ID

17911

Beschreibung

A Pilot Study of Pivanex in Patients With Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00083473

Link

https://clinicaltrials.gov/show/NCT00083473

Stichworte

Versionen (1)
  1. 07.10.16 07.10.16 -
Hochgeladen am

7. Oktober 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Leukemia, Lymphocytic, Chronic NCT00083473

Englisch

Eligibility Leukemia, Lymphocytic, Chronic NCT00083473

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have a confirmed diagnosis of cll or small lymphocytic lymphoma (sll) based upon the revised nci-sponsored working group guidelines for cll;
Beschreibung

Chronic Lymphocytic Leukemia | Small Lymphocytic Lymphoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0023434
UMLS CUI [2]
C0855095
relapsed or refractory disease after previous chemotherapy treatment;
Beschreibung

Recurrent disease Post Prior Chemotherapy | Refractory Disease Post Prior Chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0277556
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C1514457
UMLS CUI [2,1]
C1514815
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C1514457
age > 18 years;
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
adequate renal function with creatinine <= 1.5 mg/dl;
Beschreibung

Renal function | Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
adequate liver function with alkaline phosphatase <= 2.5 x upper limit of normal, serum glutamic oxaloacetic transaminase (sgot), and serum glutamic pyruvic transaminase (sgpt) <= 2.5 x upper limit of normal; and total bilirubin <= 2.0 x upper limit of normal;
Beschreibung

Liver function | Alkaline phosphatase measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0201850
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5]
C1278039
adequate bone marrow function as determined by having platelets > 50,000/mm3 without transfusion in the preceding 2 weeks and an absolute neutrophil count (anc) => 1,500 cells/mm3 without growth factor support; unless cytopenias due to marrow infiltration;
Beschreibung

Bone Marrow Function | Platelet Count measurement | Blood Transfusion | Absolute neutrophil count | Growth Factor Supportive care | Cytopenia Due to Bone marrow infiltration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0005841
UMLS CUI [4]
C0948762
UMLS CUI [5,1]
C0018284
UMLS CUI [5,2]
C0344211
UMLS CUI [6,1]
C0010828
UMLS CUI [6,2]
C0678226
UMLS CUI [6,3]
C3854434
able to give informed consent;
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
a minimum of 4 weeks must have elapsed from the completion of any previous treatment regimen, including radiation and biologic therapies (6 weeks if a prior nitrosourea or mitomycin c, 12 weeks if radioimmunotherapy) to treatment on day 1 cycle 1. patients must have recovery from treatment-associated toxicity(ies);
Beschreibung

Prior Therapy Complete | Therapeutic radiology procedure | Biological treatment | Nitrosourea | Mitomycin | Radioimmunotherapy | Toxic effect Associated with Therapeutic procedure | Patients Recovered

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0205197
UMLS CUI [2]
C1522449
UMLS CUI [3]
C1531518
UMLS CUI [4]
C0028210
UMLS CUI [5]
C0002475
UMLS CUI [6]
C0085101
UMLS CUI [7,1]
C0600688
UMLS CUI [7,2]
C0332281
UMLS CUI [7,3]
C0087111
UMLS CUI [8,1]
C0030705
UMLS CUI [8,2]
C0521108
a predicted life expectancy of at least 6 months; and
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
eastern cooperative oncology group (ecog) performance status of 0, 1, or 2.
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
more than three systemic treatment regimens for cll/sll (excluding immunotherapies and biologic therapies);
Beschreibung

systemic therapy Quantity Chronic Lymphocytic Leukemia | systemic therapy Quantity Small Lymphocytic Lymphoma | Immunotherapy | Biological treatment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0023434
UMLS CUI [2,1]
C1515119
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0855095
UMLS CUI [3]
C0021083
UMLS CUI [4]
C1531518
concurrent malignancy that the patient has not been free of for at least 5 years, excluding curatively treated carcinoma-in-situ or non-melanoma skin cancer;
Beschreibung

Malignant Neoplasms | Carcinoma in Situ curative treatment | Skin carcinoma curative treatment

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0007099
UMLS CUI [2,2]
C1273390
UMLS CUI [3,1]
C0699893
UMLS CUI [3,2]
C1273390
any pregnant or lactating females. females of childbearing potential must have a negative pregnancy test and all male and female patients of reproductive potential must agree to use adequate birth control;
Beschreibung

Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test negative | Fertility Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0427780
UMLS CUI [4,1]
C0015895
UMLS CUI [4,2]
C0700589
known hiv-positive patients;
Beschreibung

HIV Seropositivity

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
any underlying medical conditions or circumstances that would contraindicate therapy with study treatment, affect compliance or impair evaluation of study endpoints;
Beschreibung

medical condition Contraindication Therapies, Investigational | medical condition Compliance behavior Limited | medical condition Interferes with research results | Condition Contraindication Therapies, Investigational | Condition Compliance behavior Limited | Condition Interferes with research results

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0522473
UMLS CUI [1,3]
C0949266
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C1321605
UMLS CUI [2,3]
C0439801
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0683954
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C0522473
UMLS CUI [4,3]
C0949266
UMLS CUI [5,1]
C0348080
UMLS CUI [5,2]
C1321605
UMLS CUI [5,3]
C0439801
UMLS CUI [6,1]
C0348080
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C0683954
receiving investigational agents within 4 weeks of the study treatment; and
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
known allergy to reagents in the study.
Beschreibung

Hypersensitivity Reagents Investigational

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0034760
UMLS CUI [1,3]
C1517586
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Ähnliche Modelle

Eligibility Leukemia, Lymphocytic, Chronic NCT00083473

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Lymphocytic Leukemia | Small Lymphocytic Lymphoma
Item
patients must have a confirmed diagnosis of cll or small lymphocytic lymphoma (sll) based upon the revised nci-sponsored working group guidelines for cll;
boolean
C0023434 (UMLS CUI [1])
C0855095 (UMLS CUI [2])
Recurrent disease Post Prior Chemotherapy | Refractory Disease Post Prior Chemotherapy
Item
relapsed or refractory disease after previous chemotherapy treatment;
boolean
C0277556 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C1514457 (UMLS CUI [1,3])
C1514815 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C1514457 (UMLS CUI [2,3])
Age
Item
age > 18 years;
boolean
C0001779 (UMLS CUI [1])
Renal function | Creatinine measurement, serum
Item
adequate renal function with creatinine <= 1.5 mg/dl;
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Liver function | Alkaline phosphatase measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement
Item
adequate liver function with alkaline phosphatase <= 2.5 x upper limit of normal, serum glutamic oxaloacetic transaminase (sgot), and serum glutamic pyruvic transaminase (sgpt) <= 2.5 x upper limit of normal; and total bilirubin <= 2.0 x upper limit of normal;
boolean
C0232741 (UMLS CUI [1])
C0201850 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
Bone Marrow Function | Platelet Count measurement | Blood Transfusion | Absolute neutrophil count | Growth Factor Supportive care | Cytopenia Due to Bone marrow infiltration
Item
adequate bone marrow function as determined by having platelets > 50,000/mm3 without transfusion in the preceding 2 weeks and an absolute neutrophil count (anc) => 1,500 cells/mm3 without growth factor support; unless cytopenias due to marrow infiltration;
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0032181 (UMLS CUI [2])
C0005841 (UMLS CUI [3])
C0948762 (UMLS CUI [4])
C0018284 (UMLS CUI [5,1])
C0344211 (UMLS CUI [5,2])
C0010828 (UMLS CUI [6,1])
C0678226 (UMLS CUI [6,2])
C3854434 (UMLS CUI [6,3])
Informed Consent
Item
able to give informed consent;
boolean
C0021430 (UMLS CUI [1])
Prior Therapy Complete | Therapeutic radiology procedure | Biological treatment | Nitrosourea | Mitomycin | Radioimmunotherapy | Toxic effect Associated with Therapeutic procedure | Patients Recovered
Item
a minimum of 4 weeks must have elapsed from the completion of any previous treatment regimen, including radiation and biologic therapies (6 weeks if a prior nitrosourea or mitomycin c, 12 weeks if radioimmunotherapy) to treatment on day 1 cycle 1. patients must have recovery from treatment-associated toxicity(ies);
boolean
C1514463 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2])
C1531518 (UMLS CUI [3])
C0028210 (UMLS CUI [4])
C0002475 (UMLS CUI [5])
C0085101 (UMLS CUI [6])
C0600688 (UMLS CUI [7,1])
C0332281 (UMLS CUI [7,2])
C0087111 (UMLS CUI [7,3])
C0030705 (UMLS CUI [8,1])
C0521108 (UMLS CUI [8,2])
Life Expectancy
Item
a predicted life expectancy of at least 6 months; and
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0, 1, or 2.
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
systemic therapy Quantity Chronic Lymphocytic Leukemia | systemic therapy Quantity Small Lymphocytic Lymphoma | Immunotherapy | Biological treatment
Item
more than three systemic treatment regimens for cll/sll (excluding immunotherapies and biologic therapies);
boolean
C1515119 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0023434 (UMLS CUI [1,3])
C1515119 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0855095 (UMLS CUI [2,3])
C0021083 (UMLS CUI [3])
C1531518 (UMLS CUI [4])
Malignant Neoplasms | Carcinoma in Situ curative treatment | Skin carcinoma curative treatment
Item
concurrent malignancy that the patient has not been free of for at least 5 years, excluding curatively treated carcinoma-in-situ or non-melanoma skin cancer;
boolean
C0006826 (UMLS CUI [1])
C0007099 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0699893 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test negative | Fertility Contraceptive methods
Item
any pregnant or lactating females. females of childbearing potential must have a negative pregnancy test and all male and female patients of reproductive potential must agree to use adequate birth control;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
C0015895 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
HIV Seropositivity
Item
known hiv-positive patients;
boolean
C0019699 (UMLS CUI [1])
medical condition Contraindication Therapies, Investigational | medical condition Compliance behavior Limited | medical condition Interferes with research results | Condition Contraindication Therapies, Investigational | Condition Compliance behavior Limited | Condition Interferes with research results
Item
any underlying medical conditions or circumstances that would contraindicate therapy with study treatment, affect compliance or impair evaluation of study endpoints;
boolean
C3843040 (UMLS CUI [1,1])
C0522473 (UMLS CUI [1,2])
C0949266 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C1321605 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0683954 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C0522473 (UMLS CUI [4,2])
C0949266 (UMLS CUI [4,3])
C0348080 (UMLS CUI [5,1])
C1321605 (UMLS CUI [5,2])
C0439801 (UMLS CUI [5,3])
C0348080 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C0683954 (UMLS CUI [6,3])
Investigational New Drugs
Item
receiving investigational agents within 4 weeks of the study treatment; and
boolean
C0013230 (UMLS CUI [1])
Hypersensitivity Reagents Investigational
Item
known allergy to reagents in the study.
boolean
C0020517 (UMLS CUI [1,1])
C0034760 (UMLS CUI [1,2])
C1517586 (UMLS CUI [1,3])
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