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])
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])