ID

13864

Beschreibung

A Study of AC220 Given After Transplant in Subjects With Acute Myeloid Leukemia (AML); ODM derived from: https://clinicaltrials.gov/show/NCT01468467

Link

https://clinicaltrials.gov/show/NCT01468467

Stichworte

Versionen (1)
  1. 12.03.16 12.03.16 -
Hochgeladen am

12. März 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Leukemia, Myeloid, Acute, NCT01468467

Englisch

Eligibility Leukemia, Myeloid, Acute, NCT01468467

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject has a diagnosis of acute myeloid leukemia (aml) according to who classification (2008) and has received a high dose or a reduced intensity conditioning allogeneic hematopoietic stem cell transplant (hsct) during first or second remission and within 30 to 60 days prior to first dose of ac220. donors may be human leukocyte antigen (hla)-matched for hla-a, b, c, drb1, and dqb1 by high resolution typing, related or unrelated (only a single allele disparity will be allowed for hla-a, b, or c as defined by high resolution typing) note: more than one hsct is allowed
Beschreibung

acute myeloid leukemia; allogeneic hematopoietic stem cell transplant; HLA Antigens

Datentyp

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2]
C1456094
UMLS CUI [3]
C0019721
subject must be in morphologic remission (< 5% marrow blasts) and without active central nervous system (cns) aml within 14 days prior to first dose of ac220
Beschreibung

Cancer Remission; marrow blasts; Central nervous system leukaemia

Datentyp

boolean

Alias
UMLS CUI [1]
C0687702
UMLS CUI [2]
C1982687
UMLS CUI [3]
C1332884
subject must have cd3 donor chimerism > 50 % at screening
Beschreibung

chimerism; screening

Datentyp

boolean

Alias
UMLS CUI [1]
C0333678
UMLS CUI [2]
C0220908
subject has a karnofsky performance status (kps) of ≥ 60
Beschreibung

karnofsky performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C0206065
subject must have absolute neutrophil count (anc) > 1000/mm3 and platelet count > 50,000/mm3 without platelet transfusion support within 2 weeks prior to first dose
Beschreibung

absolute neutrophil count; platelet count; platelet transfusion

Datentyp

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0086818
subject must have adequate renal, hepatic, and coagulation parameters
Beschreibung

laboratory renal hepatic coagulation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0681902
UMLS CUI [1,2]
C0022646
UMLS CUI [1,3]
C0205054
UMLS CUI [1,4]
C0005778
female subjects must not be lactating and must not be breastfeeding at screening or during the study period and for 28 days [or five half lives of the study drug whichever is longer] after final study drug administration.
Beschreibung

pregnancy; lactating

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
subject is able to comply with study procedures and follow-up examinations
Beschreibung

compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C1321605
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject received ac220 and relapsed during treatment with ac220
Beschreibung

therapy ac220; Cancer Relapse

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2348498
UMLS CUI [2]
C0699753
subject has active ≥ grade 2 graft versus host disease (gvhd)
Beschreibung

graft versus host disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0018133
subject has received concurrent chemotherapy, immunotherapy, or radio-therapy within 21 days prior to the first dose of ac220, or any antineoplastic therapy that is considered to be investigational (i.e., used for non-approved indications(s) and in the context of a research investigation) within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug
Beschreibung

concurrent therapy chemotherapy immunotherapy radiotherapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009429
UMLS CUI [1,2]
C3665472
UMLS CUI [1,3]
C0021083
UMLS CUI [1,4]
C1522449
subject requires treatment with concomitant drugs that prolong qt/qtc interval or strong cytochrome p-3a4 (cyp3a4) inhibitors or inducers with the exception of immunosuppressants, antibiotics, antifungals, and antivirals that are used as standard of care post-transplant or to prevent or treat infections and other such drugs that are considered absolutely essential for the care of the subject
Beschreibung

concomitant medication; Prolonged QT interval; immunosuppressants; antibiotics; antifungals

Datentyp

boolean

Alias
UMLS CUI [1]
C2347852
UMLS CUI [2]
C0151878
UMLS CUI [3]
C0021081
UMLS CUI [4]
C0003232
UMLS CUI [5]
C0003308
subject requires treatment with anticoagulant therapy
Beschreibung

anticoagulant therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0150457
subject has a known positive test for human immunodeficiency virus, hepatitis c, or hepatitis b surface antigen
Beschreibung

hiv positive; Hepatitis B Surface Antigens

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0019168
subject had major surgery within 4 weeks prior to first dose of ac220
Beschreibung

major surgery; dosage ac220

Datentyp

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C2348498
subject has uncontrolled or significant cardiovascular disease
Beschreibung

cardiovascular disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0007222
subject has an active acute fungal, bacterial, or other infection that is unresponsive to therapy
Beschreibung

infection; Unresponsive to Treatment

Datentyp

boolean

Alias
UMLS CUI [1]
C3714514
UMLS CUI [2]
C0205269
subject has participated in any interventional clinical study or has been treated with any investigational drugs within 30 days or 5 half lives whichever is longer, prior to the initiation of screening.
Beschreibung

Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
subject has any medical, psychiatric, addictive or other kind of disorder which compromises the ability of the subject to give written informed consent and/or to comply with procedures
Beschreibung

Compliance behavior Limited Comorbidity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
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Ähnliche Modelle

Eligibility Leukemia, Myeloid, Acute, NCT01468467

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
acute myeloid leukemia; allogeneic hematopoietic stem cell transplant; HLA Antigens
Item
subject has a diagnosis of acute myeloid leukemia (aml) according to who classification (2008) and has received a high dose or a reduced intensity conditioning allogeneic hematopoietic stem cell transplant (hsct) during first or second remission and within 30 to 60 days prior to first dose of ac220. donors may be human leukocyte antigen (hla)-matched for hla-a, b, c, drb1, and dqb1 by high resolution typing, related or unrelated (only a single allele disparity will be allowed for hla-a, b, or c as defined by high resolution typing) note: more than one hsct is allowed
boolean
C0023467 (UMLS CUI [1])
C1456094 (UMLS CUI [2])
C0019721 (UMLS CUI [3])
Cancer Remission; marrow blasts; Central nervous system leukaemia
Item
subject must be in morphologic remission (< 5% marrow blasts) and without active central nervous system (cns) aml within 14 days prior to first dose of ac220
boolean
C0687702 (UMLS CUI [1])
C1982687 (UMLS CUI [2])
C1332884 (UMLS CUI [3])
chimerism; screening
Item
subject must have cd3 donor chimerism > 50 % at screening
boolean
C0333678 (UMLS CUI [1])
C0220908 (UMLS CUI [2])
karnofsky performance status
Item
subject has a karnofsky performance status (kps) of ≥ 60
boolean
C0206065 (UMLS CUI [1])
absolute neutrophil count; platelet count; platelet transfusion
Item
subject must have absolute neutrophil count (anc) > 1000/mm3 and platelet count > 50,000/mm3 without platelet transfusion support within 2 weeks prior to first dose
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0086818 (UMLS CUI [3])
laboratory renal hepatic coagulation
Item
subject must have adequate renal, hepatic, and coagulation parameters
boolean
C0681902 (UMLS CUI [1,1])
C0022646 (UMLS CUI [1,2])
C0205054 (UMLS CUI [1,3])
C0005778 (UMLS CUI [1,4])
pregnancy; lactating
Item
female subjects must not be lactating and must not be breastfeeding at screening or during the study period and for 28 days [or five half lives of the study drug whichever is longer] after final study drug administration.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
compliance
Item
subject is able to comply with study procedures and follow-up examinations
boolean
C1321605 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
therapy ac220; Cancer Relapse
Item
subject received ac220 and relapsed during treatment with ac220
boolean
C0087111 (UMLS CUI [1,1])
C2348498 (UMLS CUI [1,2])
C0699753 (UMLS CUI [2])
graft versus host disease
Item
subject has active ≥ grade 2 graft versus host disease (gvhd)
boolean
C0018133 (UMLS CUI [1])
concurrent therapy chemotherapy immunotherapy radiotherapy
Item
subject has received concurrent chemotherapy, immunotherapy, or radio-therapy within 21 days prior to the first dose of ac220, or any antineoplastic therapy that is considered to be investigational (i.e., used for non-approved indications(s) and in the context of a research investigation) within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug
boolean
C0009429 (UMLS CUI [1,1])
C3665472 (UMLS CUI [1,2])
C0021083 (UMLS CUI [1,3])
C1522449 (UMLS CUI [1,4])
concomitant medication; Prolonged QT interval; immunosuppressants; antibiotics; antifungals
Item
subject requires treatment with concomitant drugs that prolong qt/qtc interval or strong cytochrome p-3a4 (cyp3a4) inhibitors or inducers with the exception of immunosuppressants, antibiotics, antifungals, and antivirals that are used as standard of care post-transplant or to prevent or treat infections and other such drugs that are considered absolutely essential for the care of the subject
boolean
C2347852 (UMLS CUI [1])
C0151878 (UMLS CUI [2])
C0021081 (UMLS CUI [3])
C0003232 (UMLS CUI [4])
C0003308 (UMLS CUI [5])
anticoagulant therapy
Item
subject requires treatment with anticoagulant therapy
boolean
C0150457 (UMLS CUI [1])
hiv positive; Hepatitis B Surface Antigens
Item
subject has a known positive test for human immunodeficiency virus, hepatitis c, or hepatitis b surface antigen
boolean
C0019699 (UMLS CUI [1])
C0019168 (UMLS CUI [2])
major surgery; dosage ac220
Item
subject had major surgery within 4 weeks prior to first dose of ac220
boolean
C0679637 (UMLS CUI [1])
C0178602 (UMLS CUI [2,1])
C2348498 (UMLS CUI [2,2])
cardiovascular disease
Item
subject has uncontrolled or significant cardiovascular disease
boolean
C0007222 (UMLS CUI [1])
infection; Unresponsive to Treatment
Item
subject has an active acute fungal, bacterial, or other infection that is unresponsive to therapy
boolean
C3714514 (UMLS CUI [1])
C0205269 (UMLS CUI [2])
Study Subject Participation Status
Item
subject has participated in any interventional clinical study or has been treated with any investigational drugs within 30 days or 5 half lives whichever is longer, prior to the initiation of screening.
boolean
C2348568 (UMLS CUI [1])
Compliance behavior Limited Comorbidity
Item
subject has any medical, psychiatric, addictive or other kind of disorder which compromises the ability of the subject to give written informed consent and/or to comply with procedures
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
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