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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT02533401 |
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Date of registration:
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24/08/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study of Rituximab (MabThera) in Participants With Chronic Lymphocytic Leukemia (CLL)
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Scientific title:
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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) |
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Date of first enrolment:
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February 2006 |
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Target sample size:
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34 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02533401 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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Argentina
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Venezuela
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Lymphocytic Leukemia, Chronic
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Intervention(s)
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Drug: Rituximab
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Drug: Cyclophosphamide
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Drug: Fludarabine
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Primary Outcome(s)
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Percentage of Participants With Complete Response (CR), Nodular Partial Response (nPR), or Partial Response (PR)
[Time Frame: 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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Percentage of Participants Who Died
[Time Frame: Up to 5 years (from Baseline until death)]
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Percentage of Participants With Death or Disease Progression
[Time Frame: Up to 5 years (from Baseline until disease progression or death, whichever occurred first)]
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Progression-Free Survival (PFS)
[Time Frame: Up to 5 years (from Baseline until disease progression or death, whichever occurred first)]
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Overall Survival (OS)
[Time Frame: Up to 5 years (from Baseline until death)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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