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

December 8, 2017 updated by: Hoffmann-La Roche

Rituximab in the Treatment of Chronic Lymphocytic Leukemia, "CLL NIS"

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

681

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Frechen, Germany, 50226
        • PIOH PD Dr. R. Schnell - Dr. H. Schulz - Dr. M. Hellmann

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants with CLL on chemotherapy receiving rituximab

Description

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)

Exclusion Criteria:

  • Participants with contraindication to rituximab treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants With CLL
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.
Drug: Rituximab
Rituximab IV
Other Names:
  • MabThera

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS) as Assessed Using Kaplan-Meier Estimate
Time Frame: 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.
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 Without Progression or Death
Time Frame: 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.
From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Progression and Death
Time Frame: 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.
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 Who Received Each Treatment During the Course of Study
Time Frame: 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.
Baseline, Cycle 1, 2, 3, 4, 5, 6, 7, 8, last Cycle (Cycle 18) (each cycle=1 month)
Mean Body Weight
Time Frame: Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months)
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
Time Frame: 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.
Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months)
Percentage of Participants With Karnofsky Performance Status Index
Time Frame: 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.
Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months)
Percentage of Participants With General Symptoms
Time Frame: 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.
Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months)
Percentage of Participants With B-Symptoms
Time Frame: Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months)
B-symptoms included fever, night sweats, weight loss.
Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months)
Percentage of Participants With Best Overall Response (BOR)
Time Frame: 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.
From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 22, 2010

Primary Completion (ACTUAL)

June 30, 2015

Study Completion (ACTUAL)

June 30, 2015

Study Registration Dates

First Submitted

August 6, 2010

First Submitted That Met QC Criteria

August 6, 2010

First Posted (ESTIMATE)

August 9, 2010

Study Record Updates

Last Update Posted (ACTUAL)

October 5, 2018

Last Update Submitted That Met QC Criteria

December 8, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML22610

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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