ID

17845

Description

RAD001 in Relapsed or Refractory AML, ALL, CML in Blastic-Phase, Agnogenic Myeloid Metaplasia, CLL, T-Cell Leukemia, or Mantle Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00081874

Link

https://clinicaltrials.gov/show/NCT00081874

Keywords

Versions (1)
  1. 10/5/16 10/5/16 -
Uploaded on

October 5, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Leukemia NCT00081874

English

Eligibility Leukemia NCT00081874

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00081874
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with advanced, relapsed or refractory: acute leukemias (aml, all), mds, cmml in transformation with greater than or equal to 10% peripheral blood/bone marrow blasts, cml in blastic phase, agnogenic myeloid metaplasia (amm), cll, t-cell leukemia, or mantle cell lymphoma.
Description

AML Advanced | AML Relapsed | AML refractory | Acute lymphocytic leukemia Advanced | Acute lymphocytic leukemia Relapsed | Acute lymphocytic leukaemia refractory | MYELODYSPLASTIC SYNDROME Advanced | MYELODYSPLASTIC SYNDROME Relapsed | MYELODYSPLASTIC SYNDROME refractory | CMML Advanced | CMML Relapsed | CMML refractory | peripheral blood Blast count procedure | Bone Marrow Blast count procedure | Blast Phase | Primary Myelofibrosis | Chronic Lymphocytic Leukemia | Leukemia, T-Cell | Mantle cell lymphoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0205179
UMLS CUI [2,1]
C0023467
UMLS CUI [2,2]
C0205336
UMLS CUI [3,1]
C0023467
UMLS CUI [3,2]
C0205269
UMLS CUI [4,1]
C0023449
UMLS CUI [4,2]
C0205179
UMLS CUI [5,1]
C0023449
UMLS CUI [5,2]
C0205336
UMLS CUI [6]
C4049242
UMLS CUI [7,1]
C3463824
UMLS CUI [7,2]
C0205179
UMLS CUI [8,1]
C3463824
UMLS CUI [8,2]
C0205336
UMLS CUI [9,1]
C3463824
UMLS CUI [9,2]
C0205269
UMLS CUI [10,1]
C0023480
UMLS CUI [10,2]
C0205179
UMLS CUI [11,1]
C0023480
UMLS CUI [11,2]
C0205336
UMLS CUI [12,1]
C0023480
UMLS CUI [12,2]
C0205269
UMLS CUI [13,1]
C0229664
UMLS CUI [13,2]
C0523113
UMLS CUI [14,1]
C0005953
UMLS CUI [14,2]
C0523113
UMLS CUI [15]
C0005699
UMLS CUI [16]
C0001815
UMLS CUI [17]
C0023434
UMLS CUI [18]
C0023492
UMLS CUI [19]
C0334634
2. serum bilirubin <= 2 mg/dl, sgot or sgpt < 3 upper limit of normal, serum creatinine <= 2 mg/dl, unless considered due to organ leukemic involvement or gilbert's syndrome
Description

Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Creatinine measurement, serum | Organ leukemia Involvement with | Gilbert Disease

Data type

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201976
UMLS CUI [5,1]
C0178784
UMLS CUI [5,2]
C0023418
UMLS CUI [5,3]
C1314939
UMLS CUI [6]
C0017551
3. the effects of rad001 on the developing human fetus are unknown. for this reason and because inhibitors of mrna translation are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Description

RAD 001 Effect Fetus Unknown | mRNA Translation inhibitors | Teratogenesis | Childbearing Potential Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence | Gender Contraceptive methods | Patient currently pregnant Informing Treating Physician

Data type

boolean

Alias
UMLS CUI [1,1]
C0962969
UMLS CUI [1,2]
C1280500
UMLS CUI [1,3]
C0015965
UMLS CUI [1,4]
C0439673
UMLS CUI [2,1]
C0597295
UMLS CUI [2,2]
C0243077
UMLS CUI [3]
C0232910
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [5]
C2985296
UMLS CUI [6]
C0004764
UMLS CUI [7]
C0036899
UMLS CUI [8,1]
C0079399
UMLS CUI [8,2]
C0700589
UMLS CUI [9,1]
C0549206
UMLS CUI [9,2]
C0700287
UMLS CUI [9,3]
C1710470
4. ability to understand and the willingness to sign a written informed consent document.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients who have had cytotoxic chemotherapy (other than hydroxyurea or corticosteroids) or radiotherapy within 7 days prior to entering the study.
Description

Cytotoxic Chemotherapy | hydroxyurea | Adrenal Cortex Hormones | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C0677881
UMLS CUI [2]
C0020402
UMLS CUI [3]
C0001617
UMLS CUI [4]
C1522449
2. patients may not be receiving any other cytotoxic investigational agents.
Description

Cytotoxic agent Investigational

Data type

boolean

Alias
UMLS CUI [1,1]
C0304497
UMLS CUI [1,2]
C1517586
3. history of allergic reactions attributed to compounds of similar chemical or biologic composition to rad001. rad001 must not be administered to patients with known hypersensitivity to everolimus, sirolimus or to any of its excipients. excipients include butylated hydroxytoluene, magnesium stearate, hydroxypropylmethyl-cellulose, crospovidone, and lactose.
Description

Allergic Reaction Compound RAD 001 Similar | RAD 001 | Hypersensitivity everolimus | Hypersensitivity Sirolimus | Hypersensitivity Pharmaceutical Excipient | Hypersensitivity Butylated Hydroxytoluene | Hypersensitivity Magnesium stearate | Hypromellose allergy | Hypersensitivity Crospovidone | Hypersensitivity Lactose

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1706082
UMLS CUI [1,3]
C0962969
UMLS CUI [1,4]
C2348205
UMLS CUI [2]
C0962969
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0541315
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0072980
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0015237
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0006507
UMLS CUI [7,1]
C0020517
UMLS CUI [7,2]
C0126791
UMLS CUI [8]
C0571249
UMLS CUI [9,1]
C0020517
UMLS CUI [9,2]
C0728803
UMLS CUI [10,1]
C0020517
UMLS CUI [10,2]
C0022949
4. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Description

Illness Uncontrolled | Communicable Diseases | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorder Protocol Compliance Limited | social situation Protocol Compliance Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0742758
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0003811
UMLS CUI [6,1]
C0004936
UMLS CUI [6,2]
C0525058
UMLS CUI [6,3]
C0439801
UMLS CUI [7,1]
C0748872
UMLS CUI [7,2]
C0525058
UMLS CUI [7,3]
C0439801
5. pregnant women are excluded from this study because rad001 has a potential for teratogenic or abortifacient effects. because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with rad001, breastfeeding should be discontinued if the mother is treated with rad001.
Description

Pregnancy | RAD 001 | Teratogenesis | Abortifacient Effect | Adverse event Risk | Breast Feeding Discontinued

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0962969
UMLS CUI [3]
C0232910
UMLS CUI [4]
C3179338
UMLS CUI [5,1]
C0877248
UMLS CUI [5,2]
C0035647
UMLS CUI [6,1]
C0006147
UMLS CUI [6,2]
C1444662
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Similar models

Eligibility Leukemia NCT00081874

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00081874
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
AML Advanced | AML Relapsed | AML refractory | Acute lymphocytic leukemia Advanced | Acute lymphocytic leukemia Relapsed | Acute lymphocytic leukaemia refractory | MYELODYSPLASTIC SYNDROME Advanced | MYELODYSPLASTIC SYNDROME Relapsed | MYELODYSPLASTIC SYNDROME refractory | CMML Advanced | CMML Relapsed | CMML refractory | peripheral blood Blast count procedure | Bone Marrow Blast count procedure | Blast Phase | Primary Myelofibrosis | Chronic Lymphocytic Leukemia | Leukemia, T-Cell | Mantle cell lymphoma
Item
1. patients with advanced, relapsed or refractory: acute leukemias (aml, all), mds, cmml in transformation with greater than or equal to 10% peripheral blood/bone marrow blasts, cml in blastic phase, agnogenic myeloid metaplasia (amm), cll, t-cell leukemia, or mantle cell lymphoma.
boolean
C0023467 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0023467 (UMLS CUI [2,1])
C0205336 (UMLS CUI [2,2])
C0023467 (UMLS CUI [3,1])
C0205269 (UMLS CUI [3,2])
C0023449 (UMLS CUI [4,1])
C0205179 (UMLS CUI [4,2])
C0023449 (UMLS CUI [5,1])
C0205336 (UMLS CUI [5,2])
C4049242 (UMLS CUI [6])
C3463824 (UMLS CUI [7,1])
C0205179 (UMLS CUI [7,2])
C3463824 (UMLS CUI [8,1])
C0205336 (UMLS CUI [8,2])
C3463824 (UMLS CUI [9,1])
C0205269 (UMLS CUI [9,2])
C0023480 (UMLS CUI [10,1])
C0205179 (UMLS CUI [10,2])
C0023480 (UMLS CUI [11,1])
C0205336 (UMLS CUI [11,2])
C0023480 (UMLS CUI [12,1])
C0205269 (UMLS CUI [12,2])
C0229664 (UMLS CUI [13,1])
C0523113 (UMLS CUI [13,2])
C0005953 (UMLS CUI [14,1])
C0523113 (UMLS CUI [14,2])
C0005699 (UMLS CUI [15])
C0001815 (UMLS CUI [16])
C0023434 (UMLS CUI [17])
C0023492 (UMLS CUI [18])
C0334634 (UMLS CUI [19])
Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Creatinine measurement, serum | Organ leukemia Involvement with | Gilbert Disease
Item
2. serum bilirubin <= 2 mg/dl, sgot or sgpt < 3 upper limit of normal, serum creatinine <= 2 mg/dl, unless considered due to organ leukemic involvement or gilbert's syndrome
boolean
C1278039 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201976 (UMLS CUI [4])
C0178784 (UMLS CUI [5,1])
C0023418 (UMLS CUI [5,2])
C1314939 (UMLS CUI [5,3])
C0017551 (UMLS CUI [6])
RAD 001 Effect Fetus Unknown | mRNA Translation inhibitors | Teratogenesis | Childbearing Potential Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence | Gender Contraceptive methods | Patient currently pregnant Informing Treating Physician
Item
3. the effects of rad001 on the developing human fetus are unknown. for this reason and because inhibitors of mrna translation are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
boolean
C0962969 (UMLS CUI [1,1])
C1280500 (UMLS CUI [1,2])
C0015965 (UMLS CUI [1,3])
C0439673 (UMLS CUI [1,4])
C0597295 (UMLS CUI [2,1])
C0243077 (UMLS CUI [2,2])
C0232910 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C2985296 (UMLS CUI [5])
C0004764 (UMLS CUI [6])
C0036899 (UMLS CUI [7])
C0079399 (UMLS CUI [8,1])
C0700589 (UMLS CUI [8,2])
C0549206 (UMLS CUI [9,1])
C0700287 (UMLS CUI [9,2])
C1710470 (UMLS CUI [9,3])
Informed Consent
Item
4. ability to understand and the willingness to sign a written informed consent document.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cytotoxic Chemotherapy | hydroxyurea | Adrenal Cortex Hormones | Therapeutic radiology procedure
Item
1. patients who have had cytotoxic chemotherapy (other than hydroxyurea or corticosteroids) or radiotherapy within 7 days prior to entering the study.
boolean
C0677881 (UMLS CUI [1])
C0020402 (UMLS CUI [2])
C0001617 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
Cytotoxic agent Investigational
Item
2. patients may not be receiving any other cytotoxic investigational agents.
boolean
C0304497 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
Allergic Reaction Compound RAD 001 Similar | RAD 001 | Hypersensitivity everolimus | Hypersensitivity Sirolimus | Hypersensitivity Pharmaceutical Excipient | Hypersensitivity Butylated Hydroxytoluene | Hypersensitivity Magnesium stearate | Hypromellose allergy | Hypersensitivity Crospovidone | Hypersensitivity Lactose
Item
3. history of allergic reactions attributed to compounds of similar chemical or biologic composition to rad001. rad001 must not be administered to patients with known hypersensitivity to everolimus, sirolimus or to any of its excipients. excipients include butylated hydroxytoluene, magnesium stearate, hydroxypropylmethyl-cellulose, crospovidone, and lactose.
boolean
C1527304 (UMLS CUI [1,1])
C1706082 (UMLS CUI [1,2])
C0962969 (UMLS CUI [1,3])
C2348205 (UMLS CUI [1,4])
C0962969 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0541315 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0072980 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0015237 (UMLS CUI [5,2])
C0020517 (UMLS CUI [6,1])
C0006507 (UMLS CUI [6,2])
C0020517 (UMLS CUI [7,1])
C0126791 (UMLS CUI [7,2])
C0571249 (UMLS CUI [8])
C0020517 (UMLS CUI [9,1])
C0728803 (UMLS CUI [9,2])
C0020517 (UMLS CUI [10,1])
C0022949 (UMLS CUI [10,2])
Illness Uncontrolled | Communicable Diseases | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorder Protocol Compliance Limited | social situation Protocol Compliance Limited
Item
4. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
boolean
C0221423 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6,1])
C0525058 (UMLS CUI [6,2])
C0439801 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C0525058 (UMLS CUI [7,2])
C0439801 (UMLS CUI [7,3])
Pregnancy | RAD 001 | Teratogenesis | Abortifacient Effect | Adverse event Risk | Breast Feeding Discontinued
Item
5. pregnant women are excluded from this study because rad001 has a potential for teratogenic or abortifacient effects. because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with rad001, breastfeeding should be discontinued if the mother is treated with rad001.
boolean
C0032961 (UMLS CUI [1])
C0962969 (UMLS CUI [2])
C0232910 (UMLS CUI [3])
C3179338 (UMLS CUI [4])
C0877248 (UMLS CUI [5,1])
C0035647 (UMLS CUI [5,2])
C0006147 (UMLS CUI [6,1])
C1444662 (UMLS CUI [6,2])
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