ID

11903

Beschreibung

Pilot Clinical Trial of Pazopanib in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) or at Initial Diagnosis When no Intensive Treatment is Possible; ODM derived from: https://clinicaltrials.gov/show/NCT01361334 Principal Investigator: PD Dr. Torsten Kessler, University Hospital Muenster, Germany

Link

https://clinicaltrials.gov/show/NCT01361334

Stichworte

Versionen (6)
  1. 11.04.13 11.04.13 - Martin Dugas
  2. 26.07.13 26.07.13 - Martin Dugas
  3. 20.04.14 20.04.14 - Julian Varghese
  4. 18.08.15 18.08.15 - Martin Dugas
  5. 14.01.16 14.01.16 -
  6. 11.02.16 11.02.16 -
Hochgeladen am

18. August 2015

DOI

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Eligibility Acute Myeloid Leukemia NCT01361334

Englisch

Eligibility Acute Myeloid Leukemia NCT01361334

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
1. subjects must provide written informed consent prior to performance of study-specific procedures or assessments which are not routinely performed for diagnosis or monitoring of acute myeloid leukemia (aml), and the subjects must be willing to comply with treatment and to follow up assessments and procedures
Beschreibung

1. subjects must provide written informed consent prior to performance of study-specific procedures or assessments which are not routinely performed for diagnosis or monitoring of acute myeloid leukemia (aml), and the subjects must be willing to comply with treatment and to follow up assessments and procedures

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
2. histologically or cytologically confirmed diagnosis of aml relapsed after or refractory to at least one induction regimen, or patients with aml at initial diagnosis who are not eligible for allogeneic transplant or intensive induction chemotherapy, except for aml m3 (acute promyelocytic leukemia)
Beschreibung

2. histologically or cytologically confirmed diagnosis of aml relapsed after or refractory to at least one induction regimen, or patients with aml at initial diagnosis who are not eligible for allogeneic transplant or intensive induction chemotherapy, except for aml m3 (acute promyelocytic leukemia)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0205269
UMLS CUI [1,3]
C0278780
UMLS CUI [2,1]
C1554961
UMLS CUI [2,2]
C0023487
3. age at least 18 years
Beschreibung

3. age at least 18 years

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
4. eastern cooperative oncology group (ecog) performance status of ≤3
Beschreibung

4. eastern cooperative oncology group (ecog) performance status of ≤3

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
5. measurable disease burden (blasts in bm and/or pb, extramedullary blasts [chloroma])
Beschreibung

5. measurable disease burden (blasts in bm and/or pb, extramedullary blasts [chloroma])

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1513041
6. able to swallow and retain oral medication
Beschreibung

6. able to swallow and retain oral medication

Datentyp

boolean

Alias
UMLS CUI [1]
C2712086
7. a life expectancy of at least 4 weeks
Beschreibung

7. a life expectancy of at least 4 weeks

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023671
8. adequate contraception methods
Beschreibung

8. adequate contraception methods

Datentyp

boolean

Alias
UMLS CUI [1]
C0700589
9. adequate organ function as defined in the study protocol
Beschreibung

9. adequate organ function as defined in the study protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0678852
UMLS CUI [1,2]
C0205411
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
1. patients with a valid option for intensive chemotherapy and/or stem cell transplantation (patients after allogeneic stem cell transplant must be off immunosuppressive agents for at least 2 weeks prior to study entry and graft-versus host disease must have resolved to grade ≤2)
Beschreibung

1. patients with a valid option for intensive chemotherapy and/or stem cell transplantation (patients after allogeneic stem cell transplant must be off immunosuppressive agents for at least 2 weeks prior to study entry and graft-versus host disease must have resolved to grade ≤2)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0683525
UMLS CUI [1,2]
C1504389
UMLS CUI [1,3]
C0392920
2. history of cancer that according to the investigator might confound the assessment of the endpoints of the study
Beschreibung

2. history of cancer that according to the investigator might confound the assessment of the endpoints of the study

Datentyp

boolean

Alias
UMLS CUI [1]
C2735088
3. uncontrolled peptic ulcer disease or clinically significant gastrointestinal abnormalities which interfere with oral dosing or any unstable or serious concurrent condition (e.g., active uncontrolled infection)
Beschreibung

3. uncontrolled peptic ulcer disease or clinically significant gastrointestinal abnormalities which interfere with oral dosing or any unstable or serious concurrent condition (e.g., active uncontrolled infection)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030920
4. poorly controlled hypertension [defined as systolic blood pressure (sbp) of ≥140 mmhg or diastolic blood pressure (dbp) of ≥90 mmhg]. note: initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. bp must be re-assessed on two occasions that are separated by a minimum of 1 hour; on each of these occasions, the mean (of 3 readings) sbp / dbp values from each bp assessment must be <140/90 mmhg in order for a subject to be eligible for the study
Beschreibung

4. poorly controlled hypertension [defined as systolic blood pressure (sbp) of ≥140 mmhg or diastolic blood pressure (dbp) of ≥90 mmhg]. note: initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. bp must be re-assessed on two occasions that are separated by a minimum of 1 hour; on each of these occasions, the mean (of 3 readings) sbp / dbp values from each bp assessment must be <140/90 mmhg in order for a subject to be eligible for the study

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1868885
5. prolongation of corrected qt interval (qtc) >480 milliseconds
Beschreibung

5. prolongation of corrected qt interval (qtc) >480 milliseconds

Datentyp

boolean

Alias
UMLS CUI [1]
C0489625
6. history of any one of more of the following cardiovascular conditions within the past 6 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, symptomatic peripheral vascular disease, class iii or iv congestive heart failure, as defined by the new york heart association (nyha)
Beschreibung

6. history of any one of more of the following cardiovascular conditions within the past 6 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, symptomatic peripheral vascular disease, class iii or iv congestive heart failure, as defined by the new york heart association (nyha)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0010068
UMLS CUI [2,1]
C0085096
UMLS CUI [3,1]
C0018802
7. history of cerebrovascular infarction or bleeding, pulmonary embolism, or untreated deep venous thrombosis (dvt) within the past 6 months. note: subjects with recent dvt who have been treated with therapeutic anti-coagulant agents for at least 6 weeks are eligible
Beschreibung

7. history of cerebrovascular infarction or bleeding, pulmonary embolism, or untreated deep venous thrombosis (dvt) within the past 6 months. note: subjects with recent dvt who have been treated with therapeutic anti-coagulant agents for at least 6 weeks are eligible

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007785
UMLS CUI [2,1]
C2937358
UMLS CUI [3,1]
C0034065
UMLS CUI [4,1]
C0149871
8. evidence of serious active bleeding or bleeding diathesis (except for bleeding or petechiae due to aml-related thrombocytopenia which will be treated using platelet transfusions). also, patients with known endobronchial lesions and/or lesions infiltrating major pulmonary vessels will be excluded from the study due to excess risk of bleeding.
Beschreibung

8. evidence of serious active bleeding or bleeding diathesis (except for bleeding or petechiae due to aml-related thrombocytopenia which will be treated using platelet transfusions). also, patients with known endobronchial lesions and/or lesions infiltrating major pulmonary vessels will be excluded from the study due to excess risk of bleeding.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1458140
9. prior major surgery or trauma within 28 days prior to first dose of study drug
Beschreibung

9. prior major surgery or trauma within 28 days prior to first dose of study drug

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0679637
UMLS CUI [2,1]
C3263723
10. treatment with an investigational agent within 28 days or 5 half-lives, whichever is longer prior to the first dose of study drug (for bevacizumab 60 days).
Beschreibung

10. treatment with an investigational agent within 28 days or 5 half-lives, whichever is longer prior to the first dose of study drug (for bevacizumab 60 days).

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013230
11. concurrent cytoreductive chemotherapy (hydroxyurea must be discontinued at least one day before start of study medication)
Beschreibung

11. concurrent cytoreductive chemotherapy (hydroxyurea must be discontinued at least one day before start of study medication)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0205420
12. known immediate or delayed hypersensitivity reaction or idiosyncrasy to pazopanib
Beschreibung

12. known immediate or delayed hypersensitivity reaction or idiosyncrasy to pazopanib

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1831796
13. patients with psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol
Beschreibung

13. patients with psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0376405
14. pregnant or lactating and actively breastfeeding patients
Beschreibung

14. pregnant or lactating and actively breastfeeding patients

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0549206
UMLS CUI [2,1]
C0006147
15. patients taking any of the following prohibited medication: clarithromycin, telithromycin, troleandomycin (antibiotics)
Beschreibung

15. patients taking any of the following prohibited medication: clarithromycin, telithromycin, troleandomycin (antibiotics)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0683610
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0055856
UMLS CUI [1,4]
C0907410
UMLS CUI [1,5]
C0041165
ritonavir, indinavir, saquinavir, nelfinavir, amprenavir, lopinavir (hiv protease inhibitors)
Beschreibung

ritonavir, indinavir, saquinavir, nelfinavir, amprenavir, lopinavir (hiv protease inhibitors)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0683610
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0754188
UMLS CUI [2]
C0525005
UMLS CUI [3]
C0286738
UMLS CUI [4]
C0292818
itraconazole, ketoconazole, voriconazole, fluconazole (antifungals)
Beschreibung

itraconazole, ketoconazole, voriconazole, fluconazole (antifungals)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0683610
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0022625
UMLS CUI [2]
C0064113
UMLS CUI [3]
C0016277
nefazodone (antidepressant)
Beschreibung

nefazodone (antidepressant)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0683610
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0068485
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Ähnliche Modelle

Eligibility Acute Myeloid Leukemia NCT01361334

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Informed consent
Item
1. subjects must provide written informed consent prior to performance of study-specific procedures or assessments which are not routinely performed for diagnosis or monitoring of acute myeloid leukemia (aml), and the subjects must be willing to comply with treatment and to follow up assessments and procedures
boolean
C0021430 (UMLS CUI [1])
Leukemia, Myelocytic, Acute; Unresponsive to Treatment; recurrent adult acute myeloid leukemia | exception Acute Promyelocytic Leukemia
Item
2. histologically or cytologically confirmed diagnosis of aml relapsed after or refractory to at least one induction regimen, or patients with aml at initial diagnosis who are not eligible for allogeneic transplant or intensive induction chemotherapy, except for aml m3 (acute promyelocytic leukemia)
boolean
C0023467 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0278780 (UMLS CUI [1,3])
C1554961 (UMLS CUI [2,1])
C0023487 (UMLS CUI [2,2])
age at least 18 years
Item
3. age at least 18 years
boolean
C0001779 (UMLS CUI [1])
ECOG
Item
4. eastern cooperative oncology group (ecog) performance status of ≤3
boolean
C1520224 (UMLS CUI [1])
Measurable Disease
Item
5. measurable disease burden (blasts in bm and/or pb, extramedullary blasts [chloroma])
boolean
C1513041 (UMLS CUI [1,1])
able to swallow
Item
6. able to swallow and retain oral medication
boolean
C2712086 (UMLS CUI [1])
Life Expectancy
Item
7. a life expectancy of at least 4 weeks
boolean
C0023671 (UMLS CUI [1,1])
adequate contraception
Item
8. adequate contraception methods
boolean
C0700589 (UMLS CUI [1])
Adequate organ function
Item
9. adequate organ function as defined in the study protocol
boolean
C0678852 (UMLS CUI [1,1])
C0205411 (UMLS CUI [1,2])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Treatment options Stem cell transplant or intensive Chemotherapy
Item
1. patients with a valid option for intensive chemotherapy and/or stem cell transplantation (patients after allogeneic stem cell transplant must be off immunosuppressive agents for at least 2 weeks prior to study entry and graft-versus host disease must have resolved to grade ≤2)
boolean
C0683525 (UMLS CUI [1,1])
C1504389 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
history of cancer
Item
2. history of cancer that according to the investigator might confound the assessment of the endpoints of the study
boolean
C2735088 (UMLS CUI [1])
Uncontrolled peptic ulcer
Item
3. uncontrolled peptic ulcer disease or clinically significant gastrointestinal abnormalities which interfere with oral dosing or any unstable or serious concurrent condition (e.g., active uncontrolled infection)
boolean
C0030920 (UMLS CUI [1,1])
Uncontrolled hypertension
Item
4. poorly controlled hypertension [defined as systolic blood pressure (sbp) of ≥140 mmhg or diastolic blood pressure (dbp) of ≥90 mmhg]. note: initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. bp must be re-assessed on two occasions that are separated by a minimum of 1 hour; on each of these occasions, the mean (of 3 readings) sbp / dbp values from each bp assessment must be <140/90 mmhg in order for a subject to be eligible for the study
boolean
C1868885 (UMLS CUI [1,1])
QTc interval
Item
5. prolongation of corrected qt interval (qtc) >480 milliseconds
boolean
C0489625 (UMLS CUI [1])
Coronary heart disease | Peripheral Vascular Diseases | Congestive heart failure
Item
6. history of any one of more of the following cardiovascular conditions within the past 6 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, symptomatic peripheral vascular disease, class iii or iv congestive heart failure, as defined by the new york heart association (nyha)
boolean
C0010068 (UMLS CUI [1,1])
C0085096 (UMLS CUI [2,1])
C0018802 (UMLS CUI [3,1])
Cerebral Infarction | Cerebral Hemorrhage | Pulmonary Embolism | Deep Vein Thrombosis
Item
7. history of cerebrovascular infarction or bleeding, pulmonary embolism, or untreated deep venous thrombosis (dvt) within the past 6 months. note: subjects with recent dvt who have been treated with therapeutic anti-coagulant agents for at least 6 weeks are eligible
boolean
C0007785 (UMLS CUI [1,1])
C2937358 (UMLS CUI [2,1])
C0034065 (UMLS CUI [3,1])
C0149871 (UMLS CUI [4,1])
Bleeding tendency
Item
8. evidence of serious active bleeding or bleeding diathesis (except for bleeding or petechiae due to aml-related thrombocytopenia which will be treated using platelet transfusions). also, patients with known endobronchial lesions and/or lesions infiltrating major pulmonary vessels will be excluded from the study due to excess risk of bleeding.
boolean
C1458140 (UMLS CUI [1,1])
major surgery | Traumatic injury
Item
9. prior major surgery or trauma within 28 days prior to first dose of study drug
boolean
C0679637 (UMLS CUI [1,1])
C3263723 (UMLS CUI [2,1])
Investigational New Drugs
Item
10. treatment with an investigational agent within 28 days or 5 half-lives, whichever is longer prior to the first dose of study drug (for bevacizumab 60 days).
boolean
C0013230 (UMLS CUI [1,1])
Chemotherapy Regimen; Concurrent
Item
11. concurrent cytoreductive chemotherapy (hydroxyurea must be discontinued at least one day before start of study medication)
boolean
C0392920 (UMLS CUI [1,1])
C0205420 (UMLS CUI [1,2])
Hypersensitivity; pazopanib
Item
12. known immediate or delayed hypersensitivity reaction or idiosyncrasy to pazopanib
boolean
C0020517 (UMLS CUI [1,1])
C1831796 (UMLS CUI [1,2])
Patient Non-Compliance
Item
13. patients with psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol
boolean
C0376405 (UMLS CUI [1,1])
Patient currently pregnant | Breast Feeding
Item
14. pregnant or lactating and actively breastfeeding patients
boolean
C0549206 (UMLS CUI [1,1])
C0006147 (UMLS CUI [2,1])
Prohibited medication: clarithromycin; telithromycin; troleandomycin
Item
15. patients taking any of the following prohibited medication: clarithromycin, telithromycin, troleandomycin (antibiotics)
boolean
C0683610 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0055856 (UMLS CUI [1,3])
C0907410 (UMLS CUI [1,4])
C0041165 (UMLS CUI [1,5])
Prohibited Medication: amprenavir; nelfinavir; saquinavir; ritonavir
Item
ritonavir, indinavir, saquinavir, nelfinavir, amprenavir, lopinavir (hiv protease inhibitors)
boolean
C0683610 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0754188 (UMLS CUI [1,3])
C0525005 (UMLS CUI [2])
C0286738 (UMLS CUI [3])
C0292818 (UMLS CUI [4])
Prohibited medication: ketoconazole; itraconazole; fluconazole
Item
itraconazole, ketoconazole, voriconazole, fluconazole (antifungals)
boolean
C0683610 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0022625 (UMLS CUI [1,3])
C0064113 (UMLS CUI [2])
C0016277 (UMLS CUI [3])
Prohibited medication: nefazodone
Item
nefazodone (antidepressant)
boolean
C0683610 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0068485 (UMLS CUI [1,3])
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