ID

41065

Beschreibung

Phase l/II Study of Ruxolitinib for Acute Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01251965

Link

https://clinicaltrials.gov/show/NCT01251965

Stichworte

Versionen (1)
  1. 18.06.20 18.06.20 -
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See clinicaltrials.gov

Hochgeladen am

18. Juni 2020

DOI

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Eligibility Leukemia NCT01251965

Englisch

Eligibility Leukemia NCT01251965

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01251965
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. must be >14 years of age
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. must be diagnosed with refractory or relapsed aml or all.
Beschreibung

Refractory Acute Myeloid Leukemia | Acute myeloid leukaemia recurrent | Refractory acute lymphoid leukemia | Acute lymphocytic leukemia recurrent

Datentyp

boolean

Alias
UMLS CUI [1]
C4528668
UMLS CUI [2]
C1142169
UMLS CUI [3]
C4302097
UMLS CUI [4]
C1504403
3. must have adequate organ function as demonstrated by the following: o alt (sgot) and/or ast (sgpt) equal to or less than 1.5x upper limit of normal o serum creatinine equal to or less than 2.5 mg/dl
Beschreibung

Organ function | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201976
4. ecog performance status (ps) of 0, 1, or 2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
5. at least 2 weeks from prior leukemia-directed treatment to starting treatment drug (except for hydroxyurea, which is allowed if clinically indicated but should be stopped after 2 weeks of receiving study drug, and glucocorticoids, which are allowed but should be stopped upon starting treatment drug).
Beschreibung

Prior Therapy Leukemia | Hydroxyurea To be stopped | Glucocorticoids To be stopped

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0023418
UMLS CUI [2,1]
C0020402
UMLS CUI [2,2]
C1272691
UMLS CUI [3,1]
C0017710
UMLS CUI [3,2]
C1272691
6. treatment-related toxicities from prior therapies must have resolved to grade equal to or less than 1 (except for peripheral neuropathy, which should resolve to grade equal to or less than 2)
Beschreibung

Toxicity Due to Prior Therapy | Resolved CTCAE Grades | Exception Peripheral Neuropathy CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C1514463
UMLS CUI [2,1]
C1514893
UMLS CUI [2,2]
C1516728
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0031117
UMLS CUI [3,3]
C1516728
7. no active malignancies with the exception of basal cell or squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.
Beschreibung

Malignant Neoplasms Absent | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Carcinoma in situ of uterine cervix | Exception Carcinoma in situ of female breast

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332197
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
8. females of childbearing potential (fcbp)(a female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) must have negative pregnancy test. fcbp and males participating in the study must agree to use a reliable form of contraception or to practice complete abstinence from heterosexual intercourse while participating in the study and for at least 28 days after discontinuation from the study. if pregnancy or a positive pregnancy test does occur in a study subject, treatment with the study drug must be immediately discontinued.
Beschreibung

Childbearing Potential | Hysterectomy Absent | Bilateral oophorectomy Absent | Postmenopausal state Absent | Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Childbearing Potential Abstinence Coitus | Gender Abstinence Coitus

Datentyp

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2,1]
C0020699
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0278321
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0232970
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C3831118
UMLS CUI [5,2]
C0427780
UMLS CUI [6,1]
C3831118
UMLS CUI [6,2]
C0700589
UMLS CUI [7,1]
C0079399
UMLS CUI [7,2]
C0700589
UMLS CUI [8,1]
C3831118
UMLS CUI [8,2]
C0036899
UMLS CUI [8,3]
C0009253
UMLS CUI [9,1]
C0079399
UMLS CUI [9,2]
C0036899
UMLS CUI [9,3]
C0009253
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. known positive status for hiv, or known active hepatitis a, b, or c infection.
Beschreibung

HIV Seropositivity | Hepatitis A | Hepatitis B | Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0019159
UMLS CUI [3]
C0019163
UMLS CUI [4]
C0019196
2. any serious medical condition or psychiatric illness that would prevent, (as judged by the treating physician) the subject from signing the informed consent form or any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
Beschreibung

Medical condition Serious Preventing Informed Consent | Mental disorders Preventing Informed Consent | Condition Study Subject Participation Status At risk | LABORATORY ABNORMALITIES Study Subject Participation Status At risk | Condition Interferes with Interpretation Research data | LABORATORY ABNORMALITIES Interfere with Interpretation Research data

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C1292733
UMLS CUI [1,4]
C0021430
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0021430
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C1444641
UMLS CUI [4,1]
C1853129
UMLS CUI [4,2]
C2348568
UMLS CUI [4,3]
C1444641
UMLS CUI [5,1]
C0348080
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0459471
UMLS CUI [5,4]
C0681873
UMLS CUI [6,1]
C1853129
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C0459471
UMLS CUI [6,4]
C0681873
3. pregnant or lactating females.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
4. acute promyelocytic leukemia
Beschreibung

Acute Promyelocytic Leukemia

Datentyp

boolean

Alias
UMLS CUI [1]
C0023487
5. concurrent use of strong inducers or strong inhibitors of cyp3a4. strong inducers are rifampin and st. john's worth. strong inhibitors are hiv-antivirals, clarythromycin, itraconazole, ketoconazole, nefazodone, and telithromycin.
Beschreibung

CYP3A4 Inducers Strong | CYP3A4 Inhibitors Strong | Rifampin | ST. JOHN'S WORT EXTRACT | Antiviral Agents HIV | Clarithromycin | Itraconazole | Ketoconazole | nefazodone | telithromycin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3850041
UMLS CUI [1,2]
C0442821
UMLS CUI [2,1]
C3850053
UMLS CUI [2,2]
C0442821
UMLS CUI [3]
C0035608
UMLS CUI [4]
C0813171
UMLS CUI [5,1]
C0003451
UMLS CUI [5,2]
C0019682
UMLS CUI [6]
C0055856
UMLS CUI [7]
C0064113
UMLS CUI [8]
C0022625
UMLS CUI [9]
C0068485
UMLS CUI [10]
C0907410
6. participating in any other research trial.
Beschreibung

Study Subject Participation Status | Clinical Trial

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
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Ähnliche Modelle

Eligibility Leukemia NCT01251965

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01251965
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. must be >14 years of age
boolean
C0001779 (UMLS CUI [1])
Refractory Acute Myeloid Leukemia | Acute myeloid leukaemia recurrent | Refractory acute lymphoid leukemia | Acute lymphocytic leukemia recurrent
Item
2. must be diagnosed with refractory or relapsed aml or all.
boolean
C4528668 (UMLS CUI [1])
C1142169 (UMLS CUI [2])
C4302097 (UMLS CUI [3])
C1504403 (UMLS CUI [4])
Organ function | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Creatinine measurement, serum
Item
3. must have adequate organ function as demonstrated by the following: o alt (sgot) and/or ast (sgpt) equal to or less than 1.5x upper limit of normal o serum creatinine equal to or less than 2.5 mg/dl
boolean
C0678852 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201976 (UMLS CUI [4])
ECOG performance status
Item
4. ecog performance status (ps) of 0, 1, or 2
boolean
C1520224 (UMLS CUI [1])
Prior Therapy Leukemia | Hydroxyurea To be stopped | Glucocorticoids To be stopped
Item
5. at least 2 weeks from prior leukemia-directed treatment to starting treatment drug (except for hydroxyurea, which is allowed if clinically indicated but should be stopped after 2 weeks of receiving study drug, and glucocorticoids, which are allowed but should be stopped upon starting treatment drug).
boolean
C1514463 (UMLS CUI [1,1])
C0023418 (UMLS CUI [1,2])
C0020402 (UMLS CUI [2,1])
C1272691 (UMLS CUI [2,2])
C0017710 (UMLS CUI [3,1])
C1272691 (UMLS CUI [3,2])
Toxicity Due to Prior Therapy | Resolved CTCAE Grades | Exception Peripheral Neuropathy CTCAE Grades
Item
6. treatment-related toxicities from prior therapies must have resolved to grade equal to or less than 1 (except for peripheral neuropathy, which should resolve to grade equal to or less than 2)
boolean
C0600688 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
C1514893 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0031117 (UMLS CUI [3,2])
C1516728 (UMLS CUI [3,3])
Malignant Neoplasms Absent | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Carcinoma in situ of uterine cervix | Exception Carcinoma in situ of female breast
Item
7. no active malignancies with the exception of basal cell or squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.
boolean
C0006826 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
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])
Childbearing Potential | Hysterectomy Absent | Bilateral oophorectomy Absent | Postmenopausal state Absent | Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Childbearing Potential Abstinence Coitus | Gender Abstinence Coitus
Item
8. females of childbearing potential (fcbp)(a female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) must have negative pregnancy test. fcbp and males participating in the study must agree to use a reliable form of contraception or to practice complete abstinence from heterosexual intercourse while participating in the study and for at least 28 days after discontinuation from the study. if pregnancy or a positive pregnancy test does occur in a study subject, treatment with the study drug must be immediately discontinued.
boolean
C3831118 (UMLS CUI [1])
C0020699 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0278321 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0232970 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C3831118 (UMLS CUI [5,1])
C0427780 (UMLS CUI [5,2])
C3831118 (UMLS CUI [6,1])
C0700589 (UMLS CUI [6,2])
C0079399 (UMLS CUI [7,1])
C0700589 (UMLS CUI [7,2])
C3831118 (UMLS CUI [8,1])
C0036899 (UMLS CUI [8,2])
C0009253 (UMLS CUI [8,3])
C0079399 (UMLS CUI [9,1])
C0036899 (UMLS CUI [9,2])
C0009253 (UMLS CUI [9,3])
Item Group
C0680251 (UMLS CUI)
HIV Seropositivity | Hepatitis A | Hepatitis B | Hepatitis C
Item
1. known positive status for hiv, or known active hepatitis a, b, or c infection.
boolean
C0019699 (UMLS CUI [1])
C0019159 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0019196 (UMLS CUI [4])
Medical condition Serious Preventing Informed Consent | Mental disorders Preventing Informed Consent | Condition Study Subject Participation Status At risk | LABORATORY ABNORMALITIES Study Subject Participation Status At risk | Condition Interferes with Interpretation Research data | LABORATORY ABNORMALITIES Interfere with Interpretation Research data
Item
2. any serious medical condition or psychiatric illness that would prevent, (as judged by the treating physician) the subject from signing the informed consent form or any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1292733 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,4])
C0004936 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C1444641 (UMLS CUI [3,3])
C1853129 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C1444641 (UMLS CUI [4,3])
C0348080 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0459471 (UMLS CUI [5,3])
C0681873 (UMLS CUI [5,4])
C1853129 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C0459471 (UMLS CUI [6,3])
C0681873 (UMLS CUI [6,4])
Pregnancy | Breast Feeding
Item
3. pregnant or lactating females.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Acute Promyelocytic Leukemia
Item
4. acute promyelocytic leukemia
boolean
C0023487 (UMLS CUI [1])
CYP3A4 Inducers Strong | CYP3A4 Inhibitors Strong | Rifampin | ST. JOHN'S WORT EXTRACT | Antiviral Agents HIV | Clarithromycin | Itraconazole | Ketoconazole | nefazodone | telithromycin
Item
5. concurrent use of strong inducers or strong inhibitors of cyp3a4. strong inducers are rifampin and st. john's worth. strong inhibitors are hiv-antivirals, clarythromycin, itraconazole, ketoconazole, nefazodone, and telithromycin.
boolean
C3850041 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
C3850053 (UMLS CUI [2,1])
C0442821 (UMLS CUI [2,2])
C0035608 (UMLS CUI [3])
C0813171 (UMLS CUI [4])
C0003451 (UMLS CUI [5,1])
C0019682 (UMLS CUI [5,2])
C0055856 (UMLS CUI [6])
C0064113 (UMLS CUI [7])
C0022625 (UMLS CUI [8])
C0068485 (UMLS CUI [9])
C0907410 (UMLS CUI [10])
Study Subject Participation Status | Clinical Trial
Item
6. participating in any other research trial.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
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