ID

42590

Beschreibung

Plerixafor and Granulocyte Colony-stimulating Factor (G-CSF) With Busulfan, Fludarabine and Thymoglobulin; ODM derived from: https://clinicaltrials.gov/show/NCT00822770

Link

https://clinicaltrials.gov/show/NCT00822770

Stichworte

Versionen (1)
  1. 15.09.21 15.09.21 -
Rechteinhaber

M.D. Anderson Cancer Center Genzyme, a Sanofi Company

Hochgeladen am

15. September 2021

DOI

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Lizenz

Creative Commons BY-NC 4.0
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Eligibility Stem Cell Transplantation NCT00822770

Englisch

Eligibility Stem Cell Transplantation NCT00822770

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients age >/=18 to </= 65 years.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. diagnosis of aml in first or greater remission, first or subsequent relapse, or primary induction failure; mds with intermediate or high risk international prognostic scoring system (ipss) score having failed to respond or recurred after chemotherapy; in remission or having active disease after treatment; aml arising from mds; or cml which has failed to respond to imatinib or other tyrosine kinase inhibitor and has had >5% blasts in the blood or bone marrow. patients receiving second transplants after relapse are considered in the relapse group.
Beschreibung

AML in remission | AML in relapse | Primary induction failure in AML | MDS (IPPS score) having failed to respond or recurred after chemotherapy | AML arising from MDS | CML which has failed to respond to imatinib or other tyrosine kinase inhibitor, blasts in the blood or bone marrow

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0544452
UMLS CUI [2,1]
C0023467
UMLS CUI [2,2]
C0277556
UMLS CUI [3,1]
C0023467
UMLS CUI [3,2]
C2347677
UMLS CUI [4,1]
C3463824
UMLS CUI [4,2]
C2827405
UMLS CUI [4,3]
C0392920
UMLS CUI [4,4]
C0231175
UMLS CUI [5,1]
C3463824
UMLS CUI [5,2]
C2827405
UMLS CUI [5,3]
C0392920
UMLS CUI [5,4]
C0034897
UMLS CUI [6,1]
C0023467
UMLS CUI [6,2]
C0678226
UMLS CUI [6,3]
C3463824
UMLS CUI [7,1]
C0023473
UMLS CUI [7,2]
C0935989
UMLS CUI [7,3]
C0162643
UMLS CUI [7,4]
C0368761
UMLS CUI [7,5]
C0005953
UMLS CUI [7,6]
C0368761
UMLS CUI [7,7]
C0229664
UMLS CUI [8,1]
C0023473
UMLS CUI [8,2]
C1268567
UMLS CUI [8,3]
C0162643
UMLS CUI [8,4]
C0368761
UMLS CUI [8,5]
C0005953
UMLS CUI [8,6]
C0368761
UMLS CUI [8,7]
C0229664
3. white blood count (cbc) </= 20 * 10^9/l.
Beschreibung

White blood cell count

Datentyp

boolean

Alias
UMLS CUI [1]
C0023508
4. patients should have a histocompatible, related or unrelated volunteer donor available. a histocompatible donor is defined as hla matched related donor or an unrelated donor matched for hla- a, b, c, and dr antigens by high-resolution dna techniques.
Beschreibung

Histocompatible, related or unrelated volunteer donor available, HLA antigens

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C4330663
UMLS CUI [1,3]
C0019721
UMLS CUI [2,1]
C0470187
UMLS CUI [2,2]
C4318937
UMLS CUI [2,3]
C0019721
5. zubrod performance status 0 or 1, or karnofsky performance status 90-100%.
Beschreibung

Zubrod performance status | Karnofsky performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C3714786
UMLS CUI [2]
C0206065
6. left ventricular ejection fraction >/= 45 %. no uncontrolled arrhythmias or uncontrolled symptomatic cardiac disease.
Beschreibung

Left ventricular ejection fraction | Absence of uncontrolled arrythmias | Absence of uncontrolled symptomatic cardiac disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0428772
UMLS CUI [2,1]
C0003811
UMLS CUI [2,2]
C0205318
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0018799
UMLS CUI [3,2]
C0231220
UMLS CUI [3,3]
C0205318
UMLS CUI [3,4]
C0332197
7. no symptomatic pulmonary disease. forced expiratory volume in 1 s (fev1), forced vital capacity (fvc) and diffusion capacity of carbon monoxide (dlco) >/= 50 % of expected, corrected for hemoglobin.
Beschreibung

Absence of symptomatic pulmonary disease | FEV1 | FVC | DLCO

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024115
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C0332197
UMLS CUI [2]
C0849974
UMLS CUI [3]
C3714541
UMLS CUI [4]
C1516251
8. serum creatinine </=1.5 mg/dl.
Beschreibung

Serum creatinine measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
9. serum glutamic pyruvic transaminase (sgpt) </= 200 iu/ml unless related to the malignancy.
Beschreibung

Serum glutamic pyruvic transaminase | Serum glutamic pyruvic transaminase related to the malignancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2,1]
C0201836
UMLS CUI [2,2]
C0586721
UMLS CUI [2,3]
C1705847
UMLS CUI [2,4]
C0006826
UMLS CUI [2,5]
C0678226
10. total serum bilirubin </=1.5 mg/dl (unless gilbert's syndrome) and alkaline phosphatase </=2.5 times laboratory standard upper limit of normal (uln).
Beschreibung

Total serum bilirubin | Total serum bilirubin due to Gilbert's syndrome | ALP

Datentyp

boolean

Alias
UMLS CUI [1]
C0201913
UMLS CUI [2,1]
C0201913
UMLS CUI [2,2]
C1705847
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C0017551
UMLS CUI [3]
C0201850
11. patient or patient's legal representative able to sign informed consent.
Beschreibung

Informed consent signed by patient | Informed consent signed by patient's legal representative

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. history of hiv positive.
Beschreibung

History of HIV seropositivity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019699
UMLS CUI [1,2]
C0262926
2. positive beta human chorionic gonadotropin (hcg) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
Beschreibung

HCG test positive in a woman with childbearing potential

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0032976
UMLS CUI [1,3]
C0428402
UMLS CUI [1,4]
C1446409
3. pleural/pericardial effusion or ascites estimated >/= 1 liter.
Beschreibung

Pleural effusion | Pericardial effusion | Ascites

Datentyp

boolean

Alias
UMLS CUI [1]
C0032227
UMLS CUI [2]
C0031039
UMLS CUI [3]
C0003962
4. uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy.
Beschreibung

Uncontrolled infection not responding to antimicrobial agents after 7 days of therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C0443071
UMLS CUI [1,4]
C0205269
UMLS CUI [1,5]
C1948053
5. history of acute hepatitis, chronic active hepatitis or cirrhosis.
Beschreibung

History of acute hepatitis | Chronic active hepatitis | Cirrhosis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0267797
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0520463
UMLS CUI [3,1]
C0262926
UMLS CUI [3,2]
C0023890
6. patients with class 3 or 4 angina (new york heart association (nyha) criteria).
Beschreibung

Agina pectoris, NYHA classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0002962
UMLS CUI [1,2]
C1275491
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Ähnliche Modelle

Eligibility Stem Cell Transplantation NCT00822770

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. patients age >/=18 to </= 65 years.
boolean
C0001779 (UMLS CUI [1])
AML in remission | AML in relapse | Primary induction failure in AML | MDS (IPPS score) having failed to respond or recurred after chemotherapy | AML arising from MDS | CML which has failed to respond to imatinib or other tyrosine kinase inhibitor, blasts in the blood or bone marrow
Item
2. diagnosis of aml in first or greater remission, first or subsequent relapse, or primary induction failure; mds with intermediate or high risk international prognostic scoring system (ipss) score having failed to respond or recurred after chemotherapy; in remission or having active disease after treatment; aml arising from mds; or cml which has failed to respond to imatinib or other tyrosine kinase inhibitor and has had >5% blasts in the blood or bone marrow. patients receiving second transplants after relapse are considered in the relapse group.
boolean
C0023467 (UMLS CUI [1,1])
C0544452 (UMLS CUI [1,2])
C0023467 (UMLS CUI [2,1])
C0277556 (UMLS CUI [2,2])
C0023467 (UMLS CUI [3,1])
C2347677 (UMLS CUI [3,2])
C3463824 (UMLS CUI [4,1])
C2827405 (UMLS CUI [4,2])
C0392920 (UMLS CUI [4,3])
C0231175 (UMLS CUI [4,4])
C3463824 (UMLS CUI [5,1])
C2827405 (UMLS CUI [5,2])
C0392920 (UMLS CUI [5,3])
C0034897 (UMLS CUI [5,4])
C0023467 (UMLS CUI [6,1])
C0678226 (UMLS CUI [6,2])
C3463824 (UMLS CUI [6,3])
C0023473 (UMLS CUI [7,1])
C0935989 (UMLS CUI [7,2])
C0162643 (UMLS CUI [7,3])
C0368761 (UMLS CUI [7,4])
C0005953 (UMLS CUI [7,5])
C0368761 (UMLS CUI [7,6])
C0229664 (UMLS CUI [7,7])
C0023473 (UMLS CUI [8,1])
C1268567 (UMLS CUI [8,2])
C0162643 (UMLS CUI [8,3])
C0368761 (UMLS CUI [8,4])
C0005953 (UMLS CUI [8,5])
C0368761 (UMLS CUI [8,6])
C0229664 (UMLS CUI [8,7])
White blood cell count
Item
3. white blood count (cbc) </= 20 * 10^9/l.
boolean
C0023508 (UMLS CUI [1])
Histocompatible, related or unrelated volunteer donor available, HLA antigens
Item
4. patients should have a histocompatible, related or unrelated volunteer donor available. a histocompatible donor is defined as hla matched related donor or an unrelated donor matched for hla- a, b, c, and dr antigens by high-resolution dna techniques.
boolean
C0470187 (UMLS CUI [1,1])
C4330663 (UMLS CUI [1,2])
C0019721 (UMLS CUI [1,3])
C0470187 (UMLS CUI [2,1])
C4318937 (UMLS CUI [2,2])
C0019721 (UMLS CUI [2,3])
Zubrod performance status | Karnofsky performance status
Item
5. zubrod performance status 0 or 1, or karnofsky performance status 90-100%.
boolean
C3714786 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
Left ventricular ejection fraction | Absence of uncontrolled arrythmias | Absence of uncontrolled symptomatic cardiac disease
Item
6. left ventricular ejection fraction >/= 45 %. no uncontrolled arrhythmias or uncontrolled symptomatic cardiac disease.
boolean
C0428772 (UMLS CUI [1])
C0003811 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0018799 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C0205318 (UMLS CUI [3,3])
C0332197 (UMLS CUI [3,4])
Absence of symptomatic pulmonary disease | FEV1 | FVC | DLCO
Item
7. no symptomatic pulmonary disease. forced expiratory volume in 1 s (fev1), forced vital capacity (fvc) and diffusion capacity of carbon monoxide (dlco) >/= 50 % of expected, corrected for hemoglobin.
boolean
C0024115 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0849974 (UMLS CUI [2])
C3714541 (UMLS CUI [3])
C1516251 (UMLS CUI [4])
Serum creatinine measurement
Item
8. serum creatinine </=1.5 mg/dl.
boolean
C0201976 (UMLS CUI [1])
Serum glutamic pyruvic transaminase | Serum glutamic pyruvic transaminase related to the malignancy
Item
9. serum glutamic pyruvic transaminase (sgpt) </= 200 iu/ml unless related to the malignancy.
boolean
C0201836 (UMLS CUI [1])
C0201836 (UMLS CUI [2,1])
C0586721 (UMLS CUI [2,2])
C1705847 (UMLS CUI [2,3])
C0006826 (UMLS CUI [2,4])
C0678226 (UMLS CUI [2,5])
Total serum bilirubin | Total serum bilirubin due to Gilbert's syndrome | ALP
Item
10. total serum bilirubin </=1.5 mg/dl (unless gilbert's syndrome) and alkaline phosphatase </=2.5 times laboratory standard upper limit of normal (uln).
boolean
C0201913 (UMLS CUI [1])
C0201913 (UMLS CUI [2,1])
C1705847 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0017551 (UMLS CUI [2,4])
C0201850 (UMLS CUI [3])
Informed consent signed by patient | Informed consent signed by patient's legal representative
Item
11. patient or patient's legal representative able to sign informed consent.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
History of HIV seropositivity
Item
1. history of hiv positive.
boolean
C0019699 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
HCG test positive in a woman with childbearing potential
Item
2. positive beta human chorionic gonadotropin (hcg) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
boolean
C3831118 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
C0428402 (UMLS CUI [1,3])
C1446409 (UMLS CUI [1,4])
Pleural effusion | Pericardial effusion | Ascites
Item
3. pleural/pericardial effusion or ascites estimated >/= 1 liter.
boolean
C0032227 (UMLS CUI [1])
C0031039 (UMLS CUI [2])
C0003962 (UMLS CUI [3])
Uncontrolled infection not responding to antimicrobial agents after 7 days of therapy
Item
4. uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0443071 (UMLS CUI [1,3])
C0205269 (UMLS CUI [1,4])
C1948053 (UMLS CUI [1,5])
History of acute hepatitis | Chronic active hepatitis | Cirrhosis
Item
5. history of acute hepatitis, chronic active hepatitis or cirrhosis.
boolean
C0262926 (UMLS CUI [1,1])
C0267797 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0520463 (UMLS CUI [2,2])
C0262926 (UMLS CUI [3,1])
C0023890 (UMLS CUI [3,2])
Agina pectoris, NYHA classification
Item
6. patients with class 3 or 4 angina (new york heart association (nyha) criteria).
boolean
C0002962 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
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