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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00532129
First received: September 18, 2007
Last updated: December 3, 2012
Last verified: December 2012
History of Changes
  Purpose

This single arm study will assess the safety and effect on response rate of a combination of MabThera and chlorambucil in previously untreated patients with B-cell chronic lymphocytic leukemia. Patients will receive 6x monthly cycles of combination treatment, followed by up to 6 cycles of chlorambucil alone. MabThera will be administered on day 1 of each cycle, at a dose of 375mg/m2 iv in cycle 1, and 500mg/m2 in subsequent cycles, and chlorambucil will be administered on days 1-7 of each cycle at a dose of 10mg/m2/day po. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.


Condition Intervention Phase
Lymphocytic Leukemia, Chronic
 Drug: rituximab [MabThera/Rituxan]
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Study to Characterize the Safety and Response Rate of MabThera (Rituximab) Plus Chlorambucil in Previously Untreated Patients With CD20-positive B-cell Chronic Lymphocytic Leukemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • AE profile; laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tumor response rate, PFS, DFS, duration of response, overall survival, molecular remission. [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: October 2007
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: rituximab [MabThera/Rituxan]
375mg/m2 iv on day 1 of cycle 1; 500mg/m2 on day 1 of cycles 2-6

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • previously untreated patients with CD20-positive B-cell chronic lymphocytic leukemia;
  • patients with progressive Binet stage B, or C requiring therapy according to NCI criteria;
  • ECOG performance status <=2.

Exclusion Criteria:

  • previous treatment for CLL;
  • known concomitant hematological malignancy;
  • transformation to aggressive B-cell malignancy;
  • history of severe cardiac disease;
  • known hypersensitivity or anaphylactic reactions to murine antibodies.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00532129

Locations
United Kingdom
Birmingham, United Kingdom, B9 5SS
Bournemouth, United Kingdom, BH7 7DW
Cambridge, United Kingdom, CB2 2QQ
Canterbury, United Kingdom, CT1 3NE
Cottingham, United Kingdom, HU16 5JQ
Leeds, United Kingdom, LS9 7TF
Leicester, United Kingdom, LE1 5WW
Liverpool, United Kingdom, L7 8XP
London, United Kingdom, WC1E 6HX
London, United Kingdom, EC1 A7BE
Sutton, United Kingdom, SM2 5PT
Wakefield, United Kingdom, WF1 4DG
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00532129     History of Changes
Other Study ID Numbers: MO20927
Study First Received: September 18, 2007
Last Updated: December 3, 2012
Health Authority: England: National Patient Safety Agency and Research Ethics Committees

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Chronic Disease
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease Attributes
 Pathologic Processes
Chlorambucil
Rituximab
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 16, 2013