ID

13019

Description

Cytarabine and UCN-01 in Treating Patients With Refractory or Relapsed Acute Myelogenous Leukemia or Myelodysplastic Syndrome; ODM derived from: https://clinicaltrials.gov/show/NCT00004263

Link

https://clinicaltrials.gov/show/NCT00004263

Keywords

  1. 1/12/16 1/12/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

January 12, 2016

DOI

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License

Creative Commons BY-NC 3.0

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Eligibility Leukemia NCT00004263

Eligibility Leukemia NCT00004263

  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00004263
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. 1. patients with refractory or relapsed acute myelogenous leukemia, or myelodysplastic syndromes (raeb or raeb-t).
Description

relapsed acute myelogenous leukemia, or myelodysplastic syndromes

Data type

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2]
C3463824
2. 2. performance status of =< 2
Description

performance status

Data type

boolean

Alias
UMLS CUI [1]
C1518965
3. 3. signed informed consent indicating that patients are aware of the investigational nature of this study in keeping with the policies of the hospital. the only acceptable consent form is the one attached at the end of this protocol for each participating institution.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
4. 4. patients must have been off chemotherapy for 2 weeks prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease.
Description

chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
5. 5. bilirubin and creatinine (or creatinine clearance) should be within institutional normal limits.
Description

bilirubin and creatinine

Data type

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201976
6. 6. patients must have relapsed or failed to respond after high-dose ara-c-based (>=1g/m2/day x 3 days) chemotherapy.
Description

high-dose ara-c-based (>=1g/m2/day x 3 days) chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0010711
7. 7. corrected dlco >50%.
Description

DLCO

Data type

boolean

Alias
UMLS CUI [1]
C1516251
8. 8. patients with >=3 cardiac risk factors (smoking, hypertension, family history of coronary artery disease, diabetes mellitus, hypercholesterolemia) should have a nuclear medicine stress test.
Description

cardiac risk factors

Data type

boolean

Alias
UMLS CUI [1]
C2024776
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. 1. the anti-proliferative activity of the experimental drug may be harmful to the developing fetus or nursing infant. therefore, pregnant and nursing females will be excluded. patients of childbearing potential should practice effective methods of contraception.
Description

pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0700589
2. 2. patients who are eligible for allogeneic marrow transplant and who have a donor will be offered transplant.
Description

allogeneic marrow transplant

Data type

boolean

Alias
UMLS CUI [1]
C0149615
3. 3. patients with existing pulmonary diseases, history of coronary artery disease or who have received radiotherapy to the mediastinum.
Description

comorbidity or radiotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C1522449

Similar models

Eligibility Leukemia NCT00004263

  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00004263
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
relapsed acute myelogenous leukemia, or myelodysplastic syndromes
Item
1. 1. patients with refractory or relapsed acute myelogenous leukemia, or myelodysplastic syndromes (raeb or raeb-t).
boolean
C0023467 (UMLS CUI [1])
C3463824 (UMLS CUI [2])
performance status
Item
2. 2. performance status of =< 2
boolean
C1518965 (UMLS CUI [1])
informed consent
Item
3. 3. signed informed consent indicating that patients are aware of the investigational nature of this study in keeping with the policies of the hospital. the only acceptable consent form is the one attached at the end of this protocol for each participating institution.
boolean
C0021430 (UMLS CUI [1])
chemotherapy
Item
4. 4. patients must have been off chemotherapy for 2 weeks prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease.
boolean
C0392920 (UMLS CUI [1])
bilirubin and creatinine
Item
5. 5. bilirubin and creatinine (or creatinine clearance) should be within institutional normal limits.
boolean
C1278039 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
high-dose ara-c-based (>=1g/m2/day x 3 days) chemotherapy
Item
6. 6. patients must have relapsed or failed to respond after high-dose ara-c-based (>=1g/m2/day x 3 days) chemotherapy.
boolean
C0010711 (UMLS CUI [1])
DLCO
Item
7. 7. corrected dlco >50%.
boolean
C1516251 (UMLS CUI [1])
cardiac risk factors
Item
8. 8. patients with >=3 cardiac risk factors (smoking, hypertension, family history of coronary artery disease, diabetes mellitus, hypercholesterolemia) should have a nuclear medicine stress test.
boolean
C2024776 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
pregnancy
Item
1. 1. the anti-proliferative activity of the experimental drug may be harmful to the developing fetus or nursing infant. therefore, pregnant and nursing females will be excluded. patients of childbearing potential should practice effective methods of contraception.
boolean
C0032961 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
allogeneic marrow transplant
Item
2. 2. patients who are eligible for allogeneic marrow transplant and who have a donor will be offered transplant.
boolean
C0149615 (UMLS CUI [1])
comorbidity or radiotherapy
Item
3. 3. patients with existing pulmonary diseases, history of coronary artery disease or who have received radiotherapy to the mediastinum.
boolean
C0009488 (UMLS CUI [1])
C1522449 (UMLS CUI [2])

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