ID

20105

Beschreibung

FCM-R (Fludarabine, Cyclophosphamide, Mitoxantrone, Rituximab) in Previously Untreated Patients With Chronic Lymphocytic Leukemia (CLL) < 70 Years; ODM derived from: https://clinicaltrials.gov/show/NCT00254410

Link

https://clinicaltrials.gov/show/NCT00254410

Stichworte

Versionen (1)
  1. 06.02.17 06.02.17 -
Hochgeladen am

6. Februar 2017

DOI

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Creative Commons BY 4.0
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Eligibility Chronic Lymphocytic Leukemia NCT00254410

Englisch

Eligibility Chronic Lymphocytic Leukemia NCT00254410

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Chronic Lymphocytic Leukemia untreated Indication of Therapeutic procedure | Chronic lymphocytic prolymphocytic leukemia syndrome untreated Indication of Therapeutic procedure | Small Lymphocytic Lymphoma untreated Indication of Therapeutic procedure | Symptoms Disease Related | Fever | Night sweats | Weight decreased | Fatigue Severe | advanced disease Rai Staging System | advanced disease 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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023434
UMLS CUI [1,2]
C0332155
UMLS CUI [1,3]
C0392360
UMLS CUI [1,4]
C0087111
UMLS CUI [2,1]
C0349630
UMLS CUI [2,2]
C0332155
UMLS CUI [2,3]
C0392360
UMLS CUI [2,4]
C0087111
UMLS CUI [3,1]
C0855095
UMLS CUI [3,2]
C0332155
UMLS CUI [3,3]
C0392360
UMLS CUI [3,4]
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]
C0679246
UMLS CUI [9,2]
C1514715
UMLS CUI [10,1]
C0679246
UMLS CUI [10,2]
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
2. age < 70 years.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
3. adequate liver function (total bilirubin </= 2.5 mg/dl, sgpt </=4 x uln) and renal function (serum creatinine </= 2.0 mg/dl). 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.
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0232804
UMLS CUI [5]
C0201976
UMLS CUI [6,1]
C3279454
UMLS CUI [6,2]
C0678226
UMLS CUI [6,3]
C0024264
UMLS CUI [6,4]
C0332448
UMLS CUI [7,1]
C0086565
UMLS CUI [7,2]
C0678226
UMLS CUI [7,3]
C0024264
UMLS CUI [7,4]
C0332448
UMLS CUI [8]
C0017551
4. beta-2-microglobulin </= 4 mg/dl.
Beschreibung

Beta-2-microglobulin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201910
5. ecog performance status </= 2.
Beschreibung

ECOG performance status

Datentyp

boolean

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

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
7. 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 postmenopausal or surgically sterilized) need a negative serum or urine pregnancy test within 14 days of study enrollment.
Beschreibung

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

Datentyp

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
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. active hepatitis b (at least one of the following markers positive: hbsag, hbeag, igm anti-hbc, hbv dna).
Beschreibung

Hepatitis B | Hepatitis B surface antigen positive | Hepatitis B e antigen positive | Anti-HBc IgM antibody positive | Hbv DNA Test Positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0149709
UMLS CUI [3]
C0392390
UMLS CUI [4]
C1096146
UMLS CUI [5,1]
C1256114
UMLS CUI [5,2]
C1514241
2. concurrent chemotherapy or immunotherapy.
Beschreibung

Chemotherapy | Immunotherapy

Datentyp

boolean

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

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
4. history of hiv
Beschreibung

HIV Infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0019693
5. symptomatic cns disease
Beschreibung

CNS disorder Symptomatic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007682
UMLS CUI [1,2]
C0231220
6. symptomatic heart disease (nyha class >/= 3) or lv ejection fraction < 40% (by muga or echocardiogram)
Beschreibung

Heart Disease Symptomatic New York Heart Association Classification | Left ventricular ejection fraction | Multiple gated acquisition scanning | Echocardiography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C1275491
UMLS CUI [2]
C0428772
UMLS CUI [3]
C0521317
UMLS CUI [4]
C0013516
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Ähnliche Modelle

Eligibility Chronic Lymphocytic Leukemia NCT00254410

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Lymphocytic Leukemia untreated Indication of Therapeutic procedure | Chronic lymphocytic prolymphocytic leukemia syndrome untreated Indication of Therapeutic procedure | Small Lymphocytic Lymphoma untreated Indication of Therapeutic procedure | Symptoms Disease Related | Fever | Night sweats | Weight decreased | Fatigue Severe | advanced disease Rai Staging System | advanced disease 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
1. untreated cll, cll/pll, or sll (small lymphocytic lymphoma) with indication for therapy (indications for therapy include at least one of the following: i) one or more disease-related symptoms [fever, night sweats, weight loss, pronounced fatigue]; ii) advanced stage disease (rai stage >/= 3 or binet stage c); iii) autoimmune anemia and/or thrombocytopenia that is unresponsive to other therapies; iv) massive or progressive hepatomegaly and/or splenomegaly and/or lymphadenopathy; iv) recurrent infections; v) rapid lymphocyte doubling time of < 6 months).
boolean
C0023434 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C0349630 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0392360 (UMLS CUI [2,3])
C0087111 (UMLS CUI [2,4])
C0855095 (UMLS CUI [3,1])
C0332155 (UMLS CUI [3,2])
C0392360 (UMLS CUI [3,3])
C0087111 (UMLS CUI [3,4])
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])
C0679246 (UMLS CUI [9,1])
C1514715 (UMLS CUI [9,2])
C0679246 (UMLS CUI [10,1])
C1511118 (UMLS CUI [10,2])
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])
Age
Item
2. age < 70 years.
boolean
C0001779 (UMLS CUI [1])
Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum | Renal dysfunction Due to Lymphocyte Infiltration | Liver Dysfunction Due to Lymphocyte Infiltration | Gilbert Disease
Item
3. adequate liver function (total bilirubin </= 2.5 mg/dl, sgpt </=4 x uln) and renal function (serum creatinine </= 2.0 mg/dl). 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])
C3279454 (UMLS CUI [6,1])
C0678226 (UMLS CUI [6,2])
C0024264 (UMLS CUI [6,3])
C0332448 (UMLS CUI [6,4])
C0086565 (UMLS CUI [7,1])
C0678226 (UMLS CUI [7,2])
C0024264 (UMLS CUI [7,3])
C0332448 (UMLS CUI [7,4])
C0017551 (UMLS CUI [8])
Beta-2-microglobulin measurement
Item
4. beta-2-microglobulin </= 4 mg/dl.
boolean
C0201910 (UMLS CUI [1])
ECOG performance status
Item
5. ecog performance status </= 2.
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
6. 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
7. 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 postmenopausal or surgically sterilized) need a negative serum or urine pregnancy test within 14 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 | Hbv DNA Test Positive
Item
1. active hepatitis b (at least one of the following markers positive: hbsag, hbeag, igm anti-hbc, hbv dna).
boolean
C0019163 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C0392390 (UMLS CUI [3])
C1096146 (UMLS CUI [4])
C1256114 (UMLS CUI [5,1])
C1514241 (UMLS CUI [5,2])
Chemotherapy | Immunotherapy
Item
2. concurrent chemotherapy or immunotherapy.
boolean
C0392920 (UMLS CUI [1])
C0021083 (UMLS CUI [2])
Pregnancy
Item
3. pregnant patients.
boolean
C0032961 (UMLS CUI [1])
HIV Infection
Item
4. history of hiv
boolean
C0019693 (UMLS CUI [1])
CNS disorder Symptomatic
Item
5. symptomatic cns disease
boolean
C0007682 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Heart Disease Symptomatic New York Heart Association Classification | Left ventricular ejection fraction | Multiple gated acquisition scanning | Echocardiography
Item
6. symptomatic heart disease (nyha class >/= 3) or lv ejection fraction < 40% (by muga or echocardiogram)
boolean
C0018799 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
C0428772 (UMLS CUI [2])
C0521317 (UMLS CUI [3])
C0013516 (UMLS CUI [4])
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