ID

20603

Description

Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00630565

Link

https://clinicaltrials.gov/show/NCT00630565

Keywords

Versions (1)
  1. 3/6/17 3/6/17 -
Uploaded on

March 6, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Leukemia NCT00630565

English

Eligibility Leukemia NCT00630565

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00630565
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
children under the age of two are eligible for this protocol, but will not receive total body irradiation. instead, children under the age of two will receive busulfan/cyclophosphamide (bu/cy) conditioning as the preparative regimen in order to obviate deleterious effects of radiation at this age. patients who cannot receive total body irradiation (tbi) (for example those with prior radiation therapy) will also receive the bu/cy conditioning.
Description

Child; Age | Whole-Body Irradiation | busulfan/cyclophosphamide; Preparative Regimen | prior radiation therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0008059
UMLS CUI [1,2]
C0001779
UMLS CUI [2]
C0043162
UMLS CUI [3,1]
C0278611
UMLS CUI [3,2]
C1882454
UMLS CUI [4]
C0279134
acute myeloid leukemia (aml)
Description

aml

Data type

boolean

Alias
UMLS CUI [1]
C0023467
all children and adults less than the age of 70 with aml who have achieved a first or second bone marrow remission are eligible for this protocol. patients must undergo peripheral blood stem cell collection or marrow harvest while in remission and must not be expected to have better outcomes with allogeneic transplantation.
Description

Age | Leukemia, Myelocytic, Acute | Acute myeloid leukemia in remission; Bone Marrow | Harvesting of peripheral blood stem cells | Bone marrow harvesting for transplantation; autologous | Allogeneic bone marrow transplantation; Treatment outcome

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0023467
UMLS CUI [3,1]
C0153886
UMLS CUI [3,2]
C0005953
UMLS CUI [4]
C0457411
UMLS CUI [5]
C3248104
UMLS CUI [6,1]
C0149615
UMLS CUI [6,2]
C0085415
patients with cytogenetic abnormalities suggesting an improved prognosis [t(8:21), t(15;17) and inv(16)] will be eligible for transplantation in first remission.
Description

cytogenetic abnormalities suggesting an improved prognosis, remission

Data type

boolean

Alias
UMLS CUI [1,1]
C1541330
UMLS CUI [1,2]
C1514475
UMLS CUI [2]
C0544452
UMLS CUI [3]
C1504389
allogeneic transplant with an hla-identical sibling will be recommended for patients <55 years. if the patient refuses allogeneic transplant, they may still be eligible for this protocol.
Description

Allogeneic bone marrow transplantation | Histocompatibility Testing; Allograft of bone marrow from sibling donor | Age

Data type

boolean

Alias
UMLS CUI [1]
C0149615
UMLS CUI [2,1]
C0019633
UMLS CUI [2,2]
C1960320
UMLS CUI [3]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients can also be deemed not eligible for transplant because of specific organ toxicity. specifically, patients with pre-existing compromise to the heart, lungs, kidney, cns or liver may be excluded:
Description

Drug toxicity | Heart Diseases | Lung diseases | Kidney Diseases | Liver diseases | CNS disorder

Data type

boolean

Alias
UMLS CUI [1]
C0013221
UMLS CUI [2]
C0018799
UMLS CUI [3]
C0024115
UMLS CUI [4]
C0022658
UMLS CUI [5]
C0023895
UMLS CUI [6]
C0007682
eastern cooperative oncology group (ecog) performance status: 0 or 1
Description

ecog

Data type

boolean

Alias
UMLS CUI [1]
C1520224
heart - the patient must be free of symptoms of uncontrolled cardiac disease, and must not have compromised cardiac function detected by echo or by gated cardiac blood flow scan (muga) lvef >45%).
Description

Heart Diseases | Left ventricular ejection fraction | Echocardiography | Multiple gated acquisition scanning

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0428772
UMLS CUI [3]
C0013516
UMLS CUI [4]
C0521317
kidney - the patient must have a corrected creatinine clearance >50% of normal.
Description

creatinine clearance

Data type

boolean

Alias
UMLS CUI [1]
C0373595
liver - the total serum bilirubin < 2.5 mg/dl; alt <2 x upper limit of normal.
Description

total serum bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201836
lung - patients must have no significant obstructive airways disease or resting hypoxemia (po2 <80), and must have acceptable diffusion capacity (dlco > 50% of predicted).
Description

Lung Diseases, Obstructive | Hypoxemia | Diffusion capacity of lung, function

Data type

boolean

Alias
UMLS CUI [1]
C0600260
UMLS CUI [2]
C0700292
UMLS CUI [3]
C0231971
central nervous system (cns): patients must be free of active or ongoing ischemic or degenerative cns disease and no active or resistant cns leukemia.
Description

ischemic or degenerative cns disease and no cns leukemia

Data type

boolean

Alias
UMLS CUI [1]
C0917798
UMLS CUI [2]
C0270715
UMLS CUI [3]
C1332884
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Similar models

Eligibility Leukemia NCT00630565

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00630565
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Child; Age | Whole-Body Irradiation | busulfan/cyclophosphamide; Preparative Regimen | prior radiation therapy
Item
children under the age of two are eligible for this protocol, but will not receive total body irradiation. instead, children under the age of two will receive busulfan/cyclophosphamide (bu/cy) conditioning as the preparative regimen in order to obviate deleterious effects of radiation at this age. patients who cannot receive total body irradiation (tbi) (for example those with prior radiation therapy) will also receive the bu/cy conditioning.
boolean
C0008059 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
C0043162 (UMLS CUI [2])
C0278611 (UMLS CUI [3,1])
C1882454 (UMLS CUI [3,2])
C0279134 (UMLS CUI [4])
aml
Item
acute myeloid leukemia (aml)
boolean
C0023467 (UMLS CUI [1])
Age | Leukemia, Myelocytic, Acute | Acute myeloid leukemia in remission; Bone Marrow | Harvesting of peripheral blood stem cells | Bone marrow harvesting for transplantation; autologous | Allogeneic bone marrow transplantation; Treatment outcome
Item
all children and adults less than the age of 70 with aml who have achieved a first or second bone marrow remission are eligible for this protocol. patients must undergo peripheral blood stem cell collection or marrow harvest while in remission and must not be expected to have better outcomes with allogeneic transplantation.
boolean
C0001779 (UMLS CUI [1])
C0023467 (UMLS CUI [2])
C0153886 (UMLS CUI [3,1])
C0005953 (UMLS CUI [3,2])
C0457411 (UMLS CUI [4])
C3248104 (UMLS CUI [5])
C0149615 (UMLS CUI [6,1])
C0085415 (UMLS CUI [6,2])
cytogenetic abnormalities suggesting an improved prognosis, remission
Item
patients with cytogenetic abnormalities suggesting an improved prognosis [t(8:21), t(15;17) and inv(16)] will be eligible for transplantation in first remission.
boolean
C1541330 (UMLS CUI [1,1])
C1514475 (UMLS CUI [1,2])
C0544452 (UMLS CUI [2])
C1504389 (UMLS CUI [3])
Allogeneic bone marrow transplantation | Histocompatibility Testing; Allograft of bone marrow from sibling donor | Age
Item
allogeneic transplant with an hla-identical sibling will be recommended for patients <55 years. if the patient refuses allogeneic transplant, they may still be eligible for this protocol.
boolean
C0149615 (UMLS CUI [1])
C0019633 (UMLS CUI [2,1])
C1960320 (UMLS CUI [2,2])
C0001779 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Drug toxicity | Heart Diseases | Lung diseases | Kidney Diseases | Liver diseases | CNS disorder
Item
patients can also be deemed not eligible for transplant because of specific organ toxicity. specifically, patients with pre-existing compromise to the heart, lungs, kidney, cns or liver may be excluded:
boolean
C0013221 (UMLS CUI [1])
C0018799 (UMLS CUI [2])
C0024115 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0023895 (UMLS CUI [5])
C0007682 (UMLS CUI [6])
ecog
Item
eastern cooperative oncology group (ecog) performance status: 0 or 1
boolean
C1520224 (UMLS CUI [1])
Heart Diseases | Left ventricular ejection fraction | Echocardiography | Multiple gated acquisition scanning
Item
heart - the patient must be free of symptoms of uncontrolled cardiac disease, and must not have compromised cardiac function detected by echo or by gated cardiac blood flow scan (muga) lvef >45%).
boolean
C0018799 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
C0013516 (UMLS CUI [3])
C0521317 (UMLS CUI [4])
creatinine clearance
Item
kidney - the patient must have a corrected creatinine clearance >50% of normal.
boolean
C0373595 (UMLS CUI [1])
total serum bilirubin
Item
liver - the total serum bilirubin < 2.5 mg/dl; alt <2 x upper limit of normal.
boolean
C1278039 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Lung Diseases, Obstructive | Hypoxemia | Diffusion capacity of lung, function
Item
lung - patients must have no significant obstructive airways disease or resting hypoxemia (po2 <80), and must have acceptable diffusion capacity (dlco > 50% of predicted).
boolean
C0600260 (UMLS CUI [1])
C0700292 (UMLS CUI [2])
C0231971 (UMLS CUI [3])
ischemic or degenerative cns disease and no cns leukemia
Item
central nervous system (cns): patients must be free of active or ongoing ischemic or degenerative cns disease and no active or resistant cns leukemia.
boolean
C0917798 (UMLS CUI [1])
C0270715 (UMLS CUI [2])
C1332884 (UMLS CUI [3])
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