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

Lymphocytic Leukemia, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01178086
• Other study ID #: ML22610
• Status: Completed
• Start date: February 22, 2010
• Est. completion date: June 30, 2015

Study information

• Verified date: December 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 681
• Est. completion date: June 30, 2015
• Est. primary completion date: June 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Rituximab
Rituximab IV

Locations

Country	Name	City	State
Germany	PIOH PD Dr. R. Schnell - Dr. H. Schulz - Dr. M. Hellmann	Frechen

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival (PFS) as Assessed Using Kaplan-Meier Estimate	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)
Primary	Percentage of Participants Without Progression or Death	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	Percentage of Participants With Progression and Death	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)
Secondary	Percentage of Participants Who Received Each Treatment During the Course of Study	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)
Secondary	Mean Body Weight		Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months)
Secondary	Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status	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)
Secondary	Percentage of Participants With Karnofsky Performance Status Index	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)
Secondary	Percentage of Participants With General Symptoms	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)
Secondary	Percentage of Participants With B-Symptoms	B-symptoms included fever, night sweats, weight loss.	Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months)
Secondary	Percentage of Participants With Best Overall Response (BOR)	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)