A Study of Rituximab (MabThera) in Combination With Chemotherapy in Participants With CD20-Positive B-Cell Chronic Lymphocytic Leukemia

Completed

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

• Registration Number: NCT01609023
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This observational study will evaluate the safety and efficacy of rituximab in combination with chemotherapy in first- and second-line treatment of participants with cluster of differentiation 20 (CD20)-positive B-cell chronic lymphocytic leukemia. Data will be collected from eligible participants receiving rituximab according to the Summary of Product Characteristics (SPC) during 6 months of treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-05-29
• Study First Submitted QC: 2012-05-29
• Study First Posted: 2012-05-31
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Results First Submitted: 2017-03-28
• Results First Submitted QC: 2017-03-28
• Results First Posted: 2017-06-14
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-05
• Last Update Posted: 2018-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

• Participants with CD20-positive B-cell chronic lymphocytic leukemia eligible for first-line or second-line therapy according to the approved SPC

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Exclusion Criteria

• Contraindications to rituximab therapy according to the approved SPC

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rituximab	Rituximab	Participants with chronic lymphocytic leukemia treated with rituximab in combination with chemotherapy according to SPC and routine clinical practice will be observed for 24 months.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Adverse Events (AEs)	Baseline up to 24 months	An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Objective Response of Complete Response (CR) or Partial Response (PR) Assessed Using Local Standards	Months 6, 12, 18, and 24	Percentage of participants with CR or PR as determined by the investigator was reported. CR was defined as disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Percentage of Participants With CR Assessed Using Local Standards	Months 6, 12, 18, and 24	Percentage of participants with CR as determined by the investigator was reported. CR was defined as disappearance of all target lesions.
Progression-Free Survival (PFS) Assessed Using Local Standards	From enrollment until disease progression or death, assessed up to 24 months	PFS was defined as the time from enrollment to the first documented progression of disease or death due to any cause. Progressive disease (PD) was defined as at least a 20 percent (%) increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. KaplanMeier estimate was used for analysis.
Percentage of Participants With Disease Progression or Death Assessed Using Local Standards	Months 6, 12, 18, and 24	PD was defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Percentage of Participants With PR Assessed Using Local Standards	Months 6, 12, 18, and 24	Percentage of participants with PR as determined by the investigator was reported. PR was defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Time to Progression (TTP) Assessed Using Local Standards	From enrollment until disease progression or death, assessed up to 26 months	TTP is defined as the time from enrollment to the PD. PD was defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Kaplan-Meier estimate was used for analysis.

Trial Locations

Locations (9)

Metropolitan Hospital; Hematology Dept; 🇬🇷 Athens, Greece

University Hospital of Larissa; Hematology Dept.; 🇬🇷 Larissa, Greece

Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine; 🇬🇷 Athens, Greece

General Hospital of Athens Evangelismos; Hematology; 🇬🇷 Athens, Greece

Georgios Papanikolaou Hospital; Hematology Department; 🇬🇷 Thessaloniki, Greece

University General Hospital of Alexandroupolis; Haemotology; 🇬🇷 Alexandroupolis, Greece

Periph. University General Hospital of Heraklion; Hematology; 🇬🇷 Heraklion, Greece

University Hospital Of Patras; Dept. Of Internal Medicine-Hematology Division; 🇬🇷 Patras, Greece

General Hospital of Patras Agios Andreas; Hematology Department; 🇬🇷 Patra, Greece