ID

41075

Beschrijving

Inotuzumab Ozogamycin in Elderly Acute Lymphoblastic Leukemia (ALL); ODM derived from: https://clinicaltrials.gov/show/NCT01371630

Link

https://clinicaltrials.gov/show/NCT01371630

Trefwoorden

Versies (1)
  1. 19-06-20 19-06-20 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

19 juni 2020

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 :

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

Eligibility Leukemia NCT01371630

Engels

Eligibility Leukemia NCT01371630

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01371630
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients age 60 years or older with previously untreated all of pre-b, philadelphia chromosome (ph-) negative all. minimal prior therapy (less than 1 week of steroids, vincristine, and/or 1 dose of anthracycline or alkylating agents) are allowed.
Beschrijving

Age | Pre B-cell acute lymphoblastic leukemia Untreated | Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative | Prior Therapy Minimal | Steroids | Vincristine | Anthracyclines | Alkylating Agents

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0349636
UMLS CUI [2,2]
C0332155
UMLS CUI [3]
C4289946
UMLS CUI [4,1]
C1514463
UMLS CUI [4,2]
C0547040
UMLS CUI [5]
C0038317
UMLS CUI [6]
C0042679
UMLS CUI [7]
C0282564
UMLS CUI [8]
C0002073
2. zubrod performance status 0-3.
Beschrijving

Zubrod Performance Status

Datatype

boolean

Alias
UMLS CUI [1]
C3714786
3. adequate liver function (bilirubin </= 1.5 mg/dl and sgpt or sgot </= 3 x upper limit of normal [uln], unless considered due to tumor), and renal function (creatinine </= 2 mg/dl). even if organ function abnormalities are considered due to tumor, the upper limit for bilirubin is </= 2.0 mg/dl and creatinine </= 3 mg/dl.
Beschrijving

Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Exception Due to Neoplasm | Renal function | Creatinine measurement, serum | Organ function Abnormality Due to Neoplasm

Datatype

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201899
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0678226
UMLS CUI [5,3]
C0027651
UMLS CUI [6]
C0232804
UMLS CUI [7]
C0201976
UMLS CUI [8,1]
C0678852
UMLS CUI [8,2]
C1704258
UMLS CUI [8,3]
C0678226
UMLS CUI [8,4]
C0027651
4. provision of written informed consent.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
5. patients in first remission are eligible.
Beschrijving

Remission First

Datatype

boolean

Alias
UMLS CUI [1,1]
C0544452
UMLS CUI [1,2]
C0205435
6. patients with refractory-relapsed all of any age are eligible, provided they are not eligible for regimens of higher priority. currently study 2012-0151 (inotuzumab vs. intensive chemotherapy in all salvage 1 and 2) is an fda pivotal trial and is a higher priority (september 10, 2012).
Beschrijving

Refractory acute lymphoid leukemia | Acute lymphocytic leukemia recurrent | Age | Ineligibility Clinical Trial High priority

Datatype

boolean

Alias
UMLS CUI [1]
C4302097
UMLS CUI [2]
C1504403
UMLS CUI [3]
C0001779
UMLS CUI [4,1]
C1512714
UMLS CUI [4,2]
C0008976
UMLS CUI [4,3]
C1273516
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. ph-positive all, burkitt's leukemia or lymphoma, t-cell all or lymphoblastic lymphoma.
Beschrijving

Philadelphia positive acute lymphocytic leukaemia | Burkitt Lymphoma | T-ALL | Lymphoblastic Lymphoma

Datatype

boolean

Alias
UMLS CUI [1]
C4524071
UMLS CUI [2]
C0006413
UMLS CUI [3]
C1961099
UMLS CUI [4]
C0855146
2. patient with active heart disease (nyha class >/= 3 as assessed by history and physical examination).
Beschrijving

Heart Disease New York Heart Association Classification

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C1275491
3. patients with a cardiac ejection fraction (as measured by either muga or echocardiogram) < 40% are excluded.
Beschrijving

Cardiac ejection fraction MUGA scan | Cardiac ejection fraction Echocardiography

Datatype

boolean

Alias
UMLS CUI [1,1]
C0232174
UMLS CUI [1,2]
C0521317
UMLS CUI [2,1]
C0232174
UMLS CUI [2,2]
C0013516
4. patients with active hepatitis are excluded.
Beschrijving

Hepatitis

Datatype

boolean

Alias
UMLS CUI [1]
C0019158
5. pregnant or breast-feeding women are excluded.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Terug naar het begin van de pagina

Similar models

Eligibility Leukemia NCT01371630

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01371630
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age | Pre B-cell acute lymphoblastic leukemia Untreated | Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative | Prior Therapy Minimal | Steroids | Vincristine | Anthracyclines | Alkylating Agents
Item
1. patients age 60 years or older with previously untreated all of pre-b, philadelphia chromosome (ph-) negative all. minimal prior therapy (less than 1 week of steroids, vincristine, and/or 1 dose of anthracycline or alkylating agents) are allowed.
boolean
C0001779 (UMLS CUI [1])
C0349636 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C4289946 (UMLS CUI [3])
C1514463 (UMLS CUI [4,1])
C0547040 (UMLS CUI [4,2])
C0038317 (UMLS CUI [5])
C0042679 (UMLS CUI [6])
C0282564 (UMLS CUI [7])
C0002073 (UMLS CUI [8])
Zubrod Performance Status
Item
2. zubrod performance status 0-3.
boolean
C3714786 (UMLS CUI [1])
Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Exception Due to Neoplasm | Renal function | Creatinine measurement, serum | Organ function Abnormality Due to Neoplasm
Item
3. adequate liver function (bilirubin </= 1.5 mg/dl and sgpt or sgot </= 3 x upper limit of normal [uln], unless considered due to tumor), and renal function (creatinine </= 2 mg/dl). even if organ function abnormalities are considered due to tumor, the upper limit for bilirubin is </= 2.0 mg/dl and creatinine </= 3 mg/dl.
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0678226 (UMLS CUI [5,2])
C0027651 (UMLS CUI [5,3])
C0232804 (UMLS CUI [6])
C0201976 (UMLS CUI [7])
C0678852 (UMLS CUI [8,1])
C1704258 (UMLS CUI [8,2])
C0678226 (UMLS CUI [8,3])
C0027651 (UMLS CUI [8,4])
Informed Consent
Item
4. provision of written informed consent.
boolean
C0021430 (UMLS CUI [1])
Remission First
Item
5. patients in first remission are eligible.
boolean
C0544452 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
Refractory acute lymphoid leukemia | Acute lymphocytic leukemia recurrent | Age | Ineligibility Clinical Trial High priority
Item
6. patients with refractory-relapsed all of any age are eligible, provided they are not eligible for regimens of higher priority. currently study 2012-0151 (inotuzumab vs. intensive chemotherapy in all salvage 1 and 2) is an fda pivotal trial and is a higher priority (september 10, 2012).
boolean
C4302097 (UMLS CUI [1])
C1504403 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C1512714 (UMLS CUI [4,1])
C0008976 (UMLS CUI [4,2])
C1273516 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Philadelphia positive acute lymphocytic leukaemia | Burkitt Lymphoma | T-ALL | Lymphoblastic Lymphoma
Item
1. ph-positive all, burkitt's leukemia or lymphoma, t-cell all or lymphoblastic lymphoma.
boolean
C4524071 (UMLS CUI [1])
C0006413 (UMLS CUI [2])
C1961099 (UMLS CUI [3])
C0855146 (UMLS CUI [4])
Heart Disease New York Heart Association Classification
Item
2. patient with active heart disease (nyha class >/= 3 as assessed by history and physical examination).
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Cardiac ejection fraction MUGA scan | Cardiac ejection fraction Echocardiography
Item
3. patients with a cardiac ejection fraction (as measured by either muga or echocardiogram) < 40% are excluded.
boolean
C0232174 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0232174 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
Hepatitis
Item
4. patients with active hepatitis are excluded.
boolean
C0019158 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
5. pregnant or breast-feeding women are excluded.
boolean
C0032961 (UMLS CUI [1])
C0006147 (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