NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

CHAIROS Study A Study of MabThera/Rituxan (Rituximab) Maintenance Therapy in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) Naive to Chemotherapy

NCT02013817

CompletedPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Lymphocytic Leukemia, Chronic

Interventions: rituximab [MabThera/Rituxan], fludarabine, cyclophosphamide

Countries: Austria

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (8)

Innsbruck, Austria
Leoben, Austria
Linz, Austria
Linz, Austria
Linz, Austria
Rankweil, Austria
Salzburg, Austria
Wels, Austria