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

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-11

Study Completion Date

2012-09-24

Brief Summary

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This study will evaluate the efficacy and safety of intense combination treatment including MabThera/Rituxan (rituximab), followed by MabThera/Rituxan maintenance therapy in patients with B-cell CLL who are naive to chemotherapy. The anticipated time on study treatment is 2.5 years.

Detailed Description

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Conditions

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Lymphocytic Leukemia, Chronic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MabThera/Rituxan

Group Type EXPERIMENTAL

rituximab [MabThera/Rituxan]

Intervention Type DRUG

Every 4 weeks for 6 cycles of induction, followed by maintenance therapy every 3 months x 8

fludarabine

Intervention Type DRUG

Every 4 weeks, 6 cycles

cyclophosphamide

Intervention Type DRUG

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

Intervention Type DRUG

fludarabine

Every 4 weeks, 6 cycles

Intervention Type DRUG

cyclophosphamide

Every 4 weeks, 3 cycles

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients, \>/= 18 years of age
* B-cell CLL
* No previous chemotherapy, radiotherapy, or immunotherapy

Exclusion Criteria

* Reduced organ function, or bone marrow dysfunction not due to CLL
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

LKH Hochsteiermark; Abt. für Innere Medizin

Leoben, , Austria

Site Status

Kh Der Barmherzigen Schwestern; Interne I X

Linz, , Austria

Site Status

A.Ö. Krankenhaus Der Elisabethinen Linz; I. Interne Abt.

Linz, , Austria

Site Status

Kepler Universitätskliniken GmbH - Med Campus III; I. Medizinische Abteilung

Linz, , Austria

Site Status

Landeskrankenhaus Rankweil; Interne E

Rankweil, , Austria

Site Status

Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.

Salzburg, , Austria

Site Status

Klinikum Kreuzschwestern Wels; Iii. Interne Abt.

Wels, , Austria

Site Status

Countries

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Austria

Other Identifiers

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ML18434

Identifier Type: -

Identifier Source: org_study_id

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