ID

30222

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT00990249

Trefwoorden

Versies (1)
  1. 22-05-18 22-05-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

22 mei 2018

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

  • Nieuwste
  • Oudste
  • Populair
  • Nieuwste
    • Nieuwste
    • Oudste
    • Populair

Geen commentaren

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Leukemia NCT00990249

Engels

Eligibility Leukemia NCT00990249

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00990249
Inclusion Criteria
Beschrijving

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.
Beschrijving

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

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

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

Datatype

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%.
Beschrijving

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

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

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

Datatype

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
Beschrijving

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.
Beschrijving

Toxicity CTCAE Grades | Etiology Prior Therapy | Resolution Lacking

Datatype

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.
Beschrijving

CNS disorder

Datatype

boolean

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

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

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

Age

Datatype

boolean

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

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

Datatype

boolean

Alias
UMLS CUI [1]
C1831743
UMLS CUI [2]
C1705576
Terug naar het begin van de pagina

Similar models

Eligibility Leukemia NCT00990249

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00990249
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial