- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT00738374
A Study of MabThera (Rituximab) Plus Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia.
6 lipca 2017 zaktualizowane przez: Hoffmann-La Roche
A Study of Chlorambucil Plus MabThera as Induction Therapy Followed in Responders by Maintenance Therapy Versus Observation on Response Rate in Patients >=60 Years With Previously Untreated Chronic Lymphocytic Leukemia
This single arm study will assess the efficacy and safety of MabThera + chlorambucil as induction therapy, followed in responders by maintenance therapy or observation in elderly patients with previously untreated chronic lymphocytic leukemia.
During the induction phase patients will receive 2 x 4 weekly courses of chlorambucil followed by 8 x 4 weekly courses of chlorambucil + MabThera.
Subsequently, responders will be randomized to receive 12 doses of MabThera given every 8 weeks, or no further treatment.
The anticipated time on study treatment is 2+ years, and the target sample size is <100 individuals.
Przegląd badań
Status
Zakończony
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
97
Faza
- Faza 2
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Calabria
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Catanzaro, Calabria, Włochy, 88100
- Az. Osp. Pugliese; Dh Oncologico
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Cosenza, Calabria, Włochy, 87100
- P.O. Annunziata; U.O. Ematologia
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Reggio Calabria, Calabria, Włochy, 89100
- Ospedale Riuniti; Divisione Di Ematologia
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Campania
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Napoli, Campania, Włochy, 80131
- Ospedale Cardarelli; Divisione Di Ematologia
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Emilia-Romagna
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Bologna, Emilia-Romagna, Włochy, 40138
- A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
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Ferrara, Emilia-Romagna, Włochy, 44100
- Arcispedale S. Anna; Sezione Di Ematologia
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Lazio
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Roma, Lazio, Włochy, 00161
- Universita' Degli Studi La Sapienza-Ist.Di Ematologia;Dip. Biotecnologie Cel CELLULARI ED EMATOLOGIA
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Roma, Lazio, Włochy, 00144
- Ospedale S. Eugenio; Divisione Di Ematologia
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Liguria
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Genova, Liguria, Włochy, 16132
- Uni Degli Studi Di Genova; 1A Divisione Di Ematologia
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Lombardia
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Milano, Lombardia, Włochy, 20122
- Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora
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Milano, Lombardia, Włochy, 20162
- Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
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Piemonte
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Torino, Piemonte, Włochy, 10126
- A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette;S.C. Ematologia
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Torino, Piemonte, Włochy, 10126
- Ospedale Molinette - Universita' Di Torino; Cliniche Universitarie Ematologia I
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Puglia
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Bari, Puglia, Włochy, 70124
- Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica
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Sicilia
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Messina, Sicilia, Włochy, 98165
- Az. Osp. Papardo; Struttura Complessa Di Ematologia
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Via S. Sofia 78, Sicilia, Włochy, 95123
- Ospedale Ferrarotto; Divisione Di Ematologia
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Toscana
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Firenze, Toscana, Włochy, 50135
- Az. Osp. Di Careggi; Divisione Di Ematologia
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Siena, Toscana, Włochy, 53100
- A.O. Universitaria Senese; Ematologia
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Veneto
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Padova, Veneto, Włochy, 35128
- Uni Degli Studi; Dip.Med.Clinica E Sperim. Ematologia
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Verona, Veneto, Włochy, 37134
- Policlinico G. B. Rossi; Divisione Di Ematologia
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
60 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
Inclusion Criteria:
- adult patients, >=60 years of age;
- CD20+ chronic lymphocytic leukemia (CLL);
- no previous treatment for CLL;
- ECOG performance status 0-1.
Exclusion Criteria:
- co-morbid conditions requiring long term use of systemic corticosteroids during study treatment;
- history of severe cardiac disease;
- transformation to aggressive B-cell malignancy.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 1
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375mg/m2 iv on day 1 of course 3; 500mg/m2 iv on day 1 of courses 4-8 (induction phase); 375mg/m2 iv every 8 weeks (maintenance phase).
8mg/m2 po on days 1-7 of courses 1-8
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Percentage of Participants With Documented CR, CRi, or PR at the End of Induction Treatment
Ramy czasowe: Month 10
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CR defined as: 1) laboratory CR: peripheral blood lymphocytes (PBL) less than (<) 4000/microliter (μL), neutrophils (PMN) greater than (>) 1500/μL, platelets >100,000/μL, and hemoglobin (Hb) >11 grams per deciliter (g/dL); 2) clinical CR: lymph nodes (LN) <1.5 centimeter (cm), and no constitutional symptoms, hepatomegaly (HM) or splenomegaly (SM); 3) instrumental CR: LN <1.5 cm and no HM/SM, and 4) bone marrow (BM) CR: normocellular aspirate/biopsy for participant age <30 percent (%) lymphocytes, and no B cell lymphoid nodules.
CRi was defined as CR with anemia, thrombocytopenia, or neutropenia not related to chronic lymphocytic leukemia (CLL), with no clonal infiltrate in aspirate or biopsy.
PR defined as: a 50% decrease in PBL, a 50% decrease in LN size, no increase in LN size, no new enlarged LN, a 50% reduction from baseline (BL) in the HM/SM, and 1 of the following: PMN >1500/μL, platelets >100,000/μL or >50% improvement from BL, and Hb >11.0 g/dL or >50% improvement from BL.
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Month 10
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Percentage of Participants With Documented CR, CRi, or PR at the End of Study
Ramy czasowe: Month 35
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CR defined as: 1) laboratory CR: PBL <4000/μL, PMN > 1500/μL, platelets > 100,000/μL, and Hb > 11 g/dL; 2) clinical CR: LN < 1.5 cm, and no constitutional symptoms, HM or SM; 3) instrumental CR: LN < 1.5 cm and no HM/SM, and 4) bone marrow CR: normocellular aspirate/biopsy for participant age < 30% lymphocytes, and no B cell lymphoid nodules.
CRi was defined as CR with anemia, thrombocytopenia, or neutropenia not related to CLL, with no clonal infiltrate in aspirate or biopsy.
PR defined as: a 50% decrease in PBL, a 50% decrease in LN size, no increase in LN size, no new enlarged LN, a 50% reduction from BL in the HM/SM, and 1 of the following: PMN > 1500/μL, platelets > 100,000/μL or > 50% improvement from BL, and Hb >11.0 g/dL or > 50% improvement from BL.
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Month 35
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Percentage of Participants With CR, CRi, PR, Stable Disease (SD), Progressive Disease (PD), Relapse, or Nodular PR at the End of Induction Treatment
Ramy czasowe: Month 10
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CR, CRi, and PR as previously defined.
PD was defined by 1 of the following: 1) lymphadenopathy: any new lesion, HM/SM, or other organ infiltrates, or a greater than or equal to (≥) 50% increase in greatest diameter of any previously noted lesion; 2) a ≥ 50% increase in previously noted HM/SM, or new appearance of HM/SM; 3) a ≥ 50% increase in blood lymphocyte count with at least 5000 B lymphocytes/μL; 4) transformation to a more aggressive histology, e.g., Richter's syndrome; or 5) occurrence of cytopenia attributable to CLL.
SD was defined by the absence of necessary criteria to achieve CR or PR, but no advancement to PD. Relapse was defined by a previously noted CR or PR with advancement to PD after a period of ≥ 6 months.
Nodular PR was defined by the presence of residual lymphoid nodules.
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Month 10
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Percentage of Participants With CR, PR, SD, PD, Relapse, or Nodular PR at the End of Study
Ramy czasowe: Month 35
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CR, and PR as previously defined.
PD was defined by 1 of the following: 1) lymphadenopathy: any new lesion, HM/SM, or other organ infiltrates, or a ≥ 50% increase in greatest diameter of any previously noted lesion; 2) a ≥50% increase in previously noted HM/SM, or new appearance of HM/SM; 3) a ≥50% increase in blood lymphocyte count with at least 5000 B lymphocytes/μL; 4) transformation to a more aggressive histology, e.g., Richter's syndrome; or 5) occurrence of cytopenia attributable to CLL.
SD was defined by the absence of necessary criteria to achieve CR or PR, but no advancement to PD. Relapse was defined by a previously noted CR or PR with advancement to PD after a period of ≥6 months.
Nodular PR was defined by the presence of residual lymphoid nodules.
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Month 35
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Number of Participants With Immunophenotypic CR - BM, Immunophenotypic CR - Peripheral Blood (PB), Molecular CR - BM, or Molecular CR - PB at the End of Induction Treatment
Ramy czasowe: Month 10
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Immunophenotypic CR was defined as the absence of minimal residual disease (MRD) evaluated in participants with CR by 4-color flow cytometry of PB and BM B cells to confirm that tissue was comprised of non-CLL cells.
Molecular CR was defined as the absence of MRD evaluated in participants with CR by quantitative polymerase chain reaction (PCR) in PB and BM B cells to confirm that tissue was comprised of non-CLL cells.
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Month 10
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Percentage of Participants With CR, CRi, PR, SD, PD, or Relapse at the End of Study
Ramy czasowe: Month 35
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CR, CRi, PR, SD, PD, relapse, and nodular PR as previously defined.
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Month 35
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Percentage of Participants With Immunophenotypic CR - BM or Immunophenotypic CR - PB at the End of Study
Ramy czasowe: Month 35
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Immunophenotypic CR was defined as the absence of MRD evaluated in participants who achieved CR by 4-color flow cytometry of PB and BM B cells to confirm that tissue was comprised of non-CLL cells.
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Month 35
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Percentage of Participants With Molecular CR - BM or Molecular CR - PB at the End of Study
Ramy czasowe: Month 35
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Molecular CR was defined as the absence of MRD evaluated in participants who achieved CR by quantitative PCR in PB and BM B cells to confirm that tissue was comprised of non-CLL cells.
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Month 35
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Number of Participants With Disease Progression, Relapse, Death, Withdrawal Because of an Adverse Event (AE), or New CLL Treatment
Ramy czasowe: Screening, Days 1 and 15 of Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.
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Event-free Survival (EFS) was defined as the time from the first dose of study treatment to the date of first documentation of disease progression, relapse for participants with previous CR, death due to any cause, withdrawal due to AE, or beginning new CLL treatment.
CR and PD as previously defined.
Participants were censored at the time of data cut-off to the most recent date of disease assessment.
Participants without a post-BL disease assessment were censored at the time of first dose of study treatment.
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Screening, Days 1 and 15 of Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.
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EFS
Ramy czasowe: Screening, Days 1 and 15 of Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.
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The median time, in days, from the the date of first dose of study treatment to the date of first documentation of disease progression, relapse for participants with CR, death due to any cause, withdrawal due to AE, or new CLL treatment.
CR and PD as previously defined.
Participants were censored at the time of data cut-off to the most recent date of disease assessment.
Participants without a post-BL disease assessment were censored at the time of first dose if study treatment.
The 95% CI was determined using Kaplan-Meier methodology.
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Screening, Days 1 and 15 of Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.
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Number of Participants With Disease Progression or Death
Ramy czasowe: Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.
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Progression-free survival (PFS) was defined as the time from the first dose of study treatment to the first documentation of disease progression or death.
PD as previously defined.
Participants who were withdrawn from the study without documented disease progression were censored at the date of the last tumor assessment when the participant was known to be progression-free.
Participants without a post-BL tumor assessment, but known to be alive, were censored at the time of the first dose of study treatment.
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Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.
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PFS
Ramy czasowe: Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.
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The median time, in days, from the date of the first dose of study treatment to the date of first documentation of disease progression or death.
CR and PD as previously defined.
Participants who were withdrawn from the study without documented disease progression were censored at the date of the last tumor assessment when the participant was known to be progression-free.
Participants without a post-BL tumor assessment, but known to be alive, were censored at the time of the first dose of study treatment.
The 95% CI was determined using Kaplan-Meier methodology.
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Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.
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Number of Participants With New CLL Treatment or Death
Ramy czasowe: Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.
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Time to new CLL treatment (TTNT) was defined as the time from the first dose of study treatment to the date of new CLL treatment received or the date of death from any cause.
Participants who did not receive new CLL treatment and were alive at the time of the analysis were censored at the date of the last follow-up assessment.
Participants without a follow-up assessment were censored at the day of last dose of study treatment.
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Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.
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Time to Next Treatment (TTNT)
Ramy czasowe: Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.
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The mean time, in days, from the date of the first dose of study treatment to the date of new CLL treatment or the date of death from any cause.
Participants who did not receive new CLL treatment and were alive at the time of the analysis were censored at the date of the last follow-up assessment.
Participants without a follow-up assessment were censored at the day of last dose of study treatment.
Mean survival time and it's standard error (SE) were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.
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Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.
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Number of Participants Who Died
Ramy czasowe: Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.
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Overall Survival (OS) was defined as the time from the date of the first dose of study treatment to the date of death due to any cause.
Participants were censored at the date of the last follow-up assessment.
Participants without a follow-up assessment were censored at the day of last dose of study treatment.
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Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.
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OS
Ramy czasowe: Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.
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The mean time, in days, from the date of the first dose of study treatment to the date of death due to any cause.
Participants were censored at the date of the last follow-up assessment.
Participants without a follow-up assessment were censored at the day of last dose of study treatment.
The mean survival time and it's SE were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.
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Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.
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Number of Participants With PD or Death After a Confirmed CR, CRi, or PR
Ramy czasowe: Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.
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Duration of response was defined as the time from the date of the first documented CR, CRi, or PR to the date of disease progression or death.
CR, CRi, PR, and PD as previously defined.
Participants with no documented PD after CR, CRi, or PR were censored at the last date at which they were known to have had CR, CRi, or PR, respectively.
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Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.
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Duration of Response
Ramy czasowe: Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.
|
The mean time, in days, from the date of first documented CR, CRi or PR to the date disease progression or death.
CR, CRi, PR, and PD as previously defined.
Participants with no documented PD after CR, CRi, or PR were censored at the last date at which they were known to have had CR, CRi, or PR, respectively.
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Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.
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Number of Participants With PD or Death After a Confirmed CR/CRi
Ramy czasowe: Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.
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Disease-free survival was defined at the time from the date of first documented CR or CRi to the date of disease progression or death.
CR, CRi, and PD as previously defined.
Participants with no documented PD after CR or CRi were censored on the last date at which they were known to have had CR or CRi.
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Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.
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Disease-Free Survival
Ramy czasowe: Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.
|
The mean time, in days, from the date of first documented CR or CRi to the date of disease progression or death.
CR, CRi, and PD as previously defined.
Participants with no documented PD after CR or CRi were censored on the last date at which they were known to have had CR or CRi.
In both groups, the mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.
|
Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
3 listopada 2008
Zakończenie podstawowe (Rzeczywisty)
14 stycznia 2013
Ukończenie studiów (Rzeczywisty)
14 stycznia 2013
Daty rejestracji na studia
Pierwszy przesłany
18 sierpnia 2008
Pierwszy przesłany, który spełnia kryteria kontroli jakości
19 sierpnia 2008
Pierwszy wysłany (Oszacować)
20 sierpnia 2008
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
15 sierpnia 2017
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
6 lipca 2017
Ostatnia weryfikacja
1 czerwca 2017
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
- Choroby układu odpornościowego
- Nowotwory według typu histologicznego
- Nowotwory
- Zaburzenia limfoproliferacyjne
- Choroby limfatyczne
- Zaburzenia immunoproliferacyjne
- Białaczka, komórki B
- Białaczka
- Białaczka, Limfocytowa, Przewlekła, B-Cell
- Białaczka, układ limfatyczny
- Fizjologiczne skutki leków
- Molekularne mechanizmy działania farmakologicznego
- Środki przeciwreumatyczne
- Środki przeciwnowotworowe
- Czynniki immunologiczne
- Środki przeciwnowotworowe, alkilujące
- Środki alkilujące
- Środki przeciwnowotworowe, immunologiczne
- Rytuksymab
- Chlorambucyl
Inne numery identyfikacyjne badania
- ML21445
- 2008-001612-20
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
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