [3,2]
C0205318
UMLS CUI [4,1]
C1514873
UMLS CUI [4,2]
C1515119
UMLS CUI [5]
C0019693
UMLS CUI [6]
C0019163
UMLS CUI [7]
C0019196
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Similar models

Eligibility Relapsed Peripheral T-Cell Lymphoma NCT02464228

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Peripheral T-Cell Lymphoma WHO tumor classification
Item
diagnosis of ptcl according to the most recent edition of the world health organization (who) classification of tumors of hematopoietic or lymphoid tissues, as follows:
boolean
C0079774 (UMLS CUI [1,1])
C1301142 (UMLS CUI [1,2])
ALK-positive anaplastic large cell lymphoma
Item
1. anaplastic large cell lymphoma (alcl), alk positive
boolean
C1332079 (UMLS CUI [1])
Anaplastic large cell lymphoma, ALK negative
Item
2. alcl, alk negative
boolean
C1332078 (UMLS CUI [1])
Angioimmunoblastic T-cell lymphoma
Item
3. angioimmunoblastic t-cell lymphoma (aitl)
boolean
C0020981 (UMLS CUI [1])
Enteropathy-Associated T-Cell Lymphoma
Item
4. enteropathy-associated t-cell lymphoma
boolean
C0456889 (UMLS CUI [1])
Nasal Type Extranodal NK/T-Cell Lymphoma
Item
5. extranodal natural killer (nk) t-cell lymphoma, nasal type
boolean
C0392788 (UMLS CUI [1])
Hepatosplenic T-cell lymphoma
Item
6. hepatosplenic t-cell lymphoma
boolean
C1333984 (UMLS CUI [1])
Peripheral T-Cell Lymphoma
Item
7. peripheral t-cell lymphoma, no otherwise specified (nos)
boolean
C0079774 (UMLS CUI [1])
Subcutaneous panniculitis-like T-cell lymphoma
Item
8. subcutaneous panniculitis-like t-cell lymphoma
boolean
C0522624 (UMLS CUI [1])
Cytotoxic Chemotherapy Systemic Quantity | Disease recurrence | Refractory Disease | Conventional Treatment Previous
Item
relapsed or are refractory to at least 1 prior systemic cytotoxic therapy. -subjects must have received conventional therapy as a prior therapy.
boolean
C0677881 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0679254 (UMLS CUI [2])
C1514815 (UMLS CUI [3])
C2945704 (UMLS CUI [4,1])
C0205156 (UMLS CUI [4,2])
ECOG performance status
Item
ecog performance status of 0-2
boolean
C1520224 (UMLS CUI [1])
Liver function | Renal function
Item
acceptable liver and renal function
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
Hematologic function
Item
acceptable hematologic status
boolean
C0221130 (UMLS CUI [1])
Gender
Item
female subjects must be either:
boolean
C0079399 (UMLS CUI [1])
Childbearing Potential Absent | Female Sterilization | Postmenopausal state
Item
1. of non-child-bearing potential (surgically sterilized or at least 2 years post-menopausal); or
boolean
C3831118 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0015787 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
Childbearing Potential Contraceptive methods | Barrier Contraception Double | Contraception, Barrier | Spermatocidal Agents | Intrauterine Devices | Gender Partner Childbearing Potential | Gender Contraceptive methods | Gender Serum pregnancy test negative | Gender Urine pregnancy test negative
Item
2. if of child-bearing potential, subject must use an adequate method of contraception consisting of two-barrier method or one barrier method with a spermicide or intrauterine device. both females and male subjects with female partners of child-bearing potential must agree to use an adequate method of contraception for 2 weeks prior to screening, during, and at least 4 weeks after last dose of trial medication. female subjects must have a negative serum or urine pregnancy test within 72 hours prior to start of trial medication.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0004764 (UMLS CUI [2,1])
C0205173 (UMLS CUI [2,2])
C0004764 (UMLS CUI [3])
C0037862 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
C0079399 (UMLS CUI [6,1])
C0682323 (UMLS CUI [6,2])
C3831118 (UMLS CUI [6,3])
C0079399 (UMLS CUI [7,1])
C0700589 (UMLS CUI [7,2])
C0079399 (UMLS CUI [8,1])
C0430061 (UMLS CUI [8,2])
C0079399 (UMLS CUI [9,1])
C0430057 (UMLS CUI [9,2])
Breast Feeding Absent
Item
3. not breast feeding at any time during the study.
boolean
C0006147 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Informed Consent
Item
written and voluntary informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diagnosis
Item
diagnosis of any of the following:
boolean
C0011900 (UMLS CUI [1])
Precursor T-cell lymphoblastic lymphoma | Precursor T-Cell Lymphoblastic Leukemia
Item
1. precursor t-cell lymphoma or leukemia
boolean
C1292758 (UMLS CUI [1])
C1961099 (UMLS CUI [2])
Adult T-Cell Lymphoma/Leukemia
Item
2. adult t-cell lymphoma/leukemia (atll)
boolean
C0023493 (UMLS CUI [1])
T-Cell Prolymphocytic Leukemia
Item
3. t-cell prolymphocytic leukemia
boolean
C2363142 (UMLS CUI [1])
T-Cell Large Granular Lymphocyte Leukemia
Item
4. t-cell large granular lymphocytic leukemia
boolean
C1955861 (UMLS CUI [1])
Primary Cutaneous Anaplastic Large Cell Lymphoma
Item
5. primary cutaneous type anaplastic large cell lymphoma
boolean
C1301362 (UMLS CUI [1])
Mycosis Fungoides | Sezary Syndrome
Item
6. mycosis fungoide/sezary syndrome
boolean
C0026948 (UMLS CUI [1])
C0036920 (UMLS CUI [2])
Antineoplastic Agents | Exception Study Protocol
Item
ongoing treatment with an anticancer agent not contemplated in this protocol.
boolean
C0003392 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
Coronary Artery Disease | Myocardial Infarction
Item
any history of clinically relevant coronary artery disease or myocardial infarction within the last 3 years.
boolean
C1956346 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
Central nervous system lymphoma
Item
known central nervous system lymphoma.
boolean
C0742472 (UMLS CUI [1])
Stem cell transplant
Item
stem cell transplant less than 3 months prior to enrolment.
boolean
C1504389 (UMLS CUI [1])
Neuropathy CTCAE Grades | Neurologic Symptoms Unstable
Item
non-tolerable > grade 2 neuropathy or evidence of unstable neurological symptoms within 4 weeks of cycle 1 day 1.
boolean
C0442874 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0235031 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
Major surgery | Exception Diagnostic surgical procedure | Complete Recovery Lacking
Item
major surgery, other than diagnostic surgery, within 2 weeks prior to cycle 1 day 1, without complete recovery.
boolean
C0679637 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0522769 (UMLS CUI [2,2])
C2826210 (UMLS CUI [3,1])
C0332268 (UMLS CUI [3,2])
Cancer Other Treatment required for | Therapeutic radiology procedure | Chemotherapy | Immunotherapy
Item
other active malignancy requiring therapy such as radiation, chemotherapy, or immunotherapy.
boolean
C1707251 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C0021083 (UMLS CUI [4])
Bacterial Infections Uncontrolled | Virus Diseases Uncontrolled | Mycoses Uncontrolled | Requirement Systemic therapy | HIV Infection | Hepatitis B | Hepatitis C
Item
active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy. known infection with hiv, or an active infection with hepatitis b or hepatitis c.
boolean
C0004623 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0042769 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0026946 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C1514873 (UMLS CUI [4,1])
C1515119 (UMLS CUI [4,2])
C0019693 (UMLS CUI [5])
C0019163 (UMLS CUI [6])
C0019196 (UMLS CUI [7])
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