ID

36267

Description

Ruxolitinib or Dasatinib With Chemotherapy in Patients With Philadelphia Chromosome (Ph)-Like Acute Lymphoblastic Leukemia (ALL); ODM derived from: https://clinicaltrials.gov/show/NCT02420717

Link

https://clinicaltrials.gov/show/NCT02420717

Keywords

Versions (1)
  1. 4/26/19 4/26/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 26, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Leukemia NCT02420717

English

Eligibility Leukemia NCT02420717

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT02420717
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with previously treated philadelphia-chromosome-negative b-cell all (relapsed and/or refractory after prior therapy)
Description

Prior Therapy Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia | Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia Recurrent | Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia Refractory

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C4075283
UMLS CUI [2,1]
C4075283
UMLS CUI [2,2]
C2945760
UMLS CUI [3,1]
C4075283
UMLS CUI [3,2]
C0205269
2. bone marrow involvement with >/= 5% lymphoblasts
Description

Bone Marrow Involvement Lymphoblast Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C1517677
UMLS CUI [1,2]
C0229613
UMLS CUI [1,3]
C0439165
3. age >/= 10 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
4. documented genetic lesion(s) known to confer susceptibility to inhibition by either ruxolitinib or dasatinib or crlf2 positivity by flow cytometry (for the ruxolitinib cohort)
Description

Lesion Genetic | Susceptibility Inhibition Due to Ruxolitinib | Susceptibility Inhibition Due to Dasatinib | CRLF2 Positive Flow Cytometry

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0314603
UMLS CUI [2,1]
C1264642
UMLS CUI [2,2]
C3463820
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C2931926
UMLS CUI [3,1]
C1264642
UMLS CUI [3,2]
C3463820
UMLS CUI [3,3]
C0678226
UMLS CUI [3,4]
C1455147
UMLS CUI [4,1]
C4329604
UMLS CUI [4,2]
C0016263
5. eastern cooperative oncology group (ecog) performance status </= 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
6. adequate organ function (total bilirubin < 2.0 mg/dl, sgpt or sgot < 3 x upper limit of normal [uln], creatinine < 2 mg/dl)
Description

Organ function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201899
UMLS CUI [5]
C0201976
7. females of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (beta-hcg) pregnancy test result within 14 days prior to the first dose of study drugs and must agree to use an effective contraception method during the study and for 30 days following the last dose of study drug. females of non- childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy. appropriate methods of birth control include the following: -- any 2 of the following methods used together:--birth control implants, injections, or pills (except for progesterone only pills),
Description

Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine Choriogonadotropin beta Pregnancy test Negative | Childbearing Potential Contraceptive methods | Postmenopausal state | Bilateral tubal ligation | Hysterectomy | Contraceptive implant | Contraceptive injection | Contraceptives, Oral | Exception Progesterone only pill

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C2964947
UMLS CUI [2,3]
C1513916
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [4]
C0232970
UMLS CUI [5]
C0589114
UMLS CUI [6]
C0020699
UMLS CUI [7]
C1657106
UMLS CUI [8]
C1656586
UMLS CUI [9]
C0009905
UMLS CUI [10,1]
C1705847
UMLS CUI [10,2]
C0850455
-intrauterine device (iud), --vasectomy, --tubal ligation, --barrier method (female or male condom with spermicide, cervical cap with spermicide, diaphragm with spermicide); --male condom with spermicide and diaphragm; male condom with spermicide and cervical cap
Description

Intrauterine Device | Vasectomy | Tubal Ligation | Contraception, Barrier | Female Condoms | Condoms, Male | Spermatocidal Agents | CERVICAL CAP FOR CONTRACEPTIVE USE | Vaginal contraceptive diaphragm

Data type

boolean

Alias
UMLS CUI [1]
C0021900
UMLS CUI [2]
C0042387
UMLS CUI [3]
C0520483
UMLS CUI [4]
C0004764
UMLS CUI [5]
C0221829
UMLS CUI [6]
C0009653
UMLS CUI [7]
C0037862
UMLS CUI [8]
C0493327
UMLS CUI [9]
C0042241
8. (continuation of #7) unacceptable methods of birth control include using no birth control, withdrawal, rhythm method, vaginal sponge, any barrier method that does not use spermicide, progesterone only pills, and using male and female condoms at the same time.
Description

Contraceptive methods Unacceptable | Contraceptive methods Absent | Withdrawal - birth control | Rhythm method of contraception | Contraceptive Sponge | Barrier Contraception Without Spermatocidal Agents | Progesterone only pill | Male Condom Female Condom Simultaneous

Data type

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C1883420
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C3812880
UMLS CUI [4]
C0035513
UMLS CUI [5]
C0183461
UMLS CUI [6,1]
C0004764
UMLS CUI [6,2]
C0332288
UMLS CUI [6,3]
C0037862
UMLS CUI [7]
C0850455
UMLS CUI [8,1]
C0009653
UMLS CUI [8,2]
C0221829
UMLS CUI [8,3]
C0521115
9. males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 30 days following the last dose of study drug
Description

Gender Contraceptive methods | Partner Childbearing Potential

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0682323
UMLS CUI [2,2]
C3831118
10. patients or their legally authorized representative must provide written informed consent
Description

Informed Consent | Informed Consent Patient Representative

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. ph-positive all, burkitt's leukemia or lymphoma, t-cell all or lymphoblastic lymphoma
Description

Philadelphia positive acute lymphocytic leukaemia | Burkitt Lymphoma | Adult T Acute Lymphoblastic Leukemia | Lymphoblastic T-cell lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C4524071
UMLS CUI [2]
C0006413
UMLS CUI [3]
C0279592
UMLS CUI [4]
C2853920
2. patients having undergone prior allogeneic stem cell transplant within 3 months or having active graft versus host disease
Description

Allogeneic Stem Cell Transplantation | Graft-vs-Host Disease

Data type

boolean

Alias
UMLS CUI [1]
C2242529
UMLS CUI [2]
C0018133
3. patient is pregnant or breastfeeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
4. patients with uncontrolled active infections (fever >/= 38 degree c, septic shock)
Description

Communicable Diseases Uncontrolled | Fever | Septic Shock

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0015967
UMLS CUI [3]
C0036983
5. isolated extramedullary relapse (i.e. testicular, central nervous system)
Description

Recurrent disease Extramedullary Isolated | Testicular Disease Recurrent | CNS disorder Recurrent

Data type

boolean

Alias
UMLS CUI [1,1]
C0277556
UMLS CUI [1,2]
C1517060
UMLS CUI [1,3]
C0205409
UMLS CUI [2,1]
C0039584
UMLS CUI [2,2]
C2945760
UMLS CUI [3,1]
C0007682
UMLS CUI [3,2]
C2945760
6. current or chronic hepatitis b or c infection, or known seropositivity for hiv
Description

Hepatitis B | Hepatitis B, Chronic | Hepatitis C | Hepatitis C, Chronic | HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0524909
UMLS CUI [3]
C0019196
UMLS CUI [4]
C0524910
UMLS CUI [5]
C0019699
7. concurrent chemotherapy (except intrathecal chemotherapy)
Description

Chemotherapy | Exception Chemotherapy Intrathecal

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0392920
UMLS CUI [2,3]
C0677897
8. major surgery within 4 weeks prior to first study dose
Description

Major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
9. systemic chemotherapy/radiotherapy/investigational therapy within 14 days (with the exception of hydroxyurea and steroids) prior to starting therapy. for patients receiving all maintenance with 6-mercaptopurine, methotrexate, vincristine, and steroids - these agents should be discontinued at least 48 hours prior to start of study drugs.
Description

Systemic Chemotherapy | Systemic Radiation Therapy | Investigational Therapy Systemic | Exception Hydroxyurea | Exception Steroids | Maintenance therapy Acute lymphocytic leukemia | Mercaptopurine To be stopped | Methotrexate To be stopped | Vincristine To be stopped | Steroids To be stopped

Data type

boolean

Alias
UMLS CUI [1]
C1883256
UMLS CUI [2]
C2985381
UMLS CUI [3,1]
C0949266
UMLS CUI [3,2]
C0205373
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0020402
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0038317
UMLS CUI [6,1]
C0677908
UMLS CUI [6,2]
C0023449
UMLS CUI [7,1]
C0000618
UMLS CUI [7,2]
C1272691
UMLS CUI [8,1]
C0025677
UMLS CUI [8,2]
C1272691
UMLS CUI [9,1]
C0042679
UMLS CUI [9,2]
C1272691
UMLS CUI [10,1]
C0038317
UMLS CUI [10,2]
C1272691
10. patients must have recovered from acute non hematologic toxicity (to </= grade 1) of all previous therapy prior to enrollment
Description

Toxicity Due to Prior Therapy | Patient recovered CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C1514463
UMLS CUI [2,1]
C1115804
UMLS CUI [2,2]
C1516728
11. active central nervous system (cns) leukemia, as defined by unequivocal morphologic evidence of lymphoblasts in the cerebrospinal fluid (csf), use of cns-directed local treatment for active disease within the prior 28 days, symptomatic cns leukemia (i.e., cranial nerve palsies or other significant neurologic dysfunction) within 28 days. patients may have history of cns leukemic involvement if definitively treated with prior therapy and no evidence of active disease (defined as >/= 2 consecutive spinal fluid assessments with no evidence of disease) at the time of registration. prophylactic intrathecal chemotherapy is not a criterion for exclusion.
Description

Central nervous system leukaemia | Cerebrospinal fluid lymphoblasts | Local Therapy CNS disorder | Central nervous system leukaemia Symptomatic | Cranial nerve palsies | Neurological Deficit or Dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C1332884
UMLS CUI [2]
C2026634
UMLS CUI [3,1]
C1517925
UMLS CUI [3,2]
C0007682
UMLS CUI [4,1]
C1332884
UMLS CUI [4,2]
C0231220
UMLS CUI [5]
C0151311
UMLS CUI [6]
C1709219
12. patients with active heart disease (nyha class 3-4 as assessed by history and physical examination, unstable angina/stroke/myocardial infarction within the last 6 months)
Description

Heart Disease New York Heart Association Classification | Angina, Unstable | Cerebrovascular accident | Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0038454
UMLS CUI [4]
C0027051
13. patients with a cardiac ejection fraction (as measured by either multi-gated acquisition (muga) scan or echocardiogram) < 40%. (note: patients who have had prior anthracycline exposure of >250 mg/m2 may be eligible after discussion with the pi).
Description

Cardiac ejection fraction MUGA scan | Cardiac ejection fraction Echocardiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0232174
UMLS CUI [1,2]
C0521317
UMLS CUI [2,1]
C0232174
UMLS CUI [2,2]
C0013516
14. second malignancy other than basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix or the breast, unless they are successfully treated with curative intent for more than 2 years before entering the study
Description

Second Cancer | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Carcinoma in situ of uterine cervix | Exception Carcinoma in situ of female breast | Exception Curative treatment Successful

Data type

boolean

Alias
UMLS CUI [1]
C0751623
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0686288
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C1273390
UMLS CUI [6,3]
C1272703
15. malabsorption syndrome or other conditions that preclude enteral route of administration
Description

Malabsorption Syndrome Excludes Enteral Route of Drug Administration | Condition Excludes Enteral Route of Drug Administration

Data type

boolean

Alias
UMLS CUI [1,1]
C0024523
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C1522196
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C1522196
16. patients requiring strong cyp3a4 inhibitors. (complete list of inhibitors can be found at: http://medicine.iupui.edu/clinpharm/ddis/table.aspx)
Description

CYP3A4 Inhibitor Strong

Data type

boolean

Alias
UMLS CUI [1,1]
C3830624
UMLS CUI [1,2]
C0442821
17. other severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and/or would make the patient inappropriate for enrollment into this study.
Description

Medical condition Study Subject Participation Status At risk | Chronic disease Study Subject Participation Status At risk | Mental condition Study Subject Participation Status At risk | Chronic mental disorder Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk | Medical condition Investigational New Drugs At risk | Chronic disease Investigational New Drugs At risk | Mental condition Investigational New Drugs At risk | Chronic mental disorder Investigational New Drugs At risk | Laboratory test result abnormal Investigational New Drugs At risk | Medical condition Interferes with Interpretation Research results | Chronic disease Interferes with Interpretation Research results | Mental condition Interferes with Interpretation Research results | Chronic mental disorder Interferes with Interpretation Research results | Laboratory test result abnormal Interferes with Interpretation Research results | Medical condition Study Subject Participation Status Inappropriate | Chronic disease Study Subject Participation Status Inappropriate | Mental condition Study Subject Participation Status Inappropriate | Chronic mental disorder Study Subject Participation Status Inappropriate | Laboratory test result abnormal Study Subject Participation Status Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C1444641
UMLS CUI [3,1]
C3840291
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C1444641
UMLS CUI [4,1]
C0870281
UMLS CUI [4,2]
C2348568
UMLS CUI [4,3]
C1444641
UMLS CUI [5,1]
C0438215
UMLS CUI [5,2]
C2348568
UMLS CUI [5,3]
C1444641
UMLS CUI [6,1]
C3843040
UMLS CUI [6,2]
C0013230
UMLS CUI [6,3]
C1444641
UMLS CUI [7,1]
C0008679
UMLS CUI [7,2]
C0013230
UMLS CUI [7,3]
C1444641
UMLS CUI [8,1]
C3840291
UMLS CUI [8,2]
C0013230
UMLS CUI [8,3]
C1444641
UMLS CUI [9,1]
C0870281
UMLS CUI [9,2]
C0013230
UMLS CUI [9,3]
C1444641
UMLS CUI [10,1]
C0438215
UMLS CUI [10,2]
C0013230
UMLS CUI [10,3]
C1444641
UMLS CUI [11,1]
C3843040
UMLS CUI [11,2]
C0521102
UMLS CUI [11,3]
C0459471
UMLS CUI [11,4]
C0683954
UMLS CUI [12,1]
C0008679
UMLS CUI [12,2]
C0521102
UMLS CUI [12,3]
C0459471
UMLS CUI [12,4]
C0683954
UMLS CUI [13,1]
C3840291
UMLS CUI [13,2]
C0521102
UMLS CUI [13,3]
C0459471
UMLS CUI [13,4]
C0683954
UMLS CUI [14,1]
C0870281
UMLS CUI [14,2]
C0521102
UMLS CUI [14,3]
C0459471
UMLS CUI [14,4]
C0683954
UMLS CUI [15,1]
C0438215
UMLS CUI [15,2]
C0521102
UMLS CUI [15,3]
C0459471
UMLS CUI [15,4]
C0683954
UMLS CUI [16,1]
C3843040
UMLS CUI [16,2]
C2348568
UMLS CUI [16,3]
C1548788
UMLS CUI [17,1]
C0008679
UMLS CUI [17,2]
C2348568
UMLS CUI [17,3]
C1548788
UMLS CUI [18,1]
C3840291
UMLS CUI [18,2]
C2348568
UMLS CUI [18,3]
C1548788
UMLS CUI [19,1]
C0870281
UMLS CUI [19,2]
C2348568
UMLS CUI [19,3]
C1548788
UMLS CUI [20,1]
C0438215
UMLS CUI [20,2]
C2348568
UMLS CUI [20,3]
C1548788
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Similar models

Eligibility Leukemia NCT02420717

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT02420717
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Prior Therapy Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia | Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia Recurrent | Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia Refractory
Item
1. patients with previously treated philadelphia-chromosome-negative b-cell all (relapsed and/or refractory after prior therapy)
boolean
C1514463 (UMLS CUI [1,1])
C4075283 (UMLS CUI [1,2])
C4075283 (UMLS CUI [2,1])
C2945760 (UMLS CUI [2,2])
C4075283 (UMLS CUI [3,1])
C0205269 (UMLS CUI [3,2])
Bone Marrow Involvement Lymphoblast Percentage
Item
2. bone marrow involvement with >/= 5% lymphoblasts
boolean
C1517677 (UMLS CUI [1,1])
C0229613 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Age
Item
3. age >/= 10 years
boolean
C0001779 (UMLS CUI [1])
Lesion Genetic | Susceptibility Inhibition Due to Ruxolitinib | Susceptibility Inhibition Due to Dasatinib | CRLF2 Positive Flow Cytometry
Item
4. documented genetic lesion(s) known to confer susceptibility to inhibition by either ruxolitinib or dasatinib or crlf2 positivity by flow cytometry (for the ruxolitinib cohort)
boolean
C0221198 (UMLS CUI [1,1])
C0314603 (UMLS CUI [1,2])
C1264642 (UMLS CUI [2,1])
C3463820 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C2931926 (UMLS CUI [2,4])
C1264642 (UMLS CUI [3,1])
C3463820 (UMLS CUI [3,2])
C0678226 (UMLS CUI [3,3])
C1455147 (UMLS CUI [3,4])
C4329604 (UMLS CUI [4,1])
C0016263 (UMLS CUI [4,2])
ECOG performance status
Item
5. eastern cooperative oncology group (ecog) performance status </= 2
boolean
C1520224 (UMLS CUI [1])
Organ function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Creatinine measurement, serum
Item
6. adequate organ function (total bilirubin < 2.0 mg/dl, sgpt or sgot < 3 x upper limit of normal [uln], creatinine < 2 mg/dl)
boolean
C0678852 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine Choriogonadotropin beta Pregnancy test Negative | Childbearing Potential Contraceptive methods | Postmenopausal state | Bilateral tubal ligation | Hysterectomy | Contraceptive implant | Contraceptive injection | Contraceptives, Oral | Exception Progesterone only pill
Item
7. females of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (beta-hcg) pregnancy test result within 14 days prior to the first dose of study drugs and must agree to use an effective contraception method during the study and for 30 days following the last dose of study drug. females of non- childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy. appropriate methods of birth control include the following: -- any 2 of the following methods used together:--birth control implants, injections, or pills (except for progesterone only pills),
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C2964947 (UMLS CUI [2,2])
C1513916 (UMLS CUI [2,3])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0232970 (UMLS CUI [4])
C0589114 (UMLS CUI [5])
C0020699 (UMLS CUI [6])
C1657106 (UMLS CUI [7])
C1656586 (UMLS CUI [8])
C0009905 (UMLS CUI [9])
C1705847 (UMLS CUI [10,1])
C0850455 (UMLS CUI [10,2])
Intrauterine Device | Vasectomy | Tubal Ligation | Contraception, Barrier | Female Condoms | Condoms, Male | Spermatocidal Agents | CERVICAL CAP FOR CONTRACEPTIVE USE | Vaginal contraceptive diaphragm
Item
-intrauterine device (iud), --vasectomy, --tubal ligation, --barrier method (female or male condom with spermicide, cervical cap with spermicide, diaphragm with spermicide); --male condom with spermicide and diaphragm; male condom with spermicide and cervical cap
boolean
C0021900 (UMLS CUI [1])
C0042387 (UMLS CUI [2])
C0520483 (UMLS CUI [3])
C0004764 (UMLS CUI [4])
C0221829 (UMLS CUI [5])
C0009653 (UMLS CUI [6])
C0037862 (UMLS CUI [7])
C0493327 (UMLS CUI [8])
C0042241 (UMLS CUI [9])
Contraceptive methods Unacceptable | Contraceptive methods Absent | Withdrawal - birth control | Rhythm method of contraception | Contraceptive Sponge | Barrier Contraception Without Spermatocidal Agents | Progesterone only pill | Male Condom Female Condom Simultaneous
Item
8. (continuation of #7) unacceptable methods of birth control include using no birth control, withdrawal, rhythm method, vaginal sponge, any barrier method that does not use spermicide, progesterone only pills, and using male and female condoms at the same time.
boolean
C0700589 (UMLS CUI [1,1])
C1883420 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C3812880 (UMLS CUI [3])
C0035513 (UMLS CUI [4])
C0183461 (UMLS CUI [5])
C0004764 (UMLS CUI [6,1])
C0332288 (UMLS CUI [6,2])
C0037862 (UMLS CUI [6,3])
C0850455 (UMLS CUI [7])
C0009653 (UMLS CUI [8,1])
C0221829 (UMLS CUI [8,2])
C0521115 (UMLS CUI [8,3])
Gender Contraceptive methods | Partner Childbearing Potential
Item
9. males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 30 days following the last dose of study drug
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0682323 (UMLS CUI [2,1])
C3831118 (UMLS CUI [2,2])
Informed Consent | Informed Consent Patient Representative
Item
10. patients or their legally authorized representative must provide written informed consent
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Philadelphia positive acute lymphocytic leukaemia | Burkitt Lymphoma | Adult T Acute Lymphoblastic Leukemia | Lymphoblastic T-cell lymphoma
Item
1. ph-positive all, burkitt's leukemia or lymphoma, t-cell all or lymphoblastic lymphoma
boolean
C4524071 (UMLS CUI [1])
C0006413 (UMLS CUI [2])
C0279592 (UMLS CUI [3])
C2853920 (UMLS CUI [4])
Allogeneic Stem Cell Transplantation | Graft-vs-Host Disease
Item
2. patients having undergone prior allogeneic stem cell transplant within 3 months or having active graft versus host disease
boolean
C2242529 (UMLS CUI [1])
C0018133 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
3. patient is pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Communicable Diseases Uncontrolled | Fever | Septic Shock
Item
4. patients with uncontrolled active infections (fever >/= 38 degree c, septic shock)
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0015967 (UMLS CUI [2])
C0036983 (UMLS CUI [3])
Recurrent disease Extramedullary Isolated | Testicular Disease Recurrent | CNS disorder Recurrent
Item
5. isolated extramedullary relapse (i.e. testicular, central nervous system)
boolean
C0277556 (UMLS CUI [1,1])
C1517060 (UMLS CUI [1,2])
C0205409 (UMLS CUI [1,3])
C0039584 (UMLS CUI [2,1])
C2945760 (UMLS CUI [2,2])
C0007682 (UMLS CUI [3,1])
C2945760 (UMLS CUI [3,2])
Hepatitis B | Hepatitis B, Chronic | Hepatitis C | Hepatitis C, Chronic | HIV Seropositivity
Item
6. current or chronic hepatitis b or c infection, or known seropositivity for hiv
boolean
C0019163 (UMLS CUI [1])
C0524909 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
C0524910 (UMLS CUI [4])
C0019699 (UMLS CUI [5])
Chemotherapy | Exception Chemotherapy Intrathecal
Item
7. concurrent chemotherapy (except intrathecal chemotherapy)
boolean
C0392920 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C0677897 (UMLS CUI [2,3])
Major surgery
Item
8. major surgery within 4 weeks prior to first study dose
boolean
C0679637 (UMLS CUI [1])
Systemic Chemotherapy | Systemic Radiation Therapy | Investigational Therapy Systemic | Exception Hydroxyurea | Exception Steroids | Maintenance therapy Acute lymphocytic leukemia | Mercaptopurine To be stopped | Methotrexate To be stopped | Vincristine To be stopped | Steroids To be stopped
Item
9. systemic chemotherapy/radiotherapy/investigational therapy within 14 days (with the exception of hydroxyurea and steroids) prior to starting therapy. for patients receiving all maintenance with 6-mercaptopurine, methotrexate, vincristine, and steroids - these agents should be discontinued at least 48 hours prior to start of study drugs.
boolean
C1883256 (UMLS CUI [1])
C2985381 (UMLS CUI [2])
C0949266 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0020402 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0038317 (UMLS CUI [5,2])
C0677908 (UMLS CUI [6,1])
C0023449 (UMLS CUI [6,2])
C0000618 (UMLS CUI [7,1])
C1272691 (UMLS CUI [7,2])
C0025677 (UMLS CUI [8,1])
C1272691 (UMLS CUI [8,2])
C0042679 (UMLS CUI [9,1])
C1272691 (UMLS CUI [9,2])
C0038317 (UMLS CUI [10,1])
C1272691 (UMLS CUI [10,2])
Toxicity Due to Prior Therapy | Patient recovered CTCAE Grades
Item
10. patients must have recovered from acute non hematologic toxicity (to </= grade 1) of all previous therapy prior to enrollment
boolean
C0600688 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
C1115804 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
Central nervous system leukaemia | Cerebrospinal fluid lymphoblasts | Local Therapy CNS disorder | Central nervous system leukaemia Symptomatic | Cranial nerve palsies | Neurological Deficit or Dysfunction
Item
11. active central nervous system (cns) leukemia, as defined by unequivocal morphologic evidence of lymphoblasts in the cerebrospinal fluid (csf), use of cns-directed local treatment for active disease within the prior 28 days, symptomatic cns leukemia (i.e., cranial nerve palsies or other significant neurologic dysfunction) within 28 days. patients may have history of cns leukemic involvement if definitively treated with prior therapy and no evidence of active disease (defined as >/= 2 consecutive spinal fluid assessments with no evidence of disease) at the time of registration. prophylactic intrathecal chemotherapy is not a criterion for exclusion.
boolean
C1332884 (UMLS CUI [1])
C2026634 (UMLS CUI [2])
C1517925 (UMLS CUI [3,1])
C0007682 (UMLS CUI [3,2])
C1332884 (UMLS CUI [4,1])
C0231220 (UMLS CUI [4,2])
C0151311 (UMLS CUI [5])
C1709219 (UMLS CUI [6])
Heart Disease New York Heart Association Classification | Angina, Unstable | Cerebrovascular accident | Myocardial Infarction
Item
12. patients with active heart disease (nyha class 3-4 as assessed by history and physical examination, unstable angina/stroke/myocardial infarction within the last 6 months)
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0002965 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
Cardiac ejection fraction MUGA scan | Cardiac ejection fraction Echocardiography
Item
13. patients with a cardiac ejection fraction (as measured by either multi-gated acquisition (muga) scan or echocardiogram) < 40%. (note: patients who have had prior anthracycline exposure of >250 mg/m2 may be eligible after discussion with the pi).
boolean
C0232174 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0232174 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
Second Cancer | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Carcinoma in situ of uterine cervix | Exception Carcinoma in situ of female breast | Exception Curative treatment Successful
Item
14. second malignancy other than basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix or the breast, unless they are successfully treated with curative intent for more than 2 years before entering the study
boolean
C0751623 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0686288 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C1273390 (UMLS CUI [6,2])
C1272703 (UMLS CUI [6,3])
Malabsorption Syndrome Excludes Enteral Route of Drug Administration | Condition Excludes Enteral Route of Drug Administration
Item
15. malabsorption syndrome or other conditions that preclude enteral route of administration
boolean
C0024523 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C1522196 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C1522196 (UMLS CUI [2,3])
CYP3A4 Inhibitor Strong
Item
16. patients requiring strong cyp3a4 inhibitors. (complete list of inhibitors can be found at: http://medicine.iupui.edu/clinpharm/ddis/table.aspx)
boolean
C3830624 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
Medical condition Study Subject Participation Status At risk | Chronic disease Study Subject Participation Status At risk | Mental condition Study Subject Participation Status At risk | Chronic mental disorder Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk | Medical condition Investigational New Drugs At risk | Chronic disease Investigational New Drugs At risk | Mental condition Investigational New Drugs At risk | Chronic mental disorder Investigational New Drugs At risk | Laboratory test result abnormal Investigational New Drugs At risk | Medical condition Interferes with Interpretation Research results | Chronic disease Interferes with Interpretation Research results | Mental condition Interferes with Interpretation Research results | Chronic mental disorder Interferes with Interpretation Research results | Laboratory test result abnormal Interferes with Interpretation Research results | Medical condition Study Subject Participation Status Inappropriate | Chronic disease Study Subject Participation Status Inappropriate | Mental condition Study Subject Participation Status Inappropriate | Chronic mental disorder Study Subject Participation Status Inappropriate | Laboratory test result abnormal Study Subject Participation Status Inappropriate
Item
17. other severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and/or would make the patient inappropriate for enrollment into this study.
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0008679 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C3840291 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C1444641 (UMLS CUI [3,3])
C0870281 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C1444641 (UMLS CUI [4,3])
C0438215 (UMLS CUI [5,1])
C2348568 (UMLS CUI [5,2])
C1444641 (UMLS CUI [5,3])
C3843040 (UMLS CUI [6,1])
C0013230 (UMLS CUI [6,2])
C1444641 (UMLS CUI [6,3])
C0008679 (UMLS CUI [7,1])
C0013230 (UMLS CUI [7,2])
C1444641 (UMLS CUI [7,3])
C3840291 (UMLS CUI [8,1])
C0013230 (UMLS CUI [8,2])
C1444641 (UMLS CUI [8,3])
C0870281 (UMLS CUI [9,1])
C0013230 (UMLS CUI [9,2])
C1444641 (UMLS CUI [9,3])
C0438215 (UMLS CUI [10,1])
C0013230 (UMLS CUI [10,2])
C1444641 (UMLS CUI [10,3])
C3843040 (UMLS CUI [11,1])
C0521102 (UMLS CUI [11,2])
C0459471 (UMLS CUI [11,3])
C0683954 (UMLS CUI [11,4])
C0008679 (UMLS CUI [12,1])
C0521102 (UMLS CUI [12,2])
C0459471 (UMLS CUI [12,3])
C0683954 (UMLS CUI [12,4])
C3840291 (UMLS CUI [13,1])
C0521102 (UMLS CUI [13,2])
C0459471 (UMLS CUI [13,3])
C0683954 (UMLS CUI [13,4])
C0870281 (UMLS CUI [14,1])
C0521102 (UMLS CUI [14,2])
C0459471 (UMLS CUI [14,3])
C0683954 (UMLS CUI [14,4])
C0438215 (UMLS CUI [15,1])
C0521102 (UMLS CUI [15,2])
C0459471 (UMLS CUI [15,3])
C0683954 (UMLS CUI [15,4])
C3843040 (UMLS CUI [16,1])
C2348568 (UMLS CUI [16,2])
C1548788 (UMLS CUI [16,3])
C0008679 (UMLS CUI [17,1])
C2348568 (UMLS CUI [17,2])
C1548788 (UMLS CUI [17,3])
C3840291 (UMLS CUI [18,1])
C2348568 (UMLS CUI [18,2])
C1548788 (UMLS CUI [18,3])
C0870281 (UMLS CUI [19,1])
C2348568 (UMLS CUI [19,2])
C1548788 (UMLS CUI [19,3])
C0438215 (UMLS CUI [20,1])
C2348568 (UMLS CUI [20,2])
C1548788 (UMLS CUI [20,3])
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