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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01609023
First Posted: May 31, 2012
Last Update Posted: June 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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.

Condition Intervention
Lymphocytic Leukemia, Chronic Drug: Rituximab

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants With Adverse Events (AEs) [ Time Frame: 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:
  • Progression-Free Survival (PFS) Assessed Using Local Standards [ Time Frame: 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 [ Time Frame: 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 Objective Response of Complete Response (CR) or Partial Response (PR) Assessed Using Local Standards [ Time Frame: 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 [ Time Frame: 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.

  • Percentage of Participants With PR Assessed Using Local Standards [ Time Frame: 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 [ Time Frame: 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.


Enrollment: 67
Study Start Date: April 2012
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Drug: Rituximab
Rituximab will be administered in combination with chemotherapy according to SPC and routine clinical practice.
Other Name: MabThera

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants with CD20-positive B-cell chronic lymphocytic leukemia eligible for first-line or second-line therapy
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01609023


Locations
Greece
University General Hospital of Alexandroupolis; Haemotology
Alexandroupolis, Greece, 68100
General Hospital of Athens Evangelismos; Hematology
Athens, Greece, 106 76
Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine
Athens, Greece, 115 27
Metropolitan Hospital; Hematology Dept
Athens, Greece, 18547
Periph. University General Hospital of Heraklion; Hematology
Heraklion, Greece, 711 10
University Hospital of Larissa; Hematology Dept.
Larissa, Greece, 41110
University Hospital Of Patras; Dept. Of Internal Medicine-Hematology Division
Patras, Greece, 265 00
General Hospital of Patras Agios Andreas; Hematology Department
Patra, Greece, 26335
Georgios Papanikolaou Hospital; Hematology Department
Thessaloniki, Greece, 570 10
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01609023     History of Changes
Other Study ID Numbers: ML22235
First Submitted: May 29, 2012
First Posted: May 31, 2012
Results First Submitted: March 28, 2017
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents