ID

21420

Description

Pharmacokinetic Trial of Decitabine (Dacogen) Administered as a 3-hour Infusion to Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome; ODM derived from: https://clinicaltrials.gov/show/NCT01378416

Link

https://clinicaltrials.gov/show/NCT01378416

Keywords

Versions (1)
  1. 4/20/17 4/20/17 -
Uploaded on

April 20, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Leukemia NCT01378416

English

Eligibility Leukemia NCT01378416

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01378416
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
each patient had to meet the following criteria to be eligible for the study:
Description

Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. patients with mds (de novo or secondary) must have been 60 years or older and have had disease fitting any of the recognized french-american-british classifications or chronic myelomonocytic leukemia (with white blood cell [wbc] <12,000/μl) and have had an international prognostic scoring system score of ≥1.5 as determined by complete blood count, bone marrow assessment and bone marrow cytogenetics within 30 days of study entry.
Description

de novo myelodysplastic syndromes | secondary myelodysplastic syndromes | Age | Disease French-American-British Classification | Leukemia, Myelomonocytic, Chronic | White Blood Cell Count | International Prognostic Scoring System (IPSS) for Myelodysplastic Syndromes | Complete Blood Count | Bone Marrow Assessment | Bone Marrow Cytogenetic Analysis

Data type

boolean

Alias
UMLS CUI [1]
C0280451
UMLS CUI [2]
C0280745
UMLS CUI [3]
C0001779
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C2984084
UMLS CUI [5]
C0023480
UMLS CUI [6]
C0023508
UMLS CUI [7]
C2827405
UMLS CUI [8]
C0009555
UMLS CUI [9,1]
C0005953
UMLS CUI [9,2]
C1516048
UMLS CUI [10,1]
C0005953
UMLS CUI [10,2]
C0752095
2. patients with aml (≥30% bone marrow blasts) must have been age 18 years or older and had previously received standard induction chemotherapy and/or had failed approved therapies.
Description

Leukemia, Myelocytic, Acute | Bone marrow Blasts Percentage | Age | Induction Chemotherapy Standard | Standard therapy failed

Data type

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2,1]
C1982687
UMLS CUI [2,2]
C0439165
UMLS CUI [3]
C0001779
UMLS CUI [4,1]
C3179010
UMLS CUI [4,2]
C1442989
UMLS CUI [5,1]
C2936643
UMLS CUI [5,2]
C0231175
3. must have had eastern cooperative oncology group (ecog) performance status of 0 to 2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
4. must have signed an institutional review board (irb)-approved informed consent form, indicating his/her awareness of the investigational nature of this study and its potential hazards prior to initiation of any study-specific procedures or treatment.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
5. must have had adequate renal and hepatic function (creatinine ≤2.0 mg/dl, total bilirubin <2.0 mg/dl, aspartate aminotransferase (ast) and alanine aminotransferase (alt) <3.0 x institutional upper limit of normal).
Description

Renal function | Liver function | Creatinine measurement, serum | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0201976
UMLS CUI [4]
C1278039
UMLS CUI [5]
C0201899
UMLS CUI [6]
C0201836
6. must have had life expectancy of at least 12 weeks.
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
7. must have recovered from all toxic effects of all prior therapy before entry into this study.
Description

Therapeutic procedure Toxic effect Patient recovered

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0600688
UMLS CUI [1,3]
C1115804
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with mds must not have been candidates for high-dose chemotherapy, bone marrow or stem cell transplant.
Description

MYELODYSPLASTIC SYNDROME | High-dose chemotherapy | Bone Marrow Transplantation | Stem cell transplant

Data type

boolean

Alias
UMLS CUI [1]
C3463824
UMLS CUI [2]
C1328050
UMLS CUI [3]
C0005961
UMLS CUI [4]
C1504389
2. must not have had acute promyelocytic leukemia (m3 classification).
Description

Acute Promyelocytic Leukemia French-American-British Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0023487
UMLS CUI [1,2]
C2984084
3. must not have received immunosuppressive therapy for 30 days prior to study entry.
Description

Therapeutic immunosuppression

Data type

boolean

Alias
UMLS CUI [1]
C0021079
4. must not have had central nervous system (cns) leukemia.
Description

Central nervous system leukaemia

Data type

boolean

Alias
UMLS CUI [1]
C1332884
5. must not have received systemic corticosteroids, interferon, interleukins or other hormonal therapy within 30 days prior to study entry. use of corticosteroids (topical and inhaled corticosteroids) was permitted and prophylactic steroids may have been used to treat or prevent transfusion reactions.
Description

CORTICOSTEROIDS FOR SYSTEMIC USE | Interferon | Interleukins | Hormone Therapy | Topical corticosteroids | inhaled steroids | Steroids Prophylactic treatment Transfusion Reaction

Data type

boolean

Alias
UMLS CUI [1]
C3653708
UMLS CUI [2]
C3652465
UMLS CUI [3]
C0021764
UMLS CUI [4]
C0279025
UMLS CUI [5]
C0304604
UMLS CUI [6]
C2065041
UMLS CUI [7,1]
C0038317
UMLS CUI [7,2]
C0199176
UMLS CUI [7,3]
C0274435
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Similar models

Eligibility Leukemia NCT01378416

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01378416
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Fulfill
Item
each patient had to meet the following criteria to be eligible for the study:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
de novo myelodysplastic syndromes | secondary myelodysplastic syndromes | Age | Disease French-American-British Classification | Leukemia, Myelomonocytic, Chronic | White Blood Cell Count | International Prognostic Scoring System (IPSS) for Myelodysplastic Syndromes | Complete Blood Count | Bone Marrow Assessment | Bone Marrow Cytogenetic Analysis
Item
1. patients with mds (de novo or secondary) must have been 60 years or older and have had disease fitting any of the recognized french-american-british classifications or chronic myelomonocytic leukemia (with white blood cell [wbc] <12,000/μl) and have had an international prognostic scoring system score of ≥1.5 as determined by complete blood count, bone marrow assessment and bone marrow cytogenetics within 30 days of study entry.
boolean
C0280451 (UMLS CUI [1])
C0280745 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0012634 (UMLS CUI [4,1])
C2984084 (UMLS CUI [4,2])
C0023480 (UMLS CUI [5])
C0023508 (UMLS CUI [6])
C2827405 (UMLS CUI [7])
C0009555 (UMLS CUI [8])
C0005953 (UMLS CUI [9,1])
C1516048 (UMLS CUI [9,2])
C0005953 (UMLS CUI [10,1])
C0752095 (UMLS CUI [10,2])
Leukemia, Myelocytic, Acute | Bone marrow Blasts Percentage | Age | Induction Chemotherapy Standard | Standard therapy failed
Item
2. patients with aml (≥30% bone marrow blasts) must have been age 18 years or older and had previously received standard induction chemotherapy and/or had failed approved therapies.
boolean
C0023467 (UMLS CUI [1])
C1982687 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0001779 (UMLS CUI [3])
C3179010 (UMLS CUI [4,1])
C1442989 (UMLS CUI [4,2])
C2936643 (UMLS CUI [5,1])
C0231175 (UMLS CUI [5,2])
ECOG performance status
Item
3. must have had eastern cooperative oncology group (ecog) performance status of 0 to 2.
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
4. must have signed an institutional review board (irb)-approved informed consent form, indicating his/her awareness of the investigational nature of this study and its potential hazards prior to initiation of any study-specific procedures or treatment.
boolean
C0021430 (UMLS CUI [1])
Renal function | Liver function | Creatinine measurement, serum | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
5. must have had adequate renal and hepatic function (creatinine ≤2.0 mg/dl, total bilirubin <2.0 mg/dl, aspartate aminotransferase (ast) and alanine aminotransferase (alt) <3.0 x institutional upper limit of normal).
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
C0201836 (UMLS CUI [6])
Life Expectancy
Item
6. must have had life expectancy of at least 12 weeks.
boolean
C0023671 (UMLS CUI [1])
Therapeutic procedure Toxic effect Patient recovered
Item
7. must have recovered from all toxic effects of all prior therapy before entry into this study.
boolean
C0087111 (UMLS CUI [1,1])
C0600688 (UMLS CUI [1,2])
C1115804 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
MYELODYSPLASTIC SYNDROME | High-dose chemotherapy | Bone Marrow Transplantation | Stem cell transplant
Item
1. patients with mds must not have been candidates for high-dose chemotherapy, bone marrow or stem cell transplant.
boolean
C3463824 (UMLS CUI [1])
C1328050 (UMLS CUI [2])
C0005961 (UMLS CUI [3])
C1504389 (UMLS CUI [4])
Acute Promyelocytic Leukemia French-American-British Classification
Item
2. must not have had acute promyelocytic leukemia (m3 classification).
boolean
C0023487 (UMLS CUI [1,1])
C2984084 (UMLS CUI [1,2])
Therapeutic immunosuppression
Item
3. must not have received immunosuppressive therapy for 30 days prior to study entry.
boolean
C0021079 (UMLS CUI [1])
Central nervous system leukaemia
Item
4. must not have had central nervous system (cns) leukemia.
boolean
C1332884 (UMLS CUI [1])
CORTICOSTEROIDS FOR SYSTEMIC USE | Interferon | Interleukins | Hormone Therapy | Topical corticosteroids | inhaled steroids | Steroids Prophylactic treatment Transfusion Reaction
Item
5. must not have received systemic corticosteroids, interferon, interleukins or other hormonal therapy within 30 days prior to study entry. use of corticosteroids (topical and inhaled corticosteroids) was permitted and prophylactic steroids may have been used to treat or prevent transfusion reactions.
boolean
C3653708 (UMLS CUI [1])
C3652465 (UMLS CUI [2])
C0021764 (UMLS CUI [3])
C0279025 (UMLS CUI [4])
C0304604 (UMLS CUI [5])
C2065041 (UMLS CUI [6])
C0038317 (UMLS CUI [7,1])
C0199176 (UMLS CUI [7,2])
C0274435 (UMLS CUI [7,3])
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