ID

41075

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT01371630

Stichworte

Versionen (1)
  1. 19.06.20 19.06.20 -
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See clinicaltrials.gov

Hochgeladen am

19. Juni 2020

DOI

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Creative Commons BY 4.0
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Eligibility Leukemia NCT01371630

Englisch

Eligibility Leukemia NCT01371630

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01371630
Inclusion Criteria
Beschreibung

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Zubrod Performance Status

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Informed Consent

Datentyp

boolean

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

Remission First

Datentyp

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).
Beschreibung

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

Datentyp

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
Beschreibung

Exclusion Criteria

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

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

Datentyp

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).
Beschreibung

Heart Disease New York Heart Association Classification

Datentyp

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.
Beschreibung

Cardiac ejection fraction MUGA scan | Cardiac ejection fraction Echocardiography

Datentyp

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.
Beschreibung

Hepatitis

Datentyp

boolean

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

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Ähnliche Modelle

Eligibility Leukemia NCT01371630

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01371630
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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