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

Lymphocytic Leukemia, Chronic Clinical Trial

— CaLLypso  

Official title:

A Non-Interventional, Observational Phase IV Study to Evaluate Safety of Rituximab (Mabthera®) in Combination With Chemotherapy in Patients Treated With CD20+ Β Chronic Lymphocytic Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01609023
• Other study ID #: ML22235
• Status: Completed
• Start date: April 2012
• Est. completion date: November 2015

Study information

• Verified date: April 2018
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Contraindications to rituximab therapy according to the approved SPC

Related Conditions & MeSH terms

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

Intervention

Drug:
• Rituximab
Rituximab will be administered in combination with chemotherapy according to SPC and routine clinical practice.

Locations

Country	Name	City	State
Greece	University General Hospital of Alexandroupolis; Haemotology	Alexandroupolis
Greece	General Hospital of Athens Evangelismos; Hematology	Athens
Greece	Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine	Athens
Greece	Metropolitan Hospital; Hematology Dept	Athens
Greece	Periph. University General Hospital of Heraklion; Hematology	Heraklion
Greece	University Hospital of Larissa; Hematology Dept.	Larissa
Greece	General Hospital of Patras Agios Andreas; Hematology Department	Patra
Greece	University Hospital Of Patras; Dept. Of Internal Medicine-Hematology Division	Patras
Greece	Georgios Papanikolaou Hospital; Hematology Department	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Adverse Events (AEs)	An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.	Baseline up to 24 months
Secondary	Progression-Free Survival (PFS) Assessed Using Local Standards	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.	From enrollment until disease progression or death, assessed up to 24 months
Secondary	Percentage of Participants With Disease Progression or Death Assessed Using Local Standards	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.	Months 6, 12, 18, and 24
Secondary	Percentage of Participants With Objective Response of Complete Response (CR) or Partial Response (PR) Assessed Using Local Standards	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.	Months 6, 12, 18, and 24
Secondary	Percentage of Participants With CR Assessed Using Local Standards	Percentage of participants with CR as determined by the investigator was reported. CR was defined as disappearance of all target lesions.	Months 6, 12, 18, and 24
Secondary	Percentage of Participants With PR Assessed Using Local Standards	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.	Months 6, 12, 18, and 24
Secondary	Time to Progression (TTP) Assessed Using Local Standards	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.	From enrollment until disease progression or death, assessed up to 26 months