ID

13663

Beskrivning

A Phase II Efficacy Study of Roferon-A in Hairy Cell Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00001567

Länk

https://clinicaltrials.gov/show/NCT00001567

Nyckelord

Versioner (1)
  1. 2016-02-24 2016-02-24 -
Uppladdad den

24 februari 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hairy Cell Leukemia NCT00001567

Engelsk

Eligibility Hairy Cell Leukemia NCT00001567

1 Formulär  
Criteria
Beskrivning

Criteria

patients must have morphologically identifiable hairy cells in peripheral blood and bone marrow, or tissue biopsies with at least one of the following: 1) positive stain for the tartrate-resistant acid phosphatase 2) electron microscopy compatible with hairy cells.
Beskrivning

hairy cells, tartrate resistant acid phosphatase positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0333850
UMLS CUI [2]
C0297331
UMLS CUI [3]
C0013842
patients must be ambulatory with an expected survival greater than 16 weeks and be willing and able to give written informed consent.
Beskrivning

ambulatory patients, life expectancy, informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0002423
UMLS CUI [2]
C0023671
UMLS CUI [3]
C0021430
patients must have a disease that is assessable, defined by: 1) pancytopenia 2) bone marrow leukemic infiltrate 3) lymphadenopathy, splenomegaly, or hepatomegaly.
Beskrivning

assessable disease, definition

Datatyp

boolean

Alias
UMLS CUI [1]
C0030312
UMLS CUI [2]
C0346979
UMLS CUI [3]
C0497156
UMLS CUI [4]
C0038002 | C0019209
patients must not require palliative chemotherapy, immunotherapy or hormonal therapy other than the treatment prescribed in this protocol.
Beskrivning

palliative therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0030231
patients must be tested for hepatitis b surface antigen within one week of entry into this study.
Beskrivning

hepatitis b surface antigen

Datatyp

boolean

Alias
UMLS CUI [1]
C0019168
no pregnant or lactating women. no fertile men and women, unless using effective contraception.
Beskrivning

pregnant or lactating, fertility, contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0015895
UMLS CUI [4]
C0700589
no patients with unstable angina. patients with class iii or iv cardiovascular disease may be entered only after medical clearance by a cardiology consultant.
Beskrivning

unstable angina, cardiovascular disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0007222
no patients with severe intercurrent infection or patients having had surgery within the past four weeks unless fully recovered.
Beskrivning

infection, prior surgery

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0543467
no patients with impaired renal function (serum creatinine greater than 1.8).
Beskrivning

renal function, creatinine

Datatyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
no patients with impaired hepatic function (total bilirubin greater than 1.4).
Beskrivning

hepatic function, bilirubin

Datatyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
no patients with serum calcium greater than 12 mg/dl.
Beskrivning

serum calcium

Datatyp

boolean

Alias
UMLS CUI [1]
C0728876
no patients with a performance status less than or equal to 60% on the karnofsky scale.
Beskrivning

karnofsky

Datatyp

boolean

Alias
UMLS CUI [1]
C0206065
no patients who have had any prior (leukocyte or fibroblast) interferon therapy.
Beskrivning

interferon therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0279030
no patients unable to carry out the treatment program.
Beskrivning

able to carry out treatment program

Datatyp

boolean

Alias
UMLS CUI [1]
C1321605
no patients less than 20,000 per cu mm platelets and clinical bleeding disorder; both must be present for patient to be excluded.
Beskrivning

platelets and blood coagulation disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C0005821
UMLS CUI [2]
C0005779
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Similar models

Eligibility Hairy Cell Leukemia NCT00001567

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
hairy cells, tartrate resistant acid phosphatase positive
Item
patients must have morphologically identifiable hairy cells in peripheral blood and bone marrow, or tissue biopsies with at least one of the following: 1) positive stain for the tartrate-resistant acid phosphatase 2) electron microscopy compatible with hairy cells.
boolean
C0333850 (UMLS CUI [1])
C0297331 (UMLS CUI [2])
C0013842 (UMLS CUI [3])
ambulatory patients, life expectancy, informed consent
Item
patients must be ambulatory with an expected survival greater than 16 weeks and be willing and able to give written informed consent.
boolean
C0002423 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
assessable disease, definition
Item
patients must have a disease that is assessable, defined by: 1) pancytopenia 2) bone marrow leukemic infiltrate 3) lymphadenopathy, splenomegaly, or hepatomegaly.
boolean
C0030312 (UMLS CUI [1])
C0346979 (UMLS CUI [2])
C0497156 (UMLS CUI [3])
C0038002 | C0019209 (UMLS CUI [4])
palliative therapy
Item
patients must not require palliative chemotherapy, immunotherapy or hormonal therapy other than the treatment prescribed in this protocol.
boolean
C0030231 (UMLS CUI [1])
hepatitis b surface antigen
Item
patients must be tested for hepatitis b surface antigen within one week of entry into this study.
boolean
C0019168 (UMLS CUI [1])
pregnant or lactating, fertility, contraceptive methods
Item
no pregnant or lactating women. no fertile men and women, unless using effective contraception.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0015895 (UMLS CUI [3])
C0700589 (UMLS CUI [4])
unstable angina, cardiovascular disease
Item
no patients with unstable angina. patients with class iii or iv cardiovascular disease may be entered only after medical clearance by a cardiology consultant.
boolean
C0007222 (UMLS CUI [1])
infection, prior surgery
Item
no patients with severe intercurrent infection or patients having had surgery within the past four weeks unless fully recovered.
boolean
C0009450 (UMLS CUI [1])
C0543467 (UMLS CUI [2])
renal function, creatinine
Item
no patients with impaired renal function (serum creatinine greater than 1.8).
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
hepatic function, bilirubin
Item
no patients with impaired hepatic function (total bilirubin greater than 1.4).
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
serum calcium
Item
no patients with serum calcium greater than 12 mg/dl.
boolean
C0728876 (UMLS CUI [1])
karnofsky
Item
no patients with a performance status less than or equal to 60% on the karnofsky scale.
boolean
C0206065 (UMLS CUI [1])
interferon therapy
Item
no patients who have had any prior (leukocyte or fibroblast) interferon therapy.
boolean
C0279030 (UMLS CUI [1])
able to carry out treatment program
Item
no patients unable to carry out the treatment program.
boolean
C1321605 (UMLS CUI [1])
platelets and blood coagulation disorder
Item
no patients less than 20,000 per cu mm platelets and clinical bleeding disorder; both must be present for patient to be excluded.
boolean
C0005821 (UMLS CUI [1])
C0005779 (UMLS CUI [2])
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