ID
12228
Beschreibung
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
Stichworte
Versionen (4)
- 30.03.15 30.03.15 - Martin Dugas
- 31.03.15 31.03.15 - Martin Dugas
- 27.10.15 27.10.15 -
- 18.11.21 18.11.21 -
Hochgeladen am
27. Oktober 2015
DOI
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Lizenz
Creative Commons BY-NC 3.0 Legacy
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CLL Eligibility BO17072 NCT00090051
Eligibility Chronic Lymphocytic Leukemia NCT00090051
- StudyEvent: ODM
Beschreibung
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Beschreibung
Patients who have received prior combination treatment with cyclophosphamide and fludarabine either concurrently or sequentially.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1514457
- UMLS CUI [1,2]
- C0010583
- UMLS CUI [1,3]
- C0059985
Beschreibung
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.
Datentyp
boolean
Alias
- UMLS CUI-1
- C0205269
- UMLS CUI-2
- C0059985
Beschreibung
Patients who have had prior treatment with interferon, rituximab or another monoclonal antibody
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0021747
- UMLS CUI [2]
- C0393022
Beschreibung
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
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0005961|C1519005
Beschreibung
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).
Datentyp
boolean
Alias
- UMLS CUI-1
- C2919192
Beschreibung
Severe grade 3 or 4 non-hematological toxicity or prolonged (> 2 weeks) cytopenia on prior fludarabine regimen
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1519275
- UMLS CUI [2]
- C0010828
Beschreibung
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)
Datentyp
boolean
Alias
- UMLS CUI-1
- C3274706
Beschreibung
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
Datentyp
boolean
Alias
- UMLS CUI-1
- C3842359
Beschreibung
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
Datentyp
boolean
Alias
- UMLS CUI-1
- C2911187
Beschreibung
Patients with active bacterial, viral, or fungal infection requiring systemic therapy
Datentyp
boolean
Alias
- UMLS CUI-1
- C3714514
Beschreibung
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
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0018799
Beschreibung
Seizure disorders requiring anticonvulsant therapy
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1959629
Beschreibung
Severe chronic obstructive pulmonary disease with hypoxemia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0730607
Beschreibung
Uncontrolled diabetes mellitus
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0743113
Beschreibung
Uncontrolled hypertension
Datentyp
boolean
Alias
- UMLS CUI-1
- C1868885
Beschreibung
Transformation to aggressive B-cell malignancy (e.g., large B-cell lymphoma, Richter’s syndrome, or prolymphocytic leukemia (PLL) )
Datentyp
boolean
Alias
- UMLS CUI-1
- C3149729
Beschreibung
Known infection with HIV, hepatitis B or hepatitis C
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0019682
- UMLS CUI [1,2]
- C2711110
Beschreibung
Treatment with any other investigational agent, or participating in another clinical trial within 30 days prior to entering this study
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2348568
Beschreibung
Known hypersensitivity or anaphylactic reactions to murine antibodies or proteins
Datentyp
boolean
Alias
- UMLS CUI-1
- C0020517
Beschreibung
Any co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3242266
Beschreibung
Eligibility summary
Beschreibung
Will the patient participate in the trial?
Datentyp
boolean
Alias
- UMLS CUI-1
- C0677408
Beschreibung
Date of consent
Datentyp
date
Alias
- UMLS CUI-1
- C2985782
Beschreibung
specify reason
Datentyp
text
Alias
- UMLS CUI [1]
- C1136454
Beschreibung
Investigator signature
Datentyp
text
Alias
- UMLS CUI-1
- C2346576
Beschreibung
Investigator Signature Date
Datentyp
date
Alias
- UMLS CUI [1]
- C0011008
Ähnliche Modelle
Eligibility Chronic Lymphocytic Leukemia NCT00090051
- StudyEvent: ODM
C0002594 (UMLS CUI [2])
C0010583 (UMLS CUI [1,2])
C0059985 (UMLS CUI [1,3])
C0059985 (UMLS CUI-2)
C0393022 (UMLS CUI [2])
C0010828 (UMLS CUI [2])
C2711110 (UMLS CUI [1,2])