ID

31753

Beschreibung

Study of Cordycepin Plus Pentostatin in Patients With Refractory TdT-Positive Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00709215

Link

https://clinicaltrials.gov/show/NCT00709215

Stichworte

Versionen (1)
  1. 25.09.18 25.09.18 -
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See clinicaltrials.gov

Hochgeladen am

25. September 2018

DOI

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Eligibility Refractory TdT-Positive Leukemia NCT00709215

Englisch

Eligibility Refractory TdT-Positive Leukemia NCT00709215

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
tdt-positive leukemia (all, aml, or blastic cml) that has failed at least one standard treatment regimen and for which no standard therapies are expected to result in durable remission. leukemia is minimally defined as at least 20% blast cells present in marrow or peripheral blood. tdt must be expressed in at least 20% of blast cells present and documented either immunologically or biochemically;
Beschreibung

Leukemia TdT Positive | TdT Positive Acute Lymphoblastic Leukemia | AML TdT Positive | Blastic Phase CML TdT Positive | Standard therapy Quantity failed | Standard therapy Unexpected Resulting in Remission | Blast cells present Percentage Bone Marrow | Blast cells present Percentage Peripheral blood | Blast cells present Percentage

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023418
UMLS CUI [1,2]
C0012881
UMLS CUI [1,3]
C1514241
UMLS CUI [2]
C2348656
UMLS CUI [3,1]
C0023467
UMLS CUI [3,2]
C0012881
UMLS CUI [3,3]
C1514241
UMLS CUI [4,1]
C0005699
UMLS CUI [4,2]
C0012881
UMLS CUI [4,3]
C1514241
UMLS CUI [5,1]
C2936643
UMLS CUI [5,2]
C1265611
UMLS CUI [5,3]
C0231175
UMLS CUI [6,1]
C2936643
UMLS CUI [6,2]
C4055646
UMLS CUI [6,3]
C0332294
UMLS CUI [6,4]
C0544452
UMLS CUI [7,1]
C0427540
UMLS CUI [7,2]
C0439165
UMLS CUI [7,3]
C0005953
UMLS CUI [8,1]
C0427540
UMLS CUI [8,2]
C0439165
UMLS CUI [8,3]
C0229664
UMLS CUI [9,1]
C0427540
UMLS CUI [9,2]
C0439165
age ≥18 years;
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
must understand and voluntarily sign informed consent;
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
adequate non-hematologic organ system function, defined by:
Beschreibung

Organ function | Exception Hematologic function

Datentyp

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0221130
creatinine ≤1.5 times the upper limit of normal (uln) and/or creatinine clearance ≥60 ml/min
Beschreibung

Creatinine measurement, serum | Creatinine clearance measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0373595
ast and/or alt ≤2.5 times upper limit of normal (uln)
Beschreibung

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
total bilirubin within institutional normal range
Beschreibung

Bilirubin total normal

Datentyp

boolean

Alias
UMLS CUI [1]
C0860928
normal ekg and lvef >40%, measured by ekg and muga scan, radionuclide ventriculogram, or echocardiogram
Beschreibung

ECG normal | LVEF Electrocardiography | LVEF MUGA scan | LVEF Radionuclide Ventriculography | LVEF Echocardiography

Datentyp

boolean

Alias
UMLS CUI [1]
C0522054
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C1623258
UMLS CUI [3,1]
C0428772
UMLS CUI [3,2]
C0521317
UMLS CUI [4,1]
C0428772
UMLS CUI [4,2]
C0034610
UMLS CUI [5,1]
C0428772
UMLS CUI [5,2]
C0013516
life expectancy >3 months;
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
performance status (ps) >70% karnofsky or ecog ≤2;
Beschreibung

Karnofsky Performance Status | ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C0206065
UMLS CUI [2]
C1520224
women of childbearing potential must have a negative serum pregnancy test within 7 days of starting study drug. a woman of child-bearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e., who has had menses at any time in the preceding 24 consecutive months);
Beschreibung

Childbearing Potential Serum pregnancy test negative | Hysterectomy Absent | Postmenopausal state Absent | Normal menstruation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2,1]
C0020699
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0232970
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C0559892
male or female of child-bearing potential must agree to use adequate contraceptive methods
Beschreibung

Females & males of reproductive potential Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
failure to meet inclusion criteria;
Beschreibung

Inclusion criteria Fulfill failed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1550543
UMLS CUI [1,3]
C0231175
uncontrolled active infection;
Beschreibung

Communicable Disease Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
extramedullary (cns) disease;
Beschreibung

Disease Extramedullary | CNS disorder

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1517060
UMLS CUI [2]
C0007682
serious concomitant medical illness, such as active infection, uncontrolled congestive heart failure, or uncontrolled diabetes or other metabolic disorder, or psychiatric illness;
Beschreibung

Comorbidity Serious | Communicable Disease | Congestive heart failure Uncontrolled | Diabetic - poor control | Metabolic Disease Uncontrolled | Mental disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0009450
UMLS CUI [3,1]
C0018802
UMLS CUI [3,2]
C0205318
UMLS CUI [4]
C0421258
UMLS CUI [5,1]
C0025517
UMLS CUI [5,2]
C0205318
UMLS CUI [6]
C0004936
pregnancy or lactation; females of child bearing potential must use adequate contraceptive methods;
Beschreibung

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
less than 3 weeks since prior chemotherapy, radiation therapy, or immunotherapy. however, hydroxyurea is permitted up to 24 hours before the study is initiated;
Beschreibung

Prior Chemotherapy | Prior radiation therapy | Prior Immunotherapy | Hydroxyurea allowed

Datentyp

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2]
C0279134
UMLS CUI [3]
C1514461
UMLS CUI [4,1]
C0020402
UMLS CUI [4,2]
C0683607
less than 2 months following bone marrow or peripheral blood stem cell transplantation or treatment with donor lymphocyte infusion (dli).
Beschreibung

Bone Marrow Transplantation | Peripheral Stem Cell Transplantation | Donor Lymphocyte Infusion

Datentyp

boolean

Alias
UMLS CUI [1]
C0005961
UMLS CUI [2]
C0242602
UMLS CUI [3]
C1512034
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Ähnliche Modelle

Eligibility Refractory TdT-Positive Leukemia NCT00709215

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Leukemia TdT Positive | TdT Positive Acute Lymphoblastic Leukemia | AML TdT Positive | Blastic Phase CML TdT Positive | Standard therapy Quantity failed | Standard therapy Unexpected Resulting in Remission | Blast cells present Percentage Bone Marrow | Blast cells present Percentage Peripheral blood | Blast cells present Percentage
Item
tdt-positive leukemia (all, aml, or blastic cml) that has failed at least one standard treatment regimen and for which no standard therapies are expected to result in durable remission. leukemia is minimally defined as at least 20% blast cells present in marrow or peripheral blood. tdt must be expressed in at least 20% of blast cells present and documented either immunologically or biochemically;
boolean
C0023418 (UMLS CUI [1,1])
C0012881 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C2348656 (UMLS CUI [2])
C0023467 (UMLS CUI [3,1])
C0012881 (UMLS CUI [3,2])
C1514241 (UMLS CUI [3,3])
C0005699 (UMLS CUI [4,1])
C0012881 (UMLS CUI [4,2])
C1514241 (UMLS CUI [4,3])
C2936643 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
C0231175 (UMLS CUI [5,3])
C2936643 (UMLS CUI [6,1])
C4055646 (UMLS CUI [6,2])
C0332294 (UMLS CUI [6,3])
C0544452 (UMLS CUI [6,4])
C0427540 (UMLS CUI [7,1])
C0439165 (UMLS CUI [7,2])
C0005953 (UMLS CUI [7,3])
C0427540 (UMLS CUI [8,1])
C0439165 (UMLS CUI [8,2])
C0229664 (UMLS CUI [8,3])
C0427540 (UMLS CUI [9,1])
C0439165 (UMLS CUI [9,2])
Age
Item
age ≥18 years;
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
must understand and voluntarily sign informed consent;
boolean
C0021430 (UMLS CUI [1])
Organ function | Exception Hematologic function
Item
adequate non-hematologic organ system function, defined by:
boolean
C0678852 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0221130 (UMLS CUI [2,2])
Creatinine measurement, serum | Creatinine clearance measurement
Item
creatinine ≤1.5 times the upper limit of normal (uln) and/or creatinine clearance ≥60 ml/min
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
ast and/or alt ≤2.5 times upper limit of normal (uln)
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Bilirubin total normal
Item
total bilirubin within institutional normal range
boolean
C0860928 (UMLS CUI [1])
ECG normal | LVEF Electrocardiography | LVEF MUGA scan | LVEF Radionuclide Ventriculography | LVEF Echocardiography
Item
normal ekg and lvef >40%, measured by ekg and muga scan, radionuclide ventriculogram, or echocardiogram
boolean
C0522054 (UMLS CUI [1])
C0428772 (UMLS CUI [2,1])
C1623258 (UMLS CUI [2,2])
C0428772 (UMLS CUI [3,1])
C0521317 (UMLS CUI [3,2])
C0428772 (UMLS CUI [4,1])
C0034610 (UMLS CUI [4,2])
C0428772 (UMLS CUI [5,1])
C0013516 (UMLS CUI [5,2])
Life Expectancy
Item
life expectancy >3 months;
boolean
C0023671 (UMLS CUI [1])
Karnofsky Performance Status | ECOG performance status
Item
performance status (ps) >70% karnofsky or ecog ≤2;
boolean
C0206065 (UMLS CUI [1])
C1520224 (UMLS CUI [2])
Childbearing Potential Serum pregnancy test negative | Hysterectomy Absent | Postmenopausal state Absent | Normal menstruation
Item
women of childbearing potential must have a negative serum pregnancy test within 7 days of starting study drug. a woman of child-bearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e., who has had menses at any time in the preceding 24 consecutive months);
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C0020699 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0232970 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0559892 (UMLS CUI [4])
Females & males of reproductive potential Contraceptive methods
Item
male or female of child-bearing potential must agree to use adequate contraceptive methods
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Inclusion criteria Fulfill failed
Item
failure to meet inclusion criteria;
boolean
C1512693 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Communicable Disease Uncontrolled
Item
uncontrolled active infection;
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Disease Extramedullary | CNS disorder
Item
extramedullary (cns) disease;
boolean
C0012634 (UMLS CUI [1,1])
C1517060 (UMLS CUI [1,2])
C0007682 (UMLS CUI [2])
Comorbidity Serious | Communicable Disease | Congestive heart failure Uncontrolled | Diabetic - poor control | Metabolic Disease Uncontrolled | Mental disorders
Item
serious concomitant medical illness, such as active infection, uncontrolled congestive heart failure, or uncontrolled diabetes or other metabolic disorder, or psychiatric illness;
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0018802 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0421258 (UMLS CUI [4])
C0025517 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0004936 (UMLS CUI [6])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods
Item
pregnancy or lactation; females of child bearing potential must use adequate contraceptive methods;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Prior Chemotherapy | Prior radiation therapy | Prior Immunotherapy | Hydroxyurea allowed
Item
less than 3 weeks since prior chemotherapy, radiation therapy, or immunotherapy. however, hydroxyurea is permitted up to 24 hours before the study is initiated;
boolean
C1514457 (UMLS CUI [1])
C0279134 (UMLS CUI [2])
C1514461 (UMLS CUI [3])
C0020402 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
Bone Marrow Transplantation | Peripheral Stem Cell Transplantation | Donor Lymphocyte Infusion
Item
less than 2 months following bone marrow or peripheral blood stem cell transplantation or treatment with donor lymphocyte infusion (dli).
boolean
C0005961 (UMLS CUI [1])
C0242602 (UMLS CUI [2])
C1512034 (UMLS CUI [3])
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