ID

30222

Descrizione

Busulfan Plus Clofarabine Followed by Allogeneic Hematopoietic Stem Cell Transplantation; ODM derived from: https://clinicaltrials.gov/show/NCT00990249

collegamento

https://clinicaltrials.gov/show/NCT00990249

Keywords

versioni (1)
  1. 22/05/18 22/05/18 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

22 maggio 2018

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
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Eligibility Leukemia NCT00990249

Inglese

Eligibility Leukemia NCT00990249

1 moduli  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00990249
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with biopsy-proven acute lymphoblastic leukemia, acute lymphoblastic lymphoma, or acute biphenotypic leukemia in remission or relapse.
Descrizione

Acute lymphoid leukemia in remission | Acute lymphoblastic leukemia, in relapse | Acute biphenotypic leukemia in remission | Acute biphenotypic leukemia in relapse

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0153876
UMLS CUI [2]
C2854088
UMLS CUI [3]
C4067208
UMLS CUI [4]
C4067209
2. adequate renal function, as defined by estimated serum creatinine clearance >60 ml/min.
Descrizione

Renal function | Estimation of creatinine clearance by Cockcroft-Gault formula

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
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.
Descrizione

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

Tipo di dati

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. adequate 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.
Descrizione

Pulmonary function | FEV1 | FVC | Hemoglobin Corrected DLCO | Children Pulmonary function test Unable | Oxygen saturation measurement on room air

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0231921
UMLS CUI [2]
C0849974
UMLS CUI [3]
C3714541
UMLS CUI [4]
C4054790
UMLS CUI [5,1]
C0008059
UMLS CUI [5,2]
C0024119
UMLS CUI [5,3]
C1299582
UMLS CUI [6,1]
C0523807
UMLS CUI [6,2]
C2709070
5. adequate cardiac function with left ventricular ejection fraction at least 45% on appropriate medical therapy. no uncontrolled arrhythmias or symptomatic cardiac disease.
Descrizione

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

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0232164
UMLS CUI [2]
C0428772
UMLS CUI [3]
C0087111
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]
C0332197
6. zubrod performance status <2 or lansky/karnofsky ps equal or greater to 70%.
Descrizione

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

Tipo di dati

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.
Descrizione

Donor related HLA Identical | Unrelated Donor HLA Match | High resolution Typing

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0013018
UMLS CUI [1,2]
C0080103
UMLS CUI [1,3]
C0019721
UMLS CUI [1,4]
C0205280
UMLS CUI [2,1]
C3179133
UMLS CUI [2,2]
C0019721
UMLS CUI [2,3]
C1708943
UMLS CUI [3,1]
C1719039
UMLS CUI [3,2]
C0005844
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.
Descrizione

Informed Consent | Informed Consent Patient Representative | Informed Consent Parent | Informed Consent Guardian | Assent Minor (person) | Age

Tipo di dati

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]
C0030551
UMLS CUI [4,1]
C0021430
UMLS CUI [4,2]
C1274041
UMLS CUI [5,1]
C1879749
UMLS CUI [5,2]
C0026193
UMLS CUI [6]
C0001779
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.
Descrizione

Childbearing Potential Serum Beta-HCG Test Negative | Postmenopausal state Absent | Female Sterilization Absent

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C1255526
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
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with unresolved grade >2 non-hematologic toxicity from previous therapy. patients with grade 2 toxicity will be eligible at the discretion of the pi.
Descrizione

Toxicity CTCAE Grades | Etiology Prior Therapy | Resolution Lacking

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C1514463
UMLS CUI [3,1]
C1514893
UMLS CUI [3,2]
C0332268
2. patients with active cns disease.
Descrizione

CNS disorder

Tipo di dati

boolean

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

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

Tipo di dati

boolean

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

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

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0019693
UMLS CUI [3]
C0020097
UMLS CUI [4,1]
C0019163
UMLS CUI [4,2]
C0042749
UMLS CUI [5,1]
C0019196
UMLS CUI [5,2]
C0042749
5. patients greater than 65 years-old.
Descrizione

Age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
6. prior autologous or allogeneic hematopoietic stem cell transplant.
Descrizione

Transplantation of autologous hematopoietic stem cell | Allogeneic Hematopoietic Stem Cell Transplantation

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1831743
UMLS CUI [2]
C1705576
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Similar models

Eligibility Leukemia NCT00990249

1 moduli
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00990249
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Acute lymphoid leukemia in remission | Acute lymphoblastic leukemia, in relapse | Acute biphenotypic leukemia in remission | Acute biphenotypic leukemia in relapse
Item
1. patients with biopsy-proven acute lymphoblastic leukemia, acute lymphoblastic lymphoma, or acute biphenotypic leukemia in remission or relapse.
boolean
C0153876 (UMLS CUI [1])
C2854088 (UMLS CUI [2])
C4067208 (UMLS CUI [3])
C4067209 (UMLS CUI [4])
Renal function | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
2. adequate renal function, as defined by estimated serum creatinine clearance >60 ml/min.
boolean
C0232804 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
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 | Hemoglobin Corrected DLCO | Children Pulmonary function test Unable | Oxygen saturation measurement on room air
Item
4. adequate 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])
C4054790 (UMLS CUI [4])
C0008059 (UMLS CUI [5,1])
C0024119 (UMLS CUI [5,2])
C1299582 (UMLS CUI [5,3])
C0523807 (UMLS CUI [6,1])
C2709070 (UMLS CUI [6,2])
Cardiac function | Left ventricular ejection fraction | Therapeutic procedure | Cardiac Arrhythmia Uncontrolled Absent | Heart Disease Symptomatic Absent
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])
C0003811 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C0018799 (UMLS CUI [5,1])
C0231220 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
Zubrod Performance Status | Lansky Play-Performance Status | Karnofsky Performance Status
Item
6. zubrod performance status <2 or lansky/karnofsky ps equal or greater to 70%.
boolean
C3714786 (UMLS CUI [1])
C1522275 (UMLS CUI [2])
C0206065 (UMLS CUI [3])
Donor related HLA Identical | Unrelated Donor HLA Match | High resolution Typing
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
C0013018 (UMLS CUI [1,1])
C0080103 (UMLS CUI [1,2])
C0019721 (UMLS CUI [1,3])
C0205280 (UMLS CUI [1,4])
C3179133 (UMLS CUI [2,1])
C0019721 (UMLS CUI [2,2])
C1708943 (UMLS CUI [2,3])
C1719039 (UMLS CUI [3,1])
C0005844 (UMLS CUI [3,2])
Informed Consent | Informed Consent Patient Representative | Informed Consent Parent | Informed Consent Guardian | Assent Minor (person) | Age
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])
C0030551 (UMLS CUI [3,2])
C0021430 (UMLS CUI [4,1])
C1274041 (UMLS CUI [4,2])
C1879749 (UMLS CUI [5,1])
C0026193 (UMLS CUI [5,2])
C0001779 (UMLS CUI [6])
Childbearing Potential Serum Beta-HCG Test 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])
C1255526 (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)
Toxicity CTCAE Grades | Etiology Prior Therapy | Resolution Lacking
Item
1. patients with unresolved grade >2 non-hematologic toxicity from previous therapy. patients with grade 2 toxicity will be eligible at the discretion of the pi.
boolean
C0600688 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C1514463 (UMLS CUI [2,2])
C1514893 (UMLS CUI [3,1])
C0332268 (UMLS CUI [3,2])
CNS disorder
Item
2. patients with active cns disease.
boolean
C0007682 (UMLS CUI [1])
Hepatitis | Hepatitis, Chronic | Liver Cirrhosis | Liver Cirrhosis chronic
Item
3. 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 Infection | Hepatitis B Viremia | Hepatitis C Viremia
Item
4. 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 [4,1])
C0042749 (UMLS CUI [4,2])
C0019196 (UMLS CUI [5,1])
C0042749 (UMLS CUI [5,2])
Age
Item
5. patients greater than 65 years-old.
boolean
C0001779 (UMLS CUI [1])
Transplantation of autologous hematopoietic stem cell | Allogeneic Hematopoietic Stem Cell Transplantation
Item
6. prior autologous or allogeneic hematopoietic stem cell transplant.
boolean
C1831743 (UMLS CUI [1])
C1705576 (UMLS CUI [2])
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