ID

36262

Description

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

Link

https://clinicaltrials.gov/show/NCT02083250

Keywords

Versions (1)
  1. 4/25/19 4/25/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 25, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Leukemia NCT02083250

English

Eligibility Leukemia NCT02083250

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT02083250
Inclusion Criteria
Description

Inclusion Criteria

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

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

Data type

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.
Description

Estimation of creatinine clearance by Cockcroft-Gault formula

Data type

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.
Description

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

Data type

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.
Description

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

Data type

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.
Description

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

Data type

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%.
Description

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

Data type

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.
Description

Matched Related Donor | Matched Unrelated Donor

Data type

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.
Description

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

Data type

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.
Description

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

Data type

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
Description

Exclusion Criteria

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

CNS disorder

Data type

boolean

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

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

Data type

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.
Description

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

Data type

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.
Description

Age

Data type

boolean

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

Allogeneic Stem Cell Transplantation

Data type

boolean

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

Transplantation of autologous hematopoietic stem cell

Data type

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).
Description

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

Data type

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.
Description

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

Data type

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.
Description

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

Data type

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
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Similar models

Eligibility Leukemia NCT02083250

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT02083250
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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