ID

12228

Beschrijving

An open-label, multicenter, randomized, comparative, phase III study to evaluate the efficacy and safety of rituximab plus fludarabine and cyclophosphamide (FCR) versus fludarabine and cyclophosphamide alone (FC) in previously treated patients with CD20 positive B-cell chronic lymphocytic leukemia (CLL). FCR Versus FC Alone in the Treatment of Chronic Lymphocytic Leukemia (CLL) in Relapsed Patients NCT00090051 Roche BO17072

Trefwoorden

Versies (4)
  1. 30-03-15 30-03-15 - Martin Dugas
  2. 31-03-15 31-03-15 - Martin Dugas
  3. 27-10-15 27-10-15 -
  4. 18-11-21 18-11-21 -
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27 oktober 2015

DOI

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Creative Commons BY-NC 3.0 Legacy
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CLL Eligibility BO17072 NCT00090051

Engels

Eligibility Chronic Lymphocytic Leukemia NCT00090051

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Age 18 years or older
Beschrijving

Age 18 years or older

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
Established diagnosis of B-cell CLL by NCI Working Group criteria
Beschrijving

Established diagnosis of B-cell CLL by NCI Working Group criteria

Datatype

boolean

Alias
UMLS CUI-1
C0475774
Patients with CD20-positive B-cell CLL (NCI criteria) who have been previously treated with one of the following chemotherapy regimens: - single agent chlorambucil +/- prednisone/prednisolone, - single agent fludarabine (or other nucleoside analogue), - alkylator-containing combination therapy (e.g. CHOP/CVP).
Beschrijving

Patients with CD20-positive B-cell CLL (NCI criteria) who have been previously treated with one of the following chemotherapy regimens: - single agent chlorambucil +/- prednisone/prednisolone, - single agent fludarabine (or other nucleoside analogue), - alkylator-containing combination therapy (e.g. CHOP/CVP).

Datatype

boolean

Alias
UMLS CUI-1
C1514457
Life expectancy > 6 months
Beschrijving

Life expectancy > 6 months

Datatype

boolean

Alias
UMLS CUI-1
C0023671
ECOG performance status 0-1
Beschrijving

ECOG performance status 0-1

Datatype

boolean

Alias
UMLS CUI-1
C1520224
ANC >= 1 x 10E9/L
Beschrijving

ANC >= 1 x 10E9/L

Datatype

boolean

Alias
UMLS CUI [1]
C0948762
Platelet count >= 50 x 10E9/L
Beschrijving

Platelet count >= 50 x 10E9/L

Datatype

boolean

Alias
UMLS CUI [1]
C0005821
Creatinine clearance, calculated according to the formula of Cockroft and Gault >= 50 ml/min
Beschrijving

Creatinine clearance, calculated according to the formula of Cockroft and Gault >= 50 ml/min

Datatype

boolean

Alias
UMLS CUI-1
C0373595
Total bilirubin <= 2 x ULN
Beschrijving

Total bilirubin <= 2 x ULN

Datatype

boolean

Alias
UMLS CUI-1
C0201913
Alkaline phosphatase and transaminases <= 2 x ULN
Beschrijving

Alkaline phosphatase and transaminases <= 2 x ULN

Datatype

boolean

Alias
UMLS CUI [1]
C0201850
UMLS CUI [2]
C0002594
A negative serum pregnancy test one week prior to treatment must be available both for pre-menopausal women and for women who are < 2 years after the onset of menopause
Beschrijving

A negative serum pregnancy test one week prior to treatment must be available both for pre-menopausal women and for women who are < 2 years after the onset of menopause

Datatype

boolean

Alias
UMLS CUI-1
C0232973
Written informed consent
Beschrijving

Written informed consent

Datatype

boolean

Alias
UMLS CUI-1
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Patients who have received prior combination treatment with cyclophosphamide and fludarabine either concurrently or sequentially.
Beschrijving

Patients who have received prior combination treatment with cyclophosphamide and fludarabine either concurrently or sequentially.

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0010583
UMLS CUI [1,3]
C0059985
Patients who are refractory to fludarabine (or any nucleoside analogue). Refractory is defined as not achieving at least a PR for a minimum duration of 6 months.
Beschrijving

Patients who are refractory to fludarabine (or any nucleoside analogue). Refractory is defined as not achieving at least a PR for a minimum duration of 6 months.

Datatype

boolean

Alias
UMLS CUI-1
C0205269
UMLS CUI-2
C0059985
Patients who have had prior treatment with interferon, rituximab or another monoclonal antibody
Beschrijving

Patients who have had prior treatment with interferon, rituximab or another monoclonal antibody

Datatype

boolean

Alias
UMLS CUI [1]
C0021747
UMLS CUI [2]
C0393022
Patients who have had a prior allogeneic BMT or autologous BMT or peripheral stem cell transplant (PBSCT) or patients who are considered to be candidates for allogeneic or autologous BMT or PSCT as assessed by his/her treating physician
Beschrijving

Patients who have had a prior allogeneic BMT or autologous BMT or peripheral stem cell transplant (PBSCT) or patients who are considered to be candidates for allogeneic or autologous BMT or PSCT as assessed by his/her treating physician

Datatype

boolean

Alias
UMLS CUI [1]
C0005961|C1519005
Fertile men or women of childbearing potential not using adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile).
Beschrijving

Fertile men or women of childbearing potential not using adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile).

Datatype

boolean

Alias
UMLS CUI-1
C2919192
Severe grade 3 or 4 non-hematological toxicity or prolonged (> 2 weeks) cytopenia on prior fludarabine regimen
Beschrijving

Severe grade 3 or 4 non-hematological toxicity or prolonged (> 2 weeks) cytopenia on prior fludarabine regimen

Datatype

boolean

Alias
UMLS CUI [1]
C1519275
UMLS CUI [2]
C0010828
Patients with a history of Fludarabine-induced or clinically significant autoimmune cytopenia as assessed by his/her treating physician (Coombs-positive patients without clinical signs of autoimmune hemolytic anemia are eligible for study entry)
Beschrijving

Patients with a history of Fludarabine-induced or clinically significant autoimmune cytopenia as assessed by his/her treating physician (Coombs-positive patients without clinical signs of autoimmune hemolytic anemia are eligible for study entry)

Datatype

boolean

Alias
UMLS CUI-1
C3274706
Patients with a history of other malignancies within 2 years prior to study entry, except for adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage localized prostate cancer treated surgically with curative intent; good prognosis DCIS of the breast treated with lumpectomy alone with curative intent
Beschrijving

Patients with a history of other malignancies within 2 years prior to study entry, except for adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage localized prostate cancer treated surgically with curative intent; good prognosis DCIS of the breast treated with lumpectomy alone with curative intent

Datatype

boolean

Alias
UMLS CUI-1
C3842359
Patients with co - morbid conditions that would require long term use (> 1 month) of systemic corticosteroids during study treatment (e.g. chronic obstructive pulmonary disease [COPD]). Steroid use <= 1 month is permissible
Beschrijving

Patients with co - morbid conditions that would require long term use (> 1 month) of systemic corticosteroids during study treatment (e.g. chronic obstructive pulmonary disease [COPD]). Steroid use <= 1 month is permissible

Datatype

boolean

Alias
UMLS CUI-1
C2911187
Patients with active bacterial, viral, or fungal infection requiring systemic therapy
Beschrijving

Patients with active bacterial, viral, or fungal infection requiring systemic therapy

Datatype

boolean

Alias
UMLS CUI-1
C3714514
Patients with a history of severe cardiac disease; e.g. NYHA Functional Class III or IV heart failure, myocardial infarction within 6 months, ventricular tachyarrythmias requiring ongoing treatment, or unstable angina
Beschrijving

Patients with a history of severe cardiac disease; e.g. NYHA Functional Class III or IV heart failure, myocardial infarction within 6 months, ventricular tachyarrythmias requiring ongoing treatment, or unstable angina

Datatype

boolean

Alias
UMLS CUI [1]
C0018799
Seizure disorders requiring anticonvulsant therapy
Beschrijving

Seizure disorders requiring anticonvulsant therapy

Datatype

boolean

Alias
UMLS CUI [1]
C1959629
Severe chronic obstructive pulmonary disease with hypoxemia
Beschrijving

Severe chronic obstructive pulmonary disease with hypoxemia

Datatype

boolean

Alias
UMLS CUI [1]
C0730607
Uncontrolled diabetes mellitus
Beschrijving

Uncontrolled diabetes mellitus

Datatype

boolean

Alias
UMLS CUI [1]
C0743113
Uncontrolled hypertension
Beschrijving

Uncontrolled hypertension

Datatype

boolean

Alias
UMLS CUI-1
C1868885
Transformation to aggressive B-cell malignancy (e.g., large B-cell lymphoma, Richter’s syndrome, or prolymphocytic leukemia (PLL) )
Beschrijving

Transformation to aggressive B-cell malignancy (e.g., large B-cell lymphoma, Richter’s syndrome, or prolymphocytic leukemia (PLL) )

Datatype

boolean

Alias
UMLS CUI-1
C3149729
Known infection with HIV, hepatitis B or hepatitis C
Beschrijving

Known infection with HIV, hepatitis B or hepatitis C

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019682
UMLS CUI [1,2]
C2711110
Treatment with any other investigational agent, or participating in another clinical trial within 30 days prior to entering this study
Beschrijving

Treatment with any other investigational agent, or participating in another clinical trial within 30 days prior to entering this study

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
Known hypersensitivity or anaphylactic reactions to murine antibodies or proteins
Beschrijving

Known hypersensitivity or anaphylactic reactions to murine antibodies or proteins

Datatype

boolean

Alias
UMLS CUI-1
C0020517
Any co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
Beschrijving

Any co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C3242266
Eligibility summary
Beschrijving

Eligibility summary

Will the patient participate in the trial?
Beschrijving

Will the patient participate in the trial?

Datatype

boolean

Alias
UMLS CUI-1
C0677408
Date of consent
Beschrijving

Date of consent

Datatype

date

Alias
UMLS CUI-1
C2985782
specify reason
Beschrijving

specify reason

Datatype

text

Alias
UMLS CUI [1]
C1136454
Investigator signature
Beschrijving

Investigator signature

Datatype

text

Alias
UMLS CUI-1
C2346576
Investigator Signature Date
Beschrijving

Investigator Signature Date

Datatype

date

Alias
UMLS CUI [1]
C0011008
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Similar models

Eligibility Chronic Lymphocytic Leukemia NCT00090051

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Age 18 years or older
Item
Age 18 years or older
boolean
C0001779 (UMLS CUI [1])
B-cell CLL
Item
Established diagnosis of B-cell CLL by NCI Working Group criteria
boolean
C0475774 (UMLS CUI-1)
Prior chemotherapy
Item
Patients with CD20-positive B-cell CLL (NCI criteria) who have been previously treated with one of the following chemotherapy regimens: - single agent chlorambucil +/- prednisone/prednisolone, - single agent fludarabine (or other nucleoside analogue), - alkylator-containing combination therapy (e.g. CHOP/CVP).
boolean
C1514457 (UMLS CUI-1)
Life expectancy
Item
Life expectancy > 6 months
boolean
C0023671 (UMLS CUI-1)
ECOG
Item
ECOG performance status 0-1
boolean
C1520224 (UMLS CUI-1)
ANC
Item
ANC >= 1 x 10E9/L
boolean
C0948762 (UMLS CUI [1])
Platelets
Item
Platelet count >= 50 x 10E9/L
boolean
C0005821 (UMLS CUI [1])
Creatinine clearance
Item
Creatinine clearance, calculated according to the formula of Cockroft and Gault >= 50 ml/min
boolean
C0373595 (UMLS CUI-1)
Total Bilirubin
Item
Total bilirubin <= 2 x ULN
boolean
C0201913 (UMLS CUI-1)
Alkaline Phosphatase and Transaminases
Item
Alkaline phosphatase and transaminases <= 2 x ULN
boolean
C0201850 (UMLS CUI [1])
C0002594 (UMLS CUI [2])
not pregnant
Item
A negative serum pregnancy test one week prior to treatment must be available both for pre-menopausal women and for women who are < 2 years after the onset of menopause
boolean
C0232973 (UMLS CUI-1)
Written informed consent
Item
Written informed consent
boolean
C0021430 (UMLS CUI-1)
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Prior chemotherapy with cyclophosphamide and fludarabine
Item
Patients who have received prior combination treatment with cyclophosphamide and fludarabine either concurrently or sequentially.
boolean
C1514457 (UMLS CUI [1,1])
C0010583 (UMLS CUI [1,2])
C0059985 (UMLS CUI [1,3])
Refractory to fludarabine
Item
Patients who are refractory to fludarabine (or any nucleoside analogue). Refractory is defined as not achieving at least a PR for a minimum duration of 6 months.
boolean
C0205269 (UMLS CUI-1)
C0059985 (UMLS CUI-2)
Prior treatment interferon or rituximab
Item
Patients who have had prior treatment with interferon, rituximab or another monoclonal antibody
boolean
C0021747 (UMLS CUI [1])
C0393022 (UMLS CUI [2])
BMT or PSCT
Item
Patients who have had a prior allogeneic BMT or autologous BMT or peripheral stem cell transplant (PBSCT) or patients who are considered to be candidates for allogeneic or autologous BMT or PSCT as assessed by his/her treating physician
boolean
C0005961|C1519005 (UMLS CUI [1])
no contraception
Item
Fertile men or women of childbearing potential not using adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile).
boolean
C2919192 (UMLS CUI-1)
Toxicity grade 3 or more
Item
Severe grade 3 or 4 non-hematological toxicity or prolonged (> 2 weeks) cytopenia on prior fludarabine regimen
boolean
C1519275 (UMLS CUI [1])
C0010828 (UMLS CUI [2])
Cytopenia, autoimmune
Item
Patients with a history of Fludarabine-induced or clinically significant autoimmune cytopenia as assessed by his/her treating physician (Coombs-positive patients without clinical signs of autoimmune hemolytic anemia are eligible for study entry)
boolean
C3274706 (UMLS CUI-1)
Other malignancy
Item
Patients with a history of other malignancies within 2 years prior to study entry, except for adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage localized prostate cancer treated surgically with curative intent; good prognosis DCIS of the breast treated with lumpectomy alone with curative intent
boolean
C3842359 (UMLS CUI-1)
Long term use of systemic steroids
Item
Patients with co - morbid conditions that would require long term use (> 1 month) of systemic corticosteroids during study treatment (e.g. chronic obstructive pulmonary disease [COPD]). Steroid use <= 1 month is permissible
boolean
C2911187 (UMLS CUI-1)
Infection, active
Item
Patients with active bacterial, viral, or fungal infection requiring systemic therapy
boolean
C3714514 (UMLS CUI-1)
Cardiac disease, severe
Item
Patients with a history of severe cardiac disease; e.g. NYHA Functional Class III or IV heart failure, myocardial infarction within 6 months, ventricular tachyarrythmias requiring ongoing treatment, or unstable angina
boolean
C0018799 (UMLS CUI [1])
Seizures
Item
Seizure disorders requiring anticonvulsant therapy
boolean
C1959629 (UMLS CUI [1])
COPD with hypoxemia
Item
Severe chronic obstructive pulmonary disease with hypoxemia
boolean
C0730607 (UMLS CUI [1])
Uncontrolled diabetes mellitus
Item
Uncontrolled diabetes mellitus
boolean
C0743113 (UMLS CUI [1])
Uncontrolled hypertension
Item
Uncontrolled hypertension
boolean
C1868885 (UMLS CUI-1)
Aggressive malignancy
Item
Transformation to aggressive B-cell malignancy (e.g., large B-cell lymphoma, Richter’s syndrome, or prolymphocytic leukemia (PLL) )
boolean
C3149729 (UMLS CUI-1)
HIV, Hepatitis B or Hepatitis C
Item
Known infection with HIV, hepatitis B or hepatitis C
boolean
C0019682 (UMLS CUI [1,1])
C2711110 (UMLS CUI [1,2])
Other trial within 30 days
Item
Treatment with any other investigational agent, or participating in another clinical trial within 30 days prior to entering this study
boolean
C2348568 (UMLS CUI [1])
Hypersensitivity
Item
Known hypersensitivity or anaphylactic reactions to murine antibodies or proteins
boolean
C0020517 (UMLS CUI-1)
patient not eligible
Item
Any co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
boolean
C3242266 (UMLS CUI [1])
Participate in trial
Item
Will the patient participate in the trial?
boolean
C0677408 (UMLS CUI-1)
Consent date
Item
Date of consent
date
C2985782 (UMLS CUI-1)
Reason for refusal to participate
Item
specify reason
text
C1136454 (UMLS CUI [1])
Investigator signature
Item
Investigator signature
text
C2346576 (UMLS CUI-1)
Investigator Signature Date
Item
Investigator Signature Date
date
C0011008 (UMLS CUI [1])
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