ID

21381

Description

Clinical Evaluation of Nelarabine (506U78)in Japanese Patients With Leukemia or Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00406757

Link

https://clinicaltrials.gov/show/NCT00406757

Keywords

Versions (1)
  1. 4/18/17 4/18/17 -
Uploaded on

April 18, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Leukaemia, Lymphoblastic, Acute and Lymphoma, Lymphoblastic NCT00406757

English

Eligibility Leukaemia, Lymphoblastic, Acute and Lymphoma, Lymphoblastic NCT00406757

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologic or cytogenetic documented diagnosis of t-all or t-lbl.
Description

T-Cell Acute Lymphoblastic Leukemia | Lymphoblastic T-cell lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C1961099
UMLS CUI [2]
C2853920
disease that is refractory to at least one prior chemotherapy regimen, or has relapsed following complete remission to at least one prior chemotherapy regimen.
Description

Chemotherapy Regimen Quantity | Refractory Disease | Recurrent disease Post Complete remission

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C1514815
UMLS CUI [3,1]
C0277556
UMLS CUI [3,2]
C0687676
UMLS CUI [3,3]
C0677874
at least 4 weeks since the last dose of prior last chemotherapy, or radiotherapy before beginning treatment with 506u78 (2 weeks is permitted if growth of blast cells is significant).
Description

Chemotherapy Last Time last dose | Therapeutic radiology procedure | 506U78 | Blast Cells Growth

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C0946444
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0759671
UMLS CUI [4,1]
C0368761
UMLS CUI [4,2]
C0220844
adequate function of other organ systems as measured as follows.serum creatinine is less than 1.5 times of upper limit of normal and estimated creatinine clearance >=50 ml/min. hepatic transaminases (sgpt and sgot) <=3 x upper limit of normal, bilirubin is less than 1.5 times of upper limit of normal(<=5 x upper limit of normal if it is related by t-all or t-lbl).
Description

Organ system function | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula | Transaminases Hepatic | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Serum total bilirubin measurement | Serum total bilirubin measurement T-ALL Related | Serum total bilirubin measurement T-LBL Related

Data type

boolean

Alias
UMLS CUI [1,1]
C0460002
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0201976
UMLS CUI [3]
C2711451
UMLS CUI [4,1]
C0002594
UMLS CUI [4,2]
C0205054
UMLS CUI [5]
C0201836
UMLS CUI [6]
C0201899
UMLS CUI [7]
C1278039
UMLS CUI [8,1]
C1278039
UMLS CUI [8,2]
C1961099
UMLS CUI [8,3]
C0439849
UMLS CUI [9,1]
C1278039
UMLS CUI [9,2]
C2853920
UMLS CUI [9,3]
C0439849
adequate performance status (ecog-ps<=2).
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
capable of giving informed consent which includes compliance with the requirements and restrictions listed in the consent form.
Description

Informed Consent | Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
patient is willing to accept hospitalization during the blood sampling for pharmacokinetic measurement (i.e., cohort 1: for pharmacokinetic sample collection during both cycle 1 and 2; and cohort 2: for pharmacokinetic sample collection during cycle 1).
Description

Hospitalization Willing | Blood sampling Pharmacokinetics Measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0600109
UMLS CUI [2,1]
C0005834
UMLS CUI [2,2]
C0031328
UMLS CUI [2,3]
C0242485
female subjects who are of child-bearing potential must have a negative pregnancy test at the screening visit and agree to utilize contraceptive methods during participation in the study and for at least six months following the last dose of 506u78 injection. female subjects may be defined as of non-child-bearing potential if they are physiologically incapable of becoming pregnant, including any female who is post-menopausal. for purposes of this study, postmenopausal is defined as one year without menses.
Description

Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods | Female infertility | Postmenopausal state | Menstruation absent Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [3]
C0021361
UMLS CUI [4]
C0232970
UMLS CUI [5,1]
C0497456
UMLS CUI [5,2]
C0449238
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
active infection at time of treatment.
Description

Communicable Disease

Data type

boolean

Alias
UMLS CUI [1]
C0009450
concurrent disease or condition that would make the subject inappropriate for study participation.
Description

Comorbidity Study Subject Participation Status Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1548788
receiving any other anticancer agents or enrolled on any investigational study during the course of the study.
Description

Antineoplastic Agents | Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0003392
UMLS CUI [2]
C2348568
UMLS CUI [3]
C0013230
patients must have recovered to grade i or less toxicity of all previous chemotherapy prior to treatment.
Description

Chemotherapy | CTCAE Grades Patient recovered

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2,1]
C1516728
UMLS CUI [2,2]
C1115804
history of seizure disorder within one year prior to the date of informed consent.
Description

Seizures

Data type

boolean

Alias
UMLS CUI [1]
C0036572
pregnancy (as demonstrated by a positive pregnancy test at pre-study/screening) or breastfeeding. fertile women and men must practice adequate contraception throughout the study and at least 6 month after the last dose of study drug.
Description

Pregnancy Pregnancy test positive | Breast Feeding | Fertility Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0240802
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0015895
UMLS CUI [3,2]
C0700589
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Similar models

Eligibility Leukaemia, Lymphoblastic, Acute and Lymphoma, Lymphoblastic NCT00406757

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
T-Cell Acute Lymphoblastic Leukemia | Lymphoblastic T-cell lymphoma
Item
histologic or cytogenetic documented diagnosis of t-all or t-lbl.
boolean
C1961099 (UMLS CUI [1])
C2853920 (UMLS CUI [2])
Chemotherapy Regimen Quantity | Refractory Disease | Recurrent disease Post Complete remission
Item
disease that is refractory to at least one prior chemotherapy regimen, or has relapsed following complete remission to at least one prior chemotherapy regimen.
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1514815 (UMLS CUI [2])
C0277556 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C0677874 (UMLS CUI [3,3])
Chemotherapy Last Time last dose | Therapeutic radiology procedure | 506U78 | Blast Cells Growth
Item
at least 4 weeks since the last dose of prior last chemotherapy, or radiotherapy before beginning treatment with 506u78 (2 weeks is permitted if growth of blast cells is significant).
boolean
C0392920 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0946444 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2])
C0759671 (UMLS CUI [3])
C0368761 (UMLS CUI [4,1])
C0220844 (UMLS CUI [4,2])
Organ system function | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula | Transaminases Hepatic | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Serum total bilirubin measurement | Serum total bilirubin measurement T-ALL Related | Serum total bilirubin measurement T-LBL Related
Item
adequate function of other organ systems as measured as follows.serum creatinine is less than 1.5 times of upper limit of normal and estimated creatinine clearance >=50 ml/min. hepatic transaminases (sgpt and sgot) <=3 x upper limit of normal, bilirubin is less than 1.5 times of upper limit of normal(<=5 x upper limit of normal if it is related by t-all or t-lbl).
boolean
C0460002 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0201976 (UMLS CUI [2])
C2711451 (UMLS CUI [3])
C0002594 (UMLS CUI [4,1])
C0205054 (UMLS CUI [4,2])
C0201836 (UMLS CUI [5])
C0201899 (UMLS CUI [6])
C1278039 (UMLS CUI [7])
C1278039 (UMLS CUI [8,1])
C1961099 (UMLS CUI [8,2])
C0439849 (UMLS CUI [8,3])
C1278039 (UMLS CUI [9,1])
C2853920 (UMLS CUI [9,2])
C0439849 (UMLS CUI [9,3])
ECOG performance status
Item
adequate performance status (ecog-ps<=2).
boolean
C1520224 (UMLS CUI [1])
Informed Consent | Protocol Compliance
Item
capable of giving informed consent which includes compliance with the requirements and restrictions listed in the consent form.
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Hospitalization Willing | Blood sampling Pharmacokinetics Measurement
Item
patient is willing to accept hospitalization during the blood sampling for pharmacokinetic measurement (i.e., cohort 1: for pharmacokinetic sample collection during both cycle 1 and 2; and cohort 2: for pharmacokinetic sample collection during cycle 1).
boolean
C0019993 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C0005834 (UMLS CUI [2,1])
C0031328 (UMLS CUI [2,2])
C0242485 (UMLS CUI [2,3])
Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods | Female infertility | Postmenopausal state | Menstruation absent Duration
Item
female subjects who are of child-bearing potential must have a negative pregnancy test at the screening visit and agree to utilize contraceptive methods during participation in the study and for at least six months following the last dose of 506u78 injection. female subjects may be defined as of non-child-bearing potential if they are physiologically incapable of becoming pregnant, including any female who is post-menopausal. for purposes of this study, postmenopausal is defined as one year without menses.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0021361 (UMLS CUI [3])
C0232970 (UMLS CUI [4])
C0497456 (UMLS CUI [5,1])
C0449238 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
Communicable Disease
Item
active infection at time of treatment.
boolean
C0009450 (UMLS CUI [1])
Comorbidity Study Subject Participation Status Inappropriate
Item
concurrent disease or condition that would make the subject inappropriate for study participation.
boolean
C0009488 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
Antineoplastic Agents | Study Subject Participation Status | Investigational New Drugs
Item
receiving any other anticancer agents or enrolled on any investigational study during the course of the study.
boolean
C0003392 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
Chemotherapy | CTCAE Grades Patient recovered
Item
patients must have recovered to grade i or less toxicity of all previous chemotherapy prior to treatment.
boolean
C0392920 (UMLS CUI [1])
C1516728 (UMLS CUI [2,1])
C1115804 (UMLS CUI [2,2])
Seizures
Item
history of seizure disorder within one year prior to the date of informed consent.
boolean
C0036572 (UMLS CUI [1])
Pregnancy Pregnancy test positive | Breast Feeding | Fertility Contraceptive methods
Item
pregnancy (as demonstrated by a positive pregnancy test at pre-study/screening) or breastfeeding. fertile women and men must practice adequate contraception throughout the study and at least 6 month after the last dose of study drug.
boolean
C0032961 (UMLS CUI [1,1])
C0240802 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2])
C0015895 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
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