Informações:
Falhas:
ID
12803
Descrição
CMC-544 in Relapsed Refractory Acute Lymphoblastic Leukemia (ALL); ODM derived from: https://clinicaltrials.gov/show/NCT01134575
Link
https://clinicaltrials.gov/show/NCT01134575
Palavras-chave
Versões (1)
- 21/12/2015 21/12/2015 -
Transferido a
21 de dezembro de 2015
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Acute Lymphoblastic Leukemia NCT01134575
Eligibility Acute Lymphoblastic Leukemia NCT01134575
- StudyEvent: Eligibility
Similar models
Eligibility Acute Lymphoblastic Leukemia NCT01134575
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
all recurrent disease
Item
previously treated all (including burkitt's lymphoma and lymphoblastic lymphoma) in relapse or primary refractory. patients in first relapse will be eligible regardless of the first remission duration. at least 10 patients in salvage 1-2 will be treated to assess anti-all response more precisely.
boolean
C0023449 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
C0277556 (UMLS CUI [2])
age
Item
age 16 years or older. pediatric patients (<16 years old) will be allowed into the study after safety is established, that is at least 10 adult patients having received 1 or more cycles each.
boolean
C0001779 (UMLS CUI [1])
zubrod performance
Item
zubrod performance status 0-3.
boolean
C3714786 (UMLS CUI [1])
liver and renal function
Item
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])
C0232804 (UMLS CUI [2])
C0232804 (UMLS CUI [2])
contraception, negative pregnancy test
Item
male and female patients who are of childbearing potential agree to use an effective barrier method of birth control (e.g., latex condom, diaphragm, cervical cap, etc.) to avoid pregnancy. female patients need a negative serum or urine pregnancy test within 14 days of study start (applies only if patient is of childbearing potential. non-childbearing is defined as >/= 1 year postmenopausal or surgically sterilized).
boolean
C0427780 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
C0700589 (UMLS CUI [2])
heart failure
Item
patient with active heart disease (nyha class >/= 3 as assessed by history and physical examination).
boolean
C0018801 (UMLS CUI [1])
ejection fraction reduced
Item
patients with a cardiac ejection fraction (as measured by either muga or echocardiogram) < 45 percent are excluded.
boolean
C4022792 (UMLS CUI [1])
chemotherapy
Item
patients who receive other chemotherapy. patients must have been off previous therapy for >/= 2 weeks and must have recovered from acute toxicity (to grade 1 or less) of all previous therapy prior to enrollment (consent signing). (concurrent therapy for central nervous system [cns] prophylaxis or treatment for cns relapse is permitted). treatment may start earlier if necessitated by the patient's medical condition (e.g. rapidly progressive disease) following discussion with the principal investigator.
boolean
C0392920 (UMLS CUI [1])
allogeneic stem cell transplant
Item
prior allogeneic stem cell transplant in previous 4 months.
boolean
C2242529 (UMLS CUI [1])
peripheral lymphoblasts
Item
peripheral lymphoblasts > 50 x 10^9/l.
boolean
C1167770 (UMLS CUI [1])
pregnant or breastfeeding
Item
pregnant and breast-feeding patients are excluded.
boolean
C0549206 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
hepatitis b positivity
Item
patients with known hepatitis b are excluded.
boolean
C0856706 (UMLS CUI [1])