ID

43815

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT01428635

Stichworte

Versionen (2)
  1. 12.03.16 12.03.16 -
  2. 20.09.21 20.09.21 -
Hochgeladen am

20. September 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Leukemia NCT01428635

Englisch

Eligibility Leukemia NCT01428635

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01428635
Inclusion Criteria
Beschreibung

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%.
Beschreibung

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

Datentyp

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.
Beschreibung

thrombocytopenia; platelets

Datentyp

boolean

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

therapy Tyrosine Kinase Inhibitor

Datentyp

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
Beschreibung

total bilirubin; alt and ast; creatinine

Datentyp

boolean

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

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.
Beschreibung

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

Datentyp

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;
Beschreibung

thrombocytopenia; Leukemia, Myeloid, Accelerated Phase

Datentyp

boolean

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

age

Datentyp

boolean

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

stem cell transplantation

Datentyp

boolean

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

active hepatitis b or c

Datentyp

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);
Beschreibung

bone marrow reticulin fibrosis

Datentyp

boolean

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

Splenomegaly

Datentyp

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.
Beschreibung

pregnancy; lactating; urine pregnancy test; Contraception status

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0430056
UMLS CUI [4]
C0086287
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.)
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0040038
UMLS CUI [2]
C0584960
UMLS CUI [3]
C0085278
UMLS CUI [4]
C0020541
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Ähnliche Modelle

Eligibility Leukemia NCT01428635

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01428635
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
C0086287 (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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