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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01609023
Other study ID # ML22235
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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