ID

42200

Description

Study of Crenolanib in Combination Combination With Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia and Activating FLT3 Mutations; ODM derived from: https://clinicaltrials.gov/show/NCT02298166

Link

https://clinicaltrials.gov/show/NCT02298166

Keywords

Versions (2)
  1. 3/22/16 3/22/16 -
  2. 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
Uploaded on

April 13, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Acute Myeloid Leukemia NCT02298166

English

Eligibility Acute Myeloid Leukemia NCT02298166

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
Patients with confirmed diagnosis of aml either refractory to induction therapy or relapsed after first line treatment including chemotherapy, autologous and allogeneic hsct
Description

AML

Data type

boolean

Alias
UMLS CUI [1]
C0023467
Refractory to induction therapy is defined as no cr, cri, pr (according to standard criteria, 28) after one intensive induction therapy including at least 7 days of cytarabine 100-200mg/m² continuously and 3 days of an anthracycline (e.g. daunorubicin, idarubucin )
Description

Refractory to induction therapy

Data type

boolean

Alias
UMLS CUI [1]
C1514832
Relapsed after first line therapy is defined as relapsed aml (according to standard criteria, 28) after a first line therapy including at least one intensive induction and consolidation therapy
Description

relapsed aml

Data type

boolean

Alias
UMLS CUI [1]
C0278780
Presence of flt3-activating mutation at the time of refractory disease or relapse assessed in the central amlsg reference laboratories; positivity positivity of flt3-itd and flt3-tkd is defined based on genescan analysis with a mutant to wild-type ratio equal or above 5%
Description

Presence of flt3-activating mutation

Data type

boolean

Alias
UMLS CUI [1]
C1953284
Patients considered eligible for intensive chemotherapy
Description

Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C3665472
Ecog performance status of ≤ 2
Description

ECOG performance status

Data type

boolean

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

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
Non-pregnant and non-nursing women of childbearing potential (wocbp) must have a negative serum or urine pregnancy test within a sensitivity of at least 25 miu/ml within 72 hours prior to registration ("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)
Description

Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1]
C0427780
Female patients of reproductive age and male patients must agree to avoid getting pregnant or to father a child while on therapy and for 3 months after the last dose of crenolanib
Description

Agree to avoid getting pregnant

Data type

boolean

Alias
UMLS CUI [1]
C0425965
Women of child-bearing potential must either commit to continued abstinence from heterosexual intercourse or begin one acceptable method of birth control (iud, tubal ligation, or partner's vasectomy). hormonal contraception is an inadequate method of birth control
Description

Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0700589
men must use a latex condom during any sexual contact with women of childbearing potential, even if they have undergone a successful vasectomy (while on therapy and for 3 month after the last dose of crenolanib)
Description

Latex condom

Data type

boolean

Alias
UMLS CUI [1]
C3873750
Willing to adhere to protocol specific requirements
Description

Protocol requirements

Data type

boolean

Alias
UMLS CUI [1]
C1709747
Following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study related activity is carried out
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
ecog performance status >2 3
Description

ECOG

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Known or suspected hypersensitivity to the study drugs and/or any excipients
Description

Hypertensitvity

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013227
inadequate cardiac function defined as: ejection fraction < 45% confirmed by echocardiography
Description

heart function

Data type

boolean

Alias
UMLS CUI [1]
C2700378
inadequat renal function at the screening visit defined as: creatinine >1.5x upper normal serum level
Description

Renal function

Data type

boolean

Alias
UMLS CUI [1]
C0151746
inadequat liver function at the screening visit defined as: total bilirubin, ast or alt >2.5 upper normal serum level
Description

Liver function

Data type

boolean

Alias
UMLS CUI [1]
C0151766
Any clinically significant, advanced or unstable disease or history of that may interfere with primary or secondary variable evaluations or put the patient at special risk
Description

Disease

Data type

boolean

Alias
UMLS CUI [1]
C0679246
myocardial infarction, unstable angina within 3 months before screening
Description

myocardial infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
heart failure nyha iii/iv
Description

heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0278962
severe obstructive or restrictive ventilation disorder
Description

obstructive or restrictive ventilation disorder

Data type

boolean

Alias
UMLS CUI [1]
C0600260
UMLS CUI [2]
C0085581
uncontrolled infection 6. severe neurological or psychiatric disorder interfering with ability of giving an informed consent 7. currently receiving a therapy not permitted during the study, as defined in section 10.6.5 8. active graft-versus-host disease (gvhd) under immunosuppressive therapy different from steroids 9. patients with a "currently active" second malignancy other than non-melanoma skin cancers. patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse within one year 10. known history of positive test for hepatitis b surface antigen (hsbag) or hepatitis c antibody or history of positive test for human immunodeficiency virus (hiv) 11. hematological disorder independent of leukemia 12. no consent for registration, storage and processing of the individual disease characteristics and course as well as information of the family physician and/or other physicians involved in the treatment of the patient about study participation 13. no consent for biobanking 14. current participation in any other interventional clinical study within 30 days before the first administration of the investigational product or at any time during the study 15. patients known or suspected of not being able to comply with this trial protocol 16. breast feeding women or women with a positive pregnancy test at screening visit 17. patients of childbearing potential not willing to use adequate contraception during study and 3 months after last dose of crenolanib
Description

Infection, Disease etc.

Data type

boolean

Alias
UMLS CUI [1,1]
C3714514
UMLS CUI [1,2]
C0004936
UMLS CUI [2]
C0018133
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Similar models

Eligibility Acute Myeloid Leukemia NCT02298166

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
AML
Item
Patients with confirmed diagnosis of aml either refractory to induction therapy or relapsed after first line treatment including chemotherapy, autologous and allogeneic hsct
boolean
C0023467 (UMLS CUI [1])
Refractory to induction therapy
Item
Refractory to induction therapy is defined as no cr, cri, pr (according to standard criteria, 28) after one intensive induction therapy including at least 7 days of cytarabine 100-200mg/m² continuously and 3 days of an anthracycline (e.g. daunorubicin, idarubucin )
boolean
C1514832 (UMLS CUI [1])
relapsed aml
Item
Relapsed after first line therapy is defined as relapsed aml (according to standard criteria, 28) after a first line therapy including at least one intensive induction and consolidation therapy
boolean
C0278780 (UMLS CUI [1])
Presence of flt3-activating mutation
Item
Presence of flt3-activating mutation at the time of refractory disease or relapse assessed in the central amlsg reference laboratories; positivity positivity of flt3-itd and flt3-tkd is defined based on genescan analysis with a mutant to wild-type ratio equal or above 5%
boolean
C1953284 (UMLS CUI [1])
Chemotherapy
Item
Patients considered eligible for intensive chemotherapy
boolean
C3665472 (UMLS CUI [1])
ECOG performance status
Item
Ecog performance status of ≤ 2
boolean
C1520224 (UMLS CUI [1])
Age
Item
Age ≥ 18 years with the capacity to give written informed consent
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Pregnancy test negative
Item
Non-pregnant and non-nursing women of childbearing potential (wocbp) must have a negative serum or urine pregnancy test within a sensitivity of at least 25 miu/ml within 72 hours prior to registration ("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)
boolean
C0427780 (UMLS CUI [1])
Agree to avoid getting pregnant
Item
Female patients of reproductive age and male patients must agree to avoid getting pregnant or to father a child while on therapy and for 3 months after the last dose of crenolanib
boolean
C0425965 (UMLS CUI [1])
Contraceptive methods
Item
Women of child-bearing potential must either commit to continued abstinence from heterosexual intercourse or begin one acceptable method of birth control (iud, tubal ligation, or partner's vasectomy). hormonal contraception is an inadequate method of birth control
boolean
C0700589 (UMLS CUI [1])
Latex condom
Item
men must use a latex condom during any sexual contact with women of childbearing potential, even if they have undergone a successful vasectomy (while on therapy and for 3 month after the last dose of crenolanib)
boolean
C3873750 (UMLS CUI [1])
Protocol requirements
Item
Willing to adhere to protocol specific requirements
boolean
C1709747 (UMLS CUI [1])
informed consent
Item
Following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study related activity is carried out
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ECOG
Item
ecog performance status >2 3
boolean
C1520224 (UMLS CUI [1])
Hypertensitvity
Item
Known or suspected hypersensitivity to the study drugs and/or any excipients
boolean
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
heart function
Item
inadequate cardiac function defined as: ejection fraction < 45% confirmed by echocardiography
boolean
C2700378 (UMLS CUI [1])
Renal function
Item
inadequat renal function at the screening visit defined as: creatinine >1.5x upper normal serum level
boolean
C0151746 (UMLS CUI [1])
Liver function
Item
inadequat liver function at the screening visit defined as: total bilirubin, ast or alt >2.5 upper normal serum level
boolean
C0151766 (UMLS CUI [1])
Disease
Item
Any clinically significant, advanced or unstable disease or history of that may interfere with primary or secondary variable evaluations or put the patient at special risk
boolean
C0679246 (UMLS CUI [1])
myocardial infarction
Item
myocardial infarction, unstable angina within 3 months before screening
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
heart failure
Item
heart failure nyha iii/iv
boolean
C0278962 (UMLS CUI [1])
obstructive or restrictive ventilation disorder
Item
severe obstructive or restrictive ventilation disorder
boolean
C0600260 (UMLS CUI [1])
C0085581 (UMLS CUI [2])
Infection, Disease etc.
Item
uncontrolled infection 6. severe neurological or psychiatric disorder interfering with ability of giving an informed consent 7. currently receiving a therapy not permitted during the study, as defined in section 10.6.5 8. active graft-versus-host disease (gvhd) under immunosuppressive therapy different from steroids 9. patients with a "currently active" second malignancy other than non-melanoma skin cancers. patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse within one year 10. known history of positive test for hepatitis b surface antigen (hsbag) or hepatitis c antibody or history of positive test for human immunodeficiency virus (hiv) 11. hematological disorder independent of leukemia 12. no consent for registration, storage and processing of the individual disease characteristics and course as well as information of the family physician and/or other physicians involved in the treatment of the patient about study participation 13. no consent for biobanking 14. current participation in any other interventional clinical study within 30 days before the first administration of the investigational product or at any time during the study 15. patients known or suspected of not being able to comply with this trial protocol 16. breast feeding women or women with a positive pregnancy test at screening visit 17. patients of childbearing potential not willing to use adequate contraception during study and 3 months after last dose of crenolanib
boolean
C3714514 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
C0018133 (UMLS CUI [2])
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