ID

12803

Description

CMC-544 in Relapsed Refractory Acute Lymphoblastic Leukemia (ALL); ODM derived from: https://clinicaltrials.gov/show/NCT01134575

Link

https://clinicaltrials.gov/show/NCT01134575

Keywords

Versions (1)
  1. 12/21/15 12/21/15 -
Uploaded on

December 21, 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility Acute Lymphoblastic Leukemia NCT01134575

English

Eligibility Acute Lymphoblastic Leukemia NCT01134575

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
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.
Description

all recurrent disease

Data type

boolean

Alias
UMLS CUI [1]
C0023449
UMLS CUI [2]
C0277556
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.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
zubrod performance status 0-3.
Description

zubrod performance

Data type

boolean

Alias
UMLS CUI [1]
C3714786
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.
Description

liver and renal function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
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).
Description

contraception, negative pregnancy test

Data type

boolean

Alias
UMLS CUI [1]
C0427780
UMLS CUI [2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient with active heart disease (nyha class >/= 3 as assessed by history and physical examination).
Description

heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0018801
patients with a cardiac ejection fraction (as measured by either muga or echocardiogram) < 45 percent are excluded.
Description

ejection fraction reduced

Data type

boolean

Alias
UMLS CUI [1]
C4022792
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.
Description

chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
prior allogeneic stem cell transplant in previous 4 months.
Description

allogeneic stem cell transplant

Data type

boolean

Alias
UMLS CUI [1]
C2242529
peripheral lymphoblasts > 50 x 10^9/l.
Description

peripheral lymphoblasts

Data type

boolean

Alias
UMLS CUI [1]
C1167770
pregnant and breast-feeding patients are excluded.
Description

pregnant or breastfeeding

Data type

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C0006147
patients with known hepatitis b are excluded.
Description

hepatitis b positivity

Data type

boolean

Alias
UMLS CUI [1]
C0856706
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Similar models

Eligibility Acute Lymphoblastic Leukemia NCT01134575

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
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])
Item Group
C0680251 (UMLS CUI)
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])
hepatitis b positivity
Item
patients with known hepatitis b are excluded.
boolean
C0856706 (UMLS CUI [1])
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