ID

14128

Descripción

Crenolanib Maintenance Following Allogeneic Stem Cell Transplantation in FLT3-positive Acute Myeloid Leukemia Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02400255

Link

https://clinicaltrials.gov/show/NCT02400255

Palabras clave

Versiones (1)
  1. 30/3/16 30/3/16 -
Subido en

30 de marzo de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Acute Myeloid Leukemia NCT02400255

Inglés

Eligibility Acute Myeloid Leukemia NCT02400255

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
history of aml according to world health organization (who) classification
Descripción

history of aml

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023467
first allogeneic hematopoietic stem cell transplantation (hsct) using myeloablative conditioning (mac), non-myeloablative (nma), or reduced-intensity conditioning (ric) preparative regimens.
Descripción

first allogeneic hematopoietic stem cell transplantation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1705576
flt3-itd or flt3-d835 positive disease at any time during disease course.
Descripción

flt3-itd

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348499
hematopoietic stem cell source is either with peripheral blood, bone marrow or cord blood.
Descripción

Hematopoietic stem cells

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018956
donor source is matched related, unrelated, haploidentical donor or cord blood.
Descripción

donor source is matched

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0842372
at the time of allogeneic hsct
Descripción

allogeneic hsct

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0040739
no more than 1 antigen mismatch at hla-a, -b, -c, -drb1 or -dqb1 locus for unrelated donor with peripheral blood and bone marrow as the hematopoietic stem cell source; and
Descripción

antigen mismatch

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0456471
bone marrow blast ≤ 10%
Descripción

bone marrow blast

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1332565
no sooner than 45 days but no later than 90 days after allogeneic hsct.
Descripción

time span after allogeneic hsct

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0301905
post-transplant bone marrow blast count ≤ 5% confirmed within 21 days prior to starting study therapy
Descripción

post-transplant bone marrow blast count

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1332565
evidence of donor engraftment as defined by institutional standard t cell chimerism > 50%.
Descripción

Graft acceptance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0301944
adequate engraftment within 7 days prior to starting study therapy: anc ≥ 1.0 x 109/l without daily use of myeloid growth factor; and platelet ≥ 25 x 109/l without platelet transfusion within 1 week
Descripción

Absolute neutrophil count

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0948762
non-hematological toxicities ≤ grade 2
Descripción

Toxic effect

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0600688
serum creatinine ≤ 1.5 × uln or creatinine clearance ≥ 50ml/min/1.73 m2 for subjects with creatinine levels above institutional normal
Descripción

serum creatinine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0600061
adequate liver function with serum ast, alt and bilirubin within the normal range at the time of crenolanib commencement
Descripción

Liver function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232741
acute graft-versus-host disease (gvhd) ≤ grade 1, either no signs of chronic gvhd or mild chronic gvhd graded as limited disease
Descripción

Graft-vs-Host Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018133
eastern cooperative oncology group (ecog) performance status of 0-2
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
age ≥ 18 years with the capacity to give written informed consent
Descripción

age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
non-pregnant and non-nursing women of childbearing potential must have a negative serum or urine pregnancy test
Descripción

("women of childbearing potential" is defined as a sexually active mature woman who has not undergone a hysterectomy or who has had menses at any time in the preceding 24 consecutive months)

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0427780
women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation and for 90 days following completion of therapy
Descripción

Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
uncontrolled infection
Descripción

Infection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3714514
bone marrow blast > 5% within 21 days of start of study drug
Descripción

Blast Count

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2697913
active gvhd grade ≥ 2
Descripción

Acute GVH disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0856825
concurrent use of corticosteroids equivalent of prednisone at a dose > 0.5 mg/kg
Descripción

Steroid therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0149783
active and/or untreated central nervous system (cns) leukemia
Descripción

Central nervous system leukaemia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1332884
concomitant therapies for treatment or control of leukemia.
Descripción

Concomitant Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1707479
use of any of the following after transplantation and prior to starting study therapy:
Descripción

Medication

Tipo de datos

integer

Alias
UMLS CUI [1]
C0013227
known positive for human immunodeficiency virus (hiv); active hepatitis b (hbv) or hepatitis c (hcv) infection
Descripción

hiv+, hepatits b

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0856706
significant cardiac disease (new york heart association classes iii or iv) or unstable angina despite medication
Descripción

cardiac disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018799
pregnant or breast-feeding
Descripción

pregnant or breast-feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3242212
receipt of investigational agents within 5 half-lives of last dose of investigational agent
Descripción

investigational agent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
prior treatment with crenolanib with progression on treatment
Descripción

crenolanib

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1831982
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Similar models

Eligibility Acute Myeloid Leukemia NCT02400255

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
history of aml
Item
history of aml according to world health organization (who) classification
boolean
C0023467 (UMLS CUI [1])
first allogeneic hematopoietic stem cell transplantation
Item
first allogeneic hematopoietic stem cell transplantation (hsct) using myeloablative conditioning (mac), non-myeloablative (nma), or reduced-intensity conditioning (ric) preparative regimens.
boolean
C1705576 (UMLS CUI [1])
flt3-itd
Item
flt3-itd or flt3-d835 positive disease at any time during disease course.
boolean
C2348499 (UMLS CUI [1])
Hematopoietic stem cells
Item
hematopoietic stem cell source is either with peripheral blood, bone marrow or cord blood.
boolean
C0018956 (UMLS CUI [1])
donor source is matched
Item
donor source is matched related, unrelated, haploidentical donor or cord blood.
boolean
C0842372 (UMLS CUI [1])
allogeneic hsct
Item
at the time of allogeneic hsct
boolean
C0040739 (UMLS CUI [1])
antigen mismatch
Item
no more than 1 antigen mismatch at hla-a, -b, -c, -drb1 or -dqb1 locus for unrelated donor with peripheral blood and bone marrow as the hematopoietic stem cell source; and
boolean
C0456471 (UMLS CUI [1])
bone marrow blast
Item
bone marrow blast ≤ 10%
boolean
C1332565 (UMLS CUI [1])
time span after allogeneic hsct
Item
no sooner than 45 days but no later than 90 days after allogeneic hsct.
boolean
C0301905 (UMLS CUI [1])
post-transplant bone marrow blast count
Item
post-transplant bone marrow blast count ≤ 5% confirmed within 21 days prior to starting study therapy
boolean
C1332565 (UMLS CUI [1])
Graft acceptance
Item
evidence of donor engraftment as defined by institutional standard t cell chimerism > 50%.
boolean
C0301944 (UMLS CUI [1])
Absolute neutrophil count
Item
adequate engraftment within 7 days prior to starting study therapy: anc ≥ 1.0 x 109/l without daily use of myeloid growth factor; and platelet ≥ 25 x 109/l without platelet transfusion within 1 week
boolean
C0948762 (UMLS CUI [1])
Toxic effect
Item
non-hematological toxicities ≤ grade 2
boolean
C0600688 (UMLS CUI [1])
serum creatinine
Item
serum creatinine ≤ 1.5 × uln or creatinine clearance ≥ 50ml/min/1.73 m2 for subjects with creatinine levels above institutional normal
boolean
C0600061 (UMLS CUI [1])
Liver function
Item
adequate liver function with serum ast, alt and bilirubin within the normal range at the time of crenolanib commencement
boolean
C0232741 (UMLS CUI [1])
Graft-vs-Host Disease
Item
acute graft-versus-host disease (gvhd) ≤ grade 1, either no signs of chronic gvhd or mild chronic gvhd graded as limited disease
boolean
C0018133 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0-2
boolean
C1520224 (UMLS CUI [1])
age
Item
age ≥ 18 years with the capacity to give written informed consent
boolean
C0001779 (UMLS CUI [1])
Pregnancy test negative
Item
non-pregnant and non-nursing women of childbearing potential must have a negative serum or urine pregnancy test
boolean
C0427780 (UMLS CUI [1])
Contraceptive methods
Item
women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation and for 90 days following completion of therapy
boolean
C0700589 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Infection
Item
uncontrolled infection
boolean
C3714514 (UMLS CUI [1])
Blast Count
Item
bone marrow blast > 5% within 21 days of start of study drug
boolean
C2697913 (UMLS CUI [1])
Acute GVH disease
Item
active gvhd grade ≥ 2
boolean
C0856825 (UMLS CUI [1])
Steroid therapy
Item
concurrent use of corticosteroids equivalent of prednisone at a dose > 0.5 mg/kg
boolean
C0149783 (UMLS CUI [1])
Central nervous system leukaemia
Item
active and/or untreated central nervous system (cns) leukemia
boolean
C1332884 (UMLS CUI [1])
Concomitant Therapy
Item
concomitant therapies for treatment or control of leukemia.
boolean
C1707479 (UMLS CUI [1])
Item
use of any of the following after transplantation and prior to starting study therapy:
integer
C0013227 (UMLS CUI [1])
ID.26
Code List
use of any of the following after transplantation and prior to starting study therapy:
CL Item
chemotherapeutic agents for therapy of aml (note that prophylactic use of these agents is allowed in this study, e.g., methotrexate for gvhd) (1)
C0729502 (UMLS CUI-1)
CL Item
investigational agents/therapies (2)
C0013230 (UMLS CUI-1)
CL Item
azacitidine, decitabine or other demethylating agents (3)
C0004475 (UMLS CUI-1)
CL Item
lenalidomide, thalidomide and pomalidomide (4)
C1144149 (UMLS CUI-1)
hiv+, hepatits b
Item
known positive for human immunodeficiency virus (hiv); active hepatitis b (hbv) or hepatitis c (hcv) infection
boolean
C0019699 (UMLS CUI [1])
C0856706 (UMLS CUI [2])
cardiac disease
Item
significant cardiac disease (new york heart association classes iii or iv) or unstable angina despite medication
boolean
C0018799 (UMLS CUI [1])
pregnant or breast-feeding
Item
pregnant or breast-feeding
boolean
C3242212 (UMLS CUI [1])
investigational agent
Item
receipt of investigational agents within 5 half-lives of last dose of investigational agent
boolean
C0013230 (UMLS CUI [1])
crenolanib
Item
prior treatment with crenolanib with progression on treatment
boolean
C1831982 (UMLS CUI [1])
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