A Study of Rituximab (MabThera) in Participants With Chronic Lymphocytic Leukemia (CLL)
30 mars 2016 uppdaterad av: Hoffmann-La Roche
A Multicenter, Single-Arm, Phase II Study to Evaluate the Efficacy and Safety of Rituximab Plus Fludarabine and Cyclophosphamide (FCR) as First-Line Treatment in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL)
This study will evaluate the efficacy and safety of rituximab in combination with chemotherapy (fludarabine and cyclophosphamide) in participants with B-cell CLL.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
34
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Adult participants greater than or equal to (≥) 18 years of age
- B-cell CLL
- No previous treatment for leukemia
Exclusion Criteria:
- History of other malignancies within 2 years before study entry, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, prostate cancer, or breast cancer
- Comorbid condition requiring long-term (greater than [>] 1 month) systemic corticosteroids during study treatment
- Known infection with hepatitis B or C virus or with human immunodeficiency virus (HIV)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Rituximab + Fludarabine + Cyclophosphamide
Participants will receive rituximab (375 milligrams per meter-squared [mg/m^2] intravenously [IV]) on Cycle 1 Day 1, followed by fludarabine (25 mg/m^2 once daily IV) and cyclophosphamide (250 mg/m^2 once daily IV) for Days 2 to 4 of Cycle 1. Then rituximab (500 mg/m^2 IV) will be administered on Day 1 of Cycles 2 to 6, followed by IV fludarabine (25 mg/m^2 once daily IV) and cyclophosphamide (250 mg/m^2 once daily IV) on Days 1 to 3 of Cycles 2 to 6.
Each cycle will be 28 days or 4 weeks in length, and the overall duration of treatment will be approximately 6 months.
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Cyclophosphamide will be administered IV at 250 mg/m^2/day on Day 2-4 of Cycle 1 and then on Day 1-3 of Cycles 2 to 6.
Each cycle will be 28 days or 4 weeks in length.
Fludarabine will be administered IV at 25 mg/m^2/day on Day 2-4 of Cycle 1 and then on Day 1-3 of Cycles 2 to 6.
Each cycle will be 28 days or 4 weeks in length.
Rituximab will be administered IV at 375 mg/m^2 on Day 1 of Cycle 1 and then at 500 mg/m^2 on Day 1 of Cycles 2 to 6.
Each cycle will be 28 days or 4 weeks in length.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Percentage of Participants With Death or Disease Progression
Tidsram: Up to 5 years (from Baseline until disease progression or death, whichever occurred first)
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Treatment response was monitored throughout the study and assessed using standardized criteria.
Disease progression was defined as the occurrence of at least one of the following: greater than or equal to (≥) 50 percent (%) increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 centimeters (cm) from Baseline as determined by measurement below the costal margin, or ≥50% increase in the number of circulating lymphocytes.
The percentage of participants with death or documented disease progression at any time during the study was calculated.
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Up to 5 years (from Baseline until disease progression or death, whichever occurred first)
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Progression-Free Survival (PFS)
Tidsram: Up to 5 years (from Baseline until disease progression or death, whichever occurred first)
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Treatment response was monitored throughout the study and assessed using standardized criteria.
Disease progression was defined as the occurrence of at least one of the following: ≥50% increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 cm from Baseline as determined by measurement below the costal margin, or ≥50% increase in the number of circulating lymphocytes.
PFS was defined as the time from study inclusion until first event of disease progression or death and was estimated using Kaplan-Meier analysis.
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Up to 5 years (from Baseline until disease progression or death, whichever occurred first)
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Percentage of Participants Who Died
Tidsram: Up to 5 years (from Baseline until death)
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Participants were followed for survival throughout the study.
The percentage of participants who died of any cause during the study was calculated.
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Up to 5 years (from Baseline until death)
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Overall Survival (OS)
Tidsram: Up to 5 years (from Baseline until death)
|
Participants were followed for survival throughout the study.
OS was defined as the time from study inclusion until death from any cause and was estimated using Kaplan-Meier analysis
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Up to 5 years (from Baseline until death)
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Percentage of Participants With Complete Response (CR), Nodular Partial Response (nPR), or Partial Response (PR)
Tidsram: Up to 4 years (assessed every 3 months during 6-month treatment period, every 2 months during 6-month safety follow-up, then every 3 months during 3-year safety follow-up)
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Treatment response was monitored throughout the study and assessed using standardized criteria.
CR was defined as hemoglobin ≥11 grams per deciliter (g/dL), lymphocytes less than (<) 4000 cells per cubic millimeter (cells/mm^3), neutrophils greater than (>) 1500 cells/mm^3, platelets >100,000 cells/mm^3, bone marrow (BM) biopsy with <30% lymphocytes with no lymphocytic infiltrates, no evidence of lymphoid nodules on physical exam, and performance status of 0. PR was defined as >50% decrease in size of enlarged lymph nodes, hepatomegaly, and splenomegaly, with peripheral counts meeting the same criteria as CR or ≥50% improvement from pre-treatment values.
Participants with lymphoid nodules on BM biopsy who otherwise met CR criteria were considered nPR.
The percentage of participants with each level of best overall response was calculated.
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Up to 4 years (assessed every 3 months during 6-month treatment period, every 2 months during 6-month safety follow-up, then every 3 months during 3-year safety follow-up)
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 februari 2006
Primärt slutförande (Faktisk)
1 december 2014
Avslutad studie (Faktisk)
1 december 2014
Studieregistreringsdatum
Först inskickad
24 augusti 2015
Först inskickad som uppfyllde QC-kriterierna
24 augusti 2015
Första postat (Uppskatta)
26 augusti 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
2 maj 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
30 mars 2016
Senast verifierad
1 mars 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Immunsystemets sjukdomar
- Neoplasmer efter histologisk typ
- Neoplasmer
- Lymfoproliferativa störningar
- Lymfatiska sjukdomar
- Immunproliferativa störningar
- Leukemi, B-cell
- Leukemi
- Leukemi, lymfocytisk, kronisk, B-cell
- Leukemi, lymfoid
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Antireumatiska medel
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Antineoplastiska medel, Alkylering
- Alkyleringsmedel
- Myeloablativa agonister
- Antineoplastiska medel, immunologiska
- Cyklofosfamid
- Rituximab
- Fludarabin
Andra studie-ID-nummer
- ML18429
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .