ID

41091

Description

Pilot Phase II - Erlotinib for Acute Myeloid Leukemia (AML); ODM derived from: https://clinicaltrials.gov/show/NCT01664897

Link

https://clinicaltrials.gov/show/NCT01664897

Keywords

Versions (1)
  1. 6/23/20 6/23/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 23, 2020

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License

Creative Commons BY 4.0
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Eligibility Leukemia NCT01664897

English

Eligibility Leukemia NCT01664897

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01664897
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with aml who have either been refractory to prior therapy or have relapsed after prior therapy. patients with mds or cmml who received therapy with a hypomethylating agent and progress to aml are eligible if they have received any therapy for mds and failed (i.e., lack or loss of response) regardless of whether they have received therapy for aml or not. the who classification will be used for aml.
Description

AML WHO classification | Unresponsive to Prior Therapy | Recurrent disease Post Prior Therapy | MYELODYSPLASTIC SYNDROME | Leukemia, Myelomonocytic, Chronic | Hypomethylation Therapy | Disease Progression AML | Unresponsive to Treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C4267671
UMLS CUI [2,1]
C0205269
UMLS CUI [2,2]
C1514463
UMLS CUI [3,1]
C0277556
UMLS CUI [3,2]
C0687676
UMLS CUI [3,3]
C1514463
UMLS CUI [4]
C3463824
UMLS CUI [5]
C0023480
UMLS CUI [6]
C4054751
UMLS CUI [7,1]
C0242656
UMLS CUI [7,2]
C0023467
UMLS CUI [8]
C0205269
2. age >/=18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. ecog performance status </=2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
4. adequate liver (total bilirubin </=2x uln, alt </=2.5x uln) and renal (creatinine </=2x uln) function.
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0232804
UMLS CUI [5]
C0201976
5. patients must provide written informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
6. patients must have been off chemotherapy for 2 weeks prior to entering this study, unless there is evidence of rapidly progressive disease, and must have recovered from the clinically significant toxic effects of that therapy to at least grade 1. use of hydroxyurea for patients with rapidly proliferative disease is allowed before the start of study therapy and for the first four weeks on therapy.
Description

Chemotherapy Absent | Exception Rapid disease progression | Toxicity Due to Therapeutic procedure | Patient recovered CTCAE Grades | Hydroxyurea allowed Rapid disease progression

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1834700
UMLS CUI [3,1]
C0600688
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0087111
UMLS CUI [4,1]
C1115804
UMLS CUI [4,2]
C1516728
UMLS CUI [5,1]
C0020402
UMLS CUI [5,2]
C0683607
UMLS CUI [5,3]
C1834700
7. patients - both males and females - with reproductive potential (ie, menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures throughout the study. women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to initiation of study.
Description

Females & males of reproductive potential Contraceptive methods | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430061
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0430057
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with known allergy or hypersensitivity to erlotinib.
Description

Hypersensitivity Erlotinib

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1135135
2. patients with any other known disease (except carcinoma in-situ) concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes; cardiovascular disease including congestive heart failure nyha class iii or iv, myocardial infarction within 6 months, and poorly controlled hypertension; chronic renal failure; or active uncontrolled infection) which, in the opinion of the investigator could compromise participation in the study.
Description

Comorbidity Severe At risk Study Subject Participation Status | Exception Carcinoma in Situ | Medical condition Uncontrolled | Diabetic - poor control | Cardiovascular Disease | Congestive heart failure New York Heart Association Classification | Myocardial Infarction | Poor hypertension control | Kidney Failure, Chronic | Communicable Disease Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1444641
UMLS CUI [1,4]
C2348568
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007099
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0205318
UMLS CUI [4]
C0421258
UMLS CUI [5]
C0007222
UMLS CUI [6,1]
C0018802
UMLS CUI [6,2]
C1275491
UMLS CUI [7]
C0027051
UMLS CUI [8]
C0421190
UMLS CUI [9]
C0022661
UMLS CUI [10,1]
C0009450
UMLS CUI [10,2]
C0205318
3. patients unwilling or unable to comply with the protocol.
Description

Protocol Compliance Unwilling | Protocol Compliance Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1299582
4. significant gastrointestinal disorders that may interfere with absorption of erlotinib.
Description

Gastrointestinal Diseases Interfere with Absorption Erlotinib

Data type

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0237442
UMLS CUI [1,4]
C1135135
5. patients who can receive a stem cell transplant within 4 weeks.
Description

Ability Stem cell transplant Receive

Data type

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C1504389
UMLS CUI [1,3]
C1514756
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Similar models

Eligibility Leukemia NCT01664897

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01664897
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
AML WHO classification | Unresponsive to Prior Therapy | Recurrent disease Post Prior Therapy | MYELODYSPLASTIC SYNDROME | Leukemia, Myelomonocytic, Chronic | Hypomethylation Therapy | Disease Progression AML | Unresponsive to Treatment
Item
1. patients with aml who have either been refractory to prior therapy or have relapsed after prior therapy. patients with mds or cmml who received therapy with a hypomethylating agent and progress to aml are eligible if they have received any therapy for mds and failed (i.e., lack or loss of response) regardless of whether they have received therapy for aml or not. the who classification will be used for aml.
boolean
C0023467 (UMLS CUI [1,1])
C4267671 (UMLS CUI [1,2])
C0205269 (UMLS CUI [2,1])
C1514463 (UMLS CUI [2,2])
C0277556 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C1514463 (UMLS CUI [3,3])
C3463824 (UMLS CUI [4])
C0023480 (UMLS CUI [5])
C4054751 (UMLS CUI [6])
C0242656 (UMLS CUI [7,1])
C0023467 (UMLS CUI [7,2])
C0205269 (UMLS CUI [8])
Age
Item
2. age >/=18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
3. ecog performance status </=2
boolean
C1520224 (UMLS CUI [1])
Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum
Item
4. adequate liver (total bilirubin </=2x uln, alt </=2.5x uln) and renal (creatinine </=2x uln) function.
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0232804 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
Informed Consent
Item
5. patients must provide written informed consent.
boolean
C0021430 (UMLS CUI [1])
Chemotherapy Absent | Exception Rapid disease progression | Toxicity Due to Therapeutic procedure | Patient recovered CTCAE Grades | Hydroxyurea allowed Rapid disease progression
Item
6. patients must have been off chemotherapy for 2 weeks prior to entering this study, unless there is evidence of rapidly progressive disease, and must have recovered from the clinically significant toxic effects of that therapy to at least grade 1. use of hydroxyurea for patients with rapidly proliferative disease is allowed before the start of study therapy and for the first four weeks on therapy.
boolean
C0392920 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1834700 (UMLS CUI [2,2])
C0600688 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C1115804 (UMLS CUI [4,1])
C1516728 (UMLS CUI [4,2])
C0020402 (UMLS CUI [5,1])
C0683607 (UMLS CUI [5,2])
C1834700 (UMLS CUI [5,3])
Females & males of reproductive potential Contraceptive methods | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative
Item
7. patients - both males and females - with reproductive potential (ie, menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures throughout the study. women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to initiation of study.
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430061 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0430057 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Erlotinib
Item
1. patients with known allergy or hypersensitivity to erlotinib.
boolean
C0020517 (UMLS CUI [1,1])
C1135135 (UMLS CUI [1,2])
Comorbidity Severe At risk Study Subject Participation Status | Exception Carcinoma in Situ | Medical condition Uncontrolled | Diabetic - poor control | Cardiovascular Disease | Congestive heart failure New York Heart Association Classification | Myocardial Infarction | Poor hypertension control | Kidney Failure, Chronic | Communicable Disease Uncontrolled
Item
2. patients with any other known disease (except carcinoma in-situ) concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes; cardiovascular disease including congestive heart failure nyha class iii or iv, myocardial infarction within 6 months, and poorly controlled hypertension; chronic renal failure; or active uncontrolled infection) which, in the opinion of the investigator could compromise participation in the study.
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C0007099 (UMLS CUI [2,2])
C3843040 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0421258 (UMLS CUI [4])
C0007222 (UMLS CUI [5])
C0018802 (UMLS CUI [6,1])
C1275491 (UMLS CUI [6,2])
C0027051 (UMLS CUI [7])
C0421190 (UMLS CUI [8])
C0022661 (UMLS CUI [9])
C0009450 (UMLS CUI [10,1])
C0205318 (UMLS CUI [10,2])
Protocol Compliance Unwilling | Protocol Compliance Unable
Item
3. patients unwilling or unable to comply with the protocol.
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Gastrointestinal Diseases Interfere with Absorption Erlotinib
Item
4. significant gastrointestinal disorders that may interfere with absorption of erlotinib.
boolean
C0017178 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
C1135135 (UMLS CUI [1,4])
Ability Stem cell transplant Receive
Item
5. patients who can receive a stem cell transplant within 4 weeks.
boolean
C0085732 (UMLS CUI [1,1])
C1504389 (UMLS CUI [1,2])
C1514756 (UMLS CUI [1,3])
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