Clinical trial NCT02013817: CHAIROS Study A Study of MabThera/Rituxan (Rituximab) Maintenance Therapy in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) Naive to Chemotherapy
Official title: CHAIROS - Effect of Early Brief Intensification by Chemoimmunotherapy With FCR Followed by FR and Rituximab Maintenance on Clinical Response in Chemo-naïve Patients With B-CLL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphocytic Leukemia, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-12-17
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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 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.

Primary outcomes:
measure: Percentage of Participants With a Best Clinical Response of Clinical Remission (CR)
timeFrame: Weeks 1, 5, 9, 12, 13, 17, 21 and 24
Secondary outcomes:
measure: Percentage of Participants With the Best Clinical Response by Visit (Clinical Assessment)
timeFrame: Weeks 12 and 24 and at Final Staging (Week 4 after last maintenance dose)
measure: Percentage of Participants With the Best Clinical Response by Visit (Clinical + Radiological Assessment)
timeFrame: Weeks 12 and 24 and at Final Staging (Week 4 after last maintenance dose)
measure: Time to Next Treatment - Percentage of Participants With an Event
timeFrame: Weeks 1, 5, 9, 12, 13, 17, 21 and 24 and every 8 weeks for 64 Weeks and every 6 months
measure: Time to Next Treatment - Time to Event
timeFrame: Weeks 1, 5, 9, 12, 13, 17, 21 and 24 and every 8 weeks for 64 Weeks and every 6 months
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Day 1 of Cycles 1, 2, 3, 4, 5, and 6 to 28 days after the last trial medication.
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie
city: Leoben
country: Austria
facility: LKH Hochsteiermark; Abt. für Innere Medizin
city: Linz
country: Austria
facility: Kh Der Barmherzigen Schwestern; Interne I X
city: Linz
country: Austria
facility: A.Ö. Krankenhaus Der Elisabethinen Linz; I. Interne Abt.
city: Linz
country: Austria
facility: Kepler Universitätskliniken GmbH - Med Campus III; I. Medizinische Abteilung
city: Rankweil
country: Austria
facility: Landeskrankenhaus Rankweil; Interne E
city: Salzburg
country: Austria
facility: Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
city: Wels
country: Austria
facility: Klinikum Kreuzschwestern Wels; Iii. Interne Abt.
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: