A Study on Rituximab (MabThera) in Participants With Chronic Lymphocytic Leukemia (CLL)

Completed

• Conditions: Lymphocytic Leukemia, Chronic
• Interventions: Drug: Rituximab

• Registration Number: NCT01178086
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This observational study will assess the therapeutic efficiency, treatment schedules, handling procedures, and the safety profile of rituximab in routine care in participants with CLL.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-02-22
• Study First Submitted: 2010-08-06
• Study First Submitted QC: 2010-08-06
• Study First Posted: 2010-08-09
• Primary Completion: 2015-06-30
• Study Completion: 2015-06-30
• Results First Submitted: 2017-06-21
• Status Verified: 2017-12
• Results First Submitted QC: 2017-12-08
• Last Update Submitted: 2017-12-08
• Results First Posted: 2018-10-05
• Last Update Posted: 2018-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 681

Inclusion Criteria

• CLL requiring treatment
• Participants receiving a chemotherapy in combination with rituximab (decision taken by doctor prior to and independent from inclusion in this non-interventional study)
• After this trial started, an amendment to the study protocol was introduced, adding a further inclusion criterion: Comorbidities according to cumulative illness rating scale (CIRS) score greater than (>) 6 and/or creatinine clearance less than (<) 70 milliliters per minute (mL/min)

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Exclusion Criteria

• Participants with contraindication to rituximab treatment

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants With CLL	Rituximab	Participants with CLL who are being treated with intravenous (IV) rituximab in combination with chemotherapy, will be observed for 24 months including 6-month treatment period.

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS) as Assessed Using Kaplan-Meier Estimate	From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months)	PFS was defined as the time from initiation of treatment with rituximab in combination with chemotherapy to disease progression or death due to any cause, whichever occurred first. Disease progression was defined as the occurrence of at least one of the following: greater than or equal to (\>/=) 50 percent (%) increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 centimeters (cm) from Baseline as determined by measurement below the costal margin, or \>/=50% increase in the number of circulating lymphocytes. Participants without disease progression or death at the time of analysis were censored at the last date of tumor evaluation in terms of PFS.
Percentage of Participants Without Progression or Death	From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months)	Disease progression was defined as the occurrence of at least one of the following: \>/=50% increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 cm from Baseline as determined by measurement below the costal margin, or \>/=50% increase in the number of circulating lymphocytes.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With B-Symptoms	Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months)	B-symptoms included fever, night sweats, weight loss.
Percentage of Participants With General Symptoms	Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months)	General symptoms included fatigue, reduced performance, frequent infections, abdominal pain and exhaustion.
Percentage of Participants With Progression and Death	From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months)	Percentage of participants with an event (progression or death) was reported. Disease progression was defined as the occurrence of at least one of the following: \>/=50% increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 cm from Baseline as determined by measurement below the costal margin, or \>/=50% increase in the number of circulating lymphocytes.
Percentage of Participants Who Received Each Treatment During the Course of Study	Baseline, Cycle 1, 2, 3, 4, 5, 6, 7, 8, last Cycle (Cycle 18) (each cycle=1 month)	The chemotherapeutic regimen administereted during the course of study were: Rituximab-Bendamustine (R-Benda), Rituximab-Fludarabine-Cyclophosphamide (R-FC), Rituximab-Clorambucil (R-Clb), R-Other and Rituximab mono.
Mean Body Weight	Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months)
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status	Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months)	ECOG performance status was measured on a 4 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory (\>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3=Capable of only limited self-care, confined to bed/chair \>50% of waking hours.
Percentage of Participants With Karnofsky Performance Status Index	Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months)	Performance status was reflected by the Karnofsky index. Karnofsky performance status index ranges from 0-100% with higher scores indicating better functional status. An index between 90% and 100% corresponds to ECOG grade 0, index between 70% and 80% corresponds to ECOG grade 1, index between 50% and 60% corresponds to ECOG grade 2, index 40% corresponds to ECOG grade 3. ECOG grade 0=Fully active, able to carry on all pre-disease activities without restriction; grade 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; grade 2=Ambulatory (\>50% of waking hours), capable of all self-care, unable to carry out any work activities; grade 3=Capable of only limited self-care, confined to bed/chair \>50% of waking hours.
Percentage of Participants With Best Overall Response (BOR)	From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months)	Response to treatment was assessed as per clinical routine. BOR included complete response(CR or CR with incomplete hematopoietic regeneration),partial response(PR or nodular PR),stable disease(SD),progressive disease(PD). CR:hemoglobin\>/=11 grams/deciliter(g/dL), lymphocytes\<4000 cells/cubic millimeter(cells/mm\^3), neutrophils\>5000 cells/mm\^3,platelets\>100,000 cells/mm\^3,bone marrow biopsy with \<30% lymphocytes with no lymphocytic infiltrates, no evidence of lymphoid nodules on physical exam, performance status of 0. PR:\>50% decrease in size of enlarged lymph nodes, hepatomegaly, splenomegaly, with peripheral counts meeting same criteria as CR or \>/=50% improvement from pre-treatment values.PD:occurrence of at least one of following: \>/=50% increase in longest diameter of at least 2 enlarged lymph nodes, increase in spleen and liver size by at least 2 cm from Baseline, or \>/=50% increase in number of circulating lymphocytes. Participants without CR/PR or PD were considered having SD.

Trial Locations

Locations (1)

PIOH PD Dr. R. Schnell - Dr. H. Schulz - Dr. M. Hellmann; 🇩🇪 Frechen, Germany