ID
44780
Descrizione
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
Keywords
versioni (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 -
Titolare del copyright
Hoffmann-La Roche
Caricato su
18 novembre 2021
DOI
Per favore, per richiedere un accesso.
Licenza
Creative Commons BY 4.0
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CLL Eligibility BO17072 NCT00090051
Eligibility Chronic Lymphocytic Leukemia NCT00090051
- StudyEvent: ODM
Descrizione
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Descrizione
Patients who have received prior combination treatment with cyclophosphamide and fludarabine either concurrently or sequentially.
Tipo di dati
boolean
Alias
- UMLS CUI [1,1]
- C1514457
- UMLS CUI [1,2]
- C0010583
- UMLS CUI [1,3]
- C0059985
Descrizione
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.
Tipo di dati
boolean
Alias
- UMLS CUI-1
- C0205269
- UMLS CUI-2
- C0059985
Descrizione
Patients who have had prior treatment with interferon, rituximab or another monoclonal antibody
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C0021747
- UMLS CUI [2]
- C0393022
Descrizione
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
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C0005961
- UMLS CUI [2]
- C0242602
Descrizione
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).
Tipo di dati
boolean
Alias
- UMLS CUI-1
- C2919192
Descrizione
Severe grade 3 or 4 non-hematological toxicity or prolonged (> 2 weeks) cytopenia on prior fludarabine regimen
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C1519275
- UMLS CUI [2]
- C0010828
Descrizione
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)
Tipo di dati
boolean
Alias
- UMLS CUI-1
- C3274706
Descrizione
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
Tipo di dati
boolean
Alias
- UMLS CUI-1
- C3842359
Descrizione
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
Tipo di dati
boolean
Alias
- UMLS CUI-1
- C2911187
Descrizione
Patients with active bacterial, viral, or fungal infection requiring systemic therapy
Tipo di dati
boolean
Alias
- UMLS CUI-1
- C3714514
Descrizione
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
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C0018799
Descrizione
Seizure disorders requiring anticonvulsant therapy
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C1959629
Descrizione
Severe chronic obstructive pulmonary disease with hypoxemia
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C0730607
Descrizione
Uncontrolled diabetes mellitus
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C0743113
Descrizione
Uncontrolled hypertension
Tipo di dati
boolean
Alias
- UMLS CUI-1
- C1868885
Descrizione
Transformation to aggressive B-cell malignancy (e.g., large B-cell lymphoma, Richter’s syndrome, or prolymphocytic leukemia (PLL) )
Tipo di dati
boolean
Alias
- UMLS CUI-1
- C3149729
Descrizione
Known infection with HIV, hepatitis B or hepatitis C
Tipo di dati
boolean
Alias
- UMLS CUI [1,1]
- C0019682
- UMLS CUI [1,2]
- C2711110
Descrizione
Treatment with any other investigational agent, or participating in another clinical trial within 30 days prior to entering this study
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C2348568
Descrizione
Known hypersensitivity or anaphylactic reactions to murine antibodies or proteins
Tipo di dati
boolean
Alias
- UMLS CUI-1
- C0020517
Descrizione
Any co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C3242266
Descrizione
Eligibility summary
Descrizione
Will the patient participate in the trial?
Tipo di dati
boolean
Alias
- UMLS CUI-1
- C0677408
Descrizione
Date of consent
Tipo di dati
date
Alias
- UMLS CUI-1
- C2985782
Descrizione
specify reason
Tipo di dati
text
Alias
- UMLS CUI [1]
- C1136454
Descrizione
Investigator signature
Tipo di dati
text
Alias
- UMLS CUI-1
- C2346576
Descrizione
Investigator Signature Date
Tipo di dati
date
Alias
- UMLS CUI [1]
- C0011008
Similar models
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])
C0242602 (UMLS CUI [2])
C0010828 (UMLS CUI [2])
C2711110 (UMLS CUI [1,2])