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

NCT00532129 | Completed Phase 2 Results DMC

• 2 other identifiers: MO209272007-000172-16
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 12

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Treatment-Emergent Adverse Events (AEs)

  An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 56 days from the beginning of the last treatment cycle that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs as well as non-serious AEs.

  First administration of study treatment up to 56 days after the beginning of the last treatment cycle (up to 365 days)

Secondary Outcomes (14)

• Percentage of Participants With Best Overall Response (BOR) of Clinical CR or Confirmed CR

  Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)

• Percentage of Participants With BOR of Partial Response (PR)

  Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)

• Percentage of Participants With BOR of Nodular Partial Response (nPR)

  Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)

• Percentage of Participants With BOR of Progressive Disease (PD)

  Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)

• Percentage of Participants With BOR of Stable Disease (SD)

  Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)

Study Arms (1)

Rituximab plus Chlorambucil

EXPERIMENTAL

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

Drug: Rituximab; Drug: Chlorambucil

Interventions

Rituximab DRUG

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

Also known as: MabThera, Rituxan

Rituximab plus Chlorambucil

Chlorambucil DRUG

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

Rituximab plus Chlorambucil

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (12)

Unknown Facility

Birmingham, B9 5SS, United Kingdom

Location

Unknown Facility

Bournemouth, BH7 7DW, United Kingdom

Location

Unknown Facility

Cambridge, CB2 0QQ, United Kingdom

Location

Unknown Facility

Canterbury, CT1 3NE, United Kingdom

Location

Unknown Facility

Cottingham, HU16 5JQ, United Kingdom

Location

Unknown Facility

Leeds, LS9 7TF, United Kingdom

Location

Unknown Facility

Leicester, LE1 5WW, United Kingdom

Location

Unknown Facility

Liverpool, L7 8XP, United Kingdom

Location

Unknown Facility

London, EC1M 6BQ, United Kingdom

Location

Unknown Facility

London, NW1 2PG, United Kingdom

Location

Unknown Facility

Sutton, SM2 5PT, United Kingdom

Location

Unknown Facility

Wakefield, WF1 4DG, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 24638012 DERIVED

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Rituximab; Chlorambucil

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; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-LaRoche

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: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2007
• First Posted: September 19, 2007
• Study Start: November 1, 2007
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: April 6, 2016
• Results First Posted: April 6, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (12)