ID

36262

Beschreibung

Fludarabine/Clofarabine/Busulfan Combined With SAHA in Acute Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT02083250

Link

https://clinicaltrials.gov/show/NCT02083250

Stichworte

Versionen (1)
  1. 25.04.19 25.04.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

25. April 2019

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Leukemia NCT02083250

Englisch

Eligibility Leukemia NCT02083250

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT02083250
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with biopsy-proven acute lymphoblastic leukemia, acute myeloid leukemia, or myelodysplastic syndrome in remission or relapse.
Beschreibung

Acute lymphoid leukemia in remission | Acute lymphocytic leukemia in relapse | Acute myeloid leukemia in remission | Acute myelogenous leukemia in relapse | MYELODYSPLASTIC SYNDROME Remission | MYELODYSPLASTIC SYNDROME Relapse

Datentyp

boolean

Alias
UMLS CUI [1]
C0153876
UMLS CUI [2]
C2367454
UMLS CUI [3]
C0153886
UMLS CUI [4]
C2367456
UMLS CUI [5,1]
C3463824
UMLS CUI [5,2]
C0544452
UMLS CUI [6,1]
C3463824
UMLS CUI [6,2]
C0035020
2. estimated creatinine clearance at least 50 ml/min.
Beschreibung

Estimation of creatinine clearance by Cockcroft-Gault formula

Datentyp

boolean

Alias
UMLS CUI [1]
C2711451
3. bilirubin equal or less than 1.5 (unless gilbert's syndrome), sgpt <3 x upper limit of normal and alkaline phosphatase <2 x upper limit of normal.
Beschreibung

Serum total bilirubin measurement | Exception Gilbert Disease | Alanine aminotransferase measurement | Alkaline phosphatase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0017551
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201850
4. pulmonary function with fev1, fvc and dlco at least 45% of expected corrected for hemoglobin. children unable to perform pulmonary functions must have an oxygen saturation greater than 92% at room air.
Beschreibung

Pulmonary function | FEV1 | FVC | Percent Predicted Hemoglobin Corrected Diffusion Capacity of the Lung for Carbon Monoxide | Children Oxygen saturation measurement on room air

Datentyp

boolean

Alias
UMLS CUI [1]
C0231921
UMLS CUI [2]
C0849974
UMLS CUI [3]
C3714541
UMLS CUI [4]
C4054205
UMLS CUI [5,1]
C0008059
UMLS CUI [5,2]
C0523807
UMLS CUI [5,3]
C2709070
5. adequate cardiac function with left ventricular ejection fraction at least 45% on appropriate medical therapy. no uncontrolled arrhythmias or symptomatic cardiac disease.
Beschreibung

Cardiac function | Left ventricular ejection fraction | Therapeutic procedure | Absence Cardiac Arrhythmia Uncontrolled | Absence Heart Disease Symptomatic

Datentyp

boolean

Alias
UMLS CUI [1]
C0232164
UMLS CUI [2]
C0428772
UMLS CUI [3]
C0087111
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C0003811
UMLS CUI [4,3]
C0205318
UMLS CUI [5,1]
C0332197
UMLS CUI [5,2]
C0018799
UMLS CUI [5,3]
C0231220
6. zubrod performance status 0-1 or lansky/karnofsky ps equal or greater to 80%.
Beschreibung

Zubrod Performance Status | Lansky Play-Performance Status | Karnofsky Performance Status

Datentyp

boolean

Alias
UMLS CUI [1]
C3714786
UMLS CUI [2]
C1522275
UMLS CUI [3]
C0206065
7. patients must have a related, genotypically hla identical donor, or they must have a unrelated donor who is 8/8 hla match by high resolution typing.
Beschreibung

Matched Related Donor | Matched Unrelated Donor

Datentyp

boolean

Alias
UMLS CUI [1]
C4330663
UMLS CUI [2]
C4318937
8. patient or patient's legal representative, parent(s) or guardian should provide written informed consent. assent of a minor if participant's age is at least seven and less than eighteen years.
Beschreibung

Informed Consent | Informed Consent Patient Representative | Informed Consent Guardian | Assent Minor

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C1274041
UMLS CUI [4,1]
C1879749
UMLS CUI [4,2]
C0026193
9. negative beta hcg test in a woman with child bearing potential defined as not post-menopausal for 12 months and no previous surgical sterilization.
Beschreibung

Childbearing Potential Serum pregnancy test (B-HCG) Negative | Postmenopausal state Absent | Female Sterilization Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430060
UMLS CUI [1,3]
C1513916
UMLS CUI [2,1]
C0232970
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0015787
UMLS CUI [3,2]
C0332197
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with active cns disease.
Beschreibung

CNS disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0007682
2. evidence of acute or chronic active hepatitis or cirrhosis.
Beschreibung

Hepatitis | Hepatitis, Chronic | Liver Cirrhosis | Liver Cirrhosis chronic

Datentyp

boolean

Alias
UMLS CUI [1]
C0019158
UMLS CUI [2]
C0019189
UMLS CUI [3]
C0023890
UMLS CUI [4,1]
C0023890
UMLS CUI [4,2]
C0205191
3. uncontrolled infection, including hiv, htlv-1, hepatitis b or hepatitis c viremia.
Beschreibung

Communicable Disease Uncontrolled | HIV Infection | HTLV-I Infections | Hepatitis B | Hepatitis C Viremia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0019693
UMLS CUI [3]
C0020097
UMLS CUI [4]
C0019163
UMLS CUI [5,1]
C0019196
UMLS CUI [5,2]
C0042749
4. patients greater than 60 years-old.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
5. prior allogeneic sct.
Beschreibung

Allogeneic Stem Cell Transplantation

Datentyp

boolean

Alias
UMLS CUI [1]
C2242529
6. prior autologous sct in last 12 months.
Beschreibung

Transplantation of autologous hematopoietic stem cell

Datentyp

boolean

Alias
UMLS CUI [1]
C1831743
7. patients with aml in first remission after one course of induction and with favorable cytogenetics [t(8;21, inv 16, or t(15;17)] and/or molecular profile (npm1).
Beschreibung

AML Complete remission First | Status post Induction Course | Cytogenetic Analysis Favorable | t(8;21) | inv(16) | t(15;17) | Molecular Signature Favorable | NPM1

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0677874
UMLS CUI [1,3]
C0205435
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0857127
UMLS CUI [2,3]
C0750729
UMLS CUI [3,1]
C0752095
UMLS CUI [3,2]
C3640814
UMLS CUI [4]
C3897139
UMLS CUI [5]
C3897144
UMLS CUI [6]
C4287946
UMLS CUI [7,1]
C1704864
UMLS CUI [7,2]
C3640814
UMLS CUI [8]
C0069141
8. patients with all in first complete remission after one course of induction without minimal residual disease.
Beschreibung

Acute lymphocytic leukemia Complete remission First | Status post Induction Course | Minimal Residual Disease Negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023449
UMLS CUI [1,2]
C0677874
UMLS CUI [1,3]
C0205435
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0857127
UMLS CUI [2,3]
C0750729
UMLS CUI [3]
C4086585
9. prior radiation to liver in form of total body or involved field.
Beschreibung

Radiation of the liver Total body | Radiation of the liver Field Involved

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3162254
UMLS CUI [1,2]
C0043162
UMLS CUI [2,1]
C3162254
UMLS CUI [2,2]
C1882536
UMLS CUI [2,3]
C1314939
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Leukemia NCT02083250

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT02083250
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Acute lymphoid leukemia in remission | Acute lymphocytic leukemia in relapse | Acute myeloid leukemia in remission | Acute myelogenous leukemia in relapse | MYELODYSPLASTIC SYNDROME Remission | MYELODYSPLASTIC SYNDROME Relapse
Item
1. patients with biopsy-proven acute lymphoblastic leukemia, acute myeloid leukemia, or myelodysplastic syndrome in remission or relapse.
boolean
C0153876 (UMLS CUI [1])
C2367454 (UMLS CUI [2])
C0153886 (UMLS CUI [3])
C2367456 (UMLS CUI [4])
C3463824 (UMLS CUI [5,1])
C0544452 (UMLS CUI [5,2])
C3463824 (UMLS CUI [6,1])
C0035020 (UMLS CUI [6,2])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
2. estimated creatinine clearance at least 50 ml/min.
boolean
C2711451 (UMLS CUI [1])
Serum total bilirubin measurement | Exception Gilbert Disease | Alanine aminotransferase measurement | Alkaline phosphatase measurement
Item
3. bilirubin equal or less than 1.5 (unless gilbert's syndrome), sgpt <3 x upper limit of normal and alkaline phosphatase <2 x upper limit of normal.
boolean
C1278039 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0017551 (UMLS CUI [2,2])
C0201836 (UMLS CUI [3])
C0201850 (UMLS CUI [4])
Pulmonary function | FEV1 | FVC | Percent Predicted Hemoglobin Corrected Diffusion Capacity of the Lung for Carbon Monoxide | Children Oxygen saturation measurement on room air
Item
4. pulmonary function with fev1, fvc and dlco at least 45% of expected corrected for hemoglobin. children unable to perform pulmonary functions must have an oxygen saturation greater than 92% at room air.
boolean
C0231921 (UMLS CUI [1])
C0849974 (UMLS CUI [2])
C3714541 (UMLS CUI [3])
C4054205 (UMLS CUI [4])
C0008059 (UMLS CUI [5,1])
C0523807 (UMLS CUI [5,2])
C2709070 (UMLS CUI [5,3])
Cardiac function | Left ventricular ejection fraction | Therapeutic procedure | Absence Cardiac Arrhythmia Uncontrolled | Absence Heart Disease Symptomatic
Item
5. adequate cardiac function with left ventricular ejection fraction at least 45% on appropriate medical therapy. no uncontrolled arrhythmias or symptomatic cardiac disease.
boolean
C0232164 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
C0087111 (UMLS CUI [3])
C0332197 (UMLS CUI [4,1])
C0003811 (UMLS CUI [4,2])
C0205318 (UMLS CUI [4,3])
C0332197 (UMLS CUI [5,1])
C0018799 (UMLS CUI [5,2])
C0231220 (UMLS CUI [5,3])
Zubrod Performance Status | Lansky Play-Performance Status | Karnofsky Performance Status
Item
6. zubrod performance status 0-1 or lansky/karnofsky ps equal or greater to 80%.
boolean
C3714786 (UMLS CUI [1])
C1522275 (UMLS CUI [2])
C0206065 (UMLS CUI [3])
Matched Related Donor | Matched Unrelated Donor
Item
7. patients must have a related, genotypically hla identical donor, or they must have a unrelated donor who is 8/8 hla match by high resolution typing.
boolean
C4330663 (UMLS CUI [1])
C4318937 (UMLS CUI [2])
Informed Consent | Informed Consent Patient Representative | Informed Consent Guardian | Assent Minor
Item
8. patient or patient's legal representative, parent(s) or guardian should provide written informed consent. assent of a minor if participant's age is at least seven and less than eighteen years.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3,1])
C1274041 (UMLS CUI [3,2])
C1879749 (UMLS CUI [4,1])
C0026193 (UMLS CUI [4,2])
Childbearing Potential Serum pregnancy test (B-HCG) Negative | Postmenopausal state Absent | Female Sterilization Absent
Item
9. negative beta hcg test in a woman with child bearing potential defined as not post-menopausal for 12 months and no previous surgical sterilization.
boolean
C3831118 (UMLS CUI [1,1])
C0430060 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
C0232970 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0015787 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
CNS disorder
Item
1. patients with active cns disease.
boolean
C0007682 (UMLS CUI [1])
Hepatitis | Hepatitis, Chronic | Liver Cirrhosis | Liver Cirrhosis chronic
Item
2. evidence of acute or chronic active hepatitis or cirrhosis.
boolean
C0019158 (UMLS CUI [1])
C0019189 (UMLS CUI [2])
C0023890 (UMLS CUI [3])
C0023890 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
Communicable Disease Uncontrolled | HIV Infection | HTLV-I Infections | Hepatitis B | Hepatitis C Viremia
Item
3. uncontrolled infection, including hiv, htlv-1, hepatitis b or hepatitis c viremia.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0019693 (UMLS CUI [2])
C0020097 (UMLS CUI [3])
C0019163 (UMLS CUI [4])
C0019196 (UMLS CUI [5,1])
C0042749 (UMLS CUI [5,2])
Age
Item
4. patients greater than 60 years-old.
boolean
C0001779 (UMLS CUI [1])
Allogeneic Stem Cell Transplantation
Item
5. prior allogeneic sct.
boolean
C2242529 (UMLS CUI [1])
Transplantation of autologous hematopoietic stem cell
Item
6. prior autologous sct in last 12 months.
boolean
C1831743 (UMLS CUI [1])
AML Complete remission First | Status post Induction Course | Cytogenetic Analysis Favorable | t(8;21) | inv(16) | t(15;17) | Molecular Signature Favorable | NPM1
Item
7. patients with aml in first remission after one course of induction and with favorable cytogenetics [t(8;21, inv 16, or t(15;17)] and/or molecular profile (npm1).
boolean
C0023467 (UMLS CUI [1,1])
C0677874 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
C0231290 (UMLS CUI [2,1])
C0857127 (UMLS CUI [2,2])
C0750729 (UMLS CUI [2,3])
C0752095 (UMLS CUI [3,1])
C3640814 (UMLS CUI [3,2])
C3897139 (UMLS CUI [4])
C3897144 (UMLS CUI [5])
C4287946 (UMLS CUI [6])
C1704864 (UMLS CUI [7,1])
C3640814 (UMLS CUI [7,2])
C0069141 (UMLS CUI [8])
Acute lymphocytic leukemia Complete remission First | Status post Induction Course | Minimal Residual Disease Negative
Item
8. patients with all in first complete remission after one course of induction without minimal residual disease.
boolean
C0023449 (UMLS CUI [1,1])
C0677874 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
C0231290 (UMLS CUI [2,1])
C0857127 (UMLS CUI [2,2])
C0750729 (UMLS CUI [2,3])
C4086585 (UMLS CUI [3])
Radiation of the liver Total body | Radiation of the liver Field Involved
Item
9. prior radiation to liver in form of total body or involved field.
boolean
C3162254 (UMLS CUI [1,1])
C0043162 (UMLS CUI [1,2])
C3162254 (UMLS CUI [2,1])
C1882536 (UMLS CUI [2,2])
C1314939 (UMLS CUI [2,3])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video