Eligibility Leukemia NCT01390402

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StudyEvent: Eligibility
1. Eligibility Leukemia NCT01390402

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

eligibility criteria

Item

1. patients who meet the following eligibility criteria are eligible for inclusion in this study. pediatric team to assess eligibility appropriate for patient age.

boolean

C1516637 (UMLS CUI [1])

age

Item

2. age </= 70 years of age.

boolean

Chronic Myeloid Leukemia; Chronic-Phase; accelerated phase; Bone Marrow; imatinib; tyrosine kinase inhibitor therapy

Item

3. patients with diagnosis of cml in first chronic phase or accelerated phase with less than 15% blast in the blood and bone marrow at study entry which has failed to respond adequately to imatinib by the consensus criteria of baccarani et al: a) no hematologic remission at 3 months, b) no cytogenetic response at 6 months, c) no major cytogenetic response at 12 months, d) no complete cytogenetic response or major molecular response at >18 months, or e) loss of a response with increasing cytogenetic or molecular evidence of disease. or are intolerant to tyrosine kinase inhibitor therapy. or with second or greater chronic phase (with prior transformation who respond to treatment and have <15% blasts at study entry).

boolean

C0023473 (UMLS CUI [1])
C0457343 (UMLS CUI [2])
C0457345 (UMLS CUI [3])
C0005953 (UMLS CUI [4])
C0935989 (UMLS CUI [5])
C0879484 (UMLS CUI [6])

Stem cell donor; HLA Antigens

Item

4. histocompatible stem cell donor: patients must have an hla matched related or unrelated donor (hla a, b, c and dr) willing to donate for allogeneic hematopoietic transplantation.

boolean

C0375877 (UMLS CUI [1])
C0019721 (UMLS CUI [2])

KIR Ligand; haploidentical donor

Item

5. haploidentical nk cell donor: patients must have a haploidentical relative with the absence of a kir-ligand (hla molecule).

boolean

C3642144 (UMLS CUI [1])
C3829897 (UMLS CUI [2])

zubrod performance status; Lansky Play-Performance Status

Item

6. performance status: zubrod </= 2 or lansky ps greater or equal to 70%.

boolean

C3714786 (UMLS CUI [1])
C1522275 (UMLS CUI [2])

left ventricular ejection fraction; Cardiac Arrhythmia; cardiac disease

Item

7. cardiac function: left ventricular ejection fraction >/= 40%. no uncontrolled arrhythmias or uncontrolled symptomatic cardiac disease.

boolean

C0428772 (UMLS CUI [1])
C0003811 (UMLS CUI [2])
C0018799 (UMLS CUI [3])

pulmonary disease; fev1; forced vital capacity; Carbon Monoxide Diffusing Capability Test; pulse oximetry

Item

8. pulmonary function: no symptomatic pulmonary disease. forced expiratory volume at one second (fev1), forced vital capacity (fvc) and diffusion capacity of lung for carbon monoxide (dlco) >/= 50% of expected, corrected for hemoglobin. for pediatric patients, if unable to perform pulmonary function tests (most children < 7 years of age), pulse oximetry >/= 92% on room air by pulse oximetry.

boolean

C0024115 (UMLS CUI [1])
C2238302 (UMLS CUI [2])
C3714541 (UMLS CUI [3])
C1516251 (UMLS CUI [4])
C0034108 (UMLS CUI [5])

serum creatinine; creatinine clearance

Item

9. renal function: serum creatinine </= 1.8mg/dl or creatinine clearance greater or equal than 40 cc/min. creatinine for pediatric patients </= 1.5 mg/dl or </= 2 times upper limit of normal for age (whichever is less).

boolean

C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])

bilirubin; gilberts syndrome; alt or ast; chronic active hepatitis; cirrhosis; liver biopsy

Item

10. liver function: bilirubin </= 1.5 mg/dl (unless gilbert's syndrome), alt or ast </= 200 iu/ml for adults unless related to underline disease. for pediatric patients conjugated (direct) bilirubin <2x upper limit of normal, alt or ast <5 times upper limit of normal.no evidence of chronic active hepatitis or cirrhosis. if positive hepatitis serology, discuss with study chairman and consider liver biopsy.

boolean

C1278039 (UMLS CUI [1])
C0017551 (UMLS CUI [2])
C3831581 (UMLS CUI [3])
C0520463 (UMLS CUI [4])
C1623038 (UMLS CUI [5])
C0193388 (UMLS CUI [6])

informed consent

Item

11. patient or patient's legal representative, parent(s) or guardian able to provide written informed consent. assent as is age appropriate.

boolean

C0021430 (UMLS CUI [1])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

infection; antimicrobial agents

Item

1. uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy. the protocol pi is the final arbiter of eligibility.

boolean

C3714514 (UMLS CUI [1])
C1136254 (UMLS CUI [2])

pericardial effusion; pleural effusion; ascites

Item

2. pleural/pericardial effusion or ascites estimated to be >1l

boolean

C0031039 (UMLS CUI [1])
C1253943 (UMLS CUI [2])
C0003962 (UMLS CUI [3])

hiv-positive

Item

3. hiv-positive.

boolean

C0019699 (UMLS CUI [1])

pregnancy; lactating; hcg test

Item

4. breast feeding or pregnancy. pregnancy means a positive beta human chorionic gonadotropin (hcg) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.

boolean

C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0851101 (UMLS CUI [3])

hypersensitivity mouse proteins

Item

5. known allergy to mouse proteins

boolean

C0020517 (UMLS CUI [1,1])
C0369684 (UMLS CUI [1,2])

hepatitis b or c

Item

6. active hepatitis b or c infection.

boolean

C0019196 (UMLS CUI [1,1])
C0019163 (UMLS CUI [1,2])

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Eligibility Leukemia NCT01390402