ID

13863

Beschrijving

Eltrombopag for Management of Thrombocytopenia; ODM derived from: https://clinicaltrials.gov/show/NCT01428635

Link

https://clinicaltrials.gov/show/NCT01428635

Trefwoorden

Versies (2)
  1. 12-03-16 12-03-16 -
  2. 20-09-21 20-09-21 -
Geüploaded op

12 maart 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Leukemia NCT01428635

Engels

Eligibility Leukemia NCT01428635

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01428635
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. cml patients in chronic phase receiving treatment with any fda approved tki; or cml patients in accelerated or blastic phase who are considered to be in this phase because of thrombocytopenia or because of clonal evolution and with no other criteria for accelerated/blastic phase or patients with myelofibrosis receiving treatment with fda approved tki and with peripheral blood and/or bone marrow blasts </= 10%.
Beschrijving

Leukemia, Myeloid, Chronic-Phase; blastic phase; thrombocytopenia; myelofibrosis; peripheral blood blasts

Datatype

boolean

Alias
UMLS CUI [1]
C0023474
UMLS CUI [2]
C3899938
UMLS CUI [3]
C0040034
UMLS CUI [4]
C0026987
UMLS CUI [5]
C1332566
2. grade >/= 3 thrombocytopenia (platelets < 50 x 10^9/l) after the first 3 months of therapy with the tki for patients with cml and platelets <100 x 10^9/l for patients with mf after the first 3 months of therapy. thrombocytopenia must be either recurrent (i.e., second or greater episode of thrombocytopenia) or having required dose reductions of the tki.
Beschrijving

thrombocytopenia; platelets

Datatype

boolean

Alias
UMLS CUI [1]
C0040034
UMLS CUI [2]
C0032181
3. subject is anticipated to have therapy with tki continued for >/= 3 months
Beschrijving

therapy Tyrosine Kinase Inhibitor

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1268567
4. adequate organ function: total bilirubin (except for gilbert's syndrome) </= 1.5 x uln; alt and ast < 3 x uln; creatinine </= 2 x uln
Beschrijving

total bilirubin; alt and ast; creatinine

Datatype

boolean

Alias
UMLS CUI [1]
C0368753
UMLS CUI [2]
C0364051
UMLS CUI [3]
C0201975
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. cml patients in accelerated or blastic phase except for those who are considered to be in this phase because of thrombocytopenia or because of clonal evolution and with no other criteria for accelerated/blastic phase; or myelofibrosis patients who have transformed to acute leukemia or have >/= 10% blasts in peripheral blood and/or in bone marrow.
Beschrijving

Leukemia, Myeloid, Accelerated Phase; thrombocytopenia; clonal evolution; myelofibrosis; bone marrow blasts

Datatype

boolean

Alias
UMLS CUI [1]
C0023472
UMLS CUI [2]
C0040034
UMLS CUI [3]
C1516669
UMLS CUI [4]
C0026987
UMLS CUI [5]
C1982687
2. thrombocytopenia that is considered to be unrelated to treatment with tki or accelerated phase as defined above;
Beschrijving

thrombocytopenia; Leukemia, Myeloid, Accelerated Phase

Datatype

boolean

Alias
UMLS CUI [1]
C0040034
UMLS CUI [2]
C0023472
3. age < 18 years;
Beschrijving

age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
4. stem cell transplantation within preceding 60 days prior to registration;
Beschrijving

stem cell transplantation

Datatype

boolean

Alias
UMLS CUI [1]
C1504389
5. patients with documented active hepatitis b or c infection;
Beschrijving

active hepatitis b or c

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C0019163
6. patients with known bone marrow reticulin fibrosis (only applicable to patients with cml);
Beschrijving

bone marrow reticulin fibrosis

Datatype

boolean

Alias
UMLS CUI [1]
C1335762
7. patients with palpable splenomegaly >/= 16cm below coastal margin (only applicable to patients with cml).
Beschrijving

Splenomegaly

Datatype

boolean

Alias
UMLS CUI [1]
C0038002
8. female subjects who are pregnant or breastfeeding. women of childbearing potential are required to have a bhcg serum or urine pregnancy test performed within 7 days prior to first study drug dose. a female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). women of child-bearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.
Beschrijving

pregnancy; lactating; urine pregnancy test; Contraception status

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0430056
UMLS CUI [4]
C0015780
9. patients with known risk factors for thromboembolism (e.g. factor v leiden mutation, atiii deficiency, protein c and s deficiency, antiphospholipid syndrome, portal hypertension, etc.)
Beschrijving

thromboembolism; factor v leiden mutation; antiphospholipid syndrome; portal hypertension

Datatype

boolean

Alias
UMLS CUI [1]
C0040038
UMLS CUI [2]
C0584960
UMLS CUI [3]
C0085278
UMLS CUI [4]
C0020541
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Similar models

Eligibility Leukemia NCT01428635

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01428635
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Leukemia, Myeloid, Chronic-Phase; blastic phase; thrombocytopenia; myelofibrosis; peripheral blood blasts
Item
1. cml patients in chronic phase receiving treatment with any fda approved tki; or cml patients in accelerated or blastic phase who are considered to be in this phase because of thrombocytopenia or because of clonal evolution and with no other criteria for accelerated/blastic phase or patients with myelofibrosis receiving treatment with fda approved tki and with peripheral blood and/or bone marrow blasts </= 10%.
boolean
C0023474 (UMLS CUI [1])
C3899938 (UMLS CUI [2])
C0040034 (UMLS CUI [3])
C0026987 (UMLS CUI [4])
C1332566 (UMLS CUI [5])
thrombocytopenia; platelets
Item
2. grade >/= 3 thrombocytopenia (platelets < 50 x 10^9/l) after the first 3 months of therapy with the tki for patients with cml and platelets <100 x 10^9/l for patients with mf after the first 3 months of therapy. thrombocytopenia must be either recurrent (i.e., second or greater episode of thrombocytopenia) or having required dose reductions of the tki.
boolean
C0040034 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
therapy Tyrosine Kinase Inhibitor
Item
3. subject is anticipated to have therapy with tki continued for >/= 3 months
boolean
C0087111 (UMLS CUI [1,1])
C1268567 (UMLS CUI [1,2])
total bilirubin; alt and ast; creatinine
Item
4. adequate organ function: total bilirubin (except for gilbert's syndrome) </= 1.5 x uln; alt and ast < 3 x uln; creatinine </= 2 x uln
boolean
C0368753 (UMLS CUI [1])
C0364051 (UMLS CUI [2])
C0201975 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Leukemia, Myeloid, Accelerated Phase; thrombocytopenia; clonal evolution; myelofibrosis; bone marrow blasts
Item
1. cml patients in accelerated or blastic phase except for those who are considered to be in this phase because of thrombocytopenia or because of clonal evolution and with no other criteria for accelerated/blastic phase; or myelofibrosis patients who have transformed to acute leukemia or have >/= 10% blasts in peripheral blood and/or in bone marrow.
boolean
C0023472 (UMLS CUI [1])
C0040034 (UMLS CUI [2])
C1516669 (UMLS CUI [3])
C0026987 (UMLS CUI [4])
C1982687 (UMLS CUI [5])
thrombocytopenia; Leukemia, Myeloid, Accelerated Phase
Item
2. thrombocytopenia that is considered to be unrelated to treatment with tki or accelerated phase as defined above;
boolean
C0040034 (UMLS CUI [1])
C0023472 (UMLS CUI [2])
age
Item
3. age < 18 years;
boolean
C0001779 (UMLS CUI [1])
stem cell transplantation
Item
4. stem cell transplantation within preceding 60 days prior to registration;
boolean
C1504389 (UMLS CUI [1])
active hepatitis b or c
Item
5. patients with documented active hepatitis b or c infection;
boolean
C0019196 (UMLS CUI [1,1])
C0019163 (UMLS CUI [1,2])
bone marrow reticulin fibrosis
Item
6. patients with known bone marrow reticulin fibrosis (only applicable to patients with cml);
boolean
C1335762 (UMLS CUI [1])
Splenomegaly
Item
7. patients with palpable splenomegaly >/= 16cm below coastal margin (only applicable to patients with cml).
boolean
C0038002 (UMLS CUI [1])
pregnancy; lactating; urine pregnancy test; Contraception status
Item
8. female subjects who are pregnant or breastfeeding. women of childbearing potential are required to have a bhcg serum or urine pregnancy test performed within 7 days prior to first study drug dose. a female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). women of child-bearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0430056 (UMLS CUI [3])
C0015780 (UMLS CUI [4])
thromboembolism; factor v leiden mutation; antiphospholipid syndrome; portal hypertension
Item
9. patients with known risk factors for thromboembolism (e.g. factor v leiden mutation, atiii deficiency, protein c and s deficiency, antiphospholipid syndrome, portal hypertension, etc.)
boolean
C0040038 (UMLS CUI [1])
C0584960 (UMLS CUI [2])
C0085278 (UMLS CUI [3])
C0020541 (UMLS CUI [4])
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