ID

13165

Description

Haploidentical Transplantation in Patients With Acute Leukemia and Myelodysplasia; ODM derived from: https://clinicaltrials.gov/show/NCT00475384

Link

https://clinicaltrials.gov/show/NCT00475384

Keywords

Versions (1)
  1. 1/21/16 1/21/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

January 21, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Acute Myelogenous Leukemia NCT00475384

English

Eligibility Acute Myelogenous Leukemia NCT00475384

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
2. cardiac function: left ventricular ejection fraction > 45%
Description

cardiac function

Data type

boolean

Alias
UMLS CUI [1]
C0428772
3. renal function: serum creatinine < 2x upper limit of normal for age or if serum creatinine elevated beyond normal, must have creatinine clearance or glomerular filtration rate > 50% lower limit of normal for age
Description

renal function

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0373595
UMLS CUI [3]
C0017654
4. hepatic function: ast/alt < 3x upper limit of normal for age and bilirubin < 2.0 mg/dl. these criteria do not apply if liver is involved with disease.
Description

hepatic function

Data type

boolean

Alias
UMLS CUI [1]
C0364051
UMLS CUI [2]
C1278039
5. pulmonary function: patient must have room air o2 saturation >95% and no clinical evidence of pulmonary insufficiency unless the lungs are involved with disease.
Description

pulmonary function

Data type

boolean

Alias
UMLS CUI [1]
C0523807
6. patients with acute myelogenous leukemia (aml): induction failure with < 3 induction courses, >/= second or greater complete remission (cr) (defined as <5% blasts in bone marrow and no active extramedullary disease) , cr1 with high risk features defined as history of induction failure, 5q- or monosomy 7 cytogenetic findings;
Description

AML

Data type

boolean

Alias
UMLS CUI [1]
C0023467
7. patients wih acute lymphocytic leukemia (all): >/= second or greater cr (defined as <5% blasts in bone marrow and no active extramedullary disease), cr1 with high risk features defined as history of induction failure or ph+ or t(4;11) on cytogenetic analysis or any infant with mll rearrangements on cytogenetic analysis;
Description

ALL

Data type

boolean

Alias
UMLS CUI [1]
C0023449
8. patients with myelodysplastic syndrome (mds): refractory anemia (ra) with excess blasts (eb) with intermediate (int)-1, int-2 or high international prognosis score system (ipss) score, refractory anemia with excess blasts (raeb) in transformation (it) with int-1, int-2 or high ipss score and patients with ra and int-2 ipss score
Description

MDS

Data type

boolean

Alias
UMLS CUI [1]
C3463824
9. patients lacking a suitably matched family donor defined by genotypic or phenotypic identity for >/= 5/6 a, b, dr loci
Description

family donor

Data type

boolean

Alias
UMLS CUI [1]
C0013018
10. patients lacking an immediately available genotypically matched (6/6) unrelated marrow donor or umbilical cord blood donor with suitable cell dose after a search of greater than or equal to 2 months or patients whose medical condition is at high risk of deteriorating or whose disease is at high risk of progression during a donor search
Description

unrelated marrow donor or umbilical cord blood donor

Data type

boolean

Alias
UMLS CUI [1]
C0013018
11. patients must have a healthy family member donor who must be at least genotypically hla-a, b, c, dr haploidentical to the patient.
Description

healthy family member donor

Data type

boolean

Alias
UMLS CUI [1]
C0013018
12. donors must sign voluntary, written informed consent or in the case of minor donors such consent must be signed by the parent or guardian and assent will be requested as age appropriate.
Description

written informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
13. donors must be capable of undergoing leukapheresis, have adequate venous access and be willing to undergo placement of a central venous catheter should leukapheresis via peripheral access be inadequate.
Description

leukapheresis

Data type

boolean

Alias
UMLS CUI [1]
C0023416
14. note that satisfactory mobilization of donor peripheral blood stem cells (pbsc) to meet protocol criteria must take place prior to initiation of conditioning of the patient.
Description

pbsc mobilization

Data type

boolean

Alias
UMLS CUI [1]
C1518999
15. donors must be informed that they would be requested to undergo a second donation of pbsc or a bm harvest should the patient fail to demonstrate sustained engraftment after hsct
Description

second donation

Data type

boolean

Alias
UMLS CUI [1]
C0472699
16. donors must meet all the medical criteria for blood product donation, including negative test for hiv, freedom from other active infection, absence of medical condition posing a health risk to donation of pbsc or function of the graft.
Description

medical criteria for blood product donation

Data type

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C0009450
17. to provide a source of peripheral blood mononuclear cells to serve as allosensitizers patients must either: (a) have a parent disparate with the donor for the haplotype shared by the patient and parent but not shared by the patient and donor; or (b) be able to donate sufficient autologous cells by peripheral blood draw or unstimulated leukapheresis
Description

source of peripheral blood mononuclear cells to serve as allosensitizers

Data type

boolean

Alias
UMLS CUI [1]
C3839712
18. female patients of child-bearing age must have a negative pregnancy test and be using an form of contraception considered effective and medically acceptable by the investigator.
Description

pregnancy and contraception

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0700589
19. voluntary written informed consent. children will be asked for assent wherever age appropriate.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. active infection. freedom from active infection is defined as: absence of an infectious diagnosis or (in patients who have had a recent positive infectious diagnosis) the resolution of fever, documentation of negative cultures or antigen testing, continuation or completion of a course of appropriate therapy, and presence of stable to resolving clinical symptoms.
Description

active infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
2. evidence of hiv infection or known hiv positive serology
Description

HIV

Data type

boolean

Alias
UMLS CUI [1]
C0019682
3. presence of active central nervous system (cns) disease
Description

CNS disease

Data type

boolean

Alias
UMLS CUI [1]
C0007682
4. all patients who relapse with isolated extramedullary disease after completion of treatment
Description

extramedullary disease

Data type

boolean

Alias
UMLS CUI [1]
C1868812
5. any prior stem cell transplant
Description

stem cell transplant

Data type

boolean

Alias
UMLS CUI [1]
C1504389
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Similar models

Eligibility Acute Myelogenous Leukemia NCT00475384

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
cardiac function
Item
2. cardiac function: left ventricular ejection fraction > 45%
boolean
C0428772 (UMLS CUI [1])
renal function
Item
3. renal function: serum creatinine < 2x upper limit of normal for age or if serum creatinine elevated beyond normal, must have creatinine clearance or glomerular filtration rate > 50% lower limit of normal for age
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
C0017654 (UMLS CUI [3])
hepatic function
Item
4. hepatic function: ast/alt < 3x upper limit of normal for age and bilirubin < 2.0 mg/dl. these criteria do not apply if liver is involved with disease.
boolean
C0364051 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
pulmonary function
Item
5. pulmonary function: patient must have room air o2 saturation >95% and no clinical evidence of pulmonary insufficiency unless the lungs are involved with disease.
boolean
C0523807 (UMLS CUI [1])
AML
Item
6. patients with acute myelogenous leukemia (aml): induction failure with < 3 induction courses, >/= second or greater complete remission (cr) (defined as <5% blasts in bone marrow and no active extramedullary disease) , cr1 with high risk features defined as history of induction failure, 5q- or monosomy 7 cytogenetic findings;
boolean
C0023467 (UMLS CUI [1])
ALL
Item
7. patients wih acute lymphocytic leukemia (all): >/= second or greater cr (defined as <5% blasts in bone marrow and no active extramedullary disease), cr1 with high risk features defined as history of induction failure or ph+ or t(4;11) on cytogenetic analysis or any infant with mll rearrangements on cytogenetic analysis;
boolean
C0023449 (UMLS CUI [1])
MDS
Item
8. patients with myelodysplastic syndrome (mds): refractory anemia (ra) with excess blasts (eb) with intermediate (int)-1, int-2 or high international prognosis score system (ipss) score, refractory anemia with excess blasts (raeb) in transformation (it) with int-1, int-2 or high ipss score and patients with ra and int-2 ipss score
boolean
C3463824 (UMLS CUI [1])
family donor
Item
9. patients lacking a suitably matched family donor defined by genotypic or phenotypic identity for >/= 5/6 a, b, dr loci
boolean
C0013018 (UMLS CUI [1])
unrelated marrow donor or umbilical cord blood donor
Item
10. patients lacking an immediately available genotypically matched (6/6) unrelated marrow donor or umbilical cord blood donor with suitable cell dose after a search of greater than or equal to 2 months or patients whose medical condition is at high risk of deteriorating or whose disease is at high risk of progression during a donor search
boolean
C0013018 (UMLS CUI [1])
healthy family member donor
Item
11. patients must have a healthy family member donor who must be at least genotypically hla-a, b, c, dr haploidentical to the patient.
boolean
C0013018 (UMLS CUI [1])
written informed consent
Item
12. donors must sign voluntary, written informed consent or in the case of minor donors such consent must be signed by the parent or guardian and assent will be requested as age appropriate.
boolean
C0021430 (UMLS CUI [1])
leukapheresis
Item
13. donors must be capable of undergoing leukapheresis, have adequate venous access and be willing to undergo placement of a central venous catheter should leukapheresis via peripheral access be inadequate.
boolean
C0023416 (UMLS CUI [1])
pbsc mobilization
Item
14. note that satisfactory mobilization of donor peripheral blood stem cells (pbsc) to meet protocol criteria must take place prior to initiation of conditioning of the patient.
boolean
C1518999 (UMLS CUI [1])
second donation
Item
15. donors must be informed that they would be requested to undergo a second donation of pbsc or a bm harvest should the patient fail to demonstrate sustained engraftment after hsct
boolean
C0472699 (UMLS CUI [1])
medical criteria for blood product donation
Item
16. donors must meet all the medical criteria for blood product donation, including negative test for hiv, freedom from other active infection, absence of medical condition posing a health risk to donation of pbsc or function of the graft.
boolean
C0019682 (UMLS CUI [1])
C0009450 (UMLS CUI [2])
source of peripheral blood mononuclear cells to serve as allosensitizers
Item
17. to provide a source of peripheral blood mononuclear cells to serve as allosensitizers patients must either: (a) have a parent disparate with the donor for the haplotype shared by the patient and parent but not shared by the patient and donor; or (b) be able to donate sufficient autologous cells by peripheral blood draw or unstimulated leukapheresis
boolean
C3839712 (UMLS CUI [1])
pregnancy and contraception
Item
18. female patients of child-bearing age must have a negative pregnancy test and be using an form of contraception considered effective and medically acceptable by the investigator.
boolean
C0032961 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
informed consent
Item
19. voluntary written informed consent. children will be asked for assent wherever age appropriate.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
active infection
Item
1. active infection. freedom from active infection is defined as: absence of an infectious diagnosis or (in patients who have had a recent positive infectious diagnosis) the resolution of fever, documentation of negative cultures or antigen testing, continuation or completion of a course of appropriate therapy, and presence of stable to resolving clinical symptoms.
boolean
C0009450 (UMLS CUI [1])
HIV
Item
2. evidence of hiv infection or known hiv positive serology
boolean
C0019682 (UMLS CUI [1])
CNS disease
Item
3. presence of active central nervous system (cns) disease
boolean
C0007682 (UMLS CUI [1])
extramedullary disease
Item
4. all patients who relapse with isolated extramedullary disease after completion of treatment
boolean
C1868812 (UMLS CUI [1])
stem cell transplant
Item
5. any prior stem cell transplant
boolean
C1504389 (UMLS CUI [1])
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