ID

28058

Beschreibung

Multi-center Trial of Revlimid® and Rituximab, for First-Line Treatment of Chronic Lymphocytic Leukemia (CLL); ODM derived from: https://clinicaltrials.gov/show/NCT00628238

Link

https://clinicaltrials.gov/show/NCT00628238

Stichworte

Versionen (2)
  1. 13.12.17 13.12.17 -
  2. 13.12.17 13.12.17 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

13. Dezember 2017

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Eligibility Chronic Lymphocytic Leukemia NCT00628238

Englisch

Eligibility Chronic Lymphocytic Leukemia NCT00628238

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. diagnosis of chronic lymphocytic leukemia with no history of previous treatments with monoclonal antibodies or chemotherapy.
Beschreibung

Chronic Lymphocytic Leukemia | Monoclonal Antibody Therapy Absent | Chemotherapy Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0023434
UMLS CUI [2,1]
C0279694
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0332197
2. subjects must have an indication for treatment as defined by the nci working group guidelines
Beschreibung

Indication Therapeutic procedure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0087111
3. understand and voluntarily sign an informed consent form.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
4. age ≥18 years at the time of signing the informed consent form.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
5. able to adhere to the study visit schedule and other protocol requirements.
Beschreibung

Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
6. ecog performance status of ≤ 2 at study entry (see appendix a).
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
7. laboratory test results within these ranges: absolute neutrophil count ≥ 1.0 x 109/l, platelet count ≥ 50 x 109/l, serum creatinine ≤ 1.5 mg/dl, total bilirubin ≤ 1.5 mg/dl, ast & alt ≤ 2 x uln
Beschreibung

Laboratory test finding | Absolute neutrophil count | Platelet Count measurement | Creatinine measurement, serum | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0587081
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0201976
UMLS CUI [5]
C1278039
UMLS CUI [6]
C0201899
UMLS CUI [7]
C0201836
8. females of childbearing potential (fcbp)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 miu/ml within 10 - 14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control, one highly effective method and one additional effective method at the same time, at least 28 days before she starts taking lenalidomide. fcbp must also agree to ongoing pregnancy testing. men must agree to use a latex condom during sexual contact with a fcbp even if they have had a successful vasectomy. all patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
Beschreibung

Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Abstinence Coitus | Childbearing Potential Contraceptive methods Quantity | Childbearing Potential Pregnancy Tests | Gender | Latex condom | Vasectomy | Counseling Contraceptive methods | Counseling Risk Fetal exposure

Datentyp

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]
C3843422
UMLS CUI [3,3]
C0009253
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C1265611
UMLS CUI [5,1]
C3831118
UMLS CUI [5,2]
C0032976
UMLS CUI [6]
C0079399
UMLS CUI [7]
C3873750
UMLS CUI [8]
C0042387
UMLS CUI [9,1]
C0010210
UMLS CUI [9,2]
C0700589
UMLS CUI [10,1]
C0010210
UMLS CUI [10,2]
C0035647
UMLS CUI [10,3]
C0871747
9. disease free of prior malignancies for ≥ 2 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0332296
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0851140
UMLS CUI [5,3]
C1522326
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0686288
UMLS CUI [6,3]
C1522326
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. previous treatment for cll with chemotherapy or monoclonal antibodies
Beschreibung

Chemotherapy CLL | Monoclonal Antibody Therapy CLL

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0023434
UMLS CUI [2,1]
C0279694
UMLS CUI [2,2]
C0023434
2. known hepatitis b ag positive, hepatitis c positive patients
Beschreibung

Hepatitis B antigen positive | Hepatitis C positive

Datentyp

boolean

Alias
UMLS CUI [1]
C1504344
UMLS CUI [2]
C1112419
3. known hiv positive patients
Beschreibung

HIV Seropositivity

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
4. patients with uncontrolled autoimmune hemolytic anemia (aiha) or autoimmune thrombocytopenia (itp).
Beschreibung

Autoimmune hemolytic anemia Uncontrolled | Autoimmune thrombocytopenia Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0002880
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0242584
UMLS CUI [2,2]
C0205318
5. inability to provide informed consent.
Beschreibung

Informed Consent Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
6. concurrent malignancy (excluding basal and squamous cell skin cancers).
Beschreibung

Malignant Neoplasms | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
7. active fungal, bacterial, and/or viral infection.
Beschreibung

Mycoses | Bacterial Infections | Virus Diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0026946
UMLS CUI [2]
C0004623
UMLS CUI [3]
C0042769
8. any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
Beschreibung

Medical condition Preventing Informed Consent | Laboratory test result abnormal Preventing Informed Consent | Mental disorders Preventing Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C0438215
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0021430
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C1292733
UMLS CUI [3,3]
C0021430
9. pregnant or breast-feeding females. (lactating females must agree not to breast feed while taking lenalidomide).
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
10. 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

Laboratory test result abnormal Study Subject Participation Status At risk Unacceptable | Condition Interferes with Interpretation Research data | Laboratory test result abnormal Interferes with Interpretation Research data

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0438215
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
UMLS CUI [1,4]
C1883420
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0459471
UMLS CUI [2,4]
C0681873
UMLS CUI [3,1]
C0438215
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0459471
UMLS CUI [3,4]
C0681873
11. use of any other experimental drug or therapy within 28 days of baseline.
Beschreibung

Investigational New Drugs | Therapy, Investigational

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0949266
12. known hypersensitivity to thalidomide.
Beschreibung

Hypersensitivity Thalidomide

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0039736
13. the development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
Beschreibung

Erythema Nodosum | Rash desquamating | Thalidomide | Intake Pharmaceutical Preparations Similar

Datentyp

boolean

Alias
UMLS CUI [1]
C0014743
UMLS CUI [2]
C0542171
UMLS CUI [3]
C0039736
UMLS CUI [4,1]
C1512806
UMLS CUI [4,2]
C0013227
UMLS CUI [4,3]
C2348205
14. any prior use of lenalidomide.
Beschreibung

Lenalidomide

Datentyp

boolean

Alias
UMLS CUI [1]
C1144149
15. concurrent use of other anti-cancer agents or treatments.
Beschreibung

Antineoplastic Agents | Cancer treatment

Datentyp

boolean

Alias
UMLS CUI [1]
C0003392
UMLS CUI [2]
C0920425
16. patients with history of deep venous thrombus or pulmonary embolism. patients who are at increased risk of thrombosis during treatment with lenalidomide including those taking concurrent erythropoietin, darbepoetin or high-dose corticosteroids are also excluded.
Beschreibung

Deep vein Thrombus | Pulmonary Embolism | Increased risk of thrombosis | Lenalidomide | Erythropoietin | Darbepoetin | Adrenal Cortex Hormones High dose

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0226514
UMLS CUI [1,2]
C0087086
UMLS CUI [2]
C0034065
UMLS CUI [3]
C2749785
UMLS CUI [4]
C1144149
UMLS CUI [5]
C0014822
UMLS CUI [6]
C0937950
UMLS CUI [7,1]
C0001617
UMLS CUI [7,2]
C0444956
17. patients with a history of embolic events (e.g. tia) from arrhythmia or peripheral arterial disease or of recent mi whether or not treated with anti-platelet drugs
Beschreibung

Embolism | Transient Ischemic Attack | Cardiac Arrhythmia | Peripheral Arterial Diseases | Myocardial Infarction | Antiplatelet Agents

Datentyp

boolean

Alias
UMLS CUI [1]
C0013922
UMLS CUI [2]
C0007787
UMLS CUI [3]
C0003811
UMLS CUI [4]
C1704436
UMLS CUI [5]
C0027051
UMLS CUI [6]
C0085826
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Ähnliche Modelle

Eligibility Chronic Lymphocytic Leukemia NCT00628238

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Lymphocytic Leukemia | Monoclonal Antibody Therapy Absent | Chemotherapy Absent
Item
1. diagnosis of chronic lymphocytic leukemia with no history of previous treatments with monoclonal antibodies or chemotherapy.
boolean
C0023434 (UMLS CUI [1])
C0279694 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0392920 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Indication Therapeutic procedure
Item
2. subjects must have an indication for treatment as defined by the nci working group guidelines
boolean
C3146298 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Informed Consent
Item
3. understand and voluntarily sign an informed consent form.
boolean
C0021430 (UMLS CUI [1])
Age
Item
4. age ≥18 years at the time of signing the informed consent form.
boolean
C0001779 (UMLS CUI [1])
Protocol Compliance
Item
5. able to adhere to the study visit schedule and other protocol requirements.
boolean
C0525058 (UMLS CUI [1])
ECOG performance status
Item
6. ecog performance status of ≤ 2 at study entry (see appendix a).
boolean
C1520224 (UMLS CUI [1])
Laboratory test finding | Absolute neutrophil count | Platelet Count measurement | Creatinine measurement, serum | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
7. laboratory test results within these ranges: absolute neutrophil count ≥ 1.0 x 109/l, platelet count ≥ 50 x 109/l, serum creatinine ≤ 1.5 mg/dl, total bilirubin ≤ 1.5 mg/dl, ast & alt ≤ 2 x uln
boolean
C0587081 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0201976 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
C0201899 (UMLS CUI [6])
C0201836 (UMLS CUI [7])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Abstinence Coitus | Childbearing Potential Contraceptive methods Quantity | Childbearing Potential Pregnancy Tests | Gender | Latex condom | Vasectomy | Counseling Contraceptive methods | Counseling Risk Fetal exposure
Item
8. females of childbearing potential (fcbp)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 miu/ml within 10 - 14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control, one highly effective method and one additional effective method at the same time, at least 28 days before she starts taking lenalidomide. fcbp must also agree to ongoing pregnancy testing. men must agree to use a latex condom during sexual contact with a fcbp even if they have had a successful vasectomy. all patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
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])
C3843422 (UMLS CUI [3,2])
C0009253 (UMLS CUI [3,3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C3831118 (UMLS CUI [5,1])
C0032976 (UMLS CUI [5,2])
C0079399 (UMLS CUI [6])
C3873750 (UMLS CUI [7])
C0042387 (UMLS CUI [8])
C0010210 (UMLS CUI [9,1])
C0700589 (UMLS CUI [9,2])
C0010210 (UMLS CUI [10,1])
C0035647 (UMLS CUI [10,2])
C0871747 (UMLS CUI [10,3])
Malignant Neoplasms | Disease Free of | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Carcinoma in situ of female breast Treated
Item
9. disease free of prior malignancies for ≥ 2 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast
boolean
C0006826 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0851140 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0686288 (UMLS CUI [6,2])
C1522326 (UMLS CUI [6,3])
Item Group
C0680251 (UMLS CUI)
Chemotherapy CLL | Monoclonal Antibody Therapy CLL
Item
1. previous treatment for cll with chemotherapy or monoclonal antibodies
boolean
C0392920 (UMLS CUI [1,1])
C0023434 (UMLS CUI [1,2])
C0279694 (UMLS CUI [2,1])
C0023434 (UMLS CUI [2,2])
Hepatitis B antigen positive | Hepatitis C positive
Item
2. known hepatitis b ag positive, hepatitis c positive patients
boolean
C1504344 (UMLS CUI [1])
C1112419 (UMLS CUI [2])
HIV Seropositivity
Item
3. known hiv positive patients
boolean
C0019699 (UMLS CUI [1])
Autoimmune hemolytic anemia Uncontrolled | Autoimmune thrombocytopenia Uncontrolled
Item
4. patients with uncontrolled autoimmune hemolytic anemia (aiha) or autoimmune thrombocytopenia (itp).
boolean
C0002880 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0242584 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Informed Consent Unable
Item
5. inability to provide informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Malignant Neoplasms | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin
Item
6. concurrent malignancy (excluding basal and squamous cell skin cancers).
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
Mycoses | Bacterial Infections | Virus Diseases
Item
7. active fungal, bacterial, and/or viral infection.
boolean
C0026946 (UMLS CUI [1])
C0004623 (UMLS CUI [2])
C0042769 (UMLS CUI [3])
Medical condition Preventing Informed Consent | Laboratory test result abnormal Preventing Informed Consent | Mental disorders Preventing Informed Consent
Item
8. any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
boolean
C3843040 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0438215 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
Pregnancy | Breast Feeding
Item
9. pregnant or breast-feeding females. (lactating females must agree not to breast feed while taking lenalidomide).
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Laboratory test result abnormal Study Subject Participation Status At risk Unacceptable | Condition Interferes with Interpretation Research data | Laboratory test result abnormal Interferes with Interpretation Research data
Item
10. 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
C0438215 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C1883420 (UMLS CUI [1,4])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0459471 (UMLS CUI [2,3])
C0681873 (UMLS CUI [2,4])
C0438215 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0459471 (UMLS CUI [3,3])
C0681873 (UMLS CUI [3,4])
Investigational New Drugs | Therapy, Investigational
Item
11. use of any other experimental drug or therapy within 28 days of baseline.
boolean
C0013230 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
Hypersensitivity Thalidomide
Item
12. known hypersensitivity to thalidomide.
boolean
C0020517 (UMLS CUI [1,1])
C0039736 (UMLS CUI [1,2])
Erythema Nodosum | Rash desquamating | Thalidomide | Intake Pharmaceutical Preparations Similar
Item
13. the development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
boolean
C0014743 (UMLS CUI [1])
C0542171 (UMLS CUI [2])
C0039736 (UMLS CUI [3])
C1512806 (UMLS CUI [4,1])
C0013227 (UMLS CUI [4,2])
C2348205 (UMLS CUI [4,3])
Lenalidomide
Item
14. any prior use of lenalidomide.
boolean
C1144149 (UMLS CUI [1])
Antineoplastic Agents | Cancer treatment
Item
15. concurrent use of other anti-cancer agents or treatments.
boolean
C0003392 (UMLS CUI [1])
C0920425 (UMLS CUI [2])
Deep vein Thrombus | Pulmonary Embolism | Increased risk of thrombosis | Lenalidomide | Erythropoietin | Darbepoetin | Adrenal Cortex Hormones High dose
Item
16. patients with history of deep venous thrombus or pulmonary embolism. patients who are at increased risk of thrombosis during treatment with lenalidomide including those taking concurrent erythropoietin, darbepoetin or high-dose corticosteroids are also excluded.
boolean
C0226514 (UMLS CUI [1,1])
C0087086 (UMLS CUI [1,2])
C0034065 (UMLS CUI [2])
C2749785 (UMLS CUI [3])
C1144149 (UMLS CUI [4])
C0014822 (UMLS CUI [5])
C0937950 (UMLS CUI [6])
C0001617 (UMLS CUI [7,1])
C0444956 (UMLS CUI [7,2])
Embolism | Transient Ischemic Attack | Cardiac Arrhythmia | Peripheral Arterial Diseases | Myocardial Infarction | Antiplatelet Agents
Item
17. patients with a history of embolic events (e.g. tia) from arrhythmia or peripheral arterial disease or of recent mi whether or not treated with anti-platelet drugs
boolean
C0013922 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
C0003811 (UMLS CUI [3])
C1704436 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
C0085826 (UMLS CUI [6])
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