A Study of MabThera (Rituximab) Plus Chlorambucil in Participants With Chronic Lymphocytic Leukemia.

NCT ID: NCT00532129

Last Updated: 2016-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2012-04-30

Brief Summary

This single arm study will assess the safety and effect on response rate of a combination of rituximab and chlorambucil in previously untreated participants with B-cell chronic lymphocytic leukemia. Participants will receive 6 monthly cycles of combination treatment, followed by up to 6 cycles of chlorambucil alone. Rituximab will be administered on Day 1 of each cycle, at a dose of 375 milligrams per square meter (mg/m^2) intravenously (IV) in Cycle 1, and 500 mg/m^2 in subsequent cycles, and chlorambucil will be administered on Days 1-7 of each cycle at a dose of 10 mg/m^2/day per oral (PO).

Conditions

Lymphocytic Leukemia, Chronic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rituximab plus Chlorambucil

Participants will receive combination therapy of rituximab plus chlorambucil for first 6 cycles and then chlorambucil alone for a maximum of 6 additional cycles.

Group Type: EXPERIMENTAL

Rituximab

Intervention Type: DRUG

375mg/m\^2 IV on Day 1 of Cycle 1; 500mg/m\^2 on Day 1 of Cycles 2-6.

Chlorambucil

Intervention Type: DRUG

10 mg/m\^2/day PO on Days 1 to 7 of each cycle for a maximum of 12 cycles.

Interventions

Rituximab

375mg/m\^2 IV on Day 1 of Cycle 1; 500mg/m\^2 on Day 1 of Cycles 2-6.

Intervention Type: DRUG

Chlorambucil

10 mg/m\^2/day PO on Days 1 to 7 of each cycle for a maximum of 12 cycles.

Intervention Type: DRUG

Other Intervention Names

MabThera; Rituxan

Eligibility Criteria

Inclusion Criteria

• previously untreated participants with cluster of differentiation 20 (CD20) positive B-cell chronic lymphocytic leukemia;
• participants with progressive Binet stage B, or C requiring therapy according to National Cancer Institute (NCI) criteria;
• Eastern Cooperative Oncology Group (ECOG) performance status <=2.

Exclusion Criteria

• previous treatment for Chronic Lymphocytic Leukaemia (CLL);
• known concomitant hematological malignancy;
• transformation to aggressive B-cell malignancy;
• history of severe cardiac disease;
• known hypersensitivity or anaphylactic reactions to murine antibodies.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Birmingham, , United Kingdom

Bournemouth, , United Kingdom

Cambridge, , United Kingdom

Canterbury, , United Kingdom

Cottingham, , United Kingdom

Leeds, , United Kingdom

Leicester, , United Kingdom

Liverpool, , United Kingdom

London, , United Kingdom

London, , United Kingdom

Sutton, , United Kingdom

Wakefield, , United Kingdom

Countries

United Kingdom

References

Hillmen P, Gribben JG, Follows GA, Milligan D, Sayala HA, Moreton P, Oscier DG, Dearden CE, Kennedy DB, Pettitt AR, Nathwani A, Varghese A, Cohen D, Rawstron A, Oertel S, Pocock CF. Rituximab plus chlorambucil as first-line treatment for chronic lymphocytic leukemia: Final analysis of an open-label phase II study. J Clin Oncol. 2014 Apr 20;32(12):1236-41. doi: 10.1200/JCO.2013.49.6547. Epub 2014 Mar 17.

Reference Type: DERIVED

PMID: 24638012 (View on PubMed)

Other Identifiers

2007-000172-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MO20927

Identifier Type: -

Identifier Source: org_study_id