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

Lymphocytic Leukemia, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02013817
• Other study ID #: ML18434
• Status: Completed
• Phase: Phase 2
• First received: December 3, 2013
• Last updated: September 3, 2014
• Start date: October 2005
• Est. completion date: September 2012

Study information

• Verified date: September 2014
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry of Health and Women
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphocytic Leukemia, Chronic

Intervention

Drug:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With a Best Clinical Response of Clinical Remission (CR)	Best clinical response was determined according to the National Cancer Institute (NCI) Clinical and Clinical plus (+) Radiological evaluations by central response assessment. Assessment of response was performed according to the NCI revised guidelines for the diagnosis and treatment of chronic lymphocytic lymphoma (CLL) with additional computerized tomography (CT) scan evaluation of lymphadenopathy. Per NCI guidelines, CR requires all of the following criteria at least 2 months after the last treatment: no lymphadenopathy (Ly)/ hepatomegaly/ splenomegaly/constitutional symptoms; neutrophils greater than (>)1500 per microliter (/µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11.0 grams per deciliter (g/dL), lymphocytes (LC) (less than) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC.	Weeks 1, 5, 9, 12, 13, 17, 21 and 24	No
Secondary	Percentage of Participants With the Best Clinical Response by Visit (Clinical Assessment)	Best clinical response was determined according to the NCI clinical evaluation and through radiological assessment. CR, CRi, CRu, partial remission (PR), partial remission with toxicity associated (PRTox), progressive disease (PD), and stable disease (SD) were evaluated. Assessment of response was performed according to the NCI revised guidelines for the diagnosis and treatment of CLL with additional CT scan evaluation of lymphadenopathy during the treatment period (Radiological). Response assessment for interim (Week 12), end of induction (Week 24) and at Final Staging (4 weeks after last maintenance dose). Last observation carried forward (LOCF) method was used for missing data. Percentages are based on the number of nonmissing observations within each stratum.	Weeks 12 and 24 and at Final Staging (Week 4 after last maintenance dose)	No
Secondary	Percentage of Participants With the Best Clinical Response by Visit (Clinical + Radiological Assessment)	Best clinical response was determined according to the NCI clinical evaluation and through radiological assessment. CR, CRi, CRu, PR, PRTox, PD, and SD were evaluated. Assessment of response was performed according to the NCI revised guidelines for the diagnosis and treatment of CLL with additional CT scan evaluation of lymphadenopathy during the treatment period (Radiological). Response assessment for interim (Week 12), end of induction (Week 24) and at Final Staging (4 weeks after last maintenance dose). LOCF method was used for missing data. Percentages are based on the number of nonmissing observations within each stratum.	Weeks 12 and 24 and at Final Staging (Week 4 after last maintenance dose)	No
Secondary	Time to Next Treatment - Percentage of Participants With an Event	Time to next treatment was calculated as the number of days from either discontinuation of the study drug or the administration of the last dose, until the participants needed next treatment.	Weeks 1, 5, 9, 12, 13, 17, 21 and 24 and every 8 weeks for 64 Weeks and every 6 months	No
Secondary	Time to Next Treatment - Time to Event	Time to next treatment was calculated as the number of days from either discontinuation of the study drug or the administration of the last dose, until the participants needed next treatment.	Weeks 1, 5, 9, 12, 13, 17, 21 and 24 and every 8 weeks for 64 Weeks and every 6 months	No
Secondary	Percentage of Participants With Adverse Events (AEs)	AEs were recorded from the date of first medication administration until 28 days after the last trial medication.	Day 1 of Cycles 1, 2, 3, 4, 5, and 6 to 28 days after the last trial medication.	No