ID

41104

Description

Lenalidomide Maintenance With High Risk (HR) Acute Myeloid Leukemia (AML) in Remission; ODM derived from: https://clinicaltrials.gov/show/NCT02126553

Link

https://clinicaltrials.gov/show/NCT02126553

Keywords

Versions (1)
  1. 6/25/20 6/25/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 25, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Leukemia NCT02126553

English

Eligibility Leukemia NCT02126553

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT02126553
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients aged 18 to 55 years with high risk (as defined in #2) aml who have achieved their first cr or cri within 12 months of enrollment and are not immediately candidates for allogeneic stem cell transplant. patients above age 55 who are not eligible for other protocols may be considered for enrollment on a case by case basis after discussion with the pi.
Description

Age | High risk AML | Complete remission First | Complete Remission with Incomplete Hematological Recovery | Patients Inappropriate Allogeneic hematopoietic stem cell transplant

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C4319571
UMLS CUI [2,2]
C0023467
UMLS CUI [3,1]
C0677874
UMLS CUI [3,2]
C0205435
UMLS CUI [4]
C4725854
UMLS CUI [5,1]
C0030705
UMLS CUI [5,2]
C1548788
UMLS CUI [5,3]
C4255274
2. 2. patients in their first cr or cri may be eligible for enrollment only if they have a high risk feature, including, but not limited to: adverse karyotype, flt3 mutation, history of antecedent hematologic disorder (ahd), presence of dysplasia in the bone marrow, therapy-related aml, history of requiring more than 1 cycle of intensive induction chemotherapy to achieve first remission, or presence of persistent minimal residual disease (detected by cytogenetics, molecular markers, or flow cytometry) at any point after initial induction cycle. patients aged > or = 18 years with aml who have achieved a second cr or cri within 12 months of enrollment and are not immediately candidates for allogeneic stem cell transplant are also eligible.
Description

Complete remission First | Complete Remission with Incomplete Hematological Recovery | High risk Feature | Karyotype adverse | FLT3 Gene Mutation | Disease antecedent Hematologic | Bone marrow dysplasia | AML Therapy Related | Requirement Induction Chemotherapy With intensity | Detection of Minimal Residual Disease Persistent

Data type

boolean

Alias
UMLS CUI [1,1]
C0677874
UMLS CUI [1,2]
C0205435
UMLS CUI [2]
C4725854
UMLS CUI [3,1]
C4319571
UMLS CUI [3,2]
C2348519
UMLS CUI [4,1]
C1261273
UMLS CUI [4,2]
C0001688
UMLS CUI [5]
C4289309
UMLS CUI [6,1]
C0683336
UMLS CUI [6,2]
C0205488
UMLS CUI [7]
C0948437
UMLS CUI [8,1]
C0023467
UMLS CUI [8,2]
C0087111
UMLS CUI [8,3]
C0439849
UMLS CUI [9,1]
C1514873
UMLS CUI [9,2]
C3179010
UMLS CUI [9,3]
C0522510
UMLS CUI [10,1]
C1511791
UMLS CUI [10,2]
C0205322
3. patients should have received induction chemotherapy for aml and at least 1 consolidation.
Description

Induction Chemotherapy AML | Consolidation Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C3179010
UMLS CUI [1,2]
C0023467
UMLS CUI [2,1]
C1511484
UMLS CUI [2,2]
C1265611
4. patients with history of extramedullary aml, except for cns involvement that is currently controlled, will not be eligible for enrollment.
Description

AML Extramedullary | Exception Central Nervous System Involvement

Data type

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C1517060
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C4050309
5. ecog performance status of < or = 3
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
6. adequate organ function as follows: a. serum total bilirubin < or = to 1.5 x the upper limit of normal (uln) b. serum creatinine < or = to 2.5 x uln
Description

Organ function | Serum total bilirubin measurement | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201976
7. adequate bm reserve: a. absolute neutrophil count (anc) > 0.5 x 109/l b. platelet count > or = 30 x 109/l
Description

Bone Marrow Mature Neutrophils Present | Absolute neutrophil count | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C1708947
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
8. for females of childbearing age, they may participate it they: a. have a negative serum or urine pregnancy test within 10 to 14 days of enrolling (a second pregnancy test will be performed within 24hrs of starting therapy and both negative pregnancy tests will be required for starting therapy.) b. agree to either abstinence or 2 effective contraceptive methods throughout the treatment period and up to 28 days after discontinuing treatment.
Description

Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430057
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0036899
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C1265611
9. for male patients with a female partner of childbearing age, they may participate if they agree to either abstinence or 2 effective contraceptive methods throughout the treatment period and up to 28 days after discontinuing treatment.
Description

Gender Partner Childbearing Potential | Gender Sexual Abstinence | Gender Contraceptive methods Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0682323
UMLS CUI [1,3]
C3831118
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0036899
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C1265611
10. all study participants be willing and able to comply with the requirements of the rems® program.
Description

Compliance REMS Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C4282383
11. females of reproductive potential must adhere to the scheduled pregnancy testing as required in the revlimid rems® program.
Description

Childbearing Potential Pregnancy Tests

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0032976
12. ability to understand and sign informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. diagnosis of acute promyelocytic leukemia (apl), aml - m3 by fab classification based on morphology, immunophenotype, molecular, or cytogenetic s studies.
Description

Acute Promyelocytic Leukemia FAB Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0023487
UMLS CUI [1,2]
C2984084
2. diagnosis of aml associated with the following karyotypes: inv(16), t(16;16), t(8;21), t(15;17), or t(9;22)
Description

AML Associated with Karyotype inv(16) | AML Associated with Karyotype t(16;16) | AML Associated with Karyotype t(8;21) | AML Associated with Karyotype t(15;17) | AML Associated with Karyotype t(9;22)

Data type

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C1261273
UMLS CUI [1,4]
C3897144
UMLS CUI [2,1]
C0023467
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C1261273
UMLS CUI [2,4]
C4287945
UMLS CUI [3,1]
C0023467
UMLS CUI [3,2]
C0332281
UMLS CUI [3,3]
C1261273
UMLS CUI [3,4]
C3897139
UMLS CUI [4,1]
C0023467
UMLS CUI [4,2]
C0332281
UMLS CUI [4,3]
C1261273
UMLS CUI [4,4]
C4287946
UMLS CUI [5,1]
C0023467
UMLS CUI [5,2]
C0332281
UMLS CUI [5,3]
C1261273
UMLS CUI [5,4]
C3897138
3. uncontrolled intercurrent illness including, but not limited to ongoing or active uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Description

Comorbidity Uncontrolled | Communicable Disease Uncontrolled | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0742758
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0003811
UMLS CUI [6,1]
C0004936
UMLS CUI [6,2]
C0439801
UMLS CUI [6,3]
C0525058
UMLS CUI [7,1]
C0748872
UMLS CUI [7,2]
C0439801
UMLS CUI [7,3]
C0525058
4. previous treatment with lenalidomide for aml.
Description

Prior Therapy AML | lenalidomide

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0023467
UMLS CUI [2]
C1144149
5. patients with documented hypersensitivity to any components of the study program.
Description

Hypersensitivity Component Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1705248
UMLS CUI [1,3]
C2348563
6. females who are pregnant.
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
7. patients with active cns disease.
Description

CNS disorder

Data type

boolean

Alias
UMLS CUI [1]
C0007682
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Similar models

Eligibility Leukemia NCT02126553

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT02126553
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | High risk AML | Complete remission First | Complete Remission with Incomplete Hematological Recovery | Patients Inappropriate Allogeneic hematopoietic stem cell transplant
Item
1. patients aged 18 to 55 years with high risk (as defined in #2) aml who have achieved their first cr or cri within 12 months of enrollment and are not immediately candidates for allogeneic stem cell transplant. patients above age 55 who are not eligible for other protocols may be considered for enrollment on a case by case basis after discussion with the pi.
boolean
C0001779 (UMLS CUI [1])
C4319571 (UMLS CUI [2,1])
C0023467 (UMLS CUI [2,2])
C0677874 (UMLS CUI [3,1])
C0205435 (UMLS CUI [3,2])
C4725854 (UMLS CUI [4])
C0030705 (UMLS CUI [5,1])
C1548788 (UMLS CUI [5,2])
C4255274 (UMLS CUI [5,3])
Complete remission First | Complete Remission with Incomplete Hematological Recovery | High risk Feature | Karyotype adverse | FLT3 Gene Mutation | Disease antecedent Hematologic | Bone marrow dysplasia | AML Therapy Related | Requirement Induction Chemotherapy With intensity | Detection of Minimal Residual Disease Persistent
Item
2. 2. patients in their first cr or cri may be eligible for enrollment only if they have a high risk feature, including, but not limited to: adverse karyotype, flt3 mutation, history of antecedent hematologic disorder (ahd), presence of dysplasia in the bone marrow, therapy-related aml, history of requiring more than 1 cycle of intensive induction chemotherapy to achieve first remission, or presence of persistent minimal residual disease (detected by cytogenetics, molecular markers, or flow cytometry) at any point after initial induction cycle. patients aged > or = 18 years with aml who have achieved a second cr or cri within 12 months of enrollment and are not immediately candidates for allogeneic stem cell transplant are also eligible.
boolean
C0677874 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C4725854 (UMLS CUI [2])
C4319571 (UMLS CUI [3,1])
C2348519 (UMLS CUI [3,2])
C1261273 (UMLS CUI [4,1])
C0001688 (UMLS CUI [4,2])
C4289309 (UMLS CUI [5])
C0683336 (UMLS CUI [6,1])
C0205488 (UMLS CUI [6,2])
C0948437 (UMLS CUI [7])
C0023467 (UMLS CUI [8,1])
C0087111 (UMLS CUI [8,2])
C0439849 (UMLS CUI [8,3])
C1514873 (UMLS CUI [9,1])
C3179010 (UMLS CUI [9,2])
C0522510 (UMLS CUI [9,3])
C1511791 (UMLS CUI [10,1])
C0205322 (UMLS CUI [10,2])
Induction Chemotherapy AML | Consolidation Quantity
Item
3. patients should have received induction chemotherapy for aml and at least 1 consolidation.
boolean
C3179010 (UMLS CUI [1,1])
C0023467 (UMLS CUI [1,2])
C1511484 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
AML Extramedullary | Exception Central Nervous System Involvement
Item
4. patients with history of extramedullary aml, except for cns involvement that is currently controlled, will not be eligible for enrollment.
boolean
C0023467 (UMLS CUI [1,1])
C1517060 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C4050309 (UMLS CUI [2,2])
ECOG performance status
Item
5. ecog performance status of < or = 3
boolean
C1520224 (UMLS CUI [1])
Organ function | Serum total bilirubin measurement | Creatinine measurement, serum
Item
6. adequate organ function as follows: a. serum total bilirubin < or = to 1.5 x the upper limit of normal (uln) b. serum creatinine < or = to 2.5 x uln
boolean
C0678852 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
Bone Marrow Mature Neutrophils Present | Absolute neutrophil count | Platelet Count measurement
Item
7. adequate bm reserve: a. absolute neutrophil count (anc) > 0.5 x 109/l b. platelet count > or = 30 x 109/l
boolean
C0005953 (UMLS CUI [1,1])
C1708947 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods Quantity
Item
8. for females of childbearing age, they may participate it they: a. have a negative serum or urine pregnancy test within 10 to 14 days of enrolling (a second pregnancy test will be performed within 24hrs of starting therapy and both negative pregnancy tests will be required for starting therapy.) b. agree to either abstinence or 2 effective contraceptive methods throughout the treatment period and up to 28 days after discontinuing treatment.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0036899 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
Gender Partner Childbearing Potential | Gender Sexual Abstinence | Gender Contraceptive methods Quantity
Item
9. for male patients with a female partner of childbearing age, they may participate if they agree to either abstinence or 2 effective contraceptive methods throughout the treatment period and up to 28 days after discontinuing treatment.
boolean
C0079399 (UMLS CUI [1,1])
C0682323 (UMLS CUI [1,2])
C3831118 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0036899 (UMLS CUI [2,2])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Compliance REMS Protocol
Item
10. all study participants be willing and able to comply with the requirements of the rems® program.
boolean
C1321605 (UMLS CUI [1,1])
C4282383 (UMLS CUI [1,2])
Childbearing Potential Pregnancy Tests
Item
11. females of reproductive potential must adhere to the scheduled pregnancy testing as required in the revlimid rems® program.
boolean
C3831118 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
Informed Consent
Item
12. ability to understand and sign informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Acute Promyelocytic Leukemia FAB Classification
Item
1. diagnosis of acute promyelocytic leukemia (apl), aml - m3 by fab classification based on morphology, immunophenotype, molecular, or cytogenetic s studies.
boolean
C0023487 (UMLS CUI [1,1])
C2984084 (UMLS CUI [1,2])
AML Associated with Karyotype inv(16) | AML Associated with Karyotype t(16;16) | AML Associated with Karyotype t(8;21) | AML Associated with Karyotype t(15;17) | AML Associated with Karyotype t(9;22)
Item
2. diagnosis of aml associated with the following karyotypes: inv(16), t(16;16), t(8;21), t(15;17), or t(9;22)
boolean
C0023467 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C1261273 (UMLS CUI [1,3])
C3897144 (UMLS CUI [1,4])
C0023467 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C1261273 (UMLS CUI [2,3])
C4287945 (UMLS CUI [2,4])
C0023467 (UMLS CUI [3,1])
C0332281 (UMLS CUI [3,2])
C1261273 (UMLS CUI [3,3])
C3897139 (UMLS CUI [3,4])
C0023467 (UMLS CUI [4,1])
C0332281 (UMLS CUI [4,2])
C1261273 (UMLS CUI [4,3])
C4287946 (UMLS CUI [4,4])
C0023467 (UMLS CUI [5,1])
C0332281 (UMLS CUI [5,2])
C1261273 (UMLS CUI [5,3])
C3897138 (UMLS CUI [5,4])
Comorbidity Uncontrolled | Communicable Disease Uncontrolled | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
3. uncontrolled intercurrent illness including, but not limited to ongoing or active uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6,1])
C0439801 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C0439801 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
Prior Therapy AML | lenalidomide
Item
4. previous treatment with lenalidomide for aml.
boolean
C1514463 (UMLS CUI [1,1])
C0023467 (UMLS CUI [1,2])
C1144149 (UMLS CUI [2])
Hypersensitivity Component Study Protocol
Item
5. patients with documented hypersensitivity to any components of the study program.
boolean
C0020517 (UMLS CUI [1,1])
C1705248 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Pregnancy
Item
6. females who are pregnant.
boolean
C0032961 (UMLS CUI [1])
CNS disorder
Item
7. patients with active cns disease.
boolean
C0007682 (UMLS CUI [1])
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