CHAIROS Study A Study of MabThera/Rituxan (Rituximab) Maintenance Therapy in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) Naive to Chemotherapy
NCT ID: NCT02013817
Last Updated: 2017-08-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
43 participants
INTERVENTIONAL
2005-10-11
2012-09-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MabThera/Rituxan
rituximab [MabThera/Rituxan]
Every 4 weeks for 6 cycles of induction, followed by maintenance therapy every 3 months x 8
fludarabine
Every 4 weeks, 6 cycles
cyclophosphamide
Every 4 weeks, 3 cycles
Interventions
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rituximab [MabThera/Rituxan]
Every 4 weeks for 6 cycles of induction, followed by maintenance therapy every 3 months x 8
fludarabine
Every 4 weeks, 6 cycles
cyclophosphamide
Every 4 weeks, 3 cycles
Eligibility Criteria
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Inclusion Criteria
* B-cell CLL
* No previous chemotherapy, radiotherapy, or immunotherapy
Exclusion Criteria
* Patients with a history of other malignancies within 2 years prior to study entry, except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer
* Patients with a history of severe cardiac disease.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_CHAIR
Hoffmann-La Roche
Locations
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Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie
Innsbruck, , Austria
LKH Hochsteiermark; Abt. für Innere Medizin
Leoben, , Austria
Kh Der Barmherzigen Schwestern; Interne I X
Linz, , Austria
A.Ö. Krankenhaus Der Elisabethinen Linz; I. Interne Abt.
Linz, , Austria
Kepler Universitätskliniken GmbH - Med Campus III; I. Medizinische Abteilung
Linz, , Austria
Landeskrankenhaus Rankweil; Interne E
Rankweil, , Austria
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
Salzburg, , Austria
Klinikum Kreuzschwestern Wels; Iii. Interne Abt.
Wels, , Austria
Countries
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Other Identifiers
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ML18434
Identifier Type: -
Identifier Source: org_study_id
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