A Study on Rituximab (MabThera) in Participants With Chronic Lymphocytic Leukemia (CLL)

NCT01178086 | Completed Results

• 1 other identifier: ML22610
• Study Type: observational
• Target: 681
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study will assess the therapeutic efficiency, treatment schedules, handling procedures, and the safety profile of rituximab in routine care in participants with CLL.

Conditions

Lymphocytic Leukemia, Chronic

Outcome Measures

Primary Outcomes (2)

• Progression-Free Survival (PFS) as Assessed Using Kaplan-Meier Estimate

  PFS was defined as the time from initiation of treatment with rituximab in combination with chemotherapy to disease progression or death due to any cause, whichever occurred first. Disease progression was defined as the occurrence of at least one of the following: greater than or equal to (\>/=) 50 percent (%) increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 centimeters (cm) from Baseline as determined by measurement below the costal margin, or \>/=50% increase in the number of circulating lymphocytes. Participants without disease progression or death at the time of analysis were censored at the last date of tumor evaluation in terms of PFS.

  From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months)

• Percentage of Participants Without Progression or Death

  Disease progression was defined as the occurrence of at least one of the following: \>/=50% increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 cm from Baseline as determined by measurement below the costal margin, or \>/=50% increase in the number of circulating lymphocytes.

  From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months)

Secondary Outcomes (8)

• Percentage of Participants With Progression and Death

  From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months)

• Percentage of Participants Who Received Each Treatment During the Course of Study

  Baseline, Cycle 1, 2, 3, 4, 5, 6, 7, 8, last Cycle (Cycle 18) (each cycle=1 month)

• Mean Body Weight

  Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months)

• Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status

  Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months)

• Percentage of Participants With Karnofsky Performance Status Index

  Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months)

Study Arms (1)

Participants With CLL

Participants with CLL who are being treated with intravenous (IV) rituximab in combination with chemotherapy, will be observed for 24 months including 6-month treatment period.

Drug: Rituximab

Interventions

Rituximab DRUG

Rituximab IV

Also known as: MabThera

Participants With CLL

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 CLL on chemotherapy receiving rituximab

You may qualify if:

• CLL requiring treatment

You may not qualify if:

• Participants with contraindication to rituximab treatment

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

PIOH PD Dr. R. Schnell - Dr. H. Schulz - Dr. M. Hellmann

Frechen, 50226, Germany

Location

Related Publications (1)

• Reiser M, Dorfel S, Hensel M, Hoesl M, Jordan WO, Koenigsmann M, Meyer D, Reichert D, Schwarzer A, Marquardt M, Kellershohn K, Jentsch-Ullrich K. Rituximab in combination with chemotherapy for the treatment of chronic lymphocytic leukaemia in clinical practice. Eur J Haematol. 2018 May;100(5):455-464. doi: 10.1111/ejh.13040. Epub 2018 Mar 22.

  PMID: 29393986 DERIVED

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

global-roche-genentech-trials@gene.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: August 6, 2010
• First Posted: August 9, 2010
• Study Start: February 22, 2010
• Primary Completion: June 30, 2015
• Study Completion: June 30, 2015
• Last Updated: October 5, 2018
• Results First Posted: October 5, 2018

Record last verified: 2017-12

Locations

DE (1)