ID

20156

Beskrivning

FCR Plus Sargramostim (GM-CSF) as Frontline Therapy for Symptomatic Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00381004

Länk

https://clinicaltrials.gov/show/NCT00381004

Nyckelord

Versioner (1)
  1. 2017-02-08 2017-02-08 -
Uppladdad den

8 februari 2017

DOI

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Creative Commons BY 4.0
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Eligibility Chronic Lymphocytic Leukemia NCT00381004

Engelsk

Eligibility Chronic Lymphocytic Leukemia NCT00381004

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
untreated cll, cll/pll, or sll (small lymphocytic lymphoma) with indication for therapy. indications for therapy include at least one of the following: (1) one or more disease-related symptoms [fever, night sweats, weight loss > 10% in prior 6 months, pronounced fatigue]; (2) advanced stage disease (rai stage >/= 3 or binet stage c); (3) autoimmune anemia and/or thrombocytopenia that is unresponsive to other therapies; (4) massive or progressive hepatomegaly and/or splenomegaly and/or lymphadenopathy; (5) recurrent infections; (6) rapid lymphocyte doubling time of < 6 months.
Beskrivning

Chronic Lymphocytic Leukemia Requirement Therapeutic procedure | Chronic lymphocytic prolymphocytic leukemia syndrome Requirement Therapeutic procedure | Small Lymphocytic Lymphoma Requirement Therapeutic procedure | Symptoms Disease Related | Fever | Night sweats | Weight decreased | Fatigue Severe | Disease Advanced Rai Staging System | Disease Advanced Binet Staging System | Autoimmune hemolytic anemia Unresponsive to Treatment | Autoimmune thrombocytopenia Unresponsive to Treatment | HEPATOMEGALY MASSIVE | Hepatomegaly Progressive | splenomegaly massive | Splenomegaly Progressive | Lymphadenopathy massive | Lymphadenopathy Progressive | Recurrent infections | Lymphocyte Doubling Time Rapid

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023434
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0087111
UMLS CUI [2,1]
C0349630
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0087111
UMLS CUI [3,1]
C0855095
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0087111
UMLS CUI [4,1]
C1457887
UMLS CUI [4,2]
C0012634
UMLS CUI [4,3]
C0439849
UMLS CUI [5]
C0015967
UMLS CUI [6]
C0028081
UMLS CUI [7]
C1262477
UMLS CUI [8,1]
C0015672
UMLS CUI [8,2]
C0205082
UMLS CUI [9,1]
C0012634
UMLS CUI [9,2]
C0205179
UMLS CUI [9,3]
C1514715
UMLS CUI [10,1]
C0012634
UMLS CUI [10,2]
C0205179
UMLS CUI [10,3]
C1511118
UMLS CUI [11,1]
C0002880
UMLS CUI [11,2]
C0205269
UMLS CUI [12,1]
C0242584
UMLS CUI [12,2]
C0205269
UMLS CUI [13]
C0744871
UMLS CUI [14,1]
C0019209
UMLS CUI [14,2]
C0205329
UMLS CUI [15]
C0241231
UMLS CUI [16,1]
C0038002
UMLS CUI [16,2]
C0205329
UMLS CUI [17]
C0235599
UMLS CUI [18,1]
C0497156
UMLS CUI [18,2]
C0205329
UMLS CUI [19]
C0239998
UMLS CUI [20,1]
C0024264
UMLS CUI [20,2]
C2986483
UMLS CUI [20,3]
C0456962
patients who have been treated with not more than one regimen of immunotherapy (e.g. rituximab, alemtuzumab, rituximab plus alemtuzumab) for a diagnosis of cll, cll/pll, or sll (small lymphocytic lymphoma).
Beskrivning

Immunotherapy Quantity Chronic Lymphocytic Leukemia | Immunotherapy Quantity Chronic lymphocytic prolymphocytic leukemia syndrome | Immunotherapy Quantity Small Lymphocytic Lymphoma | rituximab | alemtuzumab

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021083
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0023434
UMLS CUI [2,1]
C0021083
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0349630
UMLS CUI [3,1]
C0021083
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0855095
UMLS CUI [4]
C0393022
UMLS CUI [5]
C0383429
UMLS CUI [6,1]
C0021083
UMLS CUI [6,2]
C1265611
UMLS CUI [6,3]
C0349630
UMLS CUI [7,1]
C0021083
UMLS CUI [7,2]
C1265611
UMLS CUI [7,3]
C0855095
UMLS CUI [8]
C0393022
UMLS CUI [9]
C0383429
beta-2-microglobulin </= 4 mg/dl.
Beskrivning

beta-2 Microglobulin

Datatyp

boolean

Alias
UMLS CUI [1]
C0005149
adequate liver function (total bilirubin </= 2.5 mg/dl, serum glutamate pyruvate transaminase (sgpt) </=4 x uln) and renal function (serum creatinine </= 2.0 mg/dl and/or creatinine clearance < 30 ml/hour). patients with renal or liver dysfunction due to suspected organ infiltration by lymphocytes may be eligible after discussion with the principal investigator, but upper limits for creatinine even under these circumstances must be creatinine < 3mg/dl and bilirubin < 6 mg/dl. patients with gilbert's syndrome may be entered on study with bilirubin levels </= 4 mg/dl.
Beskrivning

Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum | Creatinine clearance measurement | Renal dysfunction Due to Lymphocyte Infiltration | Liver Dysfunction Due to Lymphocyte Infiltration | Gilbert Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0232804
UMLS CUI [5]
C0201976
UMLS CUI [6]
C0373595
UMLS CUI [7,1]
C3279454
UMLS CUI [7,2]
C0678226
UMLS CUI [7,3]
C0024264
UMLS CUI [7,4]
C0332448
UMLS CUI [8,1]
C0086565
UMLS CUI [8,2]
C0678226
UMLS CUI [8,3]
C0024264
UMLS CUI [8,4]
C0332448
UMLS CUI [9]
C0017551
eastern cooperative oncology group (ecog) performance status </= 2.
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
signed informed consent in keeping with the policies of the hospital.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
male and female patients who are fertile agree to use an effective barrier method of birth control (ie, latex condom, diaphragm, cervical cap, etc) to avoid pregnancy. female patients of childbearing potential (non-childbearing is defined as >/= 1 year after menses cease and/or surgically sterilized) need a negative serum or urine pregnancy test within 2 days of study enrollment..
Beskrivning

Fertility Barrier Method Contraception | Latex condom | Vaginal contraceptive diaphragm | CERVICAL CAP FOR CONTRACEPTIVE USE | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Postmenopausal state | Female Sterilization

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0004764
UMLS CUI [2]
C3873750
UMLS CUI [3]
C0042241
UMLS CUI [4]
C0493327
UMLS CUI [5,1]
C3831118
UMLS CUI [5,2]
C0430061
UMLS CUI [6,1]
C3831118
UMLS CUI [6,2]
C0430057
UMLS CUI [7]
C0232970
UMLS CUI [8]
C0015787
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
active hepatitis b (at least one of the following markers positive: hbsag, hepatitis b e antigen (hbeag), immunoglobulin m (igm) anti-hbc, hepatitis b virus (hbv) dna).
Beskrivning

Hepatitis B | Hepatitis B surface antigen positive | Hepatitis B e antigen positive | Anti-HBc IgM antibody positive | Hepatitis B DNA detectable

Datatyp

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0149709
UMLS CUI [3]
C0392390
UMLS CUI [4]
C1096146
UMLS CUI [5]
C1096264
concurrent chemotherapy or immunotherapy.
Beskrivning

Chemotherapy | Immunotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0021083
pregnant patients.
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
history of hiv
Beskrivning

HIV Infections

Datatyp

boolean

Alias
UMLS CUI [1]
C0019693
symptomatic central nervous system (cns) disease
Beskrivning

CNS disorder Symptomatic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007682
UMLS CUI [1,2]
C0231220
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Similar models

Eligibility Chronic Lymphocytic Leukemia NCT00381004

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Lymphocytic Leukemia Requirement Therapeutic procedure | Chronic lymphocytic prolymphocytic leukemia syndrome Requirement Therapeutic procedure | Small Lymphocytic Lymphoma Requirement Therapeutic procedure | Symptoms Disease Related | Fever | Night sweats | Weight decreased | Fatigue Severe | Disease Advanced Rai Staging System | Disease Advanced Binet Staging System | Autoimmune hemolytic anemia Unresponsive to Treatment | Autoimmune thrombocytopenia Unresponsive to Treatment | HEPATOMEGALY MASSIVE | Hepatomegaly Progressive | splenomegaly massive | Splenomegaly Progressive | Lymphadenopathy massive | Lymphadenopathy Progressive | Recurrent infections | Lymphocyte Doubling Time Rapid
Item
untreated cll, cll/pll, or sll (small lymphocytic lymphoma) with indication for therapy. indications for therapy include at least one of the following: (1) one or more disease-related symptoms [fever, night sweats, weight loss > 10% in prior 6 months, pronounced fatigue]; (2) advanced stage disease (rai stage >/= 3 or binet stage c); (3) autoimmune anemia and/or thrombocytopenia that is unresponsive to other therapies; (4) massive or progressive hepatomegaly and/or splenomegaly and/or lymphadenopathy; (5) recurrent infections; (6) rapid lymphocyte doubling time of < 6 months.
boolean
C0023434 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0349630 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C0855095 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C1457887 (UMLS CUI [4,1])
C0012634 (UMLS CUI [4,2])
C0439849 (UMLS CUI [4,3])
C0015967 (UMLS CUI [5])
C0028081 (UMLS CUI [6])
C1262477 (UMLS CUI [7])
C0015672 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
C0012634 (UMLS CUI [9,1])
C0205179 (UMLS CUI [9,2])
C1514715 (UMLS CUI [9,3])
C0012634 (UMLS CUI [10,1])
C0205179 (UMLS CUI [10,2])
C1511118 (UMLS CUI [10,3])
C0002880 (UMLS CUI [11,1])
C0205269 (UMLS CUI [11,2])
C0242584 (UMLS CUI [12,1])
C0205269 (UMLS CUI [12,2])
C0744871 (UMLS CUI [13])
C0019209 (UMLS CUI [14,1])
C0205329 (UMLS CUI [14,2])
C0241231 (UMLS CUI [15])
C0038002 (UMLS CUI [16,1])
C0205329 (UMLS CUI [16,2])
C0235599 (UMLS CUI [17])
C0497156 (UMLS CUI [18,1])
C0205329 (UMLS CUI [18,2])
C0239998 (UMLS CUI [19])
C0024264 (UMLS CUI [20,1])
C2986483 (UMLS CUI [20,2])
C0456962 (UMLS CUI [20,3])
Immunotherapy Quantity Chronic Lymphocytic Leukemia | Immunotherapy Quantity Chronic lymphocytic prolymphocytic leukemia syndrome | Immunotherapy Quantity Small Lymphocytic Lymphoma | rituximab | alemtuzumab
Item
patients who have been treated with not more than one regimen of immunotherapy (e.g. rituximab, alemtuzumab, rituximab plus alemtuzumab) for a diagnosis of cll, cll/pll, or sll (small lymphocytic lymphoma).
boolean
C0021083 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0023434 (UMLS CUI [1,4])
C0021083 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0349630 (UMLS CUI [2,3])
C0021083 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0855095 (UMLS CUI [3,3])
C0393022 (UMLS CUI [4])
C0383429 (UMLS CUI [5])
C0021083 (UMLS CUI [6,1])
C1265611 (UMLS CUI [6,2])
C0349630 (UMLS CUI [6,3])
C0021083 (UMLS CUI [7,1])
C1265611 (UMLS CUI [7,2])
C0855095 (UMLS CUI [7,3])
C0393022 (UMLS CUI [8])
C0383429 (UMLS CUI [9])
beta-2 Microglobulin
Item
beta-2-microglobulin </= 4 mg/dl.
boolean
C0005149 (UMLS CUI [1])
Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum | Creatinine clearance measurement | Renal dysfunction Due to Lymphocyte Infiltration | Liver Dysfunction Due to Lymphocyte Infiltration | Gilbert Disease
Item
adequate liver function (total bilirubin </= 2.5 mg/dl, serum glutamate pyruvate transaminase (sgpt) </=4 x uln) and renal function (serum creatinine </= 2.0 mg/dl and/or creatinine clearance < 30 ml/hour). patients with renal or liver dysfunction due to suspected organ infiltration by lymphocytes may be eligible after discussion with the principal investigator, but upper limits for creatinine even under these circumstances must be creatinine < 3mg/dl and bilirubin < 6 mg/dl. patients with gilbert's syndrome may be entered on study with bilirubin levels </= 4 mg/dl.
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0232804 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
C0373595 (UMLS CUI [6])
C3279454 (UMLS CUI [7,1])
C0678226 (UMLS CUI [7,2])
C0024264 (UMLS CUI [7,3])
C0332448 (UMLS CUI [7,4])
C0086565 (UMLS CUI [8,1])
C0678226 (UMLS CUI [8,2])
C0024264 (UMLS CUI [8,3])
C0332448 (UMLS CUI [8,4])
C0017551 (UMLS CUI [9])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status </= 2.
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
signed informed consent in keeping with the policies of the hospital.
boolean
C0021430 (UMLS CUI [1])
Fertility Barrier Method Contraception | Latex condom | Vaginal contraceptive diaphragm | CERVICAL CAP FOR CONTRACEPTIVE USE | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Postmenopausal state | Female Sterilization
Item
male and female patients who are fertile agree to use an effective barrier method of birth control (ie, latex condom, diaphragm, cervical cap, etc) to avoid pregnancy. female patients of childbearing potential (non-childbearing is defined as >/= 1 year after menses cease and/or surgically sterilized) need a negative serum or urine pregnancy test within 2 days of study enrollment..
boolean
C0015895 (UMLS CUI [1,1])
C0004764 (UMLS CUI [1,2])
C3873750 (UMLS CUI [2])
C0042241 (UMLS CUI [3])
C0493327 (UMLS CUI [4])
C3831118 (UMLS CUI [5,1])
C0430061 (UMLS CUI [5,2])
C3831118 (UMLS CUI [6,1])
C0430057 (UMLS CUI [6,2])
C0232970 (UMLS CUI [7])
C0015787 (UMLS CUI [8])
Item Group
C0680251 (UMLS CUI)
Hepatitis B | Hepatitis B surface antigen positive | Hepatitis B e antigen positive | Anti-HBc IgM antibody positive | Hepatitis B DNA detectable
Item
active hepatitis b (at least one of the following markers positive: hbsag, hepatitis b e antigen (hbeag), immunoglobulin m (igm) anti-hbc, hepatitis b virus (hbv) dna).
boolean
C0019163 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C0392390 (UMLS CUI [3])
C1096146 (UMLS CUI [4])
C1096264 (UMLS CUI [5])
Chemotherapy | Immunotherapy
Item
concurrent chemotherapy or immunotherapy.
boolean
C0392920 (UMLS CUI [1])
C0021083 (UMLS CUI [2])
Pregnancy
Item
pregnant patients.
boolean
C0032961 (UMLS CUI [1])
HIV Infections
Item
history of hiv
boolean
C0019693 (UMLS CUI [1])
CNS disorder Symptomatic
Item
symptomatic central nervous system (cns) disease
boolean
C0007682 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
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