ID

43814

Description

Alloreactive Haploidentical Natural Killer (NK) Cells With Busulfan and Fludarabine/ATG; ODM derived from: https://clinicaltrials.gov/show/NCT01390402

Link

https://clinicaltrials.gov/show/NCT01390402

Keywords

Versions (2)
  1. 3/12/16 3/12/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Leukemia NCT01390402

English

Eligibility Leukemia NCT01390402

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01390402
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients who meet the following eligibility criteria are eligible for inclusion in this study. pediatric team to assess eligibility appropriate for patient age.
Description

eligibility criteria

Data type

boolean

Alias
UMLS CUI [1]
C1516637
2. age </= 70 years of age.
Description

age

Data type

boolean

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).
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0023473
UMLS CUI [2]
C0457343
UMLS CUI [3]
C0457345
UMLS CUI [4]
C0005953
UMLS CUI [5]
C0935989
UMLS CUI [6]
C0879484
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.
Description

Stem cell donor; HLA Antigens

Data type

boolean

Alias
UMLS CUI [1]
C0375877
UMLS CUI [2]
C0019721
5. haploidentical nk cell donor: patients must have a haploidentical relative with the absence of a kir-ligand (hla molecule).
Description

KIR Ligand; haploidentical donor

Data type

boolean

Alias
UMLS CUI [1]
C3642144
UMLS CUI [2]
C3829897
6. performance status: zubrod </= 2 or lansky ps greater or equal to 70%.
Description

zubrod performance status; Lansky Play-Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C3714786
UMLS CUI [2]
C1522275
7. cardiac function: left ventricular ejection fraction >/= 40%. no uncontrolled arrhythmias or uncontrolled symptomatic cardiac disease.
Description

left ventricular ejection fraction; Cardiac Arrhythmia; cardiac disease

Data type

boolean

Alias
UMLS CUI [1]
C0428772
UMLS CUI [2]
C0003811
UMLS CUI [3]
C0018799
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.
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0024115
UMLS CUI [2]
C3815113
UMLS CUI [3]
C3714541
UMLS CUI [4]
C1516251
UMLS CUI [5]
C0034108
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).
Description

serum creatinine; creatinine clearance

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0373595
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.
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0017551
UMLS CUI [3]
C3831581
UMLS CUI [4]
C0520463
UMLS CUI [5]
C1623038
UMLS CUI [6]
C0193388
11. patient or patient's legal representative, parent(s) or guardian able to provide written informed consent. assent as is age appropriate.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy. the protocol pi is the final arbiter of eligibility.
Description

infection; antimicrobial agents

Data type

boolean

Alias
UMLS CUI [1]
C3714514
UMLS CUI [2]
C1136254
2. pleural/pericardial effusion or ascites estimated to be >1l
Description

pericardial effusion; pleural effusion; ascites

Data type

boolean

Alias
UMLS CUI [1]
C0031039
UMLS CUI [2]
C1253943
UMLS CUI [3]
C0003962
3. hiv-positive.
Description

hiv-positive

Data type

boolean

Alias
UMLS CUI [1]
C0019699
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.
Description

pregnancy; lactating; hcg test

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0851101
5. known allergy to mouse proteins
Description

hypersensitivity mouse proteins

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0369684
6. active hepatitis b or c infection.
Description

hepatitis b or c

Data type

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C0019163
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Similar models

Eligibility Leukemia NCT01390402

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01390402
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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])
C3815113 (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])
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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