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

NCT01609023 | Completed Results

• 1 other identifier: ML22235
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 9

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.

Conditions

Lymphocytic Leukemia, Chronic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Progression-Free Survival (PFS) Assessed Using Local Standards

  From enrollment until disease progression or death, assessed up to 24 months

• Percentage of Participants With Disease Progression or Death Assessed Using Local Standards

  Months 6, 12, 18, and 24

• 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 Assessed Using Local Standards

  Months 6, 12, 18, and 24

• Percentage of Participants With PR Assessed Using Local Standards

  Months 6, 12, 18, and 24

Study Arms (1)

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

Interventions

Rituximab DRUG

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

Also known as: MabThera

Rituximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants with CD20-positive B-cell chronic lymphocytic leukemia eligible for first-line or second-line therapy

You may qualify if:

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

You may not qualify if:

• \- Contraindications to rituximab therapy according to the approved SPC

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (9)

University General Hospital of Alexandroupolis; Haemotology

Alexandroupoli, 68100, Greece

Location

General Hospital of Athens Evangelismos; Hematology

Athens, 106 76, Greece

Location

Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine

Athens, 115 27, Greece

Location

Metropolitan Hospital; Hematology Dept

Athens, 18547, Greece

Location

Periph. University General Hospital of Heraklion; Hematology

Heraklion, 711 10, Greece

Location

University Hospital of Larissa; Hematology Dept.

Larissa, 41110, Greece

Location

General Hospital of Patras Agios Andreas; Hematology Department

Pátrai, 26335, Greece

Location

University Hospital Of Patras; Dept. Of Internal Medicine-Hematology Division

Pátrai, 265 00, Greece

Location

Georgios Papanikolaou Hospital; Hematology Department

Thessaloniki, 570 10, Greece

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2012
• First Posted: May 31, 2012
• Study Start: April 1, 2012
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: June 26, 2018
• Results First Posted: June 14, 2017

Record last verified: 2018-04

Locations

GR (9)