ID

32486

Description

Azacitidine After Allo Blood And Marrow Transplantation (BMT) for Chronic Myelogenous Leukemia (CML); ODM derived from: https://clinicaltrials.gov/show/NCT00813124

Link

https://clinicaltrials.gov/show/NCT00813124

Keywords

Versions (1)
  1. 11/4/18 11/4/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 4, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Stem Cell Transplantation NCT00813124

English

Eligibility Stem Cell Transplantation NCT00813124

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with age <= 75 years with cml in first chronic phase, which has failed to achieve a cytogenetic or molecular complete remission or has progressed after imatinib treatment. criteria for failure are the international consensus criteria (appendix h). patients intolerant to tyrosine kinase inhibitor therapy are also eligible.
Description

Age | Leukemia, Myeloid, Chronic-Phase First | Cytogenetic Complete Response failed | Molecular Complete Response failed | Disease Progression Post Imatinib | Intolerance to Tyrosine kinase inhibitor

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0023474
UMLS CUI [2,2]
C0205435
UMLS CUI [3,1]
C4050364
UMLS CUI [3,2]
C0231175
UMLS CUI [4,1]
C4050308
UMLS CUI [4,2]
C0231175
UMLS CUI [5,1]
C0242656
UMLS CUI [5,2]
C0687676
UMLS CUI [5,3]
C0935989
UMLS CUI [6,1]
C1744706
UMLS CUI [6,2]
C1268567
2. patients with age <= 75 with cml in accelerated phase or blast crisis that have <= 15% blasts in the blood and bone marrow at study entry.
Description

Age | Leukemia, Myeloid, Accelerated Phase | Blast Phase Blasts Percentage Blood | Blast Phase Blasts Percentage Bone Marrow

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0023472
UMLS CUI [3,1]
C0005699
UMLS CUI [3,2]
C0368761
UMLS CUI [3,3]
C0439165
UMLS CUI [3,4]
C0005767
UMLS CUI [4,1]
C0005699
UMLS CUI [4,2]
C0368761
UMLS CUI [4,3]
C0439165
UMLS CUI [4,4]
C0005953
3. donor: hla-compatible related (hla-a, -b, -drb1 matched or with one-antigen mismatch) or hla-compatible unrelated (hla-a, -b, -c and -drb1 matched or with one-antigen mismatch).
Description

Donor | Relative HLA-A Antigen Match | Relative HLA-B Antigen Match | Relative HLA-C Antigen Match | Relative HLA-DRB1 antigen Match | Relative Antigen Quantity Mismatch | Unrelated HLA-A Antigen Match | Unrelated HLA-B Antigen Match | Unrelated HLA-C Antigen Match | Unrelated HLA-DRB1 antigen Match | Unrelated Antigen Quantity Mismatch

Data type

boolean

Alias
UMLS CUI [1]
C0013018
UMLS CUI [2,1]
C0080103
UMLS CUI [2,2]
C0019728
UMLS CUI [2,3]
C1708943
UMLS CUI [3,1]
C0080103
UMLS CUI [3,2]
C0019737
UMLS CUI [3,3]
C1708943
UMLS CUI [4,1]
C0080103
UMLS CUI [4,2]
C0019751
UMLS CUI [4,3]
C1708943
UMLS CUI [5,1]
C0080103
UMLS CUI [5,2]
C0122040
UMLS CUI [5,3]
C1708943
UMLS CUI [6,1]
C0080103
UMLS CUI [6,2]
C0003320
UMLS CUI [6,3]
C1265611
UMLS CUI [6,4]
C1881865
UMLS CUI [7,1]
C0445356
UMLS CUI [7,2]
C0019728
UMLS CUI [7,3]
C1708943
UMLS CUI [8,1]
C0445356
UMLS CUI [8,2]
C0019737
UMLS CUI [8,3]
C1708943
UMLS CUI [9,1]
C0445356
UMLS CUI [9,2]
C0019751
UMLS CUI [9,3]
C1708943
UMLS CUI [10,1]
C0445356
UMLS CUI [10,2]
C0122040
UMLS CUI [10,3]
C1708943
UMLS CUI [11,1]
C0445356
UMLS CUI [11,2]
C0003320
UMLS CUI [11,3]
C1265611
UMLS CUI [11,4]
C1881865
4. age 18 to 75 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
5. zubrod performance status <= 2.
Description

Zubrod Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C3714786
6. left ventricular ejection fraction => 40%.
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
7. pulmonary function test within the following parameters: forced expiratory volume at one second (fev1), forced vital capacity (fvc) and diffusing capacity of lung for carbon monoxide (dlco) => 50% of expected, corrected for hemoglobin.
Description

Pulmonary function tests | FEV1 | Forced Vital Capacity | Hemoglobin Corrected Diffusion Capacity of the Lung for Carbon Monoxide

Data type

boolean

Alias
UMLS CUI [1]
C0024119
UMLS CUI [2]
C0849974
UMLS CUI [3]
C3714541
UMLS CUI [4]
C4054790
8. serum creatinine < 1.5 mg/dl or creatinine clearance greater or equal than 40 cc/min.
Description

Creatinine measurement, serum | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0373595
9. serum direct bilirubin < 1.5 mg/dl (unless gilbert's syndrome)
Description

Serum direct bilirubin measurement | Exception Gilbert syndrome

Data type

boolean

Alias
UMLS CUI [1]
C1883011
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0017551
10. serum glutamate pyruvate transaminase (sgpt) <= 200 iu/l unless related to patient's malignancy.
Description

Alanine aminotransferase measurement | Exception Relationship Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C0006826
11. patients treated with any tyrosine kinase inhibitor, interferon or any experimental therapy are eligible.
Description

Tyrosine kinase inhibitor | Interferon | Therapies, Investigational

Data type

boolean

Alias
UMLS CUI [1]
C1268567
UMLS CUI [2]
C3652465
UMLS CUI [3]
C0949266
12. patients with age <75 years with cml in second or subsequent chronic phase.
Description

Age | Leukemia, Myeloid, Chronic-Phase second

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0023474
UMLS CUI [2,2]
C0205436
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy.
Description

Communicable Disease Uncontrolled | Antimicrobial agents Unresponsive to Treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C1136254
UMLS CUI [2,2]
C0205269
2. pleural/pericardial effusion or ascites estimated to be >1l.
Description

Pleural effusion | Pericardial effusion | Ascites

Data type

boolean

Alias
UMLS CUI [1]
C0032227
UMLS CUI [2]
C0031039
UMLS CUI [3]
C0003962
3. hiv-positive.
Description

HIV Seropositivity

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

Breast Feeding | Pregnancy | Childbearing Potential Serum pregnancy test (B-HCG) Positive | Postmenopausal state Absent | Female Sterilization Absent

Data type

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0430060
UMLS CUI [3,3]
C1514241
UMLS CUI [4,1]
C0232970
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0015787
UMLS CUI [5,2]
C0332197
5. known or suspected hypersensitivity to azacitidine or mannitol.
Description

Hypersensitivity Azacitidine | Mannitol allergy | Hypersensitivity Suspected Azacitidine | Mannitol allergy Suspected

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0004475
UMLS CUI [2]
C0571922
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0750491
UMLS CUI [3,3]
C0004475
UMLS CUI [4,1]
C0571922
UMLS CUI [4,2]
C0750491
6. patients with advanced malignant hepatic tumors.
Description

Malignant neoplasm of liver Advanced

Data type

boolean

Alias
UMLS CUI [1,1]
C0345904
UMLS CUI [1,2]
C0205179
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Similar models

Eligibility Stem Cell Transplantation NCT00813124

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Leukemia, Myeloid, Chronic-Phase First | Cytogenetic Complete Response failed | Molecular Complete Response failed | Disease Progression Post Imatinib | Intolerance to Tyrosine kinase inhibitor
Item
1. patients with age <= 75 years with cml in first chronic phase, which has failed to achieve a cytogenetic or molecular complete remission or has progressed after imatinib treatment. criteria for failure are the international consensus criteria (appendix h). patients intolerant to tyrosine kinase inhibitor therapy are also eligible.
boolean
C0001779 (UMLS CUI [1])
C0023474 (UMLS CUI [2,1])
C0205435 (UMLS CUI [2,2])
C4050364 (UMLS CUI [3,1])
C0231175 (UMLS CUI [3,2])
C4050308 (UMLS CUI [4,1])
C0231175 (UMLS CUI [4,2])
C0242656 (UMLS CUI [5,1])
C0687676 (UMLS CUI [5,2])
C0935989 (UMLS CUI [5,3])
C1744706 (UMLS CUI [6,1])
C1268567 (UMLS CUI [6,2])
Age | Leukemia, Myeloid, Accelerated Phase | Blast Phase Blasts Percentage Blood | Blast Phase Blasts Percentage Bone Marrow
Item
2. patients with age <= 75 with cml in accelerated phase or blast crisis that have <= 15% blasts in the blood and bone marrow at study entry.
boolean
C0001779 (UMLS CUI [1])
C0023472 (UMLS CUI [2])
C0005699 (UMLS CUI [3,1])
C0368761 (UMLS CUI [3,2])
C0439165 (UMLS CUI [3,3])
C0005767 (UMLS CUI [3,4])
C0005699 (UMLS CUI [4,1])
C0368761 (UMLS CUI [4,2])
C0439165 (UMLS CUI [4,3])
C0005953 (UMLS CUI [4,4])
Donor | Relative HLA-A Antigen Match | Relative HLA-B Antigen Match | Relative HLA-C Antigen Match | Relative HLA-DRB1 antigen Match | Relative Antigen Quantity Mismatch | Unrelated HLA-A Antigen Match | Unrelated HLA-B Antigen Match | Unrelated HLA-C Antigen Match | Unrelated HLA-DRB1 antigen Match | Unrelated Antigen Quantity Mismatch
Item
3. donor: hla-compatible related (hla-a, -b, -drb1 matched or with one-antigen mismatch) or hla-compatible unrelated (hla-a, -b, -c and -drb1 matched or with one-antigen mismatch).
boolean
C0013018 (UMLS CUI [1])
C0080103 (UMLS CUI [2,1])
C0019728 (UMLS CUI [2,2])
C1708943 (UMLS CUI [2,3])
C0080103 (UMLS CUI [3,1])
C0019737 (UMLS CUI [3,2])
C1708943 (UMLS CUI [3,3])
C0080103 (UMLS CUI [4,1])
C0019751 (UMLS CUI [4,2])
C1708943 (UMLS CUI [4,3])
C0080103 (UMLS CUI [5,1])
C0122040 (UMLS CUI [5,2])
C1708943 (UMLS CUI [5,3])
C0080103 (UMLS CUI [6,1])
C0003320 (UMLS CUI [6,2])
C1265611 (UMLS CUI [6,3])
C1881865 (UMLS CUI [6,4])
C0445356 (UMLS CUI [7,1])
C0019728 (UMLS CUI [7,2])
C1708943 (UMLS CUI [7,3])
C0445356 (UMLS CUI [8,1])
C0019737 (UMLS CUI [8,2])
C1708943 (UMLS CUI [8,3])
C0445356 (UMLS CUI [9,1])
C0019751 (UMLS CUI [9,2])
C1708943 (UMLS CUI [9,3])
C0445356 (UMLS CUI [10,1])
C0122040 (UMLS CUI [10,2])
C1708943 (UMLS CUI [10,3])
C0445356 (UMLS CUI [11,1])
C0003320 (UMLS CUI [11,2])
C1265611 (UMLS CUI [11,3])
C1881865 (UMLS CUI [11,4])
Age
Item
4. age 18 to 75 years.
boolean
C0001779 (UMLS CUI [1])
Zubrod Performance Status
Item
5. zubrod performance status <= 2.
boolean
C3714786 (UMLS CUI [1])
Left ventricular ejection fraction
Item
6. left ventricular ejection fraction => 40%.
boolean
C0428772 (UMLS CUI [1])
Pulmonary function tests | FEV1 | Forced Vital Capacity | Hemoglobin Corrected Diffusion Capacity of the Lung for Carbon Monoxide
Item
7. pulmonary function test within the following parameters: forced expiratory volume at one second (fev1), forced vital capacity (fvc) and diffusing capacity of lung for carbon monoxide (dlco) => 50% of expected, corrected for hemoglobin.
boolean
C0024119 (UMLS CUI [1])
C0849974 (UMLS CUI [2])
C3714541 (UMLS CUI [3])
C4054790 (UMLS CUI [4])
Creatinine measurement, serum | Creatinine clearance measurement
Item
8. serum creatinine < 1.5 mg/dl or creatinine clearance greater or equal than 40 cc/min.
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Serum direct bilirubin measurement | Exception Gilbert syndrome
Item
9. serum direct bilirubin < 1.5 mg/dl (unless gilbert's syndrome)
boolean
C1883011 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0017551 (UMLS CUI [2,2])
Alanine aminotransferase measurement | Exception Relationship Malignant Neoplasms
Item
10. serum glutamate pyruvate transaminase (sgpt) <= 200 iu/l unless related to patient's malignancy.
boolean
C0201836 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0006826 (UMLS CUI [2,3])
Tyrosine kinase inhibitor | Interferon | Therapies, Investigational
Item
11. patients treated with any tyrosine kinase inhibitor, interferon or any experimental therapy are eligible.
boolean
C1268567 (UMLS CUI [1])
C3652465 (UMLS CUI [2])
C0949266 (UMLS CUI [3])
Age | Leukemia, Myeloid, Chronic-Phase second
Item
12. patients with age <75 years with cml in second or subsequent chronic phase.
boolean
C0001779 (UMLS CUI [1])
C0023474 (UMLS CUI [2,1])
C0205436 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Communicable Disease Uncontrolled | Antimicrobial agents Unresponsive to Treatment
Item
1. uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1136254 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
Pleural effusion | Pericardial effusion | Ascites
Item
2. pleural/pericardial effusion or ascites estimated to be >1l.
boolean
C0032227 (UMLS CUI [1])
C0031039 (UMLS CUI [2])
C0003962 (UMLS CUI [3])
HIV Seropositivity
Item
3. hiv-positive.
boolean
C0019699 (UMLS CUI [1])
Breast Feeding | Pregnancy | Childbearing Potential Serum pregnancy test (B-HCG) Positive | Postmenopausal state Absent | Female Sterilization Absent
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
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0430060 (UMLS CUI [3,2])
C1514241 (UMLS CUI [3,3])
C0232970 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0015787 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Hypersensitivity Azacitidine | Mannitol allergy | Hypersensitivity Suspected Azacitidine | Mannitol allergy Suspected
Item
5. known or suspected hypersensitivity to azacitidine or mannitol.
boolean
C0020517 (UMLS CUI [1,1])
C0004475 (UMLS CUI [1,2])
C0571922 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
C0004475 (UMLS CUI [3,3])
C0571922 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
Malignant neoplasm of liver Advanced
Item
6. patients with advanced malignant hepatic tumors.
boolean
C0345904 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
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