ID

18010

Beschreibung

Fludara (Oral) Phase II Study for Indolent Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00688883

Link

https://clinicaltrials.gov/show/NCT00688883

Stichworte

Versionen (1)
  1. 13.10.16 13.10.16 -
Hochgeladen am

13. Oktober 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Lymphoma NCT00688883

Englisch

Eligibility Lymphoma NCT00688883

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00688883
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with histologically or cytologically confirmed indolent lymphoma (including mantle cell lymphoma)
Beschreibung

indolent lymphoma | Mantle cell lymphoma

Datentyp

boolean

Alias
UMLS CUI [1]
C1334170
UMLS CUI [2]
C0334634
patients with measurable lesions (major axis > 1.5 cm by ct)
Beschreibung

Measurable Disease Major Axis size | X-Ray Computed Tomography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1295723
UMLS CUI [1,3]
C0456389
UMLS CUI [2]
C0040405
patients who failed to have pr to previous chemotherapies or antibody therapies. patients with subsequent relapse after a previously attained cr or with subsequent recurrence after a previously attained pr
Beschreibung

Prior Chemotherapy partial response failed | antibody therapy partial response failed | Subsequent Relapse Post complete remission | Subsequent Relapse Post partial response

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1521726
UMLS CUI [1,3]
C0231175
UMLS CUI [2,1]
C0281176
UMLS CUI [2,2]
C1521726
UMLS CUI [2,3]
C0231175
UMLS CUI [3,1]
C4053982
UMLS CUI [3,2]
C0687676
UMLS CUI [3,3]
C0677874
UMLS CUI [4,1]
C4053982
UMLS CUI [4,2]
C0687676
UMLS CUI [4,3]
C1521726
patients who have not received chemotherapies, antibody therapies or radiotherapies for more than 4 weeks (more than 3 months in the case of the antibody therapies)
Beschreibung

Chemotherapy | antibody therapy | Therapeutic radiology procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0281176
UMLS CUI [3]
C1522449
patients who have ps grade 0 to 2 in the criteria of ecog
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
patients with adequately maintained organ functions
Beschreibung

organ function

Datentyp

boolean

Alias
UMLS CUI [1]
C0678852
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with infectious disease, serious complications, serious gastrointestinal symptoms, serious bleeding tendency (dic), cns metastases, fever more than 38 degrees celsius, interstitial pneumonia or pulmonary fibrosis, active other malignancies, aiha or the history of allergies to similar purine analogs
Beschreibung

Communicable Disease | Complication Serious | Gastrointestinal symptom Serious | Bleeding tendency Serious | Disseminated Intravascular Coagulation | CNS metastases | Fever | Pneumonia, Interstitial | Pulmonary Fibrosis | Malignant Neoplasms | Autoimmune hemolytic anemia | Hypersensitivity Purine analog

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2,1]
C0009566
UMLS CUI [2,2]
C0205404
UMLS CUI [3,1]
C0426576
UMLS CUI [3,2]
C0205404
UMLS CUI [4,1]
C1458140
UMLS CUI [4,2]
C0205404
UMLS CUI [5]
C0012739
UMLS CUI [6]
C0686377
UMLS CUI [7]
C0015967
UMLS CUI [8]
C0206061
UMLS CUI [9]
C0034069
UMLS CUI [10]
C0006826
UMLS CUI [11]
C0002880
UMLS CUI [12,1]
C0020517
UMLS CUI [12,2]
C1268902
patients who are positive for hbs antigen, hcv antibody or hiv antibody
Beschreibung

Hepatitis B surface antigen positive | Hepatitis C Antibodies Positive | HIV antibody positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2,1]
C0166049
UMLS CUI [2,2]
C1514241
UMLS CUI [3]
C0920548
patients who received g-csf or blood transfusion within 1 week before the screening test
Beschreibung

Granulocyte Colony-Stimulating Factor | Blood Transfusion

Datentyp

boolean

Alias
UMLS CUI [1]
C0079459
UMLS CUI [2]
C0005841
patients who had ever received previous therapy with fludarabine phosphate injection (fludara), pentostatin (coforin), cladribine (leustatin) or sh t 586
Beschreibung

Fludarabine phosphate Injection | Fludara | Pentostatin | Cladribine | Leustatin | SH T 586

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0060483
UMLS CUI [1,2]
C1828121
UMLS CUI [2]
C0700805
UMLS CUI [3]
C0030896
UMLS CUI [4]
C0092801
UMLS CUI [5]
C0701346
UMLS CUI [6]
C1831841
patients who are pregnant, of childbearing potential, lactating, or who do not agree to practice contraception
Beschreibung

Pregnancy | Childbearing Potential | Breast Feeding | Contraceptive methods Unwilling

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C3831118
UMLS CUI [3]
C0006147
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C0558080
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Ähnliche Modelle

Eligibility Lymphoma NCT00688883

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00688883
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
indolent lymphoma | Mantle cell lymphoma
Item
patients with histologically or cytologically confirmed indolent lymphoma (including mantle cell lymphoma)
boolean
C1334170 (UMLS CUI [1])
C0334634 (UMLS CUI [2])
Measurable Disease Major Axis size | X-Ray Computed Tomography
Item
patients with measurable lesions (major axis > 1.5 cm by ct)
boolean
C1513041 (UMLS CUI [1,1])
C1295723 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,3])
C0040405 (UMLS CUI [2])
Prior Chemotherapy partial response failed | antibody therapy partial response failed | Subsequent Relapse Post complete remission | Subsequent Relapse Post partial response
Item
patients who failed to have pr to previous chemotherapies or antibody therapies. patients with subsequent relapse after a previously attained cr or with subsequent recurrence after a previously attained pr
boolean
C1514457 (UMLS CUI [1,1])
C1521726 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0281176 (UMLS CUI [2,1])
C1521726 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
C4053982 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C0677874 (UMLS CUI [3,3])
C4053982 (UMLS CUI [4,1])
C0687676 (UMLS CUI [4,2])
C1521726 (UMLS CUI [4,3])
Chemotherapy | antibody therapy | Therapeutic radiology procedure
Item
patients who have not received chemotherapies, antibody therapies or radiotherapies for more than 4 weeks (more than 3 months in the case of the antibody therapies)
boolean
C0392920 (UMLS CUI [1])
C0281176 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
ECOG performance status
Item
patients who have ps grade 0 to 2 in the criteria of ecog
boolean
C1520224 (UMLS CUI [1])
organ function
Item
patients with adequately maintained organ functions
boolean
C0678852 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Communicable Disease | Complication Serious | Gastrointestinal symptom Serious | Bleeding tendency Serious | Disseminated Intravascular Coagulation | CNS metastases | Fever | Pneumonia, Interstitial | Pulmonary Fibrosis | Malignant Neoplasms | Autoimmune hemolytic anemia | Hypersensitivity Purine analog
Item
patients with infectious disease, serious complications, serious gastrointestinal symptoms, serious bleeding tendency (dic), cns metastases, fever more than 38 degrees celsius, interstitial pneumonia or pulmonary fibrosis, active other malignancies, aiha or the history of allergies to similar purine analogs
boolean
C0009450 (UMLS CUI [1])
C0009566 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0426576 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C1458140 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C0012739 (UMLS CUI [5])
C0686377 (UMLS CUI [6])
C0015967 (UMLS CUI [7])
C0206061 (UMLS CUI [8])
C0034069 (UMLS CUI [9])
C0006826 (UMLS CUI [10])
C0002880 (UMLS CUI [11])
C0020517 (UMLS CUI [12,1])
C1268902 (UMLS CUI [12,2])
Hepatitis B surface antigen positive | Hepatitis C Antibodies Positive | HIV antibody positive
Item
patients who are positive for hbs antigen, hcv antibody or hiv antibody
boolean
C0149709 (UMLS CUI [1])
C0166049 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0920548 (UMLS CUI [3])
Granulocyte Colony-Stimulating Factor | Blood Transfusion
Item
patients who received g-csf or blood transfusion within 1 week before the screening test
boolean
C0079459 (UMLS CUI [1])
C0005841 (UMLS CUI [2])
Fludarabine phosphate Injection | Fludara | Pentostatin | Cladribine | Leustatin | SH T 586
Item
patients who had ever received previous therapy with fludarabine phosphate injection (fludara), pentostatin (coforin), cladribine (leustatin) or sh t 586
boolean
C0060483 (UMLS CUI [1,1])
C1828121 (UMLS CUI [1,2])
C0700805 (UMLS CUI [2])
C0030896 (UMLS CUI [3])
C0092801 (UMLS CUI [4])
C0701346 (UMLS CUI [5])
C1831841 (UMLS CUI [6])
Pregnancy | Childbearing Potential | Breast Feeding | Contraceptive methods Unwilling
Item
patients who are pregnant, of childbearing potential, lactating, or who do not agree to practice contraception
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0700589 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])
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